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10760_10766_R | null | RESTRICTED | 10,766 | 10,760 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>The treatment must be for short term therapy of acute severe pain; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; or</p> <p>Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>The treatment must be for short term therapy of acute severe pain; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; or</p> <p>Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-10-01 | 3,671 |
10761_10772_R | Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months | RESTRICTED | 10,772 | 10,761 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; or</p> <p>Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.</p> <p align="justify">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats must only be considered for:</p><p align="justify">(i) severe disabling pain associated with proven malignant neoplasia; or</p><p align="justify">(ii) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or</p><p align="justify">(iii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align="justify">(iv) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; or</p> <p>Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.</p> <p align="justify">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats must only be considered for:</p><p align="justify">(i) severe disabling pain associated with proven malignant neoplasia; or</p><p align="justify">(ii) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or</p><p align="justify">(iii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align="justify">(iv) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | N | N | N | IMMEDIATE | ALL | Y | 2020-10-01 | 3,671 |
10763_10777_R | Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months | RESTRICTED | 10,777 | 10,763 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for severe disabling pain associated with malignant neoplasia or chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for severe disabling pain associated with malignant neoplasia or chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | N | N | N | IMMEDIATE | ALL | Y | 2020-10-01 | 3,671 |
10764_10764_R | Continuing PBS treatment after 1 June 2020 | RESTRICTED | 10,764 | 10,764 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Continuing PBS treatment after 1 June 2020</p><br/><p>Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020.</p> <p align="justify">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats must only be considered where the patient has received initial authority approval for:</p><p align="justify">(i) severe disabling pain associated with malignant neoplasia; or</p><p align="justify">(ii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months; or</p><p align="justify">(iii) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or</p><p align="justify">(iv) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align="justify">(v) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Continuing PBS treatment after 1 June 2020</p><br/><p>Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020.</p> <p align="justify">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats must only be considered where the patient has received initial authority approval for:</p><p align="justify">(i) severe disabling pain associated with malignant neoplasia; or</p><p align="justify">(ii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months; or</p><p align="justify">(iii) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or</p><p align="justify">(iv) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align="justify">(v) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | N | N | N | IMMEDIATE | ALL | Y | 2020-10-01 | 3,671 |
10767_10768_R | null | RESTRICTED | 10,768 | 10,767 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; or</p> <p>Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; or</p> <p>Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-10-01 | 3,671 |
10769_10765_R | Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months | RESTRICTED | 10,765 | 10,769 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; or</p> <p>The treatment must be part of pre-operative care; or</p> <p>The treatment must be used as an analgesic adjunct in general anaesthesia.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for severe disabling pain associated with malignant neoplasia or chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; or</p> <p>The treatment must be part of pre-operative care; or</p> <p>The treatment must be used as an analgesic adjunct in general anaesthesia.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for severe disabling pain associated with malignant neoplasia or chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | N | N | N | IMMEDIATE | ALL | Y | 2020-10-01 | 3,671 |
10773_10771_R | Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months | RESTRICTED | 10,771 | 10,773 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; or</p> <p>Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for severe disabling pain associated with malignant neoplasia or chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; or</p> <p>Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for severe disabling pain associated with malignant neoplasia or chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | N | N | N | IMMEDIATE | ALL | Y | 2020-10-01 | 3,671 |
10774_10891_R | Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months | RESTRICTED | 10,891 | 10,774 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cancer pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>Patient must have cancer pain; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cancer pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>Patient must have cancer pain; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | N | N | N | IMMEDIATE | ALL | Y | 2020-10-01 | 3,671 |
10775_10775_R | Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months | RESTRICTED | 10,775 | 10,775 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cancer pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>Patient must have cancer pain; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.</p> <p align="justify">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats must only be considered for:</p><p align="justify">(i) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or</p><p align="justify">(ii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align="justify">(iii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cancer pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>Patient must have cancer pain; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.</p> <p align="justify">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats must only be considered for:</p><p align="justify">(i) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or</p><p align="justify">(ii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align="justify">(iii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | N | N | N | IMMEDIATE | ALL | Y | 2020-10-01 | 3,671 |
10776_10770_R | Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months | RESTRICTED | 10,770 | 10,776 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.</p> <p align="justify">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats must only be considered for:</p><p align="justify">(i) severe disabling pain associated with proven malignant neoplasia; or</p><p align="justify">(ii) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or</p><p align="justify">(iii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align="justify">(iv) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.</p> <p align="justify">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats must only be considered for:</p><p align="justify">(i) severe disabling pain associated with proven malignant neoplasia; or</p><p align="justify">(ii) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or</p><p align="justify">(iii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align="justify">(iv) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | N | N | N | IMMEDIATE | ALL | Y | 2020-10-01 | 3,671 |
10793_10830_R | null | STREAMLINED | 10,830 | 10,793 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND</p> <p>The treatment must be commenced in a specialist unit in a hospital setting.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND</p> <p>The treatment must be commenced in a specialist unit in a hospital setting.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-10-01 | 3,671 |
10805_10807_R | Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply | AUTHORITY_REQUIRED | 10,807 | 10,805 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the continuing treatment, Whole body restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the continuing treatment, Whole body restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p> | N | N | Y | IMMEDIATE | ALL | N | 2020-10-01 | 3,671 |
10814_10814_R | Continuing PBS treatment after 1 June 2020 | AUTHORITY_REQUIRED | 10,814 | 10,814 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>Continuing PBS treatment after 1 June 2020</p><br/><p>Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020.</p> <p align="justify">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the patient has received initial authority approval and the total duration of non-PBS and PBS opioid analgesic treatment:</p><p align="justify">(i) is less than 12 months; or</p><p align="justify">(ii) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or</p><p align="justify">(iii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align="justify">(iv) has exceeded 12 months prior to 1 June 2020 and the patient's pain management and clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>Continuing PBS treatment after 1 June 2020</p><br/><p>Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020.</p> <p align="justify">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the patient has received initial authority approval and the total duration of non-PBS and PBS opioid analgesic treatment:</p><p align="justify">(i) is less than 12 months; or</p><p align="justify">(ii) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or</p><p align="justify">(iii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align="justify">(iv) has exceeded 12 months prior to 1 June 2020 and the patient's pain management and clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | N | N | N | IMMEDIATE | ALL | Y | 2020-10-01 | 3,671 |
10815_10859_R | null | RESTRICTED | 10,859 | 10,815 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-10-01 | 3,671 |
10816_10762_R | Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months | RESTRICTED | 10,762 | 10,816 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; or</p> <p>The treatment must be part of pre-operative care; or</p> <p>The treatment must be used as an analgesic adjunct in general anaesthesia.</p> <p align="justify">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats must only be considered for:</p><p align="justify">(i) severe disabling pain associated with proven malignant neoplasia; or</p><p align="justify">(ii) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or</p><p align="justify">(iii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align="justify">(iv) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; or</p> <p>The treatment must be part of pre-operative care; or</p> <p>The treatment must be used as an analgesic adjunct in general anaesthesia.</p> <p align="justify">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats must only be considered for:</p><p align="justify">(i) severe disabling pain associated with proven malignant neoplasia; or</p><p align="justify">(ii) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or</p><p align="justify">(iii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align="justify">(iv) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | N | N | N | IMMEDIATE | ALL | Y | 2020-10-01 | 3,671 |
10835_10756_R | Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months | AUTHORITY_REQUIRED | 10,756 | 10,835 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>The condition must require daily, continuous, long term opioid treatment; AND</p> <p>Patient must have cancer pain; or</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>The condition must require daily, continuous, long term opioid treatment; AND</p> <p>Patient must have cancer pain; or</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | N | N | N | IMMEDIATE | ALL | Y | 2020-10-01 | 3,671 |
