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10041_6898_R | null | STREAMLINED | 6,898 | 10,041 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe behavioural disturbances</p><br/><p>Patient must have autism spectrum disorder; AND</p> <p>The treatment must be under the supervision of a paediatrician or psychiatrist; AND</p> <p>The treatment must be in combination with non-pharmacological measures; AND</p> <p>Patient must be under 18 years of age.</p> <p align="justify">Behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful.</p> <p align="justify">The diagnosis of autism spectrum disorder must be made based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) or ICD-10 international classification of mental and behavioural disorders.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe behavioural disturbances</p><br/><p>Patient must have autism spectrum disorder; AND</p> <p>The treatment must be under the supervision of a paediatrician or psychiatrist; AND</p> <p>The treatment must be in combination with non-pharmacological measures; AND</p> <p>Patient must be under 18 years of age.</p> <p align="justify">Behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful.</p> <p align="justify">The diagnosis of autism spectrum disorder must be made based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) or ICD-10 international classification of mental and behavioural disorders.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-01-01 | 3,671 |
10045_10033_R | Initial treatment | STREAMLINED | 10,033 | 10,045 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Initial treatment</p><br/><p>Patient must be receiving PBS subsidised vemurafenib concomitantly for this condition.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Initial treatment</p><br/><p>Patient must be receiving PBS subsidised vemurafenib concomitantly for this condition.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-01-01 | 3,671 |
10046_10021_R | Continuing treatment, trial of dose reduction or cessation of treatment | AUTHORITY_REQUIRED | 10,021 | 10,046 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Behavioural disturbances</p><br/><p>Continuing treatment, trial of dose reduction or cessation of treatment</p><br/><p>The condition must be characterised by psychotic symptoms and aggression; AND</p> <p>Patient must have dementia of the Alzheimer type; AND</p> <p>Patient must have responded to an initial course of treatment with this drug for this condition; AND</p> <p>Patient must have failed to respond to non-pharmacological methods of treatment; AND</p> <p>The treatment must be for dose tapering purposes as part of a trial of treatment reduction or cessation; or</p> <p>Patient must have trialled a period of treatment reduction or cessation with this drug for this condition and experienced worsening or re-emergence of symptoms during this trial, and retrials are considered periodically; AND</p> <p>Patient must be optimised on non-pharmacological methods of treatment.</p> <p align="justify">The patient's response to treatment and a trial of treatment reduction or cessation must be discussed formally with a psychiatrist or geriatrician or in a documented clinical review process involving a least one other medical practitioner, or be reviewed by a psychiatrist or geriatrician.</p> <p align="justify">Response to treatment is defined as a significant reduction in symptoms of psychosis or aggression.</p> <p align="justify">Patients must cease treatment if there is no improvement in symptoms of psychosis and aggression, or worsening of symptoms with therapy.</p> <p align="justify">Patients must be monitored for adverse effects such as falls, drowsiness leading to reduced self-care, incontinence, reduced nutrition, reduced ability to communicate needs/wishes and take part in activities. Therapy must be ceased if harms of therapy outweigh benefits.</p> <p align="justify">Trials of reduction or cessation of therapy should be considered periodically with the intention of maintaining symptom control through non-pharmacological measures wherever possible and/or lowest effective dose therapy.</p> <p align="justify">Evidence of patient benefit from therapy, failure of non-pharmacological approaches to manage symptoms in the absence of therapy, and recurrence of symptoms following reduction or cessation of therapy, trialled on at least 1 occasion, must be documented in the patient's medical records.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Behavioural disturbances</p><br/><p>Continuing treatment, trial of dose reduction or cessation of treatment</p><br/><p>The condition must be characterised by psychotic symptoms and aggression; AND</p> <p>Patient must have dementia of the Alzheimer type; AND</p> <p>Patient must have responded to an initial course of treatment with this drug for this condition; AND</p> <p>Patient must have failed to respond to non-pharmacological methods of treatment; AND</p> <p>The treatment must be for dose tapering purposes as part of a trial of treatment reduction or cessation; or</p> <p>Patient must have trialled a period of treatment reduction or cessation with this drug for this condition and experienced worsening or re-emergence of symptoms during this trial, and retrials are considered periodically; AND</p> <p>Patient must be optimised on non-pharmacological methods of treatment.</p> <p align="justify">The patient's response to treatment and a trial of treatment reduction or cessation must be discussed formally with a psychiatrist or geriatrician or in a documented clinical review process involving a least one other medical practitioner, or be reviewed by a psychiatrist or geriatrician.</p> <p align="justify">Response to treatment is defined as a significant reduction in symptoms of psychosis or aggression.</p> <p align="justify">Patients must cease treatment if there is no improvement in symptoms of psychosis and aggression, or worsening of symptoms with therapy.</p> <p align="justify">Patients must be monitored for adverse effects such as falls, drowsiness leading to reduced self-care, incontinence, reduced nutrition, reduced ability to communicate needs/wishes and take part in activities. Therapy must be ceased if harms of therapy outweigh benefits.</p> <p align="justify">Trials of reduction or cessation of therapy should be considered periodically with the intention of maintaining symptom control through non-pharmacological measures wherever possible and/or lowest effective dose therapy.</p> <p align="justify">Evidence of patient benefit from therapy, failure of non-pharmacological approaches to manage symptoms in the absence of therapy, and recurrence of symptoms following reduction or cessation of therapy, trialled on at least 1 occasion, must be documented in the patient's medical records.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-01-01 | 3,671 |
10058_10051_R | Initial treatment | STREAMLINED | 10,051 | 10,058 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Initial treatment</p><br/><p>Patient must be receiving PBS-subsidised dabrafenib concomitantly for this condition.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Initial treatment</p><br/><p>Patient must be receiving PBS-subsidised dabrafenib concomitantly for this condition.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-01-01 | 3,671 |
10059_10020_R | Initial treatment | STREAMLINED | 10,020 | 10,059 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Behavioural disturbances</p><br/><p>Initial treatment</p><br/><p>The condition must be characterised by psychotic symptoms and aggression; AND</p> <p>Patient must have dementia of the Alzheimer type; AND</p> <p>Patient must have failed to respond to non-pharmacological methods of treatment; AND</p> <p>Patient must not receive more than 12 weeks of treatment under this restriction.</p> <p align="justify">A patient may only qualify for 12 weeks of PBS-subsidised treatment under this restriction once in a 12 month period.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Behavioural disturbances</p><br/><p>Initial treatment</p><br/><p>The condition must be characterised by psychotic symptoms and aggression; AND</p> <p>Patient must have dementia of the Alzheimer type; AND</p> <p>Patient must have failed to respond to non-pharmacological methods of treatment; AND</p> <p>Patient must not receive more than 12 weeks of treatment under this restriction.</p> <p align="justify">A patient may only qualify for 12 weeks of PBS-subsidised treatment under this restriction once in a 12 month period.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-01-01 | 3,671 |
10061_10061_R | null | STREAMLINED | 10,061 | 10,061 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)</p><br/><p>The condition must be unresectable locally advanced disease or metastatic disease; AND</p> <p>The condition must be World Health Organisation (WHO) grade 1 or 2; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.</p> <p align="justify">WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)</p><br/><p>The condition must be unresectable locally advanced disease or metastatic disease; AND</p> <p>The condition must be World Health Organisation (WHO) grade 1 or 2; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.</p> <p align="justify">WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-02-01 | 3,671 |
10063_10063_R | Continuing treatment | STREAMLINED | 10,063 | 10,063 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Secondary hyperparathyroidism</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a nephrologist; AND</p> <p>Patient must have chronic kidney disease; AND</p> <p>Patient must be on dialysis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p> <p align="justify">During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.</p> <p align="justify">During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient's response and tolerability.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Secondary hyperparathyroidism</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a nephrologist; AND</p> <p>Patient must have chronic kidney disease; AND</p> <p>Patient must be on dialysis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p> <p align="justify">During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.</p> <p align="justify">During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient's response and tolerability.</p> <p align="justify">"Sustained" means the abnormality was detected on at least 2 blood samples collected over a period of 2 to 4 months.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-02-01 | 3,671 |
10067_10067_R | Continuing treatment | STREAMLINED | 10,067 | 10,067 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Secondary hyperparathyroidism</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a nephrologist; AND</p> <p>Patient must have chronic kidney disease; AND</p> <p>Patient must be on dialysis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p> <p align="justify">During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.</p> <p align="justify">During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient's response and tolerability.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Secondary hyperparathyroidism</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a nephrologist; AND</p> <p>Patient must have chronic kidney disease; AND</p> <p>Patient must be on dialysis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p> <p align="justify">During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.</p> <p align="justify">During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient's response and tolerability.</p> <p align="justify">"Sustained" means the abnormality was detected on at least 2 blood samples collected over a period of 2 to 4 months.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-02-01 | 3,671 |
