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9642_4295_R | null | RESTRICTED | 4,295 | 9,642 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Phenylketonuria</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Phenylketonuria</p> <p align="justify">This formulation is suitable for patients aged 3 and older.</p> | N | N | N | IMMEDIATE | ALL | N | 2019-11-01 | 3,671 |
9652_9705_R | Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) | AUTHORITY_REQUIRED | 9,705 | 9,652 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">Application for authorisation must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form; and</p><p align="justify">(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and</p><p align="justify">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align="justify">A maximum of 14 weeks of treatment with this drug will be approved under this criterion. A loading dose of 200 mg at week 0 and a dose of 100 mg at weeks 2, 6 and 10.</p> <p align="justify">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align="left">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align="justify">A partial Mayo clinic assessment of the patient's response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.</p> <p align="justify">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition 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 biological medicine treatment, within the timeframes specified below.</p> <p align="justify">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing 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">Details of the accepted toxicities including severity can be found on the Department of Human Services website.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">Application for authorisation must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form; and</p><p align="justify">(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and</p><p align="justify">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align="justify">A maximum of 14 weeks of treatment with this drug will be approved under this criterion. A loading dose of 200 mg at week 0 and a dose of 100 mg at weeks 2, 6 and 10.</p> <p align="justify">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align="left">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align="justify">A partial Mayo clinic assessment of the patient's response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.</p> <p align="justify">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition 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 biological medicine treatment, within the timeframes specified below.</p> <p align="justify">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing 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">Details of the accepted toxicities including severity can be found on the Department of Human Services website.</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 | 2019-11-01 | 3,671 |
9653_9745_R | Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply | AUTHORITY_REQUIRED | 9,745 | 9,653 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 14 weeks of treatment (weeks 0, 2, 6 and 10); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 14 weeks of treatment (weeks 0, 2, 6 and 10); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 14 weeks of treatment (weeks 0, 2, 6 and 10); AND</p> <p>The treatment must provide no more than the balance of up to 14 weeks therapy available under Initial 1, 2 or 3 treatment.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 14 weeks of treatment (weeks 0, 2, 6 and 10); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 14 weeks of treatment (weeks 0, 2, 6 and 10); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 14 weeks of treatment (weeks 0, 2, 6 and 10); AND</p> <p>The treatment must provide no more than the balance of up to 14 weeks therapy available under Initial 1, 2 or 3 treatment.</p> <p align="justify">Authority approval for sufficient therapy to complete the balance of supply may be requested by telephone by contacting the Department of Human Services 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 | 2019-11-01 | 3,671 |
9667_9668_R | Subsequent continuing treatment | STREAMLINED | 9,668 | 9,667 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND</p> <p>Patient must have a total PCDAI score of 30 points or less; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align="justify">The PCDAI assessment must be no more than 1 month old at the time of prescribing.</p> <p align="justify">The PCDAI score must be documented in the patient's medical notes as the measurement of response to the prior course of therapy.</p> <p align="justify">Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND</p> <p>Patient must have a total PCDAI score of 30 points or less; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align="justify">The PCDAI assessment must be no more than 1 month old at the time of prescribing.</p> <p align="justify">The PCDAI score must be documented in the patient's medical notes as the measurement of response to the prior course of therapy.</p> <p align="justify">Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.</p> | N | N | N | IMMEDIATE | ALL | N | 2019-11-01 | 3,671 |
9671_9751_R | Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) | AUTHORITY_REQUIRED | 9,751 | 9,671 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe Crohn disease</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <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 failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition more than once in the current treatment cycle; AND</p> <p>The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align="justify">Application for authorisation must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form; and</p><p align="justify">(b) a completed Paediatric Crohn Disease PBS Authority Application -Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) Score calculation sheet; and</p><p align="justify">(ii) details of prior biological medicine treatment including details of date and duration of treatment.</p> <p align="justify">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align="justify">Where the most recent course of PBS-subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.</p> <p align="justify">If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine.</p> <p align="justify">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align="left">If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.</p> <p align="justify">A PCDAI assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.</p> <p align="justify">This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.</p> <p align="justify">Where a response assessment is not provided within this 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> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe Crohn disease</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <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 failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition more than once in the current treatment cycle; AND</p> <p>The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align="justify">Application for authorisation must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form; and</p><p align="justify">(b) a completed Paediatric Crohn Disease PBS Authority Application -Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) Score calculation sheet; and</p><p align="justify">(ii) details of prior biological medicine treatment including details of date and duration of treatment.</p> <p align="justify">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align="justify">Where the most recent course of PBS-subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.</p> <p align="justify">If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine.</p> <p align="justify">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align="left">If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.</p> <p align="justify">A PCDAI assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.</p> <p align="justify">This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.</p> <p align="justify">Where a response assessment is not provided within this 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">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 | 2019-11-01 | 3,671 |