10837_10837_R | Continuing PBS treatment after 1 June 2020 | RESTRICTED | 10,837 | 10,837 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cancer pain</p><br/><p>Continuing PBS treatment after 1 June 2020</p><br/><p>Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020.</p> <p align="justify">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the patient has received initial authority approval and the total duration of non-PBS and PBS opioid analgesic treatment:</p><p align="justify">(i) is less than 12 months; or</p><p align="justify">(ii) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or</p><p align="justify">(iii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align="justify">(iv) has exceeded 12 months prior to 1 June 2020 and the patient's pain management and clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cancer pain</p><br/><p>Continuing PBS treatment after 1 June 2020</p><br/><p>Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020.</p> <p align="justify">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the patient has received initial authority approval and the total duration of non-PBS and PBS opioid analgesic treatment:</p><p align="justify">(i) is less than 12 months; or</p><p align="justify">(ii) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or</p><p align="justify">(iii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align="justify">(iv) has exceeded 12 months prior to 1 June 2020 and the patient's pain management and clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | N | N | N | IMMEDIATE | ALL | Y | 2020-10-01 | 3,671 |
10851_10802_R | Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years) | AUTHORITY_REQUIRED | 10,802 | 10,851 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p> | N | N | Y | FULL | ALL | N | 2020-10-01 | 3,671 |
10856_10742_R | Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years) | AUTHORITY_REQUIRED | 10,742 | 10,856 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="left">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align="justify">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and</p><p align="left">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="left">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align="justify">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and</p><p align="left">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p> | N | N | Y | FULL | ALL | N | 2020-10-01 | 3,671 |
10858_10858_R | Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months | AUTHORITY_REQUIRED | 10,858 | 10,858 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>The condition must require daily, continuous, long term opioid treatment; AND</p> <p>Patient must have cancer pain; or</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.</p> <p align="justify">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment:</p><p align="justify">(i) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or</p><p align="justify">(ii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align="justify">(iii) has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>The condition must require daily, continuous, long term opioid treatment; AND</p> <p>Patient must have cancer pain; or</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.</p> <p align="justify">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment:</p><p align="justify">(i) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or</p><p align="justify">(ii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align="justify">(iii) has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | N | N | N | IMMEDIATE | ALL | Y | 2020-10-01 | 3,671 |
10864_10863_R | null | STREAMLINED | 10,863 | 10,864 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND</p> <p>The treatment must be commenced in a specialist unit in a hospital setting.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND</p> <p>The treatment must be commenced in a specialist unit in a hospital setting.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-10-01 | 3,671 |
10874_8877_R | Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply | AUTHORITY_REQUIRED | 8,877 | 10,874 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years ) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 20 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years ) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 20 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p> | N | N | Y | IMMEDIATE | ALL | N | 2020-10-01 | 3,671 |
10877_10836_R | null | AUTHORITY_REQUIRED | 10,836 | 10,877 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>The condition must require daily, continuous, long term opioid treatment; AND</p> <p>Patient must have cancer pain; or</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>The condition must require daily, continuous, long term opioid treatment; AND</p> <p>Patient must have cancer pain; or</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-10-01 | 3,671 |
10890_10890_R | Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months | RESTRICTED | 10,890 | 10,890 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>Patient must have cancer pain; or</p> <p>The treatment must be for post-operative pain following a major operative procedure; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; or</p> <p>Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.</p> <p align="justify">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats must only be considered for:</p><p align="justify">(i) severe disabling pain associated with proven malignant neoplasia; or</p><p align="justify">(ii) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or</p><p align="justify">(iii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align="justify">(iv) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>Patient must have cancer pain; or</p> <p>The treatment must be for post-operative pain following a major operative procedure; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; or</p> <p>Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.</p> <p align="justify">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats must only be considered for:</p><p align="justify">(i) severe disabling pain associated with proven malignant neoplasia; or</p><p align="justify">(ii) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or</p><p align="justify">(iii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align="justify">(iv) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | N | N | N | IMMEDIATE | ALL | Y | 2020-10-01 | 3,671 |
10903_10910_R | Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months | RESTRICTED | 10,910 | 10,903 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>Patient must have cancer pain; or</p> <p>The treatment must be for post-operative pain following a major operative procedure; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; or</p> <p>Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for severe disabling pain associated with malignant neoplasia or chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>Patient must have cancer pain; or</p> <p>The treatment must be for post-operative pain following a major operative procedure; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; or</p> <p>Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for severe disabling pain associated with malignant neoplasia or chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | N | N | N | IMMEDIATE | ALL | Y | 2020-10-01 | 3,671 |
10905_10853_R | Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) | AUTHORITY_REQUIRED | 10,853 | 10,905 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align="justify">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align="justify">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p> | N | N | Y | FULL | ALL | N | 2020-10-01 | 3,671 |
10906_10743_R | Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years) | AUTHORITY_REQUIRED | 10,743 | 10,906 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p> | N | N | Y | FULL | ALL | N | 2020-10-01 | 3,671 |
10907_10901_R | Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) | AUTHORITY_REQUIRED | 10,901 | 10,907 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align="justify">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align="justify">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p> | N | N | Y | FULL | ALL | N | 2020-10-01 | 3,671 |
10909_10860_R | null | RESTRICTED | 10,860 | 10,909 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>The treatment must be for post-operative pain following a major operative procedure; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; or</p> <p>Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>The treatment must be for post-operative pain following a major operative procedure; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; or</p> <p>Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-10-01 | 3,671 |
10909_N | null | null | null | null | null | <p>OxyContin modified release tablets are intended to be crush-deterrent and to reduce the rapid release of oxycodone upon accidental or intentional misuse.</p> | Y | N | N | null | null | N | 2014-08-01 | 3,671 |
10917_10917_R | Continuing treatment of hepatocellular carcinoma - 3 weekly treatment regimen | STREAMLINED | 10,917 | 10,917 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Continuing treatment of hepatocellular carcinoma - 3 weekly treatment regimen</p><br/><p>Patient must be undergoing combination treatment with bevacizumab until disease progression, unless not tolerated; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition.</p> <p align="justify">PBS supply of this drug must be through only one of the two continuing treatment regimens at any given time</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Continuing treatment of hepatocellular carcinoma - 3 weekly treatment regimen</p><br/><p>Patient must be undergoing combination treatment with bevacizumab until disease progression, unless not tolerated; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition.</p> <p align="justify">PBS supply of this drug must be through only one of the two continuing treatment regimens at any given time</p> | N | N | N | IMMEDIATE | ALL | N | 2020-11-01 | 3,671 |
10918_9209_R | Continuing treatment | STREAMLINED | 9,209 | 10,918 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dermatofibrosarcoma protuberans</p><br/><p>Continuing treatment</p><br/><p>The condition must be unresectable; or</p> <p>The condition must be locally recurrent; or</p> <p>The condition must be metastatic; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated a response to the PBS-subsidised treatment; AND</p> <p>The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum dose of 800 mg per day.</p> <p align="justify">Evidence that the disease has not progressed on imatinib therapy must be documented in the patient's medical records.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dermatofibrosarcoma protuberans</p><br/><p>Continuing treatment</p><br/><p>The condition must be unresectable; or</p> <p>The condition must be locally recurrent; or</p> <p>The condition must be metastatic; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated a response to the PBS-subsidised treatment; AND</p> <p>The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum dose of 800 mg per day.</p> <p align="justify">Evidence that the disease has not progressed on imatinib therapy must be documented in the patient's medical records.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-11-01 | 3,671 |
10919_6137_R | Initial treatment for up to 6 months | STREAMLINED | 6,137 | 10,919 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven combined immunoglobulin E (IgE) mediated allergy to cows'' milk protein and soy protein</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>Patient must be up to the age of 24 months.</p> <p align="justify">The name of the specialist must be documented in the patient's medical records</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven combined immunoglobulin E (IgE) mediated allergy to cows'' milk protein and soy protein</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>Patient must be up to the age of 24 months.</p> <p align="justify">The name of the specialist must be documented in the patient's medical records</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-11-01 | 3,671 |