10068_10068_R | Continuing treatment | STREAMLINED | 10,068 | 10,068 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Secondary hyperparathyroidism</p><br/><p>Continuing treatment</p><br/><p>Patient must have chronic kidney disease; AND</p> <p>Patient must be on dialysis; AND</p> <p>Patient must have achieved a decrease of at least 30% in intact parathyroid hormone (iPTH) concentrations after 6 months treatment; or</p> <p>Patient must have an intact parathyroid (iPTH) concentration greater than 15 pmol/L and an (adjusted) serum calcium concentration of less than 2.6 mmol/L after 6 months.</p> <p align="justify">During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.</p> <p align="justify">During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient's response and tolerability.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Secondary hyperparathyroidism</p><br/><p>Continuing treatment</p><br/><p>Patient must have chronic kidney disease; AND</p> <p>Patient must be on dialysis; AND</p> <p>Patient must have achieved a decrease of at least 30% in intact parathyroid hormone (iPTH) concentrations after 6 months treatment; or</p> <p>Patient must have an intact parathyroid (iPTH) concentration greater than 15 pmol/L and an (adjusted) serum calcium concentration of less than 2.6 mmol/L after 6 months.</p> <p align="justify">During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.</p> <p align="justify">During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient's response and tolerability.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-02-01 | 3,671 |
10072_10077_R | null | STREAMLINED | 10,077 | 10,072 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)</p><br/><p>The condition must be unresectable locally advanced disease or metastatic disease; AND</p> <p>The condition must be World Health Organisation (WHO) grade 1 or 2; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.</p> <p align="justify">WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)</p><br/><p>The condition must be unresectable locally advanced disease or metastatic disease; AND</p> <p>The condition must be World Health Organisation (WHO) grade 1 or 2; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.</p> <p align="justify">WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-02-01 | 3,671 |
10073_10073_R | Initial treatment | AUTHORITY_REQUIRED | 10,073 | 10,073 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Secondary hyperparathyroidism</p><br/><p>Initial treatment</p><br/><p>Must be treated by a nephrologist; AND</p> <p>Patient must have chronic kidney disease; AND</p> <p>Patient must be on dialysis; AND</p> <p>Patient must have failed to respond to conventional therapy; AND</p> <p>Patient must have sustained hyperparathyroidism with iPTH of at least 50 pmol per L; or</p> <p>Patient must have sustained hyperparathyroidism with iPTH of at least 15 pmol per L and less than 50 pmol per L and an (adjusted) serum calcium concentration at least 2.6 mmol per L.</p> <p align="justify">During the titration phase, intact PTH (iPTH) should be monitored 4 weekly (measured at least 12 hours post dose) and dose titrated until an appropriate iPTH concentration is achieved.</p> <p align="justify">During the titration phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment at a time, with doses between 30 and 180 mg per day according to the patient's response and tolerability.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Secondary hyperparathyroidism</p><br/><p>Initial treatment</p><br/><p>Must be treated by a nephrologist; AND</p> <p>Patient must have chronic kidney disease; AND</p> <p>Patient must be on dialysis; AND</p> <p>Patient must have failed to respond to conventional therapy; AND</p> <p>Patient must have sustained hyperparathyroidism with iPTH of at least 50 pmol per L; or</p> <p>Patient must have sustained hyperparathyroidism with iPTH of at least 15 pmol per L and less than 50 pmol per L and an (adjusted) serum calcium concentration at least 2.6 mmol per L.</p> <p align="justify">During the titration phase, intact PTH (iPTH) should be monitored 4 weekly (measured at least 12 hours post dose) and dose titrated until an appropriate iPTH concentration is achieved.</p> <p align="justify">During the titration phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment at a time, with doses between 30 and 180 mg per day according to the patient's response and tolerability.</p> <p align="justify">"Sustained" means the abnormality was detected on at least 2 blood samples collected over a period of 2 to 4 months.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-02-01 | 3,671 |
10075_10075_R | null | STREAMLINED | 10,075 | 10,075 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must be unresectable locally advanced disease or metastatic disease; AND</p> <p>The condition must be World Health Organisation (WHO) grade 1 or 2; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.</p> <p align="justify">WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must be unresectable locally advanced disease or metastatic disease; AND</p> <p>The condition must be World Health Organisation (WHO) grade 1 or 2; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.</p> <p align="justify">WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-02-01 | 3,671 |
10080_10076_R | Initial treatment | AUTHORITY_REQUIRED | 10,076 | 10,080 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphenylalaninaemia</p><br/><p>Initial treatment</p><br/><p>Must be treated by a metabolic physician; AND</p> <p>Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency.</p> <p align="justify">Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphenylalaninaemia</p><br/><p>Initial treatment</p><br/><p>Must be treated by a metabolic physician; AND</p> <p>Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency.</p> <p align="justify">Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.</p> <p align="justify">Patient will be eligible for a maximum of one PBS-subsidised prescription as initial therapy to enable their response to treatment with sapropterin to be assessed.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-02-01 | 3,671 |
10086_10121_R | null | STREAMLINED | 10,121 | 10,086 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p><br/><p>Patient must have significant symptoms despite regular beta-2 agonist bronchodilator therapy; AND</p> <p>Patient must have experienced at least one severe COPD exacerbation, which required hospitalisation, or two or more moderate exacerbations in the previous 12 months.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p><br/><p>Patient must have significant symptoms despite regular beta-2 agonist bronchodilator therapy; AND</p> <p>Patient must have experienced at least one severe COPD exacerbation, which required hospitalisation, or two or more moderate exacerbations in the previous 12 months.</p> <p/><p align="justify">This product is not indicated for the initiation of bronchodilator therapy in COPD. </p><p/> <p align="justify">The treatment must not be used in combination with LABA monotherapy or LAMA/LABA combination therapy.</p> <p align="justify">A LAMA/LABA includes aclidinium/formoterol, glycopyrronium/indacaterol, tiotropium/olodaterol, or umeclidinium/vilanterol.</p> <p align="justify">Diagnosis of COPD should include measurement of airflow obstruction using spirometry, with confirmation of post-bronchodilator airflow obstruction.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-03-01 | 3,671 |
10087_10157_R | Initial treatment | STREAMLINED | 10,157 | 10,087 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Initial treatment</p><br/><p>The condition must be positive for a BRAF V600 mutation; AND</p> <p>The condition must not have been treated previously with PBS-subsidised BRAF inhibitor therapy for unresectable Stage III or Stage IV disease; or</p> <p>Patient must have developed intolerance to other BRAF inhibitors of a severity necessitating permanent treatment withdrawal; AND</p> <p>Patient must not have experienced disease progression whilst on adjuvant BRAF inhibitor treatment or disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment if previously treated for resected Stage IIIB, IIIC or IIID melanoma; AND</p> <p>Patient must have a WHO performance status of 2 or less.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Initial treatment</p><br/><p>The condition must be positive for a BRAF V600 mutation; AND</p> <p>The condition must not have been treated previously with PBS-subsidised BRAF inhibitor therapy for unresectable Stage III or Stage IV disease; or</p> <p>Patient must have developed intolerance to other BRAF inhibitors of a severity necessitating permanent treatment withdrawal; AND</p> <p>Patient must not have experienced disease progression whilst on adjuvant BRAF inhibitor treatment or disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment if previously treated for resected Stage IIIB, IIIC or IIID melanoma; AND</p> <p>Patient must have a WHO performance status of 2 or less.</p> <p/><p align="justify">A patient who has had progressive disease when treated with another BRAF inhibitor is not eligible to receive PBS-subsidised treatment with this drug.</p><p/> | N | N | N | IMMEDIATE | ALL | N | 2020-03-01 | 3,671 |
10089_4295_R | null | RESTRICTED | 4,295 | 10,089 | <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 product is low in folic acid, choline and methionine and is not intended as a sole source of nutrition.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-03-01 | 3,671 |
10095_10095_R | null | RESTRICTED | 10,095 | 10,095 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe eye inflammation</p><br/><p>Patient must have had a cataract removed in the treated eye; or</p> <p>Patient must be scheduled for cataract surgery in the treated eye; AND</p> <p>Patient must identify as Aboriginal or Torres Strait Islander.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe eye inflammation</p><br/><p>Patient must have had a cataract removed in the treated eye; or</p> <p>Patient must be scheduled for cataract surgery in the treated eye; AND</p> <p>Patient must identify as Aboriginal or Torres Strait Islander.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-03-01 | 3,671 |
10111_10130_R | Continuing treatment | AUTHORITY_REQUIRED | 10,130 | 10,111 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for trametinib and dabrafenib concomitantly for adjuvant treatment following complete surgical resection; AND</p> <p>Patient must not have experienced disease recurrence; AND</p> <p>Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for trametinib and dabrafenib concomitantly for adjuvant treatment following complete surgical resection; AND</p> <p>Patient must not have experienced disease recurrence; AND</p> <p>Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-03-01 | 3,671 |
10119_10119_R | Initial treatment | AUTHORITY_REQUIRED | 10,119 | 10,119 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected Stage IIIB, IIIC, IIID or Stage IV malignant melanoma</p><br/><p>Initial treatment</p><br/><p>The treatment must be adjuvant to complete surgical resection; AND</p> <p>Patient must have a WHO performance status of 1 or less; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have received prior PBS-subsidised treatment for this condition; AND</p> <p>The treatment must commence within 12 weeks of complete resection; AND</p> <p>Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.</p> <p align="justify">Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected Stage IIIB, IIIC, IIID or Stage IV malignant melanoma</p><br/><p>Initial treatment</p><br/><p>The treatment must be adjuvant to complete surgical resection; AND</p> <p>Patient must have a WHO performance status of 1 or less; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have received prior PBS-subsidised treatment for this condition; AND</p> <p>The treatment must commence within 12 weeks of complete resection; AND</p> <p>Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.</p> <p align="justify">Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.</p> <p align="justify">In the first few months after start of immunotherapy, some patients can have a transient tumour flare with subsequent disease response. When progression is suspected, this should be confirmed through a confirmatory scan, taken at least 4 weeks later.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-03-01 | 3,671 |
10120_10120_R | Continuing treatment | AUTHORITY_REQUIRED | 10,120 | 10,120 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected Stage IIIB, IIIC, IIID or Stage IV malignant melanoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for this drug for adjuvant treatment following complete surgical resection; AND</p> <p>Patient must not have experienced disease recurrence; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.</p> <p align="justify">Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected Stage IIIB, IIIC, IIID or Stage IV malignant melanoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for this drug for adjuvant treatment following complete surgical resection; AND</p> <p>Patient must not have experienced disease recurrence; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.</p> <p align="justify">Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-03-01 | 3,671 |