9688_9688_R | null | STREAMLINED | 9,688 | 9,688 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anaemia associated with intrinsic renal disease</p><br/><p>Patient must require transfusion; AND</p> <p>Patient must have a haemoglobin level of less than 100 g per L; AND</p> <p>Patient must have intrinsic renal disease, as assessed by a nephrologist.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anaemia associated with intrinsic renal disease</p><br/><p>Patient must require transfusion; AND</p> <p>Patient must have a haemoglobin level of less than 100 g per L; AND</p> <p>Patient must have intrinsic renal disease, as assessed by a nephrologist.</p> | N | N | N | IMMEDIATE | ALL | N | 2019-11-01 | 3,671 |
9691_9691_R | Management (initiation, stabilisation and review of therapy) | STREAMLINED | 9,691 | 9,691 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Management of renal allograft rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Management of renal allograft rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p> | N | N | N | IMMEDIATE | ALL | N | 2019-11-01 | 3,671 |
9692_9692_R | Management | STREAMLINED | 9,692 | 9,692 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prophylaxis of renal allograft rejection</p><br/><p>Management</p><br/><p>The treatment must be under the supervision and direction of a transplant unit.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Prophylaxis of renal allograft rejection</p><br/><p>Management</p><br/><p>The treatment must be under the supervision and direction of a transplant unit.</p> <p>Management includes initiation, stabilisation and review of therapy as required.</p> | N | N | N | IMMEDIATE | ALL | N | 2019-11-01 | 3,671 |
9693_9693_R | Management (initiation, stabilisation and review of therapy) | STREAMLINED | 9,693 | 9,693 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Management of cardiac allograft rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Management of cardiac allograft rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p> | N | N | N | IMMEDIATE | ALL | N | 2019-11-01 | 3,671 |
9694_9694_R | Management (initiation, stabilisation and review of therapy) | STREAMLINED | 9,694 | 9,694 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nephrotic syndrome</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must have failed prior treatment with steroids and cytostatic drugs; or</p> <p>Patient must be intolerant to treatment with steroids and cytostatic drugs; or</p> <p>The condition must be considered inappropriate for treatment with steroids and cytostatic drugs; AND</p> <p>Patient must not have renal impairment; AND</p> <p>Must be treated by a nephrologist.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Nephrotic syndrome</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must have failed prior treatment with steroids and cytostatic drugs; or</p> <p>Patient must be intolerant to treatment with steroids and cytostatic drugs; or</p> <p>The condition must be considered inappropriate for treatment with steroids and cytostatic drugs; AND</p> <p>Patient must not have renal impairment; AND</p> <p>Must be treated by a nephrologist.</p> | N | N | N | IMMEDIATE | ALL | N | 2019-11-01 | 3,671 |
9695_9695_R | Management (initiation, stabilisation and review of therapy) | STREAMLINED | 9,695 | 9,695 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe atopic dermatitis</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist; AND</p> <p>The condition must be ineffective to other systemic therapies; or</p> <p>The condition must be inappropriate for other systemic therapies.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Severe atopic dermatitis</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist; AND</p> <p>The condition must be ineffective to other systemic therapies; or</p> <p>The condition must be inappropriate for other systemic therapies.</p> | N | N | N | IMMEDIATE | ALL | N | 2019-11-01 | 3,671 |
9696_9696_R | null | STREAMLINED | 9,696 | 9,696 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Disorders of erythropoiesis</p><br/><p>The condition must be associated with treatment-related chronic iron overload.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Disorders of erythropoiesis</p><br/><p>The condition must be associated with treatment-related chronic iron overload.</p> | N | N | N | IMMEDIATE | ALL | N | 2019-11-01 | 3,671 |
9697_9697_R | null | STREAMLINED | 9,697 | 9,697 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Management of rejection in patients following organ or tissue transplantation</p><br/><p>The treatment must be under the supervision and direction of a transplant unit; AND</p> <p>The treatment must include initiation, stabilisation, and review of therapy as required.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Management of rejection in patients following organ or tissue transplantation</p><br/><p>The treatment must be under the supervision and direction of a transplant unit; AND</p> <p>The treatment must include initiation, stabilisation, and review of therapy as required.</p> | N | N | N | IMMEDIATE | ALL | N | 2019-11-01 | 3,671 |
9709_9656_R | Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) | AUTHORITY_REQUIRED | 9,656 | 9,709 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior 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>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; or</p> <p>Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220 and that is no more than 4 weeks old at the time of application; AND</p> <p>Patient must have evidence of intestinal inflammation; or</p> <p>Patient must be assessed clinically as being in a high faecal output state; or</p> <p>Patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient; AND</p> <p>The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">Applications for authorisation must be made in writing and must include:</p><p align="justify">(a) two completed authority prescription forms; and</p><p align="justify">(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and</p><p align="justify">(ii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and</p><p align="justify">(iii) the date of the most recent clinical assessment.</p> <p align="justify">Evidence of intestinal inflammation includes:</p><p align="justify">(i) blood: higher than normal platelet count, or, 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; or</p><p align="justify">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align="justify">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align="justify">Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 2 vials of 45 mg and no repeats.</p> <p align="justify">A maximum quantity of a weight based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg (2 vials of 45 mg) with no repeats provide for an initial 16 week course of this drug will be authorised.</p> <p align="justify">Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient's weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.</p> <p align="left">Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</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 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 Crohn disease</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior 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>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; or</p> <p>Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220 and that is no more than 4 weeks old at the time of application; AND</p> <p>Patient must have evidence of intestinal inflammation; or</p> <p>Patient must be assessed clinically as being in a high faecal output state; or</p> <p>Patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient; AND</p> <p>The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">Applications for authorisation must be made in writing and must include:</p><p align="justify">(a) two completed authority prescription forms; and</p><p align="justify">(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and</p><p align="justify">(ii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and</p><p align="justify">(iii) the date of the most recent clinical assessment.</p> <p align="justify">Evidence of intestinal inflammation includes:</p><p align="justify">(i) blood: higher than normal platelet count, or, 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; or</p><p align="justify">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align="justify">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align="justify">Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 2 vials of 45 mg and no repeats.</p> <p align="justify">A maximum quantity of a weight based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg (2 vials of 45 mg) with no repeats provide for an initial 16 week course of this drug will be authorised.</p> <p align="justify">Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient's weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.</p> <p align="left">Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</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 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">Increase in the maximum quantity or number of units up to 4 may be authorised for the purpose of weight-based loading dose.</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 | 2019-11-01 | 3,671 |