10923_6182_R | Continuing treatment | STREAMLINED | 6,182 | 10,923 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven combined immunoglobulin E (IgE) mediated allergy to cows'' milk protein and soy protein</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>Patient must be up to the age of 24 months.</p> <p align="justify">The name of the specialist must be documented in the patient's medical records</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven combined immunoglobulin E (IgE) mediated allergy to cows'' milk protein and soy protein</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>Patient must be up to the age of 24 months.</p> <p align="justify">The name of the specialist must be documented in the patient's medical records</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-11-01 | 3,671 |
10934_10968_R | Continuing or change of treatment | AUTHORITY_REQUIRED | 10,968 | 10,934 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Narcolepsy</p><br/><p>Continuing or change of treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have previously received PBS-subsidised treatment with armodafinil for this condition.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Narcolepsy</p><br/><p>Continuing or change of treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have previously received PBS-subsidised treatment with armodafinil for this condition.</p> <p align="justify">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p> | N | N | Y | IMMEDIATE | ALL | N | 2020-11-01 | 3,671 |
10936_10935_R | Initial 2 - treatment of narcolepsy with cataplexy | AUTHORITY_REQUIRED | 10,935 | 10,936 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Narcolepsy</p><br/><p>Initial 2 - treatment of narcolepsy with cataplexy</p><br/><p>Must be treated by a qualified sleep medicine practitioner or neurologist; AND</p> <p>The treatment must be for use when therapy with dexamfetamine sulfate poses an unacceptable medical risk; or</p> <p>The treatment must be for use when intolerance to dexamfetamine sulfate is of a severity to necessitate treatment withdrawal; AND</p> <p>Patient must have experienced excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months; AND</p> <p>Patient must have a definite history of cataplexy documented in their medical records for auditing purposes; AND</p> <p>Patient must not have any medical or psychiatric disorder that could otherwise account for the hypersomnia.</p> <p align="justify">The presence of any one of the following indicates treatment with dexamfetamine sulfate poses an unacceptable medical risk:</p><p align="justify">(a) a psychiatric disorder;</p><p align="justify">(b) a cardiovascular disorder;</p><p align="justify">(c) a history of substance abuse;</p><p align="justify">(d) glaucoma;</p><p align="justify">(e) any other absolute contraindication to dexamfetamine sulfate as specified in the TGA-approved Product Information.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Narcolepsy</p><br/><p>Initial 2 - treatment of narcolepsy with cataplexy</p><br/><p>Must be treated by a qualified sleep medicine practitioner or neurologist; AND</p> <p>The treatment must be for use when therapy with dexamfetamine sulfate poses an unacceptable medical risk; or</p> <p>The treatment must be for use when intolerance to dexamfetamine sulfate is of a severity to necessitate treatment withdrawal; AND</p> <p>Patient must have experienced excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months; AND</p> <p>Patient must have a definite history of cataplexy documented in their medical records for auditing purposes; AND</p> <p>Patient must not have any medical or psychiatric disorder that could otherwise account for the hypersomnia.</p> <p align="justify">The presence of any one of the following indicates treatment with dexamfetamine sulfate poses an unacceptable medical risk:</p><p align="justify">(a) a psychiatric disorder;</p><p align="justify">(b) a cardiovascular disorder;</p><p align="justify">(c) a history of substance abuse;</p><p align="justify">(d) glaucoma;</p><p align="justify">(e) any other absolute contraindication to dexamfetamine sulfate as specified in the TGA-approved Product Information.</p> <p align="justify">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p> | N | N | Y | IMMEDIATE | ALL | N | 2020-11-01 | 3,671 |
10939_10939_R | Initial treatment | STREAMLINED | 10,939 | 10,939 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Initial treatment</p><br/><p>Patient must be undergoing combination treatment with bevacizumab and atezolizumab until disease progression, unless not tolerated; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>Patient must not be suitable for transarterial chemoembolisation; AND</p> <p>Patient must have Child Pugh class A; AND</p> <p>The condition must be untreated with systemic therapy; or</p> <p>Patient must have developed intolerance to a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Initial treatment</p><br/><p>Patient must be undergoing combination treatment with bevacizumab and atezolizumab until disease progression, unless not tolerated; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>Patient must not be suitable for transarterial chemoembolisation; AND</p> <p>Patient must have Child Pugh class A; AND</p> <p>The condition must be untreated with systemic therapy; or</p> <p>Patient must have developed intolerance to a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-11-01 | 3,671 |
10940_9243_R | Continuing treatment | STREAMLINED | 9,243 | 10,940 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Myelodysplastic or myeloproliferative disorder</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must be PDGFRB fusion gene-positive; AND</p> <p>Patient must have achieved and maintained a complete haematological response; AND</p> <p>The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum dose of 400 mg per day.</p> <p align="justify">A full blood examination report which demonstrates a complete haematological response and evidence that the disease has not progressed on imatinib therapy must be documented in the patient's medical records.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Myelodysplastic or myeloproliferative disorder</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must be PDGFRB fusion gene-positive; AND</p> <p>Patient must have achieved and maintained a complete haematological response; AND</p> <p>The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum dose of 400 mg per day.</p> <p align="justify">A full blood examination report which demonstrates a complete haematological response and evidence that the disease has not progressed on imatinib therapy must be documented in the patient's medical records.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-11-01 | 3,671 |
10941_6148_R | null | STREAMLINED | 6,148 | 10,941 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe diarrhoea of greater than 2 weeks duration</p><br/><p>Patient must be aged less than 4 months.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe diarrhoea of greater than 2 weeks duration</p><br/><p>Patient must be aged less than 4 months.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-11-01 | 3,671 |
10949_10970_R | Initial 1 - treatment of narcolepsy without cataplexy | AUTHORITY_REQUIRED | 10,970 | 10,949 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Narcolepsy</p><br/><p>Initial 1 - treatment of narcolepsy without cataplexy</p><br/><p>Must be treated by a qualified sleep medicine practitioner or neurologist; AND</p> <p>The treatment must be for use when therapy with dexamfetamine sulfate poses an unacceptable medical risk; or</p> <p>The treatment must be for use when intolerance to dexamfetamine sulfate is of a severity to necessitate treatment withdrawal; AND</p> <p>Patient must have experienced excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months; AND</p> <p>Patient must have a mean sleep latency less than or equal to 10 minutes on a Multiple Sleep Latency Test (MSLT); or</p> <p>Patient must have an electroencephalographic (EEG) recording showing the pathologically rapid development of REM sleep; AND</p> <p>Patient must not have any medical or psychiatric disorder that could otherwise account for the hypersomnia.</p> <p align="justify">The presence of any one of the following indicates treatment with dexamfetamine sulfate poses an unacceptable medical risk:</p><p align="justify">(a) a psychiatric disorder;</p><p align="justify">(b) a cardiovascular disorder;</p><p align="justify">(c) a history of substance abuse;</p><p align="justify">(d) glaucoma;</p><p align="justify">(e) any other absolute contraindication to dexamfetamine sulfate as specified in the TGA-approved Product Information.</p> <p align="left">The MSLT must be preceded by nocturnal polysomnography. Sleep prior to the MSLT must be at least 6 hours in duration.</p> <p align="justify">The authority application must be made in writing and must include the following:</p><p align="justify">(a) a completed authority prescription form; and</p><p align="justify">(b) a completed Narcolepsy Initial PBS authority application and Supporting information form; and</p><p align="justify">(c) details of the contraindication or intolerance to dexamfetamine sulfate; and</p><p align="justify">(d) either:</p><p align="justify">(i) the result and date of the polysomnography test and Multiple Sleep Latency Test (MSLT) conducted by, or under the supervision of, a qualified sleep medicine practitioner; or</p><p align="justify">(ii) the result and date of the electroencephalograph (EEG), conducted by, or under the supervision of, a neurologist.</p><p align="justify">The polysomnography, MSLT or EEG test reports must be provided with the authority application.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Narcolepsy</p><br/><p>Initial 1 - treatment of narcolepsy without cataplexy</p><br/><p>Must be treated by a qualified sleep medicine practitioner or neurologist; AND</p> <p>The treatment must be for use when therapy with dexamfetamine sulfate poses an unacceptable medical risk; or</p> <p>The treatment must be for use when intolerance to dexamfetamine sulfate is of a severity to necessitate treatment withdrawal; AND</p> <p>Patient must have experienced excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months; AND</p> <p>Patient must have a mean sleep latency less than or equal to 10 minutes on a Multiple Sleep Latency Test (MSLT); or</p> <p>Patient must have an electroencephalographic (EEG) recording showing the pathologically rapid development of REM sleep; AND</p> <p>Patient must not have any medical or psychiatric disorder that could otherwise account for the hypersomnia.</p> <p align="justify">The presence of any one of the following indicates treatment with dexamfetamine sulfate poses an unacceptable medical risk:</p><p align="justify">(a) a psychiatric disorder;</p><p align="justify">(b) a cardiovascular disorder;</p><p align="justify">(c) a history of substance abuse;</p><p align="justify">(d) glaucoma;</p><p align="justify">(e) any other absolute contraindication to dexamfetamine sulfate as specified in the TGA-approved Product Information.</p> <p align="left">The MSLT must be preceded by nocturnal polysomnography. Sleep prior to the MSLT must be at least 6 hours in duration.</p> <p align="justify">The authority application must be made in writing and must include the following:</p><p align="justify">(a) a completed authority prescription form; and</p><p align="justify">(b) a completed Narcolepsy Initial PBS authority application and Supporting information form; and</p><p align="justify">(c) details of the contraindication or intolerance to dexamfetamine sulfate; and</p><p align="justify">(d) either:</p><p align="justify">(i) the result and date of the polysomnography test and Multiple Sleep Latency Test (MSLT) conducted by, or under the supervision of, a qualified sleep medicine practitioner; or</p><p align="justify">(ii) the result and date of the electroencephalograph (EEG), conducted by, or under the supervision of, a neurologist.</p><p align="justify">The polysomnography, MSLT or EEG test reports must be provided with the authority application.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p> | N | N | Y | FULL | ALL | N | 2020-11-01 | 3,671 |