10129_10148_R | Initial treatment | AUTHORITY_REQUIRED | 10,148 | 10,129 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma</p><br/><p>Initial treatment</p><br/><p>The treatment must be adjuvant to complete surgical resection; AND</p> <p>The condition must be positive for a BRAF V600 mutation; AND</p> <p>Patient must have a WHO performance status of 1 or less; AND</p> <p>Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition; AND</p> <p>Patient must not have received prior PBS-subsidised treatment for this condition; AND</p> <p>The treatment must commence within 12 weeks of complete resection; AND</p> <p>Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma</p><br/><p>Initial treatment</p><br/><p>The treatment must be adjuvant to complete surgical resection; AND</p> <p>The condition must be positive for a BRAF V600 mutation; AND</p> <p>Patient must have a WHO performance status of 1 or less; AND</p> <p>Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition; AND</p> <p>Patient must not have received prior PBS-subsidised treatment for this condition; AND</p> <p>The treatment must commence within 12 weeks of complete resection; AND</p> <p>Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-03-01 | 3,671 |
10138_10138_R | null | STREAMLINED | 10,138 | 10,138 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND</p> <p>The treatment must be commenced in a hospital-based movement disorder clinic.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND</p> <p>The treatment must be commenced in a hospital-based movement disorder clinic.</p> <p align="justify">Patients should have adequate cognitive function to manage administration with a portable continuous infusion pump.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-03-01 | 3,671 |
10161_10161_R | null | STREAMLINED | 10,161 | 10,161 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND</p> <p>The treatment must be commenced in a hospital-based movement disorder clinic.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND</p> <p>The treatment must be commenced in a hospital-based movement disorder clinic.</p> <p align="justify">Patients should have adequate cognitive function to manage administration with a portable continuous infusion pump.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-03-01 | 3,671 |
10164_10125_R | Initial treatment 2 | STREAMLINED | 10,125 | 10,164 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment 2</p><br/><p>Patient must be undergoing combination treatment with bevacizumab and platinum-doublet chemotherapy; AND</p> <p>The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material; AND</p> <p>Patient must have progressive disease following treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) OR an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI); AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment 2</p><br/><p>Patient must be undergoing combination treatment with bevacizumab and platinum-doublet chemotherapy; AND</p> <p>The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material; AND</p> <p>Patient must have progressive disease following treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) OR an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI); AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-03-01 | 3,671 |
10185_5883_R | null | RESTRICTED | 5,883 | 10,185 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cellulitis</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cellulitis</p> | N | N | N | IMMEDIATE | ALL | N | 2020-03-01 | 3,671 |
10200_10116_R | Continuing treatment | STREAMLINED | 10,116 | 10,200 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised therapy for HIV infection.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised therapy for HIV infection.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-03-01 | 3,671 |
10205_10206_R | Initial treatment | STREAMLINED | 10,206 | 10,205 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Extensive-stage small cell lung cancer</p><br/><p>Initial treatment</p><br/><p>The condition must be previously untreated; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The treatment must be in combination with etoposide and a platinum-based antineoplastic drug.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Extensive-stage small cell lung cancer</p><br/><p>Initial treatment</p><br/><p>The condition must be previously untreated; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The treatment must be in combination with etoposide and a platinum-based antineoplastic drug.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-03-01 | 3,671 |
10207_10210_R | Initial treatment | STREAMLINED | 10,210 | 10,207 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable partial epileptic seizures</p><br/><p>Initial treatment</p><br/><p>Must be treated by a neurologist; AND</p> <p>The treatment must be in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent; AND</p> <p>The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs, which includes at least one first-line anti-epileptic agent and at least two second-line adjunctive anti-epileptic agents; AND</p> <p>The treatment must not be given concomitantly with levetiracetam, except for cross titration.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable partial epileptic seizures</p><br/><p>Initial treatment</p><br/><p>Must be treated by a neurologist; AND</p> <p>The treatment must be in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent; AND</p> <p>The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs, which includes at least one first-line anti-epileptic agent and at least two second-line adjunctive anti-epileptic agents; AND</p> <p>The treatment must not be given concomitantly with levetiracetam, except for cross titration.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-04-01 | 3,671 |
10209_10208_R | Continuing treatment | STREAMLINED | 10,208 | 10,209 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable partial epileptic seizures</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been treated with PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be given concomitantly with levetiracetam.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable partial epileptic seizures</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been treated with PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be given concomitantly with levetiracetam.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-04-01 | 3,671 |
10211_10310_R | Continuing treatment | STREAMLINED | 10,310 | 10,211 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) adenocarcinoma of the stomach or gastro-oesophageal junction</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not develop progressive disease whilst receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) adenocarcinoma of the stomach or gastro-oesophageal junction</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not develop progressive disease whilst receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-04-01 | 3,671 |
10249_10248_R | null | AUTHORITY_REQUIRED | 10,248 | 10,249 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis C infection</p><br/><p>Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND</p> <p>Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND</p> <p>The treatment must be limited to a maximum duration of 12 weeks.</p> <p align="justify"><br/>The application must include details of the prior treatment regimen containing an NS5A inhibitor.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis C infection</p><br/><p>Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND</p> <p>Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND</p> <p>The treatment must be limited to a maximum duration of 12 weeks.</p> <p align="justify"><br/>The application must include details of the prior treatment regimen containing an NS5A inhibitor.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-04-01 | 3,671 |
10252_10252_R | Initial treatment | STREAMLINED | 10,252 | 10,252 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) adenocarcinoma of the stomach or gastro-oesophageal junction</p><br/><p>Initial treatment</p><br/><p>Patient must have a WHO performance status of 1 or less; AND</p> <p>Patient must have previously received at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum and either a taxane or irinotecan; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p/><p align="justify">The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated.</p><p/> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) adenocarcinoma of the stomach or gastro-oesophageal junction</p><br/><p>Initial treatment</p><br/><p>Patient must have a WHO performance status of 1 or less; AND</p> <p>Patient must have previously received at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum and either a taxane or irinotecan; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p/><p align="justify">The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated.</p><p/> | N | N | N | IMMEDIATE | ALL | N | 2020-04-01 | 3,671 |
10253_10212_R | 3 weekly treatment regimen | STREAMLINED | 10,212 | 10,253 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early HER2 positive breast cancer</p><br/><p>3 weekly treatment regimen</p><br/><p>Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND</p> <p>Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; or</p> <p>Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.</p> <p align="justify">Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early HER2 positive breast cancer</p><br/><p>3 weekly treatment regimen</p><br/><p>Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND</p> <p>Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; or</p> <p>Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.</p> <p align="justify">Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-04-01 | 3,671 |
10257_10257_R | Continuing first-line treatment of metastatic disease, as monotherapy, where concomitant bevacizumab has ceased due to intolerance - 4 weekly treatment regimen | STREAMLINED | 10,257 | 10,257 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing first-line treatment of metastatic disease, as monotherapy, where concomitant bevacizumab has ceased due to intolerance - 4 weekly treatment regimen</p><br/><p>Patient must have experienced intolerance to combination treatment with bevacizumab; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug in this line of treatment; AND</p> <p>Patient must have stable or responding disease; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing first-line treatment of metastatic disease, as monotherapy, where concomitant bevacizumab has ceased due to intolerance - 4 weekly treatment regimen</p><br/><p>Patient must have experienced intolerance to combination treatment with bevacizumab; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug in this line of treatment; AND</p> <p>Patient must have stable or responding disease; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-04-01 | 3,671 |
10258_10215_R | Continuing treatment - 4 weekly treatment regimen | STREAMLINED | 10,215 | 10,258 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic non-small cell lung cancer</p><br/><p>Continuing treatment - 4 weekly treatment regimen</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have stable or responding disease.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic non-small cell lung cancer</p><br/><p>Continuing treatment - 4 weekly treatment regimen</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have stable or responding disease.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-04-01 | 3,671 |
10267_10268_R | null | AUTHORITY_REQUIRED | 10,268 | 10,267 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis C infection</p><br/><p>Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND</p> <p>Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND</p> <p>The treatment must be limited to a maximum duration of 16 weeks.</p> <p align="justify"><br/>The application must include details of the prior treatment regimen containing an NS5A inhibitor.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis C infection</p><br/><p>Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND</p> <p>Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND</p> <p>The treatment must be limited to a maximum duration of 16 weeks.</p> <p align="justify"><br/>The application must include details of the prior treatment regimen containing an NS5A inhibitor.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p> <p align="justify">Special Pricing Arrangements apply.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-04-01 | 3,671 |