9720_9669_R | Balance of supply for paediatric patient | AUTHORITY_REQUIRED | 9,669 | 9,720 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe Crohn disease</p><br/><p>Balance of supply for paediatric patient</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 14 weeks therapy available under Initial 1, 2 or 3 treatment; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe Crohn disease</p><br/><p>Balance of supply for paediatric patient</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 14 weeks therapy available under Initial 1, 2 or 3 treatment; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment.</p> <p align="justify">Authority approval for sufficient therapy to complete the balance of supply may be requested by telephone by contacting the Department of Human Services 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 | 2019-11-01 | 3,671 |
9725_9754_R | Balance of supply | AUTHORITY_REQUIRED | 9,754 | 9,725 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 3 doses therapy available under Initial 1, 2 or 3 treatment; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 3 doses therapy available under Initial 1, 2 or 3 treatment; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment.</p> <p align="justify">Authority approval for sufficient therapy to complete the balance of supply may be requested by telephone by contacting the Department of Human Services 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 | 2019-11-01 | 3,671 |
9732_9732_R | Subsequent continuing treatment | STREAMLINED | 9,732 | 9,732 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug.</p> <p align="justify">An adequate response is defined as:</p><p align="justify">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align="justify">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align="justify">The measurement of response to the prior course of therapy must be documented in the patient's medical notes.</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">Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug.</p> <p align="justify">An adequate response is defined as:</p><p align="justify">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align="justify">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align="justify">The measurement of response to the prior course of therapy must be documented in the patient's medical notes.</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">Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.</p> | N | N | N | IMMEDIATE | ALL | N | 2019-11-01 | 3,671 |
9742_9742_R | Management (initiation, stabilisation and review of therapy) | STREAMLINED | 9,742 | 9,742 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>The condition must have been ineffective to prior treatment with classical slow-acting anti-rheumatic agents (including methotrexate); or</p> <p>The condition must be considered inappropriate for treatment with slow-acting anti-rheumatic agents (including methotrexate); AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Severe active rheumatoid arthritis</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>The condition must have been ineffective to prior treatment with classical slow-acting anti-rheumatic agents (including methotrexate); or</p> <p>The condition must be considered inappropriate for treatment with slow-acting anti-rheumatic agents (including methotrexate); AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist.</p> | N | N | N | IMMEDIATE | ALL | N | 2019-11-01 | 3,671 |
9746_9655_R | Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) | AUTHORITY_REQUIRED | 9,655 | 9,746 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <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 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 not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">Applications for authorisation must be made in writing and must include:</p><p align="justify">(a) two completed authority prescription forms; and</p><p align="justify">(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form, which includes the following:</p><p align="justify">(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or</p><p align="justify">(ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and</p><p align="justify">(iii) the date of clinical assessment; and</p><p align="justify">(iv) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align="justify">Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 2 vials of 45 mg and no repeats.</p> <p align="justify">A maximum quantity of a weight based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg (2 vials of 45 mg) with no repeats provide for an initial 16 week course of this drug will be authorised.</p> <p align="justify">Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient's weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.</p> <p align="left">Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction.</p> <p align="justify">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy for adalimumab or ustekinumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab 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 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 Crohn disease</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <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 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 not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">Applications for authorisation must be made in writing and must include:</p><p align="justify">(a) two completed authority prescription forms; and</p><p align="justify">(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form, which includes the following:</p><p align="justify">(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or</p><p align="justify">(ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and</p><p align="justify">(iii) the date of clinical assessment; and</p><p align="justify">(iv) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align="justify">Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 2 vials of 45 mg and no repeats.</p> <p align="justify">A maximum quantity of a weight based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg (2 vials of 45 mg) with no repeats provide for an initial 16 week course of this drug will be authorised.</p> <p align="justify">Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient's weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.</p> <p align="left">Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction.</p> <p align="justify">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy for adalimumab or ustekinumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab 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 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 align="justify">Increase in the maximum quantity or number of units up to 4 may be authorised for the purpose of weight-based loading dose.</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 | 2019-11-01 | 3,671 |