10950_10988_R | Continuing treatment | STREAMLINED | 10,988 | 10,950 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this PBS indication; AND</p> <p>Patient must have demonstrated a response to treatment with this drug if treatment is continuing beyond 6 months of treatment for the first time; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; or</p> <p>The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND</p> <p>Patient must be receiving the medical service as described in item 14249 of the Medicare Benefits Schedule; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a medical physician working under the supervision of a haematologist.</p> <p align="justify">A response, for the purposes of administering this continuing restriction, is defined as attaining a reduction of at least 50% in the overall skin lesion score from baseline, for at least 4 consecutive weeks. Refer to the Product Information for directions on calculating an overall skin lesion score. The definition of a clinically significant reduction in the Product Information differs to the 50% requirement for PBS-subsidy. Response only needs to be demonstrated after the first six months of treatment</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this PBS indication; AND</p> <p>Patient must have demonstrated a response to treatment with this drug if treatment is continuing beyond 6 months of treatment for the first time; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; or</p> <p>The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND</p> <p>Patient must be receiving the medical service as described in item 14249 of the Medicare Benefits Schedule; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a medical physician working under the supervision of a haematologist.</p> <p align="justify">A response, for the purposes of administering this continuing restriction, is defined as attaining a reduction of at least 50% in the overall skin lesion score from baseline, for at least 4 consecutive weeks. Refer to the Product Information for directions on calculating an overall skin lesion score. The definition of a clinically significant reduction in the Product Information differs to the 50% requirement for PBS-subsidy. Response only needs to be demonstrated after the first six months of treatment</p> | N | N | N | IMMEDIATE | ALL | N | 2020-11-01 | 3,671 |
10951_10985_R | Initial treatment | STREAMLINED | 10,985 | 10,951 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma</p><br/><p>Initial treatment</p><br/><p>Patient must have experienced disease progression while on at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; or</p> <p>Patient must have experienced an intolerance necessitating permanent treatment withdrawal to at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; or</p> <p>The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND</p> <p>Patient must be receiving the medical service as described in item 14247 of the Medicare Benefits Schedule; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a medical physician working under the supervision of a haematologist; AND</p> <p>Patient must be aged 18 years or over.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma</p><br/><p>Initial treatment</p><br/><p>Patient must have experienced disease progression while on at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; or</p> <p>Patient must have experienced an intolerance necessitating permanent treatment withdrawal to at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; or</p> <p>The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND</p> <p>Patient must be receiving the medical service as described in item 14247 of the Medicare Benefits Schedule; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a medical physician working under the supervision of a haematologist; AND</p> <p>Patient must be aged 18 years or over.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-11-01 | 3,671 |
10961_6174_R | Initial treatment | STREAMLINED | 6,174 | 10,961 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk protein enteropathy and intolerance to soy protein</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must have failed to respond to a strict soy-based cows'' milk protein free diet; AND</p> <p>Patient must be up to the age of 24 months.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk protein enteropathy and intolerance to soy protein</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must have failed to respond to a strict soy-based cows'' milk protein free diet; AND</p> <p>Patient must be up to the age of 24 months.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-11-01 | 3,671 |
10969_10967_R | Continuing or change of treatment | AUTHORITY_REQUIRED | 10,967 | 10,969 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Narcolepsy</p><br/><p>Continuing or change of treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have previously received PBS-subsidised treatment with modafinil for this condition.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Narcolepsy</p><br/><p>Continuing or change of treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have previously received PBS-subsidised treatment with modafinil for this condition.</p> <p align="justify">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p> | N | N | Y | IMMEDIATE | ALL | N | 2020-11-01 | 3,671 |
10971_10971_R | Initial treatment | STREAMLINED | 10,971 | 10,971 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma</p><br/><p>Initial treatment</p><br/><p>Patient must have experienced disease progression while on at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; or</p> <p>Patient must have experienced an intolerance necessitating permanent treatment withdrawal to at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; or</p> <p>The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND</p> <p>Patient must be receiving the medical service as described in item 14247 of the Medicare Benefits Schedule; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a medical physician working under the supervision of a haematologist; AND</p> <p>Patient must be aged 18 years or over.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma</p><br/><p>Initial treatment</p><br/><p>Patient must have experienced disease progression while on at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; or</p> <p>Patient must have experienced an intolerance necessitating permanent treatment withdrawal to at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; or</p> <p>The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND</p> <p>Patient must be receiving the medical service as described in item 14247 of the Medicare Benefits Schedule; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a medical physician working under the supervision of a haematologist; AND</p> <p>Patient must be aged 18 years or over.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-11-01 | 3,671 |
10972_10972_R | Continuing treatment where bevacizumab is discontinued - 4 weekly treatment regimen | STREAMLINED | 10,972 | 10,972 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Continuing treatment where bevacizumab is discontinued - 4 weekly treatment regimen</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition.</p> <p align="justify">PBS supply of this drug must be through only one of the two continuing treatment regimens at any given time</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Continuing treatment where bevacizumab is discontinued - 4 weekly treatment regimen</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition.</p> <p align="justify">PBS supply of this drug must be through only one of the two continuing treatment regimens at any given time</p> | N | N | N | IMMEDIATE | ALL | N | 2020-11-01 | 3,671 |
10982_6204_R | null | STREAMLINED | 6,204 | 10,982 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk protein enteropathy and intolerance to soy protein</p><br/><p>Must be treated by a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must have failed to respond to a strict soy-based cows'' milk protein free diet; AND</p> <p>Patient must be older than 24 months of age.</p> <p align="justify">The name of the specialist must be documented in the patient's medical records</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk protein enteropathy and intolerance to soy protein</p><br/><p>Must be treated by a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must have failed to respond to a strict soy-based cows'' milk protein free diet; AND</p> <p>Patient must be older than 24 months of age.</p> <p align="justify">The name of the specialist must be documented in the patient's medical records</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-11-01 | 3,671 |
10986_6193_R | Continuing treatment | STREAMLINED | 6,193 | 10,986 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk protein enteropathy and intolerance to soy protein</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must have demonstrated a clinical improvement with the protein hydrolysate formula with medium chain triglycerides; AND</p> <p>Patient must be up to the age of 24 months.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk protein enteropathy and intolerance to soy protein</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must have demonstrated a clinical improvement with the protein hydrolysate formula with medium chain triglycerides; AND</p> <p>Patient must be up to the age of 24 months.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-11-01 | 3,671 |
10989_10989_R | Continuing treatment | STREAMLINED | 10,989 | 10,989 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this PBS indication; AND</p> <p>Patient must have demonstrated a response to treatment with this drug if treatment is continuing beyond 6 months of treatment for the first time; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; or</p> <p>The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND</p> <p>Patient must be receiving the medical service as described in item 14249 of the Medicare Benefits Schedule; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a medical physician working under the supervision of a haematologist.</p> <p align="justify">A response, for the purposes of administering this continuing restriction, is defined as attaining a reduction of at least 50% in the overall skin lesion score from baseline, for at least 4 consecutive weeks. Refer to the Product Information for directions on calculating an overall skin lesion score. The definition of a clinically significant reduction in the Product Information differs to the 50% requirement for PBS-subsidy. Response only needs to be demonstrated after the first six months of treatment</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this PBS indication; AND</p> <p>Patient must have demonstrated a response to treatment with this drug if treatment is continuing beyond 6 months of treatment for the first time; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; or</p> <p>The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND</p> <p>Patient must be receiving the medical service as described in item 14249 of the Medicare Benefits Schedule; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a medical physician working under the supervision of a haematologist.</p> <p align="justify">A response, for the purposes of administering this continuing restriction, is defined as attaining a reduction of at least 50% in the overall skin lesion score from baseline, for at least 4 consecutive weeks. Refer to the Product Information for directions on calculating an overall skin lesion score. The definition of a clinically significant reduction in the Product Information differs to the 50% requirement for PBS-subsidy. Response only needs to be demonstrated after the first six months of treatment</p> | N | N | N | IMMEDIATE | ALL | N | 2020-11-01 | 3,671 |
10993_4878_R | null | RESTRICTED | 4,878 | 10,993 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute episode of mild to moderate ulcerative proctitis</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute episode of mild to moderate ulcerative proctitis</p> | N | N | N | IMMEDIATE | ALL | N | 2020-12-01 | 3,671 |
10994_10995_R | Dose modification | AUTHORITY_REQUIRED | 10,995 | 10,994 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Dose modification</p><br/><p>The treatment must be for dose titration purposes.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Dose modification</p><br/><p>The treatment must be for dose titration purposes.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-12-01 | 3,671 |
11011_C | null | null | null | null | null | <p>This is a category X drug and must not be given to pregnant women. Pregnancy must be avoided during treatment and for at least 3 months following cessation of therapy.</p> | N | Y | N | null | null | N | 2014-09-01 | 3,671 |