10269_10306_R | Continuing treatment | STREAMLINED | 10,306 | 10,269 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for this drug; AND</p> <p>Patient must be receiving PBS-subsidised encorafenib concomitantly for this condition; AND</p> <p>Patient must have stable or responding disease.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for this drug; AND</p> <p>Patient must be receiving PBS-subsidised encorafenib concomitantly for this condition; AND</p> <p>Patient must have stable or responding disease.</p> <p/><p align="justify">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.</p><p/> | N | N | N | IMMEDIATE | ALL | N | 2020-04-01 | 3,671 |
10270_10271_R | Initial treatment | STREAMLINED | 10,271 | 10,270 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Initial treatment</p><br/><p>The condition must be positive for a BRAF V600 mutation; AND</p> <p>The condition must not have been treated previously with PBS-subsidised BRAF inhibitor therapy for unresectable Stage III or Stage IV disease; or</p> <p>Patient must have developed intolerance to other BRAF inhibitors of a severity necessitating permanent treatment withdrawal; AND</p> <p>Patient must not have experienced disease progression whilst on adjuvant BRAF inhibitor treatment or disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment if previously treated for resected Stage IIIB, IIIC or IIID melanoma; AND</p> <p>Patient must have a WHO performance status of 2 or less.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Initial treatment</p><br/><p>The condition must be positive for a BRAF V600 mutation; AND</p> <p>The condition must not have been treated previously with PBS-subsidised BRAF inhibitor therapy for unresectable Stage III or Stage IV disease; or</p> <p>Patient must have developed intolerance to other BRAF inhibitors of a severity necessitating permanent treatment withdrawal; AND</p> <p>Patient must not have experienced disease progression whilst on adjuvant BRAF inhibitor treatment or disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment if previously treated for resected Stage IIIB, IIIC or IIID melanoma; AND</p> <p>Patient must have a WHO performance status of 2 or less.</p> <p/><p align="justify">A patient who has had progressive disease when treated with another BRAF inhibitor is not eligible to receive PBS-subsidised treatment with this drug.</p><p/> | N | N | N | IMMEDIATE | ALL | N | 2020-04-01 | 3,671 |
10277_10216_R | Continuing first-line treatment of metastatic disease - 3 weekly treatment regimen | STREAMLINED | 10,216 | 10,277 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing first-line treatment of metastatic disease - 3 weekly treatment regimen</p><br/><p>Patient must be undergoing combination treatment with bevacizumab until disease progression, unless not tolerated; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug in this line of treatment; AND</p> <p>Patient must have stable or responding disease.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing first-line treatment of metastatic disease - 3 weekly treatment regimen</p><br/><p>Patient must be undergoing combination treatment with bevacizumab until disease progression, unless not tolerated; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug in this line of treatment; AND</p> <p>Patient must have stable or responding disease.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-04-01 | 3,671 |
10288_10250_R | Initial treatment | AUTHORITY_REQUIRED | 10,250 | 10,288 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Autosomal dominant polycystic kidney disease (ADPKD)</p><br/><p>Initial treatment</p><br/><p>Must be treated by a nephrologist; AND</p> <p>Patient must have an estimated glomerular filtration rate (eGFR) between 30 and 89 mL/min 1.73 m2 at the initiation of treatment with this drug for this condition; AND</p> <p>Patient must have or have had rapidly progressing disease at the time of initiation of this drug for this condition.</p> <p align="justify">Rapidly progressing disease is defined as either of the following:</p><p align="justify">A decline in eGFR of greater than or equal to 5 mL/min/1.73 m<sup>2</sup> within one year;</p><p align="justify">OR</p><p align="justify">An average decline in eGFR of greater than or equal to 2.5 mL/min/1.73 m<sup>2</sup> per year over a five year period.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Autosomal dominant polycystic kidney disease (ADPKD)</p><br/><p>Initial treatment</p><br/><p>Must be treated by a nephrologist; AND</p> <p>Patient must have an estimated glomerular filtration rate (eGFR) between 30 and 89 mL/min 1.73 m2 at the initiation of treatment with this drug for this condition; AND</p> <p>Patient must have or have had rapidly progressing disease at the time of initiation of this drug for this condition.</p> <p align="justify">Rapidly progressing disease is defined as either of the following:</p><p align="justify">A decline in eGFR of greater than or equal to 5 mL/min/1.73 m<sup>2</sup> within one year;</p><p align="justify">OR</p><p align="justify">An average decline in eGFR of greater than or equal to 2.5 mL/min/1.73 m<sup>2</sup> per year over a five year period.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-04-01 | 3,671 |
10289_10328_R | Initial treatment | STREAMLINED | 10,328 | 10,289 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Initial treatment</p><br/><p>Patient must be receiving PBS-subsidised encorafenib concomitantly for this condition.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Initial treatment</p><br/><p>Patient must be receiving PBS-subsidised encorafenib concomitantly for this condition.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-04-01 | 3,671 |
10290_6013_R | Continuing treatment | STREAMLINED | 6,013 | 10,290 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for this drug; AND</p> <p>Patient must have stable or responding disease.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for this drug; AND</p> <p>Patient must have stable or responding disease.</p> <p/><p align="justify">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.</p><p/> <p/><p align="justify">A patient who has had progressive disease when treated with another BRAF inhibitor is not eligible to receive PBS-subsidised treatment with this drug.</p><p/> | N | N | N | IMMEDIATE | ALL | N | 2020-04-01 | 3,671 |
10291_10251_R | Initial treatment | STREAMLINED | 10,251 | 10,291 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable partial epileptic seizures</p><br/><p>Initial treatment</p><br/><p>Must be treated by a neurologist; AND</p> <p>The treatment must be in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent; AND</p> <p>The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs, which includes at least one first-line anti-epileptic agent and at least two second-line adjunctive anti-epileptic agents; AND</p> <p>Patient must be unable to take a solid dose form of this drug; AND</p> <p>The treatment must not be given concomitantly with levetiracetam, except for cross titration.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable partial epileptic seizures</p><br/><p>Initial treatment</p><br/><p>Must be treated by a neurologist; AND</p> <p>The treatment must be in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent; AND</p> <p>The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs, which includes at least one first-line anti-epileptic agent and at least two second-line adjunctive anti-epileptic agents; AND</p> <p>Patient must be unable to take a solid dose form of this drug; AND</p> <p>The treatment must not be given concomitantly with levetiracetam, except for cross titration.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-04-01 | 3,671 |
10292_10213_R | Continuing treatment (weekly regimen) | STREAMLINED | 10,213 | 10,292 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early HER2 positive breast cancer</p><br/><p>Continuing treatment (weekly regimen)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND</p> <p>Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; or</p> <p>Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early HER2 positive breast cancer</p><br/><p>Continuing treatment (weekly regimen)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND</p> <p>Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; or</p> <p>Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-04-01 | 3,671 |
10307_10324_R | Initial treatment | STREAMLINED | 10,324 | 10,307 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Initial treatment</p><br/><p>Must be treated by a medical practitioner or an authorised nurse practitioner in consultation with a medical practitioner; AND</p> <p>Patient must be antiretroviral treatment naive; or</p> <p>Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen; AND</p> <p>The treatment must not be in combination with ritonavir.</p> <p>Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Initial treatment</p><br/><p>Must be treated by a medical practitioner or an authorised nurse practitioner in consultation with a medical practitioner; AND</p> <p>Patient must be antiretroviral treatment naive; or</p> <p>Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen; AND</p> <p>The treatment must not be in combination with ritonavir.</p> <p>Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity.</p> <p align="justify">The cobicistat component of the darunavir + cobicistat combination product provides the necessary pharmacokinetic enhancement of darunavir to achieve therapeutic levels of darunavir.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-04-01 | 3,671 |
10308_10309_R | Initial treatment | STREAMLINED | 10,309 | 10,308 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Initial treatment</p><br/><p>Patient must have a WHO performance status of 1 or less; AND</p> <p>Patient must have previously received treatment with fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapies, an anti-vascular endothelial growth factor (anti-VEGF) agent and an anti-epidermal growth factor receptor (anti-EGFR) agent for this condition; or</p> <p>Patient must not be a suitable candidate for treatment with fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapies, an anti-VEGF agent and an anti-EGFR agent for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p/><p align="justify">The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated.</p><p/> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Initial treatment</p><br/><p>Patient must have a WHO performance status of 1 or less; AND</p> <p>Patient must have previously received treatment with fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapies, an anti-vascular endothelial growth factor (anti-VEGF) agent and an anti-epidermal growth factor receptor (anti-EGFR) agent for this condition; or</p> <p>Patient must not be a suitable candidate for treatment with fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapies, an anti-VEGF agent and an anti-EGFR agent for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p/><p align="justify">The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated.</p><p/> | N | N | N | IMMEDIATE | ALL | N | 2020-04-01 | 3,671 |
10311_10294_R | Continuing treatment (3 weekly regimen) | STREAMLINED | 10,294 | 10,311 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early HER2 positive breast cancer</p><br/><p>Continuing treatment (3 weekly regimen)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND</p> <p>Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; or</p> <p>Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early HER2 positive breast cancer</p><br/><p>Continuing treatment (3 weekly regimen)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND</p> <p>Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; or</p> <p>Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-04-01 | 3,671 |