9747_9657_R | Continuing treatment | AUTHORITY_REQUIRED | 9,657 | 9,747 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; 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 an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; 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">Applications for authorisation must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form; and</p><p align="justify">(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or</p><p align="justify">(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and</p><p align="justify">(iii) the date of clinical assessment.</p> <p align="justify">All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application.</p> <p align="justify">An application for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be conducted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course.</p> <p align="left">The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion.</p> <p align="justify">Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, 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">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align="justify">At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats; up to 1 repeat will be authorised for patients whose dosing frequency is every 12 weeks. Up to a maximum of 2 repeats will be authorised for patients whose dosing frequency is every 8 weeks.</p> <p align="justify">Where an inadequate number of repeats are requested at the time of the application to complete a course of 24 weeks treatment, authority approvals for sufficient repeats to complete 24 weeks of treatment may be requested by telephone by contacting the Department of Human Services and applying through the Balance of Supply restriction. Under no circumstances will telephone approvals be granted for treatment that would otherwise extend continuing treatment beyond 24 months.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; 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 an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; 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">Applications for authorisation must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form; and</p><p align="justify">(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or</p><p align="justify">(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and</p><p align="justify">(iii) the date of clinical assessment.</p> <p align="justify">All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application.</p> <p align="justify">An application for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be conducted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course.</p> <p align="left">The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion.</p> <p align="justify">Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, 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">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align="justify">At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats; up to 1 repeat will be authorised for patients whose dosing frequency is every 12 weeks. Up to a maximum of 2 repeats will be authorised for patients whose dosing frequency is every 8 weeks.</p> <p align="justify">Where an inadequate number of repeats are requested at the time of the application to complete a course of 24 weeks treatment, authority approvals for sufficient repeats to complete 24 weeks of treatment may be requested by telephone by contacting the Department of Human Services and applying through the Balance of Supply restriction. Under no circumstances will telephone approvals be granted for treatment that would otherwise extend continuing treatment beyond 24 months.</p> <p align="justify">Increase in the maximum number of repeats of up to 2 may be authorised in patients whose dosing frequency is every 8 weeks.</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 | 2019-11-01 | 3,671 |
9750_9719_R | Subsequent continuing treatment | AUTHORITY_REQUIRED | 9,719 | 9,750 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND</p> <p>Patient must have a total PCDAI score of 30 points or less; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align="left">Applications for authorisation must be made in writing and must include:</p><p align="left">(a) a completed authority prescription form; and</p><p align="left">(b) a completed Paediatric Crohn Disease PBS Authority Application - Supporting Information Form, which includes the completed Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet along with the date of the assessment of the patient's condition.</p> <p align="justify">The PCDAI assessment must be no more than 1 month old at the time of application.</p> <p align="justify">Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.</p> <p align="justify">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.</p> <p align="left">If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND</p> <p>Patient must have a total PCDAI score of 30 points or less; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align="left">Applications for authorisation must be made in writing and must include:</p><p align="left">(a) a completed authority prescription form; and</p><p align="left">(b) a completed Paediatric Crohn Disease PBS Authority Application - Supporting Information Form, which includes the completed Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet along with the date of the assessment of the patient's condition.</p> <p align="justify">The PCDAI assessment must be no more than 1 month old at the time of application.</p> <p align="justify">Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.</p> <p align="justify">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.</p> <p align="left">If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period.</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 | 2019-11-01 | 3,671 |
9757_9783_R | First continuing treatment | AUTHORITY_REQUIRED | 9,783 | 9,757 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug.</p> <p align="justify">An adequate response is defined as:</p><p align="justify">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align="justify">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align="justify">Applications for authorisation must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form; and</p><p align="justify">(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition.</p> <p align="justify">The most recent fistula assessment must be no more than 1 month old at the time of application.</p> <p align="justify">The application for first continuing treatment with this drug must include an assessment of the patient's response to the initial course of treatment. The assessment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course.</p> <p align="justify">Where a response assessment is not provided within this 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">A maximum of 24 weeks of treatment with this drug will be authorised under this restriction.</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 for infusion<i>s</i> at a dose of 5 mg per kg eight weekly.</p> <p>Up to a maximum of 2 repeats will be authorised.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug.</p> <p align="justify">An adequate response is defined as:</p><p align="justify">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align="justify">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align="justify">Applications for authorisation must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form; and</p><p align="justify">(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition.</p> <p align="justify">The most recent fistula assessment must be no more than 1 month old at the time of application.</p> <p align="justify">The application for first continuing treatment with this drug must include an assessment of the patient's response to the initial course of treatment. The assessment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course.</p> <p align="justify">Where a response assessment is not provided within this 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">A maximum of 24 weeks of treatment with this drug will be authorised under this restriction.</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 for infusion<i>s</i> at a dose of 5 mg per kg eight weekly.</p> <p>Up to a maximum of 2 repeats will be authorised.</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 | 2019-11-01 | 3,671 |