11013_11013_R | Initial treatment | STREAMLINED | 11,013 | 11,013 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic stable atherosclerotic disease</p><br/><p>Initial treatment</p><br/><p>The treatment must be in combination with aspirin, but not with any other anti-platelet therapy; AND</p> <p>Patient must have a diagnosis of coronary artery disease in addition to at least one of the following risk factors: (i) diagnosed heart failure (left ventricular ejection fraction of at least 30% but less than 50%) (ii) diagnosed kidney disease classified by an eGFR in the range of 15-60 mL/min (iii) diabetes mellitus combined with at least one of the following: (a) age at least 60 years (b) concomitant microalbuminuria (c) Aboriginal/Torres Strait Islander descent; or</p> <p>Patient must have a diagnosis of peripheral artery disease in addition to at least one of the following risk factors: (i) concomitant coronary artery disease (ii) diagnosed heart failure (left ventricular ejection fraction of at least 30% but less than 50%) (iii) diagnosed kidney disease classified by an eGFR in the range of 15-60 mL/min (iv) diabetes mellitus combined with at least one of the following: (a) age at least 60 years (b) concomitant microalbuminuria (c) Aboriginal/Torres Strait Islander descent; AND</p> <p>Patient must have at least one of the following if coronary artery disease is present: (i) a previous multi-vessel coronary revascularisation procedure (ii) significant stenosis in at least 2 coronary arteries (iii) a previous single vessel coronary revascularisation procedure with significant stenosis in more than 1 coronary artery; or</p> <p>Patient must have at least one of the following if peripheral arterial disease is present: (i) a previous peripheral/carotid artery revascularisation intervention (ii) intermittent claudication with an ankle-brachial index less than 0.9 (iii) asymptomatic carotid artery stenosis greater than 50%; AND</p> <p>The condition must be diagnosed by at least one of: (i) invasive (selective) angiography (ii) non-invasive imaging (i.e. CT scan, ultrasound) (iii) ankle-brachial index measurement in the case of peripheral arterial disease with intermittent claudication; AND</p> <p>Patient must have clinical findings/observations by the treating physician that exclude each of the following: (i) high risk of bleeding (ii) prior stroke within one month of treatment initiation (iii) prior haemorrhagic / lacunar stroke (iv) severe heart failure with a known ejection fraction less than 30% (v) New York Heart Association class III to IV heart failure symptoms (i.e. symptoms corresponding to moderate to severe limitation on physical activity, whereby any of fatigue/palpitations/dyspnoea occur upon zero to minimal activity) (vi) an estimated glomerular filtration rate less than 15 mL/minute (vii) a requirement for dual antiplatelet therapy (viii) a requirement for non-acetylsalicylic acid antiplatelet therapy (ix) a requirement for a higher dose of oral anticoagulant therapy; AND</p> <p>Must be treated by a specialist physician; or</p> <p>Must be treated by a physician who has consulted a specialist physician.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic stable atherosclerotic disease</p><br/><p>Initial treatment</p><br/><p>The treatment must be in combination with aspirin, but not with any other anti-platelet therapy; AND</p> <p>Patient must have a diagnosis of coronary artery disease in addition to at least one of the following risk factors: (i) diagnosed heart failure (left ventricular ejection fraction of at least 30% but less than 50%) (ii) diagnosed kidney disease classified by an eGFR in the range of 15-60 mL/min (iii) diabetes mellitus combined with at least one of the following: (a) age at least 60 years (b) concomitant microalbuminuria (c) Aboriginal/Torres Strait Islander descent; or</p> <p>Patient must have a diagnosis of peripheral artery disease in addition to at least one of the following risk factors: (i) concomitant coronary artery disease (ii) diagnosed heart failure (left ventricular ejection fraction of at least 30% but less than 50%) (iii) diagnosed kidney disease classified by an eGFR in the range of 15-60 mL/min (iv) diabetes mellitus combined with at least one of the following: (a) age at least 60 years (b) concomitant microalbuminuria (c) Aboriginal/Torres Strait Islander descent; AND</p> <p>Patient must have at least one of the following if coronary artery disease is present: (i) a previous multi-vessel coronary revascularisation procedure (ii) significant stenosis in at least 2 coronary arteries (iii) a previous single vessel coronary revascularisation procedure with significant stenosis in more than 1 coronary artery; or</p> <p>Patient must have at least one of the following if peripheral arterial disease is present: (i) a previous peripheral/carotid artery revascularisation intervention (ii) intermittent claudication with an ankle-brachial index less than 0.9 (iii) asymptomatic carotid artery stenosis greater than 50%; AND</p> <p>The condition must be diagnosed by at least one of: (i) invasive (selective) angiography (ii) non-invasive imaging (i.e. CT scan, ultrasound) (iii) ankle-brachial index measurement in the case of peripheral arterial disease with intermittent claudication; AND</p> <p>Patient must have clinical findings/observations by the treating physician that exclude each of the following: (i) high risk of bleeding (ii) prior stroke within one month of treatment initiation (iii) prior haemorrhagic / lacunar stroke (iv) severe heart failure with a known ejection fraction less than 30% (v) New York Heart Association class III to IV heart failure symptoms (i.e. symptoms corresponding to moderate to severe limitation on physical activity, whereby any of fatigue/palpitations/dyspnoea occur upon zero to minimal activity) (vi) an estimated glomerular filtration rate less than 15 mL/minute (vii) a requirement for dual antiplatelet therapy (viii) a requirement for non-acetylsalicylic acid antiplatelet therapy (ix) a requirement for a higher dose of oral anticoagulant therapy; AND</p> <p>Must be treated by a specialist physician; or</p> <p>Must be treated by a physician who has consulted a specialist physician.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-12-01 | 3,671 |
11014_11057_R | null | STREAMLINED | 11,057 | 11,014 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 18 years or older.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 18 years or older.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-12-01 | 3,671 |
11015_11015_R | For combination use with venetoclax treatment cycles 1 to 6 inclusive in first-line therapy | STREAMLINED | 11,015 | 11,015 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>For combination use with venetoclax treatment cycles 1 to 6 inclusive in first-line therapy</p><br/><p>The condition must be untreated; AND</p> <p>The treatment must be in combination with PBS-subsidised venetoclax.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>For combination use with venetoclax treatment cycles 1 to 6 inclusive in first-line therapy</p><br/><p>The condition must be untreated; AND</p> <p>The treatment must be in combination with PBS-subsidised venetoclax.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-12-01 | 3,671 |
11047_11066_R | Continuing or change of treatment | STREAMLINED | 11,066 | 11,047 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Continuing or change of treatment</p><br/><p>Patient must have previously received PBS-subsidised therapy for HIV infection.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Continuing or change of treatment</p><br/><p>Patient must have previously received PBS-subsidised therapy for HIV infection.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-12-01 | 3,671 |
11059_11070_R | null | STREAMLINED | 11,070 | 11,059 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic renal failure</p><br/><p>Patient must be a child aged 3 years or older; AND</p> <p>Patient must require treatment with a low protein and a low phosphorus diet; or</p> <p>Patient must require treatment with a low protein, low phosphorus and low potassium diet.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic renal failure</p><br/><p>Patient must be a child aged 3 years or older; AND</p> <p>Patient must require treatment with a low protein and a low phosphorus diet; or</p> <p>Patient must require treatment with a low protein, low phosphorus and low potassium diet.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-12-01 | 3,671 |
11065_5520_R | null | STREAMLINED | 5,520 | 11,065 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven Pseudomonas aeruginosa infection</p><br/><p>Patient must have cystic fibrosis; AND</p> <p>The treatment must be for management.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven Pseudomonas aeruginosa infection</p><br/><p>Patient must have cystic fibrosis; AND</p> <p>The treatment must be for management.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-12-01 | 3,671 |
11067_11017_R | First continuing treatment (treatment cycles 2 to 6 inclusive) of first-line therapy | AUTHORITY_REQUIRED | 11,017 | 11,067 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>First continuing treatment (treatment cycles 2 to 6 inclusive) of first-line therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with obinutuzumab (refer to Product Information for timing of obinutuzumab and venetoclax doses); AND</p> <p>The treatment must cease upon disease progression.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>First continuing treatment (treatment cycles 2 to 6 inclusive) of first-line therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with obinutuzumab (refer to Product Information for timing of obinutuzumab and venetoclax doses); AND</p> <p>The treatment must cease upon disease progression.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-12-01 | 3,671 |
11068_11069_R | Continuing treatment | AUTHORITY_REQUIRED | 11,069 | 11,068 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with rituximab for up to a maximum of 6 cycles, followed by monotherapy; AND</p> <p>The treatment must be ceased on disease progression or on completion of 24 months of PBS-subsidised treatment under this restriction with this drug for this condition, whichever comes first.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with rituximab for up to a maximum of 6 cycles, followed by monotherapy; AND</p> <p>The treatment must be ceased on disease progression or on completion of 24 months of PBS-subsidised treatment under this restriction with this drug for this condition, whichever comes first.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-12-01 | 3,671 |
11078_11081_R | null | STREAMLINED | 11,081 | 11,078 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Epileptic seizures</p><br/><p>The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs; or</p> <p>Patient must be a woman of childbearing potential.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Epileptic seizures</p><br/><p>The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs; or</p> <p>Patient must be a woman of childbearing potential.</p> <p align="justify"><b>Continuing Therapy Only:</b></p><p align="justify">For prescribing by nurse practitioners as continuing therapy only, where the treatment of, and prescribing of medicine for, a patient has been initiated by a medical practitioner. Further information can be found in the Explanatory Notes for Nurse Practitioners. </p> | N | N | N | IMMEDIATE | ALL | N | 2021-01-01 | 3,671 |
11085_11153_R | Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years) | AUTHORITY_REQUIRED | 11,153 | 11,085 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="left">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align="justify">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and</p><p align="left">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="left">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align="justify">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and</p><p align="left">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p> | N | N | Y | FULL | ALL | N | 2021-01-01 | 3,671 |
11088_11154_R | Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years) | AUTHORITY_REQUIRED | 11,154 | 11,088 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p> | N | N | Y | FULL | ALL | N | 2021-01-01 | 3,671 |
11092_11120_R | Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply | AUTHORITY_REQUIRED | 11,120 | 11,092 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years ) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restriction; AND</p> <p>Must be treated by a dermatologist.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years ) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p> | N | N | Y | IMMEDIATE | ALL | N | 2021-01-01 | 3,671 |
11099_11099_R | null | RESTRICTED | 11,099 | 11,099 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p> | N | N | N | IMMEDIATE | ALL | N | 2021-01-01 | 3,671 |