10318_10297_R | Continuing treatment - 3 weekly treatment regimen | STREAMLINED | 10,297 | 10,318 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic non-small cell lung cancer</p><br/><p>Continuing treatment - 3 weekly treatment regimen</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must have stable or responding disease.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic non-small cell lung cancer</p><br/><p>Continuing treatment - 3 weekly treatment regimen</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must have stable or responding disease.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-04-01 | 3,671 |
10323_6890_R | null | RESTRICTED | 6,890 | 10,323 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dietary management of conditions requiring a source of medium chain triglycerides</p><br/><p>Patient must have fat malabsorption due to liver disease; or</p> <p>Patient must have fat malabsorption due to short gut syndrome; or</p> <p>Patient must have fat malabsorption due to cystic fibrosis; or</p> <p>Patient must have fat malabsorption due to gastrointestinal disorders; AND</p> <p>Patient must be aged from 1 to 10 years inclusive.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dietary management of conditions requiring a source of medium chain triglycerides</p><br/><p>Patient must have fat malabsorption due to liver disease; or</p> <p>Patient must have fat malabsorption due to short gut syndrome; or</p> <p>Patient must have fat malabsorption due to cystic fibrosis; or</p> <p>Patient must have fat malabsorption due to gastrointestinal disorders; AND</p> <p>Patient must be aged from 1 to 10 years inclusive.</p> <p align="justify">Not indicated for the treatment of intractable childhood epilepsy or cerebrospinal fluid glucose transporter defect requiring a ketogenic diet. </p> | N | N | N | IMMEDIATE | ALL | N | 2020-04-01 | 3,671 |
10325_10330_R | Continuing treatment | STREAMLINED | 10,330 | 10,325 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable partial epileptic seizures</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been treated with PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be unable to take a solid dose form of this drug; AND</p> <p>The treatment must not be given concomitantly with levetiracetam.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable partial epileptic seizures</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been treated with PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be unable to take a solid dose form of this drug; AND</p> <p>The treatment must not be given concomitantly with levetiracetam.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-04-01 | 3,671 |
10329_10317_R | Continuing treatment | STREAMLINED | 10,317 | 10,329 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a medical practitioner or an authorised nurse practitioner in consultation with a medical practitioner; AND</p> <p>Patient must have previously received PBS-subsidised therapy for HIV infection; AND</p> <p>The treatment must not be in combination with ritonavir.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a medical practitioner or an authorised nurse practitioner in consultation with a medical practitioner; AND</p> <p>Patient must have previously received PBS-subsidised therapy for HIV infection; AND</p> <p>The treatment must not be in combination with ritonavir.</p> <p align="justify">The cobicistat component of the darunavir + cobicistat combination product provides the necessary pharmacokinetic enhancement of darunavir to achieve therapeutic levels of darunavir.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-04-01 | 3,671 |
10352_10362_R | null | STREAMLINED | 10,362 | 10,352 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis B infection</p><br/><p>Patient must be in the third trimester of pregnancy; AND</p> <p>Patient must have elevated HBV DNA levels greater than 200,000 IU/mL (1,000,000 copies/mL), in conjunction with documented hepatitis B infection.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis B infection</p><br/><p>Patient must be in the third trimester of pregnancy; AND</p> <p>Patient must have elevated HBV DNA levels greater than 200,000 IU/mL (1,000,000 copies/mL), in conjunction with documented hepatitis B infection.</p> <p align="justify">Treatment is intended to prevent mother-to-child transmission of hepatitis B in the third trimester of pregnancy and to reduce the risk of viral reactivation in the mother up to 12 weeks post-partum.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-05-01 | 3,671 |
10353_10363_R | null | STREAMLINED | 10,363 | 10,353 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND</p> <p>The treatment must be commenced in a hospital-based movement disorder clinic; AND</p> <p>Patient must require continuous administration of levodopa without an overnight break; or</p> <p>Patient must require a total daily dose of more than 2000 mg of levodopa.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND</p> <p>The treatment must be commenced in a hospital-based movement disorder clinic; AND</p> <p>Patient must require continuous administration of levodopa without an overnight break; or</p> <p>Patient must require a total daily dose of more than 2000 mg of levodopa.</p> <p align="justify">Patients should have adequate cognitive function to manage administration with a portable continuous infusion pump.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-05-01 | 3,671 |
10365_10355_R | Continuing treatment | AUTHORITY_REQUIRED | 10,355 | 10,365 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a metabolic physician; or</p> <p>Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND</p> <p>Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p> <p align="justify">Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a metabolic physician; or</p> <p>Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND</p> <p>Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p> <p align="justify">Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-05-01 | 3,671 |
10370_N | null | null | null | null | null | <p/><p align="justify">In first-line usage, effectiveness and tolerance may be improved when irinotecan is combined with an infusional 5-fluorouracil regimen. </p><p/> | Y | N | N | null | null | N | 2014-04-01 | 3,671 |
10378_10388_R | Continuing treatment | STREAMLINED | 10,388 | 10,378 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Familial homozygous hypercholesterolaemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in conjunction with dietary therapy and exercise.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Familial homozygous hypercholesterolaemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in conjunction with dietary therapy and exercise.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-05-01 | 3,671 |
10381_10390_R | Continuing treatment | AUTHORITY_REQUIRED | 10,390 | 10,381 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphenylalaninaemia</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a metabolic physician; or</p> <p>Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND</p> <p>Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p> <p align="justify">Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphenylalaninaemia</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a metabolic physician; or</p> <p>Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND</p> <p>Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p> <p align="justify">Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-05-01 | 3,671 |
10395_10375_R | null | STREAMLINED | 10,375 | 10,395 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND</p> <p>The treatment must be commenced in a hospital-based movement disorder clinic; AND</p> <p>Patient must require continuous administration of levodopa without an overnight break; or</p> <p>Patient must require a total daily dose of more than 2000 mg of levodopa.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND</p> <p>The treatment must be commenced in a hospital-based movement disorder clinic; AND</p> <p>Patient must require continuous administration of levodopa without an overnight break; or</p> <p>Patient must require a total daily dose of more than 2000 mg of levodopa.</p> <p align="justify">Patients should have adequate cognitive function to manage administration with a portable continuous infusion pump.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-05-01 | 3,671 |
10396_10391_R | Initial treatment | AUTHORITY_REQUIRED | 10,391 | 10,396 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency</p><br/><p>Initial treatment</p><br/><p>Must be treated by a metabolic physician; AND</p> <p>Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency.</p> <p align="justify">Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency</p><br/><p>Initial treatment</p><br/><p>Must be treated by a metabolic physician; AND</p> <p>Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency.</p> <p align="justify">Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.</p> <p align="justify">Patient will be eligible for a maximum of one PBS-subsidised prescription as initial therapy to enable their response to treatment with sapropterin to be assessed.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-05-01 | 3,671 |
10401_10410_R | null | STREAMLINED | 10,410 | 10,401 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>Patient must have a pin-site infection; or</p> <p>Patient must have an infection following cardiac device insertion; or</p> <p>Patient must have acute otitis externa; or</p> <p>Patient must have streptococcal pharyngitis or tonsillitis; or</p> <p>Patient must have mastitis; or</p> <p>Patient must have periorbital (preseptal) cellulitis; or</p> <p>Patient must have acute rheumatic fever; or</p> <p>Patient must have a diabetic foot infection; or</p> <p>Patient must have a widespread infection of dermatitis; or</p> <p>Patient must require treatment for prophylaxis for invasive group A streptococcal (iGAS) infection; or</p> <p>Patient must have impetigo; or</p> <p>Patient must have pyelonephritis; or</p> <p>Patient must have a condition requiring prolonged oral antibiotic therapy.</p> <p align="justify">Midwives may prescribe under this item for the treatment of mastitis only.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>Patient must have a pin-site infection; or</p> <p>Patient must have an infection following cardiac device insertion; or</p> <p>Patient must have acute otitis externa; or</p> <p>Patient must have streptococcal pharyngitis or tonsillitis; or</p> <p>Patient must have mastitis; or</p> <p>Patient must have periorbital (preseptal) cellulitis; or</p> <p>Patient must have acute rheumatic fever; or</p> <p>Patient must have a diabetic foot infection; or</p> <p>Patient must have a widespread infection of dermatitis; or</p> <p>Patient must require treatment for prophylaxis for invasive group A streptococcal (iGAS) infection; or</p> <p>Patient must have impetigo; or</p> <p>Patient must have pyelonephritis; or</p> <p>Patient must have a condition requiring prolonged oral antibiotic therapy.</p> <p align="justify">Midwives may prescribe under this item for the treatment of mastitis only.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-05-01 | 3,671 |
10404_10404_R | null | STREAMLINED | 10,404 | 10,404 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>Patient must have a condition requiring prolonged oral antibiotic therapy.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>Patient must have a condition requiring prolonged oral antibiotic therapy.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-05-01 | 3,671 |
10406_10402_R | null | STREAMLINED | 10,402 | 10,406 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>Patient must be a male with acute cystitis; or</p> <p>Patient must have pyelonephritis; or</p> <p>Patient must have a tooth avulsion; or</p> <p>Patient must have salmonella enteritis; or</p> <p>Patient must have community acquired pneumonia; or</p> <p>Patient must have a condition requiring prolonged oral antibiotic therapy.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>Patient must be a male with acute cystitis; or</p> <p>Patient must have pyelonephritis; or</p> <p>Patient must have a tooth avulsion; or</p> <p>Patient must have salmonella enteritis; or</p> <p>Patient must have community acquired pneumonia; or</p> <p>Patient must have a condition requiring prolonged oral antibiotic therapy.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-05-01 | 3,671 |