9762_9762_R | Initiation and stabilisation | STREAMLINED | 9,762 | 9,762 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphosphataemia</p><br/><p>Initiation and stabilisation</p><br/><p>The condition must not be adequately controlled by calcium; AND</p> <p>Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; or</p> <p>The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND</p> <p>The treatment must not be used in combination with any other non-calcium phosphate binding agents; AND</p> <p>Patient must be undergoing dialysis for chronic kidney disease.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphosphataemia</p><br/><p>Initiation and stabilisation</p><br/><p>The condition must not be adequately controlled by calcium; AND</p> <p>Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; or</p> <p>The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND</p> <p>The treatment must not be used in combination with any other non-calcium phosphate binding agents; AND</p> <p>Patient must be undergoing dialysis for chronic kidney disease.</p> | N | N | N | IMMEDIATE | ALL | N | 2019-11-01 | 3,671 |
9764_9764_R | Management (initiation, stabilisation and review of therapy) | STREAMLINED | 9,764 | 9,764 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Management of transplant rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must have had an organ or tissue transplantation; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Management of transplant rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must have had an organ or tissue transplantation; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p> | N | N | N | IMMEDIATE | ALL | N | 2019-11-01 | 3,671 |
9769_9770_R | Continuing treatment | AUTHORITY_REQUIRED | 9,770 | 9,769 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align="justify">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align="justify">At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.</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>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align="justify">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align="justify">At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.</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">Authority applications for continuing treatment may be made by telephone to the Department of Human Services 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 | 2019-11-01 | 3,671 |
9772_9710_R | Initial treatment - Initial 1 (new patient) | AUTHORITY_REQUIRED | 9,710 | 9,772 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND</p> <p>Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; or</p> <p>Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; or</p> <p>Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND</p> <p>The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy; or</p> <p>Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; or</p> <p>Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below.</p> <p align="justify">Applications for authorisation must be made in writing and must include:</p><p align="justify">(a) two completed authority prescription forms; and</p><p align="justify">(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and</p><p align="justify">(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and</p><p align="justify">(iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and</p><p align="justify">(iv) the date of the most recent clinical assessment.</p> <p align="justify">Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following:</p><p align="justify">(a) patient must have evidence of intestinal inflammation;</p><p align="justify">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align="justify">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align="justify">Evidence of intestinal inflammation includes:</p><p align="justify">(i) blood: higher than normal platelet count, or, 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; or</p><p align="justify">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align="justify">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align="justify">Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 2 vials of 45 mg and no repeats.</p> <p align="justify">A maximum quantity of a weight based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg (2 vials of 45 mg) with no repeats provide for an initial 16 week course of this drug will be authorised.</p> <p align="justify">Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient's weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.</p> <p align="left">Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.</p> <p align="justify">All assessments, pathology tests and diagnostic imaging studies must be made within 1 month of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 1 month following cessation of the most recent prior treatment</p> <p align="justify">If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application. </p> <p/><p align="justify">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application. </p><p/> <p align="justify">Details of the accepted toxicities including severity can be found on the Department of Human Services website.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</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 Crohn disease</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND</p> <p>Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; or</p> <p>Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; or</p> <p>Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND</p> <p>The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy; or</p> <p>Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; or</p> <p>Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below.</p> <p align="justify">Applications for authorisation must be made in writing and must include:</p><p align="justify">(a) two completed authority prescription forms; and</p><p align="justify">(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and</p><p align="justify">(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and</p><p align="justify">(iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and</p><p align="justify">(iv) the date of the most recent clinical assessment.</p> <p align="justify">Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following:</p><p align="justify">(a) patient must have evidence of intestinal inflammation;</p><p align="justify">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align="justify">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align="justify">Evidence of intestinal inflammation includes:</p><p align="justify">(i) blood: higher than normal platelet count, or, 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; or</p><p align="justify">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align="justify">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align="justify">Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 2 vials of 45 mg and no repeats.</p> <p align="justify">A maximum quantity of a weight based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg (2 vials of 45 mg) with no repeats provide for an initial 16 week course of this drug will be authorised.</p> <p align="justify">Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient's weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.</p> <p align="left">Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.</p> <p align="justify">All assessments, pathology tests and diagnostic imaging studies must be made within 1 month of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 1 month following cessation of the most recent prior treatment</p> <p align="justify">If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application. </p> <p/><p align="justify">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application. </p><p/> <p align="justify">Details of the accepted toxicities including severity can be found on the Department of Human Services website.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</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 align="justify">Increase in the maximum quantity or number of units up to 4 may be authorised for the purpose of weight-based loading dose.</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 | 2019-11-01 | 3,671 |