11100_11160_R | Initial treatment | STREAMLINED | 11,160 | 11,100 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have Child Pugh class A; AND</p> <p>The condition must be untreated with systemic therapy; or</p> <p>Patient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression, to any of the following: (i) a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), (ii) atezolizumab/bevacizumab combination therapy.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have Child Pugh class A; AND</p> <p>The condition must be untreated with systemic therapy; or</p> <p>Patient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression, to any of the following: (i) a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), (ii) atezolizumab/bevacizumab combination therapy.</p> | N | N | N | IMMEDIATE | ALL | N | 2021-01-01 | 3,671 |
11101_11077_R | null | STREAMLINED | 11,077 | 11,101 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Partial epileptic seizures</p><br/><p>The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs; or</p> <p>Patient must be a woman of childbearing potential; AND</p> <p>Patient must be unable to take a solid dose form of levetiracetam; AND</p> <p>The treatment must not be given concomitantly with brivaracetam, except for cross titration.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Partial epileptic seizures</p><br/><p>The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs; or</p> <p>Patient must be a woman of childbearing potential; AND</p> <p>Patient must be unable to take a solid dose form of levetiracetam; AND</p> <p>The treatment must not be given concomitantly with brivaracetam, except for cross titration.</p> <p align="justify"><b>Continuing Therapy Only:</b></p><p align="justify">For prescribing by nurse practitioners as continuing therapy only, where the treatment of, and prescribing of medicine for, a patient has been initiated by a medical practitioner. Further information can be found in the Explanatory Notes for Nurse Practitioners. </p> | N | N | N | IMMEDIATE | ALL | N | 2021-01-01 | 3,671 |
11105_11143_R | null | RESTRICTED | 11,143 | 11,105 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pre-exposure prophylaxis (PrEP) against human immunodeficiency virus (HIV) infection</p><br/><p>Patient must have at least one of the following prior to having the latest PBS-subsidised prescription issued: (i) a negative HIV test result no older than 4 weeks, (ii) evidence that an HIV test has been conducted, but the result is still forthcoming.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pre-exposure prophylaxis (PrEP) against human immunodeficiency virus (HIV) infection</p><br/><p>Patient must have at least one of the following prior to having the latest PBS-subsidised prescription issued: (i) a negative HIV test result no older than 4 weeks, (ii) evidence that an HIV test has been conducted, but the result is still forthcoming.</p> | N | N | N | IMMEDIATE | ALL | N | 2021-01-01 | 3,671 |
11106_11138_R | Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) | AUTHORITY_REQUIRED | 11,138 | 11,106 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align="justify">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align="justify">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align="justify">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and</p><p align="justify">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align="justify">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align="justify">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align="justify">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and</p><p align="justify">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p> | N | N | Y | FULL | ALL | N | 2021-01-01 | 3,671 |
11110_8296_R | Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply | AUTHORITY_REQUIRED | 8,296 | 11,110 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the first continuing treatment, Whole body restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the first continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Whole body restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Face, hand, foot restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Must be treated by a dermatologist.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the first continuing treatment, Whole body restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the first continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Whole body restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Face, hand, foot restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p> | N | N | Y | IMMEDIATE | ALL | N | 2021-01-01 | 3,671 |
11118_11145_R | Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) | AUTHORITY_REQUIRED | 11,145 | 11,118 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align="justify">At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align="justify">At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p> | N | N | Y | FULL | ALL | N | 2021-01-01 | 3,671 |
11121_11089_R | Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) | AUTHORITY_REQUIRED | 11,089 | 11,121 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p> | N | N | Y | FULL | ALL | N | 2021-01-01 | 3,671 |
11132_11116_R | null | STREAMLINED | 11,116 | 11,132 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Partial epileptic seizures</p><br/><p>The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs; or</p> <p>Patient must be a woman of childbearing potential; AND</p> <p>The treatment must not be given concomitantly with brivaracetam, except for cross titration.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Partial epileptic seizures</p><br/><p>The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs; or</p> <p>Patient must be a woman of childbearing potential; AND</p> <p>The treatment must not be given concomitantly with brivaracetam, except for cross titration.</p> <p align="justify"><b>Continuing Therapy Only:</b></p><p align="justify">For prescribing by nurse practitioners as continuing therapy only, where the treatment of, and prescribing of medicine for, a patient has been initiated by a medical practitioner. Further information can be found in the Explanatory Notes for Nurse Practitioners. </p> | N | N | N | IMMEDIATE | ALL | N | 2021-01-01 | 3,671 |
11134_11107_R | Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply | AUTHORITY_REQUIRED | 11,107 | 11,134 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p> | N | N | Y | IMMEDIATE | ALL | N | 2021-01-01 | 3,671 |
11135_11161_R | Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years) | AUTHORITY_REQUIRED | 11,161 | 11,135 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align="justify">At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align="justify">At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p> | N | N | Y | FULL | ALL | N | 2021-01-01 | 3,671 |
11139_11090_R | Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years) | AUTHORITY_REQUIRED | 11,090 | 11,139 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="left">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align="justify">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and</p><p align="left">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="left">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align="justify">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and</p><p align="left">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p> | N | N | Y | FULL | ALL | N | 2021-01-01 | 3,671 |
11140_11096_R | Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years) | AUTHORITY_REQUIRED | 11,096 | 11,140 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="left">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align="justify">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and</p><p align="left">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="left">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align="justify">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and</p><p align="left">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p> | N | N | Y | FULL | ALL | N | 2021-01-01 | 3,671 |
11144_11119_R | Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) | AUTHORITY_REQUIRED | 11,119 | 11,144 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align="justify">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align="justify">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align="justify">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and</p><p align="justify">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align="justify">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align="justify">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align="justify">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and</p><p align="justify">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p> | N | N | Y | FULL | ALL | N | 2021-01-01 | 3,671 |
11163_11123_R | Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) | AUTHORITY_REQUIRED | 11,123 | 11,163 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align="justify">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align="justify">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align="justify">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align="justify">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and</p><p align="justify">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align="justify">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align="justify">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align="justify">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align="justify">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and</p><p align="justify">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p> | N | N | Y | FULL | ALL | N | 2021-01-01 | 3,671 |
11167_11168_R | Initial treatment | STREAMLINED | 11,168 | 11,167 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not be suitable for transarterial chemoembolisation; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have Child Pugh class A; AND</p> <p>The condition must be untreated with systemic therapy; or</p> <p>Patient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression, to any of the following: (i) a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), (ii) atezolizumab/bevacizumab combination therapy.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not be suitable for transarterial chemoembolisation; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have Child Pugh class A; AND</p> <p>The condition must be untreated with systemic therapy; or</p> <p>Patient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression, to any of the following: (i) a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), (ii) atezolizumab/bevacizumab combination therapy.</p> | N | N | N | IMMEDIATE | ALL | N | 2021-01-01 | 3,671 |
11173_11158_R | Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply | AUTHORITY_REQUIRED | 11,158 | 11,173 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years ) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 22 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 22 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years ) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 22 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 22 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p> | N | N | Y | IMMEDIATE | ALL | N | 2021-01-01 | 3,671 |
11175_11130_R | Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) | AUTHORITY_REQUIRED | 11,130 | 11,175 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align="justify">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align="justify">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align="justify">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align="justify">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and</p><p align="justify">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align="justify">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align="justify">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align="justify">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align="justify">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and</p><p align="justify">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p> | N | N | Y | FULL | ALL | N | 2021-01-01 | 3,671 |