10408_10405_R | null | STREAMLINED | 10,405 | 10,408 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>Patient must be a male with acute cystitis; or</p> <p>Patient must have a condition requiring prolonged oral antibiotic therapy.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>Patient must be a male with acute cystitis; or</p> <p>Patient must have a condition requiring prolonged oral antibiotic therapy.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-05-01 | 3,671 |
10409_10412_R | null | STREAMLINED | 10,412 | 10,409 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>Patient must have impaired renal function; AND</p> <p>Patient must have a pin-site infection; or</p> <p>Patient must have an infection following cardiac device insertion; or</p> <p>Patient must have acute otitis externa; or</p> <p>Patient must have streptococcal pharyngitis or tonsillitis; or</p> <p>Patient must have mastitis; or</p> <p>Patient must have periorbital (preseptal) cellulitis; or</p> <p>Patient must have acute rheumatic fever; or</p> <p>Patient must have a diabetic foot infection; or</p> <p>Patient must have a widespread infection of dermatitis; or</p> <p>Patient must require treatment for prophylaxis for invasive group A streptococcal (iGAS) infection; or</p> <p>Patient must have impetigo; or</p> <p>Patient must have pyelonephritis; or</p> <p>Patient must have a condition requiring prolonged oral antibiotic therapy.</p> <p align="justify">Midwives may prescribe under this item for the treatment of mastitis only, where the patient has impaired renal function.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>Patient must have impaired renal function; AND</p> <p>Patient must have a pin-site infection; or</p> <p>Patient must have an infection following cardiac device insertion; or</p> <p>Patient must have acute otitis externa; or</p> <p>Patient must have streptococcal pharyngitis or tonsillitis; or</p> <p>Patient must have mastitis; or</p> <p>Patient must have periorbital (preseptal) cellulitis; or</p> <p>Patient must have acute rheumatic fever; or</p> <p>Patient must have a diabetic foot infection; or</p> <p>Patient must have a widespread infection of dermatitis; or</p> <p>Patient must require treatment for prophylaxis for invasive group A streptococcal (iGAS) infection; or</p> <p>Patient must have impetigo; or</p> <p>Patient must have pyelonephritis; or</p> <p>Patient must have a condition requiring prolonged oral antibiotic therapy.</p> <p align="justify">Midwives may prescribe under this item for the treatment of mastitis only, where the patient has impaired renal function.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-05-01 | 3,671 |
10411_10413_R | null | STREAMLINED | 10,413 | 10,411 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>Patient must have periorbital (preseptal) cellulitis; or</p> <p>Patient must have postpartum endometritis; or</p> <p>Patient must have an exacerbation of bronchiectasis; or</p> <p>Patient must have pyelonephritis; or</p> <p>Patient must have pneumonia acquired in hospital or aged care; or</p> <p>Patient must have a diabetic foot infection; or</p> <p>Patient must have a condition requiring prolonged oral antibiotic therapy.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>Patient must have periorbital (preseptal) cellulitis; or</p> <p>Patient must have postpartum endometritis; or</p> <p>Patient must have an exacerbation of bronchiectasis; or</p> <p>Patient must have pyelonephritis; or</p> <p>Patient must have pneumonia acquired in hospital or aged care; or</p> <p>Patient must have a diabetic foot infection; or</p> <p>Patient must have a condition requiring prolonged oral antibiotic therapy.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-05-01 | 3,671 |
10416_10416_R | null | STREAMLINED | 10,416 | 10,416 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Community acquired pneumonia</p><br/><p>Patient must have community acquired pneumonia.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Community acquired pneumonia</p><br/><p>Patient must have community acquired pneumonia.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-05-01 | 3,671 |
10430_10431_R | Continuing treatment | AUTHORITY_REQUIRED | 10,431 | 10,430 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum of 24 weeks with this drug per authorised course under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align="justify">An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:</p><p align="justify">(a) a CRP measurement no greater than 10 mg per L; or</p><p align="justify">(b) a CRP measurement reduced by at least 20% from baseline.</p> <p align="justify">If the requirement to demonstrate an elevated CRP level could not be met under an initial treatment restriction, a reduction in the BASDAI score from baseline will suffice for the purposes of administering this continuing treatment restriction.</p> <p align="justify">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum of 24 weeks with this drug per authorised course under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align="justify">An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:</p><p align="justify">(a) a CRP measurement no greater than 10 mg per L; or</p><p align="justify">(b) a CRP measurement reduced by at least 20% from baseline.</p> <p align="justify">If the requirement to demonstrate an elevated CRP level could not be met under an initial treatment restriction, a reduction in the BASDAI score from baseline will suffice for the purposes of administering this continuing treatment restriction.</p> <p align="justify">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-06-01 | 3,671 |
10437_10482_R | null | STREAMLINED | 10,482 | 10,437 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mild asthma</p><br/><p>Patient must have asthma and require an anti-inflammatory reliever therapy; AND</p> <p>Patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA); AND</p> <p>Patient must be aged 12 years or over.</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>Mild asthma</p><br/><p>Patient must have asthma and require an anti-inflammatory reliever therapy; AND</p> <p>Patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA); AND</p> <p>Patient must be aged 12 years or over.</p> <p align="justify">Device (inhaler) technique should be reviewed at each clinical visit and before initiating treatment with this medicine.</p> <p align="left">This drug is not PBS-subsidised for the treatment of chronic obstructive pulmonary disease (COPD) or for allergen-induced or exercise-induced bronchoconstriction in the absence of asthma.</p> <p align="justify">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-06-01 | 3,671 |
10463_10464_R | null | STREAMLINED | 10,464 | 10,463 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mild asthma</p><br/><p>Patient must have asthma and require an anti-inflammatory reliever therapy; AND</p> <p>Patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA).</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>Mild asthma</p><br/><p>Patient must have asthma and require an anti-inflammatory reliever therapy; AND</p> <p>Patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA).</p> <p align="justify">Device (inhaler) technique should be reviewed at each clinical visit and before initiating treatment with this medicine.</p> <p align="left">This drug is not PBS-subsidised for the treatment of chronic obstructive pulmonary disease (COPD) or for allergen-induced or exercise-induced bronchoconstriction in the absence of asthma.</p> <p align="justify">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-06-01 | 3,671 |
10496_10521_R | Continuing treatment - 3 weekly treatment regimen | STREAMLINED | 10,521 | 10,496 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Extensive-stage small cell lung cancer</p><br/><p>Continuing treatment - 3 weekly treatment regimen</p><br/><p>The treatment must be as monotherapy; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Extensive-stage small cell lung cancer</p><br/><p>Continuing treatment - 3 weekly treatment regimen</p><br/><p>The treatment must be as monotherapy; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-07-01 | 3,671 |
10504_10499_R | null | AUTHORITY_REQUIRED | 10,499 | 10,504 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Benign prostatic hyperplasia</p><br/><p>Patient must have lower urinary tract symptoms.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Benign prostatic hyperplasia</p><br/><p>Patient must have lower urinary tract symptoms.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-07-01 | 3,671 |
10505_10498_R | null | STREAMLINED | 10,498 | 10,505 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with radiotherapy being used to treat malignancy; or</p> <p>The condition must be associated with oral chemotherapy being used to treat malignancy.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with radiotherapy being used to treat malignancy; or</p> <p>The condition must be associated with oral chemotherapy being used to treat malignancy.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-07-01 | 3,671 |
10509_10509_R | Continuing treatment - 4 weekly treatment regimen | STREAMLINED | 10,509 | 10,509 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Extensive-stage small cell lung cancer</p><br/><p>Continuing treatment - 4 weekly treatment regimen</p><br/><p>The treatment must be as monotherapy; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Extensive-stage small cell lung cancer</p><br/><p>Continuing treatment - 4 weekly treatment regimen</p><br/><p>The treatment must be as monotherapy; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-07-01 | 3,671 |
10518_10459_R | Initial 1 (New patient), Initial 2 (Change or re-commencement 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 | 10,459 | 10,518 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial 1 (New patient), Initial 2 (Change or re-commencement 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>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 18 to 20 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 18 to 20 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 18 to 20 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 20 weeks treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial 1 (New patient), Initial 2 (Change or re-commencement 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>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 18 to 20 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 18 to 20 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 18 to 20 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 20 weeks treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align="justify">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p> | N | N | Y | IMMEDIATE | ALL | N | 2020-07-01 | 3,671 |
10531_9547_R | null | STREAMLINED | 9,547 | 10,531 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe spasticity of the upper limb following an acute event</p><br/><p>The condition must be moderate to severe spasticity of the upper limb/s following an acute 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 greater than 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A); AND</p> <p>The treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per upper limb in the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per upper limb each year thereafter; AND</p> <p>Patient must not have established severe contracture in the limb to be treated; AND</p> <p>Patient must be aged 18 years or older; AND</p> <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.</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 upper limb following an acute event</p><br/><p>The condition must be moderate to severe spasticity of the upper limb/s following an acute 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 greater than 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A); AND</p> <p>The treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per upper limb in the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per upper limb each year thereafter; AND</p> <p>Patient must not have established severe contracture in the limb to be treated; AND</p> <p>Patient must be aged 18 years or older; AND</p> <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.</p> <p align="justify">Standard management includes physiotherapy and/or oral spasticity agents.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-08-01 | 3,671 |