9775_9775_R | Subsequent continuing treatment | STREAMLINED | 9,775 | 9,775 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND</p> <p>Patient must have a total PCDAI score of 30 points or less; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align="justify">The PCDAI assessment must be no more than 1 month old at the time of prescribing.</p> <p align="justify">The PCDAI score must be documented in the patient's medical notes as the measurement of response to the prior course of therapy.</p> <p align="justify">Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND</p> <p>Patient must have a total PCDAI score of 30 points or less; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align="justify">The PCDAI assessment must be no more than 1 month old at the time of prescribing.</p> <p align="justify">The PCDAI score must be documented in the patient's medical notes as the measurement of response to the prior course of therapy.</p> <p align="justify">Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.</p> | N | N | N | IMMEDIATE | ALL | N | 2019-11-01 | 3,671 |
9785_N | null | null | null | null | null | <p align="justify">Pharmaceutical benefits that have the form esomeprazole tablet 40 mg and pharmaceutical benefits that have the form esomeprazole capsule 40 mg are equivalent for the purposes of substitution.</p> | Y | N | N | null | null | N | 2015-07-01 | 3,671 |
9786_9677_R | Subsequent continuing treatment | AUTHORITY_REQUIRED | 9,677 | 9,786 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align="justify">An adequate response is defined as:</p><p align="justify">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align="justify">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align="justify">Applications for authorisation must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form; and</p><p align="justify">(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition.</p> <p align="justify">The most recent fistula assessment must be no more than 1 month old at the time of application.</p> <p align="justify">Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align="justify">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align="justify">An adequate response is defined as:</p><p align="justify">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align="justify">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align="justify">Applications for authorisation must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form; and</p><p align="justify">(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition.</p> <p align="justify">The most recent fistula assessment must be no more than 1 month old at the time of application.</p> <p align="justify">Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align="justify">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.</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 | 2019-11-01 | 3,671 |
9797_9711_R | Balance of supply | AUTHORITY_REQUIRED | 9,711 | 9,797 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (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 (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 (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 under the Continuing treatment restriction to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (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 (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 (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 under the Continuing treatment restriction to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment.</p> <p align="justify">Authority approval for sufficient therapy to complete the balance of supply may be requested by telephone by contacting the Department of Human Services 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 | 2019-11-01 | 3,671 |
9802_9803_R | Change or Recommencement of treatment after a break in therapy of less than 5 years (Initial 2) | AUTHORITY_REQUIRED | 9,803 | 9,802 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Change or Recommencement of treatment after a break in therapy of less than 5 years (Initial 2)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <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 failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle.</p> <p align="justify">Applications for authorisation must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form; and</p><p align="justify">(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and</p><p align="justify">(ii) details of prior biological medicine treatment including details of date and duration of treatment.</p> <p align="justify">The most recent fistula assessment must be no more than 1 month old at the time of application.</p> <p align="justify">Where the most recent course of PBS-subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction.</p> <p align="justify">If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine.</p> <p align="justify">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align="justify">An assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (up to 6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.</p> <p align="justify">This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.</p> <p align="justify">Where a response assessment is not provided within this 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> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Change or Recommencement of treatment after a break in therapy of less than 5 years (Initial 2)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <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 failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle.</p> <p align="justify">Applications for authorisation must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form; and</p><p align="justify">(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and</p><p align="justify">(ii) details of prior biological medicine treatment including details of date and duration of treatment.</p> <p align="justify">The most recent fistula assessment must be no more than 1 month old at the time of application.</p> <p align="justify">Where the most recent course of PBS-subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction.</p> <p align="justify">If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine.</p> <p align="justify">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align="justify">An assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (up to 6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.</p> <p align="justify">This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.</p> <p align="justify">Where a response assessment is not provided within this 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">It is recommended that an application for the first continuing treatment is submitted to the Department of Human Services at the time of the 12 week assessment, to ensure continuity of treatment for those patients who meet the first continuing treatment criteria for PBS-subsidised treatment with this drug.</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 | 2019-11-01 | 3,671 |
9804_9787_R | Subsequent continuing treatment | STREAMLINED | 9,787 | 9,804 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug.</p> <p align="justify">An adequate response is defined as:</p><p align="justify">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align="justify">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align="justify">The measurement of response to the prior course of therapy must be documented in the patient's medical notes.</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">Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug.</p> <p align="justify">An adequate response is defined as:</p><p align="justify">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align="justify">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align="justify">The measurement of response to the prior course of therapy must be documented in the patient's medical notes.</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">Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.</p> | N | N | N | IMMEDIATE | ALL | N | 2019-11-01 | 3,671 |
9809_9809_R | Management | STREAMLINED | 9,809 | 9,809 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>WHO Class III, IV or V lupus nephritis</p><br/><p>Management</p><br/><p>The condition must be proven by biopsy; AND</p> <p>Must be treated by a nephrologist or in consultation with a nephrologist.</p> <p align="justify">The name of the consulting nephrologist must be included in the patient medical records.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>WHO Class III, IV or V lupus nephritis</p><br/><p>Management</p><br/><p>The condition must be proven by biopsy; AND</p> <p>Must be treated by a nephrologist or in consultation with a nephrologist.</p> <p align="justify">The name of the consulting nephrologist must be included in the patient medical records.</p> <p>Management includes initiation, stabilisation and review of therapy as required.</p> | N | N | N | IMMEDIATE | ALL | N | 2019-11-01 | 3,671 |