11192_11195_R | Initial treatment following dose titration | AUTHORITY_REQUIRED | 11,195 | 11,192 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial treatment following dose titration</p><br/><p>Patient must have WHO Functional Class III PAH at treatment initiation with this drug; or</p> <p>Patient must have WHO Functional Class IV PAH at treatment initiation with this drug; AND</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as ''triple therapy''); or</p> <p>The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as ''dual therapy in lieu of triple therapy''); AND</p> <p>Patient must have completed the dose titration phase; AND</p> <p>The treatment must not be as monotherapy; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND</p> <p>Patient must have had at least one PBS-subsidised PAH agent prior to this authority application.</p> <p align="justify">Select one appropriate strength (determined under the 'Initial treatment - dose titration' phase) and apply under this treatment phase (Initial treatment following dose titration) once only. Should future dose adjustments be required, apply under the 'Continuing treatment' restriction.</p> <p align="justify">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align="justify">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.</p> <p align="justify">PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align="justify">PAH (WHO Group 1 pulmonary hypertension) is defined as follows:</p><p align="justify">(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or</p><p align="justify">(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial treatment following dose titration</p><br/><p>Patient must have WHO Functional Class III PAH at treatment initiation with this drug; or</p> <p>Patient must have WHO Functional Class IV PAH at treatment initiation with this drug; AND</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as ''triple therapy''); or</p> <p>The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as ''dual therapy in lieu of triple therapy''); AND</p> <p>Patient must have completed the dose titration phase; AND</p> <p>The treatment must not be as monotherapy; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND</p> <p>Patient must have had at least one PBS-subsidised PAH agent prior to this authority application.</p> <p align="justify">Select one appropriate strength (determined under the 'Initial treatment - dose titration' phase) and apply under this treatment phase (Initial treatment following dose titration) once only. Should future dose adjustments be required, apply under the 'Continuing treatment' restriction.</p> <p align="justify">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align="justify">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.</p> <p align="justify">PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align="justify">PAH (WHO Group 1 pulmonary hypertension) is defined as follows:</p><p align="justify">(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or</p><p align="justify">(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.</p> <p align="justify">PAH (WHO Group 1 pulmonary hypertension) currently includes the following subtypes:</p><ul><li>Idiopathic PAH</li><li>Heritable PAH<br/><ul><li>BMPR2 mutation</li><li>ALK-1, ENG, SMAD9, CAV1, KCNK3 mutations</li><li>Other mutations</li></ul></li><li>Drugs and toxins induced PAH</li><li>PAH associated with:<br/><ul><li>Connective tissue disease</li><li>Human immunodeficiency virus (HIV) infection</li><li>Portal hypertension</li><li>Congenital heart disease</li><li>Schistosomiasis</li></ul></li></ul> | N | N | N | IMMEDIATE | ALL | N | 2021-02-01 | 3,671 |
11193_11193_R | Continuing treatment | AUTHORITY_REQUIRED | 11,193 | 11,193 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as ''triple therapy''); or</p> <p>The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as ''dual therapy in lieu of triple therapy''); AND</p> <p>The treatment must not be as monotherapy; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align="justify">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.</p> <p align="justify">For the purposes of administering this restriction, disease progression has developed if at least one of the following has occurred:</p><p align="justify">(i) Hospitalisation due to worsening PAH;</p><p align="justify">(ii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6-Minute Walk Distance from baseline, combined with worsening of WHO functional class status;</p><p align="justify">(iii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6-Minute Walk Distance from baseline, combined with the need for additional PAH-specific therapy;</p><p align="justify">(iv) Initiation of parenteral prostanoid therapy or long-term oxygen therapy for worsening of PAH;</p><p align="justify">(v) Need for lung transplantation or balloon atrial septostomy for worsening of PAH.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as ''triple therapy''); or</p> <p>The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as ''dual therapy in lieu of triple therapy''); AND</p> <p>The treatment must not be as monotherapy; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align="justify">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.</p> <p align="justify">For the purposes of administering this restriction, disease progression has developed if at least one of the following has occurred:</p><p align="justify">(i) Hospitalisation due to worsening PAH;</p><p align="justify">(ii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6-Minute Walk Distance from baseline, combined with worsening of WHO functional class status;</p><p align="justify">(iii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6-Minute Walk Distance from baseline, combined with the need for additional PAH-specific therapy;</p><p align="justify">(iv) Initiation of parenteral prostanoid therapy or long-term oxygen therapy for worsening of PAH;</p><p align="justify">(v) Need for lung transplantation or balloon atrial septostomy for worsening of PAH.</p> | N | N | N | IMMEDIATE | ALL | N | 2021-02-01 | 3,671 |
11207_9183_R | Initial treatment - Initial 1 (new patient) | AUTHORITY_REQUIRED | 9,183 | 11,207 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p>Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p>Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align="justify">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: </p><p align="justify">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align="justify">either</p><p align="justify">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align="justify">(b) at least 4 active joints from the following list of major joints:</p><p align="justify">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align="justify">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align="justify">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) a completed authority prescription form(s); and</p><p align="justify">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align="justify">An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p>Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p>Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align="justify">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: </p><p align="justify">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align="justify">either</p><p align="justify">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align="justify">(b) at least 4 active joints from the following list of major joints:</p><p align="justify">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align="justify">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align="justify">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) a completed authority prescription form(s); and</p><p align="justify">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align="justify">An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p>Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 3 months treatment with methotrexate and 3 months treatment with sulfasalazine or leflunomide can be found on the Department of Human Services website (www.humanservices.gov.au)</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p> | N | N | Y | FULL | ALL | N | 2021-02-01 | 3,671 |
11208_9105_R | Continuing treatment | AUTHORITY_REQUIRED | 9,105 | 11,208 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="justify">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align="justify">either of the following:</p><p align="justify">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align="justify">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align="justify">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align="justify">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align="justify">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) a completed authority prescription form(s); and</p><p align="justify">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align="justify">Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="justify">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align="justify">either of the following:</p><p align="justify">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align="justify">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align="justify">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align="justify">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align="justify">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) a completed authority prescription form(s); and</p><p align="justify">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align="justify">Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p> | N | N | Y | FULL | ALL | N | 2021-02-01 | 3,671 |
11209_8830_R | Continuing treatment, Whole body | AUTHORITY_REQUIRED | 8,830 | 11,209 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="left">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.</p><p align="justify">The most recent PASI assessment must be no more than 1 month old at the time of application.</p><p align="justify">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align="justify">It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="left">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.</p><p align="justify">The most recent PASI assessment must be no more than 1 month old at the time of application.</p><p align="justify">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align="justify">It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p> | N | N | Y | FULL | ALL | N | 2021-02-01 | 3,671 |
11210_4312_R | Initial treatment for up to 6 months | AUTHORITY_REQUIRED | 4,312 | 11,210 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven combined immunoglobulin E (IgE) mediated allergy to cows'' milk protein and soy protein</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides); AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align="justify">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven combined immunoglobulin E (IgE) mediated allergy to cows'' milk protein and soy protein</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides); AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align="justify">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p> | N | N | N | IMMEDIATE | ALL | N | 2021-02-01 | 3,671 |
11211_4352_R | Initial treatment for up to 6 months | AUTHORITY_REQUIRED | 4,352 | 11,211 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe cows'' milk protein enteropathy with failure to thrive</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align="justify">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe cows'' milk protein enteropathy with failure to thrive</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align="justify">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p> | N | N | N | IMMEDIATE | ALL | N | 2021-02-01 | 3,671 |
11212_4323_R | Initial treatment for up to 6 months | AUTHORITY_REQUIRED | 4,323 | 11,212 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk protein enteropathy</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows'' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align="justify">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk protein enteropathy</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows'' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align="justify">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p> | N | N | N | IMMEDIATE | ALL | N | 2021-02-01 | 3,671 |
11213_4345_R | Continuing treatment | AUTHORITY_REQUIRED | 4,345 | 11,213 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe cows'' milk protein enteropathy with failure to thrive</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have been assessed at least once or have an appointment to be assessed by one of these specialists; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must have had failure to thrive prior to commencement with initial treatment; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align="justify">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe cows'' milk protein enteropathy with failure to thrive</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have been assessed at least once or have an appointment to be assessed by one of these specialists; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must have had failure to thrive prior to commencement with initial treatment; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align="justify">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> <p/><p align="justify">Authorities for increased maximum quantities, up to a maximum of 20, may be authorised. </p><p/> | N | N | N | IMMEDIATE | ALL | N | 2021-02-01 | 3,671 |