10574_10538_R | null | STREAMLINED | 10,538 | 10,574 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have failed PBS-subsidised fluticasone proprionate and salmeterol as a fixed dose combination for this condition; AND</p> <p>Must be treated by a respiratory physician; or</p> <p>Must be treated by a paediatrician.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have failed PBS-subsidised fluticasone proprionate and salmeterol as a fixed dose combination for this condition; AND</p> <p>Must be treated by a respiratory physician; or</p> <p>Must be treated by a paediatrician.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-08-01 | 3,671 |
10586_9519_R | Induction treatment - balance of supply | AUTHORITY_REQUIRED | 9,519 | 10,586 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Induction treatment - balance of supply</p><br/><p>The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND</p> <p>The condition must not be present in the central nervous system or testis; AND</p> <p>Patient must have previously received a tyrosine kinase inhibitor (TKI) if the condition is Philadelphia chromosome positive; AND</p> <p>Patient must have received insufficient therapy with this agent for this condition under the Induction treatment restriction to complete a maximum of 2 treatment cycles in a lifetime.</p> <p align="justify">According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a health care professional or hospitalisation is recommended.</p> <p align="justify">An amount of 784 mcg will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2.</p> <p align="justify">Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align="justify">Careful monitoring of patients is required due to risk of developing life-threatening Cytokine Release Syndrome, neurological toxicities and reactivation of John Cunningham virus (JC) viral infection.</p> <p>Acute lymphoblastic leukaemia</p><br/><p>Induction treatment - balance of supply</p><br/><p>The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND</p> <p>The condition must not be present in the central nervous system or testis; AND</p> <p>Patient must have previously received a tyrosine kinase inhibitor (TKI) if the condition is Philadelphia chromosome positive; AND</p> <p>Patient must have received insufficient therapy with this agent for this condition under the Induction treatment restriction to complete a maximum of 2 treatment cycles in a lifetime.</p> <p align="justify">According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a health care professional or hospitalisation is recommended.</p> <p align="justify">An amount of 784 mcg will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2.</p> <p align="justify">Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-08-01 | 3,671 |
10589_5937_R | Episodic treatment | STREAMLINED | 5,937 | 10,589 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent moderate to severe genital herpes</p><br/><p>Episodic treatment</p> <p align="justify">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent moderate to severe genital herpes</p><br/><p>Episodic treatment</p> <p align="justify">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p> <p align="justify">Famciclovir 125 mg is not PBS-subsidised for chickenpox, herpes zoster or herpes simplex infections other than genital herpes.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-08-01 | 3,671 |
10604_10434_R | Continuing treatment - balance of supply | AUTHORITY_REQUIRED | 10,434 | 10,604 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><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 24 weeks treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><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 24 weeks treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-08-01 | 3,671 |
10615_N | null | null | null | null | null | <p align="justify">This drug is not PBS-subsidised for the treatment of chronic obstructive pulmonary disease (COPD).</p> | Y | N | N | null | null | N | 2014-12-01 | 3,671 |
10621_9369_R | Consolidation treatment | AUTHORITY_REQUIRED | 9,369 | 10,621 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Consolidation treatment</p><br/><p>Patient must have previously received PBS-subsidised induction treatment with this drug for this condition; AND</p> <p>Patient must have achieved a complete remission; or</p> <p>Patient must have achieved a complete remission with partial haematological recovery; AND</p> <p>The treatment must not be more than 3 treatment cycles under this restriction in a lifetime; AND</p> <p>Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align="justify">Careful monitoring of patients is required due to risk of developing life-threatening Cytokine Release Syndrome, neurological toxicities and reactivation of John Cunningham virus (JC) viral infection.</p> <p>Acute lymphoblastic leukaemia</p><br/><p>Consolidation treatment</p><br/><p>Patient must have previously received PBS-subsidised induction treatment with this drug for this condition; AND</p> <p>Patient must have achieved a complete remission; or</p> <p>Patient must have achieved a complete remission with partial haematological recovery; AND</p> <p>The treatment must not be more than 3 treatment cycles under this restriction in a lifetime; AND</p> <p>Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.</p> <p align="justify">A complete remission is defined as bone marrow blasts of less than or equal to 5%, no evidence of disease and a full recovery of peripheral blood counts with platelets of greater than 100,000 per microliter, and absolute neutrophil count (ANC) of greater than 1,000 per microliter.</p> <p align="justify">A complete remission with partial haematological recovery is defined as bone marrow blasts of less than or equal to 5%, no evidence of disease and a partial recovery of peripheral blood counts with platelets of greater than 50,000 per microliter, and absolute neutrophil count (ANC) of greater than 500 per microliter.</p> <p align="justify">Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time when an assessment is required must cease PBS-subsidised therapy with this agent.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-08-01 | 3,671 |
10622_9601_R | Consolidation treatment | AUTHORITY_REQUIRED | 9,601 | 10,622 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Consolidation treatment</p><br/><p>Patient must have previously received PBS-subsidised induction treatment with this drug for this condition; AND</p> <p>Patient must have achieved a complete remission; or</p> <p>Patient must have achieved a complete remission with partial haematological recovery; AND</p> <p>The treatment must not be more than 5 treatment cycles under this restriction in a lifetime; AND</p> <p>Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.</p> <p align="justify">This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> <p align="justify">The treatment must not exceed 0.5mg per m<sup>2</sup> for all doses within a treatment cycle</p> <p align="justify">Treatment with this drug for this condition must not exceed 6 treatment cycles in a lifetime.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align="justify">Careful monitoring of patients is required due to risk of developing hepatotoxicity, including life-threatening hepatic veno-occlusive disease, and the increased risk of post-haematopoietic stem cell transplant non-relapse mortality observed in patients treated with inotuzumab.</p> <p>Acute lymphoblastic leukaemia</p><br/><p>Consolidation treatment</p><br/><p>Patient must have previously received PBS-subsidised induction treatment with this drug for this condition; AND</p> <p>Patient must have achieved a complete remission; or</p> <p>Patient must have achieved a complete remission with partial haematological recovery; AND</p> <p>The treatment must not be more than 5 treatment cycles under this restriction in a lifetime; AND</p> <p>Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.</p> <p align="justify">This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> <p align="justify">The treatment must not exceed 0.5mg per m<sup>2</sup> for all doses within a treatment cycle</p> <p align="justify">Treatment with this drug for this condition must not exceed 6 treatment cycles in a lifetime.</p> <p align="justify">A complete remission is defined as bone marrow blasts of less than or equal to 5%, no evidence of disease and a full recovery of peripheral blood counts with platelets of greater than 100,000 per microliter, and absolute neutrophil count (ANC) of greater than 1,000 per microliter.</p> <p align="justify">A complete remission with partial haematological recovery is defined as bone marrow blasts of less than or equal to 5%, no evidence of disease and a partial recovery of peripheral blood counts with platelets of greater than 50,000 per microliter, and absolute neutrophil count (ANC) of greater than 500 per microliter.</p> <p align="justify">Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time when an assessment is required must cease PBS-subsidised therapy with this agent.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-08-01 | 3,671 |
10623_5937_R | Episodic treatment | STREAMLINED | 5,937 | 10,623 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent moderate to severe genital herpes</p><br/><p>Episodic treatment</p> <p align="justify">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent moderate to severe genital herpes</p><br/><p>Episodic treatment</p> <p align="justify">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p> <p align="justify">Famciclovir 250 mg is not PBS-subsidised for chickenpox or herpes simplex infections other than genital herpes.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-08-01 | 3,671 |
10648_5789_R | null | STREAMLINED | 5,789 | 10,648 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe intractable psoriasis</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe intractable psoriasis</p> <p align="justify">Care must be taken to comply with the provisions of State/Territory law when prescribing this drug.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-09-01 | 3,671 |
10656_5727_R | null | STREAMLINED | 5,727 | 10,656 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe disorders of keratinisation</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe disorders of keratinisation</p> <p align="justify">Care must be taken to comply with the provisions of State/Territory law when prescribing this drug.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-09-01 | 3,671 |
10676_10676_R | Continuing treatment - 6 weekly treatment regimen | AUTHORITY_REQUIRED | 10,676 | 10,676 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma</p><br/><p>Continuing treatment - 6 weekly treatment regimen</p><br/><p>Patient must have previously been issued with an authority prescription for this drug for adjuvant treatment following complete surgical resection; AND</p> <p>Patient must not have experienced disease recurrence; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma</p><br/><p>Continuing treatment - 6 weekly treatment regimen</p><br/><p>Patient must have previously been issued with an authority prescription for this drug for adjuvant treatment following complete surgical resection; AND</p> <p>Patient must not have experienced disease recurrence; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-09-01 | 3,671 |
10680_10705_R | Continuing treatment - 3 weekly treatment regimen | STREAMLINED | 10,705 | 10,680 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Continuing treatment - 3 weekly treatment regimen</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously been issued with an authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Continuing treatment - 3 weekly treatment regimen</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously been issued with an authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-09-01 | 3,671 |
10700_10688_R | Initial treatment - 6 weekly treatment regimen | AUTHORITY_REQUIRED | 10,688 | 10,700 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma</p><br/><p>Initial treatment - 6 weekly treatment regimen</p><br/><p>The treatment must be adjuvant to complete surgical resection; AND</p> <p>Patient must have a WHO performance status of 1 or less; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have received prior PBS-subsidised treatment for this condition; AND</p> <p>The treatment must commence within 12 weeks of complete resection; AND</p> <p>Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma</p><br/><p>Initial treatment - 6 weekly treatment regimen</p><br/><p>The treatment must be adjuvant to complete surgical resection; AND</p> <p>Patient must have a WHO performance status of 1 or less; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have received prior PBS-subsidised treatment for this condition; AND</p> <p>The treatment must commence within 12 weeks of complete resection; AND</p> <p>Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.</p> <p align="justify">In the first few months after start of immunotherapy, some patients can have a transient tumour flare with subsequent disease response. When progression is suspected, this should be confirmed through a confirmatory scan, taken at least 4 weeks later.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-09-01 | 3,671 |