9813_9822_R | Initial treatment - Initial 1 (new patient) | AUTHORITY_REQUIRED | 9,822 | 9,813 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND</p> <p>Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">Application for authorisation of initial treatment must be in writing and must include:</p><p align="justify">(a) a completed authority prescription form; and</p><p align="justify">(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and</p><p align="justify">(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].</p> <p align="justify">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align="left">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align="justify">A partial Mayo clinic assessment of the patient's response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.</p> <p align="justify">A maximum of 14 weeks of treatment with this drug will be approved under this criterion. A loading dose of 200 mg at week 0 and a dose of 100 mg at weeks 2, 6 and 10.</p> <p align="justify">If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</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">Details of the accepted toxicities including severity can be found on the Department of Human Services website.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND</p> <p>Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">Application for authorisation of initial treatment must be in writing and must include:</p><p align="justify">(a) a completed authority prescription form; and</p><p align="justify">(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and</p><p align="justify">(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].</p> <p align="justify">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align="left">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align="justify">A partial Mayo clinic assessment of the patient's response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.</p> <p align="justify">A maximum of 14 weeks of treatment with this drug will be approved under this criterion. A loading dose of 200 mg at week 0 and a dose of 100 mg at weeks 2, 6 and 10.</p> <p align="justify">If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</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">Details of the accepted toxicities including severity can be found on the Department of Human Services website.</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 | 2019-11-01 | 3,671 |
9816_9721_R | First continuing treatment | AUTHORITY_REQUIRED | 9,721 | 9,816 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe Crohn disease</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; 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 a reduction in PCDAI Score by at least 15 points from baseline value; AND</p> <p>Patient must have a total PCDAI score of 30 points or less; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align="left">Applications for authorisation must be made in writing and must include:</p><p align="left">(a) a completed authority prescription form; and</p><p align="left">(b) a completed Paediatric Crohn Disease PBS Authority Application - Supporting Information Form, which includes the completed Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet along with the date of the assessment of the patient's condition.</p> <p align="justify">The PCDAI assessment must be no more than 1 month old at the time of application.</p> <p align="justify">The application for first continuing treatment with this drug must include a PCDAI assessment of the patient's response to the initial course of treatment. The assessment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course.</p> <p align="justify">Where a response assessment is not provided within this 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 quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.</p> <p align="left">If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe Crohn disease</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; 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 a reduction in PCDAI Score by at least 15 points from baseline value; AND</p> <p>Patient must have a total PCDAI score of 30 points or less; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align="left">Applications for authorisation must be made in writing and must include:</p><p align="left">(a) a completed authority prescription form; and</p><p align="left">(b) a completed Paediatric Crohn Disease PBS Authority Application - Supporting Information Form, which includes the completed Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet along with the date of the assessment of the patient's condition.</p> <p align="justify">The PCDAI assessment must be no more than 1 month old at the time of application.</p> <p align="justify">The application for first continuing treatment with this drug must include a PCDAI assessment of the patient's response to the initial course of treatment. The assessment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course.</p> <p align="justify">Where a response assessment is not provided within this 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 quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.</p> <p align="left">If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period.</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 | 2019-11-01 | 3,671 |
9820_9651_R | Continuing treatment - balance of supply | AUTHORITY_REQUIRED | 9,651 | 9,820 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment 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 this restriction.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment 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 this restriction.</p> <p align="justify">Authority approval for sufficient therapy to complete the balance of supply may be requested by telephone by contacting the Department of Human Services 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 | 2019-11-01 | 3,671 |
9821_9823_R | Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) | AUTHORITY_REQUIRED | 9,823 | 9,821 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <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 this drug for this condition during the current treatment cycle; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">Application for authorisation must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form; and</p><p align="justify">(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition if relevant; and</p><p align="justify">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align="justify">A maximum of 14 weeks of treatment with this drug will be approved under this criterion. A loading dose of 200 mg at week 0 and a dose of 100 mg at weeks 2, 6 and 10.</p> <p align="justify">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align="justify">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab 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 who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. 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>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <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 this drug for this condition during the current treatment cycle; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">Application for authorisation must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form; and</p><p align="justify">(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:</p><p align="justify">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition if relevant; and</p><p align="justify">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align="justify">A maximum of 14 weeks of treatment with this drug will be approved under this criterion. A loading dose of 200 mg at week 0 and a dose of 100 mg at weeks 2, 6 and 10.</p> <p align="justify">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align="justify">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab 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 who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. 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 | 2019-11-01 | 3,671 |