11214_4338_R | Continuing treatment | AUTHORITY_REQUIRED | 4,338 | 11,214 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Combined intolerance to cows'' milk protein, soy protein and protein hydrolysate formulae</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist at intervals not greater than 12 months; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be older than 24 months of age.</p> <p/><p align="justify">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Combined intolerance to cows'' milk protein, soy protein and protein hydrolysate formulae</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist at intervals not greater than 12 months; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be older than 24 months of age.</p> <p/><p align="justify">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> <p/><p align="justify">Authorities for increased maximum quantities, up to a maximum of 20, may be authorised. </p><p/> | N | N | N | IMMEDIATE | ALL | N | 2021-02-01 | 3,671 |
11215_4339_R | Continuing treatment | AUTHORITY_REQUIRED | 4,339 | 11,215 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven combined immunoglobulin E (IgE) mediated allergy to cows'' milk protein and soy protein</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides) prior to commencement with initial treatment; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align="justify">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven combined immunoglobulin E (IgE) mediated allergy to cows'' milk protein and soy protein</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides) prior to commencement with initial treatment; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align="justify">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> <p/><p align="justify">Authorities for increased maximum quantities, up to a maximum of 20, may be authorised. </p><p/> | N | N | N | IMMEDIATE | ALL | N | 2021-02-01 | 3,671 |
11216_4330_R | null | AUTHORITY_REQUIRED | 4,330 | 11,216 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk anaphylaxis</p><br/><p>Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align="justify">Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction.</p><p/> <p/><p align="justify">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk anaphylaxis</p><br/><p>Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align="justify">Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction.</p><p/> <p/><p align="justify">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> <p/><p align="justify">Authorities for increased maximum quantities, up to a maximum of 20, may be authorised. </p><p/> | N | N | N | IMMEDIATE | ALL | N | 2021-02-01 | 3,671 |
11217_4337_R | Continuing treatment | AUTHORITY_REQUIRED | 4,337 | 11,217 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk protein enteropathy</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have an appointment to be assessed by one of these specialists; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows'' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align="justify">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk protein enteropathy</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have an appointment to be assessed by one of these specialists; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows'' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align="justify">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> <p/><p align="justify">Authorities for increased maximum quantities, up to a maximum of 20, may be authorised. </p><p/> | N | N | N | IMMEDIATE | ALL | N | 2021-02-01 | 3,671 |
11218_4305_R | Initial treatment for up to 6 months | AUTHORITY_REQUIRED | 4,305 | 11,218 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Combined intolerance to cows'' milk protein, soy protein and protein hydrolysate formulae</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be older than 24 months of age.</p> <p/><p align="justify">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Combined intolerance to cows'' milk protein, soy protein and protein hydrolysate formulae</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be older than 24 months of age.</p> <p/><p align="justify">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p> | N | N | N | IMMEDIATE | ALL | N | 2021-02-01 | 3,671 |
11219_5945_R | Initial treatment for up to 3 months | AUTHORITY_REQUIRED | 5,945 | 11,219 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Eosinophilic oesophagitis</p><br/><p>Initial treatment for up to 3 months</p><br/><p>Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist; AND</p> <p>Patient must require an amino acid based formula as a component of a dietary elimination program; AND</p> <p>Patient must be 18 years of age or less.</p> <p/><p align="justify">Treatment with oral steroids should not be commenced during the period of initial treatment.</p><p/> <p align="justify">Eosinophilic oesophagitis is demonstrated by the following criteria:</p><p align="justify">(i) Chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and</p><p align="justify">(ii) A lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and</p><p align="justify">(iii) Eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies.</p> <p/><p align="justify">The date of birth of the patient must be included in the authority application.</p><p/> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Eosinophilic oesophagitis</p><br/><p>Initial treatment for up to 3 months</p><br/><p>Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist; AND</p> <p>Patient must require an amino acid based formula as a component of a dietary elimination program; AND</p> <p>Patient must be 18 years of age or less.</p> <p/><p align="justify">Treatment with oral steroids should not be commenced during the period of initial treatment.</p><p/> <p align="justify">Eosinophilic oesophagitis is demonstrated by the following criteria:</p><p align="justify">(i) Chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and</p><p align="justify">(ii) A lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and</p><p align="justify">(iii) Eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies.</p> <p/><p align="justify">The date of birth of the patient must be included in the authority application.</p><p/> <p/><p align="justify">Authorities for increased maximum quantities, up to a maximum of 20, may be authorised. </p><p/> | N | N | N | IMMEDIATE | ALL | N | 2021-02-01 | 3,671 |
11220_9276_R | Initial treatment | AUTHORITY_REQUIRED | 9,276 | 11,220 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Myelodysplastic or myeloproliferative disorder</p><br/><p>Initial treatment</p><br/><p>Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by standard karyotyping; or</p> <p>Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by fluorescence in situ hybridization (FISH); or</p> <p>Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by PDGFRB fusion gene transcript; AND</p> <p>Patient must have previously failed an adequate trial of conventional therapy with cytarabine; or</p> <p>Patient must have previously failed an adequate trial of conventional therapy with etoposide; or</p> <p>Patient must have previously failed an adequate trial of conventional therapy with hydroxycarbamide (hydroxyurea); AND</p> <p>The treatment must not exceed a maximum dose of 400 mg per day.</p> <p align="justify">A bone marrow biopsy report demonstrating the presence of a myelodysplastic or myeloproliferative disorder, a pathology report confirming the platelet-derived growth factor receptor (PDGFR) gene re-arrangement and details of the prior trialled therapy and the response must be documented in the patient's medical records.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Myelodysplastic or myeloproliferative disorder</p><br/><p>Initial treatment</p><br/><p>Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by standard karyotyping; or</p> <p>Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by fluorescence in situ hybridization (FISH); or</p> <p>Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by PDGFRB fusion gene transcript; AND</p> <p>Patient must have previously failed an adequate trial of conventional therapy with cytarabine; or</p> <p>Patient must have previously failed an adequate trial of conventional therapy with etoposide; or</p> <p>Patient must have previously failed an adequate trial of conventional therapy with hydroxycarbamide (hydroxyurea); AND</p> <p>The treatment must not exceed a maximum dose of 400 mg per day.</p> <p align="justify">A bone marrow biopsy report demonstrating the presence of a myelodysplastic or myeloproliferative disorder, a pathology report confirming the platelet-derived growth factor receptor (PDGFR) gene re-arrangement and details of the prior trialled therapy and the response must be documented in the patient's medical records.</p> | N | N | N | IMMEDIATE | ALL | N | 2021-02-01 | 3,671 |
11221_9240_R | Initial treatment | AUTHORITY_REQUIRED | 9,240 | 11,221 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dermatofibrosarcoma protuberans</p><br/><p>Initial treatment</p><br/><p>The condition must be unresectable; or</p> <p>The condition must be locally recurrent; or</p> <p>The condition must be metastatic; AND</p> <p>The treatment must not exceed a maximum dose of 800 mg per day.</p> <p align="justify">Details of unresectable tumour or site of the local recurrence or site(s) of metastatic disease must be documented in the patient's medical records.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dermatofibrosarcoma protuberans</p><br/><p>Initial treatment</p><br/><p>The condition must be unresectable; or</p> <p>The condition must be locally recurrent; or</p> <p>The condition must be metastatic; AND</p> <p>The treatment must not exceed a maximum dose of 800 mg per day.</p> <p align="justify">Details of unresectable tumour or site of the local recurrence or site(s) of metastatic disease must be documented in the patient's medical records.</p> | N | N | N | IMMEDIATE | ALL | N | 2021-02-01 | 3,671 |
11222_4229_R | null | AUTHORITY_REQUIRED | 4,229 | 11,222 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Superficial basal cell carcinoma</p><br/><p>The condition must be previously untreated; AND</p> <p>The condition must be confirmed by biopsy; AND</p> <p>Patient must have normal immune function; AND</p> <p>The condition must not be suitable for treatment with surgical excision; or</p> <p>The condition must not be suitable for treatment with cryotherapy; or</p> <p>The condition must not be suitable for treatment with curettage with diathermy; AND</p> <p>Patient must require topical drug therapy.</p> <p align="justify">The date of the pathology report and name of the Approved Pathology Authority must be provided at the time of application.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Superficial basal cell carcinoma</p><br/><p>The condition must be previously untreated; AND</p> <p>The condition must be confirmed by biopsy; AND</p> <p>Patient must have normal immune function; AND</p> <p>The condition must not be suitable for treatment with surgical excision; or</p> <p>The condition must not be suitable for treatment with cryotherapy; or</p> <p>The condition must not be suitable for treatment with curettage with diathermy; AND</p> <p>Patient must require topical drug therapy.</p> <p align="justify">The date of the pathology report and name of the Approved Pathology Authority must be provided at the time of application.</p> <p align="justify">The patient or carer must be able to understand and administer the imiquimod dosing regimen.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p> <p align="justify">Treatment of recurrent (previously treated) lesions will not be authorised.</p> <p align="justify">Pharmaceutical benefits that have the form imiquimod single use sachets and pharmaceutical benefits that have the form imiquimod multi-use pump are equivalent for the purposes of substitution.</p> | N | N | N | IMMEDIATE | ALL | N | 2021-02-01 | 3,671 |
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