9828_9828_R | null | STREAMLINED | 9,828 | 9,828 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bronchospasm</p><br/><p>Patient must be unable to achieve co-ordinated use of a metered dose inhaler containing a short-acting beta-2 agonist; or</p> <p>Patient must have developed a clinically important product-related adverse event during treatment with another short-acting beta-2 agonist.</p> <p align="justify">Device (inhaler) technique should be reviewed at each clinical visit and before initiating treatment with this medicine.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bronchospasm</p><br/><p>Patient must be unable to achieve co-ordinated use of a metered dose inhaler containing a short-acting beta-2 agonist; or</p> <p>Patient must have developed a clinically important product-related adverse event during treatment with another short-acting beta-2 agonist.</p> <p align="justify">Device (inhaler) technique should be reviewed at each clinical visit and before initiating treatment with this medicine.</p> | N | N | N | IMMEDIATE | ALL | N | 2019-11-01 | 3,671 |
9831_9831_R | null | STREAMLINED | 9,831 | 9,831 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Management of transplant rejection</p><br/><p>The treatment must be used by organ or tissue transplant recipients.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Management of transplant rejection</p><br/><p>The treatment must be used by organ or tissue transplant recipients.</p> | N | N | N | IMMEDIATE | ALL | N | 2019-11-01 | 3,671 |
9908_9987_R | Initial treatment | STREAMLINED | 9,987 | 9,908 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Initial treatment</p><br/><p>Patient must be antiretroviral treatment naive; AND</p> <p>Patient must not have suspected resistance to either antiretroviral component.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Initial treatment</p><br/><p>Patient must be antiretroviral treatment naive; AND</p> <p>Patient must not have suspected resistance to either antiretroviral component.</p> | N | N | N | IMMEDIATE | ALL | N | 2019-12-01 | 3,671 |
9914_9914_R | Management (initiation, stabilisation and review of therapy) | STREAMLINED | 9,914 | 9,914 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Management of renal allograft rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Management of renal allograft rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p> | N | N | N | IMMEDIATE | ALL | N | 2019-12-01 | 3,671 |
9915_N | null | null | null | null | null | <p align="justify">Unlike Symbicort Turbuhaler 200/6, Symbicort Rapihaler 200/6 is not recommended nor PBS-subsidised for use as 'maintenance and reliever' therapy as the approved Product Information does not specify such use.</p> | Y | N | N | null | null | N | 2014-01-01 | 3,671 |
9927_9334_R | null | STREAMLINED | 9,334 | 9,927 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe spasticity of the lower limb following an acute event</p><br/><p>Must be treated by a neurologist; or</p> <p>Must be treated by an orthopaedic surgeon; or</p> <p>Must be treated by a rehabilitation specialist; or</p> <p>Must be treated by a plastic surgeon; or</p> <p>Must be treated by a geriatrician; AND</p> <p>The condition must be moderate to severe spasticity of the lower limb/s following stroke or other acute neurological event, defined as a Modified Ashworth Scale rating of 3 or more; AND</p> <p>The treatment must only be used as second line therapy when standard management has failed; or</p> <p>The treatment must only be used as an adjunct to physical therapy; AND</p> <p>The treatment must not continue if the patient does not respond (defined as not having had a decrease in spasticity rating of at least 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A); AND</p> <p>Patient must not have established severe contracture in the limb to be treated; AND</p> <p>The treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per lower limb in the the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per lower limb each year thereafter; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">Standard management includes physiotherapy and/or oral spasticity agents.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe spasticity of the lower limb following an acute event</p><br/><p>Must be treated by a neurologist; or</p> <p>Must be treated by an orthopaedic surgeon; or</p> <p>Must be treated by a rehabilitation specialist; or</p> <p>Must be treated by a plastic surgeon; or</p> <p>Must be treated by a geriatrician; AND</p> <p>The condition must be moderate to severe spasticity of the lower limb/s following stroke or other acute neurological event, defined as a Modified Ashworth Scale rating of 3 or more; AND</p> <p>The treatment must only be used as second line therapy when standard management has failed; or</p> <p>The treatment must only be used as an adjunct to physical therapy; AND</p> <p>The treatment must not continue if the patient does not respond (defined as not having had a decrease in spasticity rating of at least 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A); AND</p> <p>Patient must not have established severe contracture in the limb to be treated; AND</p> <p>The treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per lower limb in the the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per lower limb each year thereafter; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">Standard management includes physiotherapy and/or oral spasticity agents.</p> | N | N | N | IMMEDIATE | ALL | N | 2019-12-01 | 3,671 |
9956_9981_R | Initial treatment | STREAMLINED | 9,981 | 9,956 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Initial treatment</p><br/><p>Patient must be antiretroviral treatment naive.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Initial treatment</p><br/><p>Patient must be antiretroviral treatment naive.</p> | N | N | N | IMMEDIATE | ALL | N | 2019-12-01 | 3,671 |
9977_N | null | null | null | null | null | <p align="justify">Pharmaceutical benefits that have the forms doxycycline tablet 100 mg (as hyclate (hydrochloride)), doxycycline tablet 100 mg (as monohydrate) and doxycycline modified release capsule 100 mg (as hyclate (hydrochloride)) are equivalent for the purposes of substitution.</p> | Y | N | N | null | null | N | 2014-04-01 | 3,671 |
9991_9993_R | Initial treatment | STREAMLINED | 9,993 | 9,991 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urea cycle disorders</p><br/><p>Initial treatment</p><br/><p>Patient must have elevated ammonia levels that are not controlled with diet alone and other adjunct care alone.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">An increase in the maximum quantity will be authorised to provide for up to one month's supply at a dose of up to 600 mg/kg/day in patients weighing less than 20 kg and up to 13 g/m<sup>2</sup>/day in patients weighing more than 20 kg.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urea cycle disorders</p><br/><p>Initial treatment</p><br/><p>Patient must have elevated ammonia levels that are not controlled with diet alone and other adjunct care alone.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">An increase in the maximum quantity will be authorised to provide for up to one month's supply at a dose of up to 600 mg/kg/day in patients weighing less than 20 kg and up to 13 g/m<sup>2</sup>/day in patients weighing more than 20 kg.</p> | N | N | N | IMMEDIATE | ALL | Y | 2019-12-01 | 3,671 |
9992_9919_R | Continuing treatment | STREAMLINED | 9,919 | 9,992 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urea cycle disorders</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">An increase in the maximum quantity will be authorised to provide for up to one month's supply at a dose of up to 600 mg/kg/day in patients weighing less than 20 kg and up to 13 g/m<sup>2</sup>/day in patients weighing more than 20 kg.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urea cycle disorders</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">An increase in the maximum quantity will be authorised to provide for up to one month's supply at a dose of up to 600 mg/kg/day in patients weighing less than 20 kg and up to 13 g/m<sup>2</sup>/day in patients weighing more than 20 kg.</p> | N | N | N | IMMEDIATE | ALL | Y | 2019-12-01 | 3,671 |
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