10706_10701_R | Continuing treatment - 6 weekly treatment regimen | STREAMLINED | 10,701 | 10,706 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Continuing treatment - 6 weekly treatment regimen</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously been issued with an authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Continuing treatment - 6 weekly treatment regimen</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously been issued with an authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-09-01 | 3,671 |
10720_10844_R | Maintenance therapy | STREAMLINED | 10,844 | 10,720 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Maintenance therapy</p><br/><p>Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND</p> <p>Patient must have been commenced on treatment in a specialist unit in a hospital setting.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Maintenance therapy</p><br/><p>Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND</p> <p>Patient must have been commenced on treatment in a specialist unit in a hospital setting.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-10-01 | 3,671 |
10734_7046_R | Continuing treatment | AUTHORITY_REQUIRED | 7,046 | 10,734 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spontaneous urticaria</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a clinical immunologist; or</p> <p>Must be treated by an allergist; or</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU); AND</p> <p>Patient must have demonstrated a response to the most recent PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 24 weeks per authorised course of treatment under this restriction.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spontaneous urticaria</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a clinical immunologist; or</p> <p>Must be treated by an allergist; or</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU); AND</p> <p>Patient must have demonstrated a response to the most recent PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 24 weeks per authorised course of treatment under this restriction.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-10-01 | 3,671 |
10736_10806_R | Continuing treatment, Whole body | AUTHORITY_REQUIRED | 10,806 | 10,736 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="left">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.</p><p align="justify">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p><p align="justify">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="left">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.</p><p align="justify">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p><p align="justify">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p> | N | N | Y | FULL | ALL | N | 2020-10-01 | 3,671 |
10737_10889_R | Continuing treatment, Face, hand, foot | AUTHORITY_REQUIRED | 10,889 | 10,737 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Face, hand, foot</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align="justify">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align="justify">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition.</p> <p align="justify">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align="justify">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align="justify">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Face, hand, foot</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align="justify">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align="justify">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition.</p> <p align="justify">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align="justify">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align="justify">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p> | N | N | Y | FULL | ALL | N | 2020-10-01 | 3,671 |
10738_9614_R | Initial treatment | AUTHORITY_REQUIRED | 9,614 | 10,738 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Initial treatment</p><br/><p>The condition must be expressing the Philadelphia chromosome; or</p> <p>The condition must have the transcript BCR-ABL; AND</p> <p>Patient must have failed prior treatment with PBS-subsidised dasatinib for this condition; or</p> <p>Patient must have developed intolerance to PBS-subsidised dasatinib of a severity requiring treatment withdrawal.</p> <p align="justify">Failure of treatment with dasatinib is defined as either:</p><p align="justify">1. Failure to achieve a complete morphological and cytogenetic remission after a minimum of 2 months treatment with PBS-subsidised dasatinib for this condition; or</p><p align="justify">2. Morphological or cytogenetic relapse of leukaemia after achieving a complete remission induced by PBS-subsidised dasatinib for this condition; or</p><p align="justify">3. Rising levels of BCR-ABL1 transcript on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition.</p> <p align="justify">Patients must have active leukaemia, as defined by presence on current pathology assessments of either morphological infiltration of the bone marrow (greater than 5% lymphoblasts) or cerebrospinal fluid or other sites; OR the presence of cells bearing the Philadelphia chromosome on cytogenetic or FISH analysis in the bone marrow of patients in morphological remission; OR rising levels of BCR-ABL1 transcript on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">1. a completed authority prescription form; and</p><p align="justify">2. a completed Acute Lymphoblastic Leukaemia ponatinib PBS Authority Application - Supporting Information Form; and</p><p align="justify">3. a pathology report demonstrating that the patient has active acute lymphoblastic leukaemia, manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT-PCR evidence of BCR-ABL transcript. The date of the relevant pathology report(s) need(s) to be provided; or</p><p align="justify">4. pathology reports documenting rising levels of BCR-ABL1 transcript on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition. The date of the relevant pathology report(s) need(s) to be provided</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Initial treatment</p><br/><p>The condition must be expressing the Philadelphia chromosome; or</p> <p>The condition must have the transcript BCR-ABL; AND</p> <p>Patient must have failed prior treatment with PBS-subsidised dasatinib for this condition; or</p> <p>Patient must have developed intolerance to PBS-subsidised dasatinib of a severity requiring treatment withdrawal.</p> <p align="justify">Failure of treatment with dasatinib is defined as either:</p><p align="justify">1. Failure to achieve a complete morphological and cytogenetic remission after a minimum of 2 months treatment with PBS-subsidised dasatinib for this condition; or</p><p align="justify">2. Morphological or cytogenetic relapse of leukaemia after achieving a complete remission induced by PBS-subsidised dasatinib for this condition; or</p><p align="justify">3. Rising levels of BCR-ABL1 transcript on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition.</p> <p align="justify">Patients must have active leukaemia, as defined by presence on current pathology assessments of either morphological infiltration of the bone marrow (greater than 5% lymphoblasts) or cerebrospinal fluid or other sites; OR the presence of cells bearing the Philadelphia chromosome on cytogenetic or FISH analysis in the bone marrow of patients in morphological remission; OR rising levels of BCR-ABL1 transcript on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">1. a completed authority prescription form; and</p><p align="justify">2. a completed Acute Lymphoblastic Leukaemia ponatinib PBS Authority Application - Supporting Information Form; and</p><p align="justify">3. a pathology report demonstrating that the patient has active acute lymphoblastic leukaemia, manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT-PCR evidence of BCR-ABL transcript. The date of the relevant pathology report(s) need(s) to be provided; or</p><p align="justify">4. pathology reports documenting rising levels of BCR-ABL1 transcript on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition. The date of the relevant pathology report(s) need(s) to be provided</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p> | N | N | Y | FULL | ALL | N | 2020-10-01 | 3,671 |
10739_9465_R | Continuing treatment | AUTHORITY_REQUIRED | 9,465 | 10,739 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition.</p> <p align="justify">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p> | N | N | Y | IMMEDIATE | ALL | N | 2020-10-01 | 3,671 |
10749_10755_R | Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months | STREAMLINED | 10,755 | 10,749 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>The condition must require daily, continuous, long term opioid treatment; AND</p> <p>Patient must have cancer pain; or</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>The condition must require daily, continuous, long term opioid treatment; AND</p> <p>Patient must have cancer pain; or</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | N | N | N | IMMEDIATE | ALL | Y | 2020-10-01 | 3,671 |
10750_10748_R | Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months | STREAMLINED | 10,748 | 10,750 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>The condition must require daily, continuous, long term opioid treatment; AND</p> <p>Patient must have cancer pain; or</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.</p> <p align="justify">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment:</p><p align="justify">(i) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or</p><p align="justify">(ii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align="justify">(iii) has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>The condition must require daily, continuous, long term opioid treatment; AND</p> <p>Patient must have cancer pain; or</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.</p> <p align="justify">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment:</p><p align="justify">(i) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or</p><p align="justify">(ii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align="justify">(iii) has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | N | N | N | IMMEDIATE | ALL | Y | 2020-10-01 | 3,671 |
10752_10752_R | Continuing PBS treatment after 1 June 2020 | STREAMLINED | 10,752 | 10,752 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe pain</p><br/><p>Continuing PBS treatment after 1 June 2020</p><br/><p>Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020.</p> <p align="justify">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the patient has received initial authority approval and the total duration of non-PBS and PBS opioid analgesic treatment:</p><p align="justify">(i) is less than 12 months; or</p><p align="justify">(ii) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or</p><p align="justify">(iii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align="justify">(iv) has exceeded 12 months prior to 1 June 2020 and the patient's pain management and clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe pain</p><br/><p>Continuing PBS treatment after 1 June 2020</p><br/><p>Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020.</p> <p align="justify">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the patient has received initial authority approval and the total duration of non-PBS and PBS opioid analgesic treatment:</p><p align="justify">(i) is less than 12 months; or</p><p align="justify">(ii) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or</p><p align="justify">(iii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align="justify">(iv) has exceeded 12 months prior to 1 June 2020 and the patient's pain management and clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p> | N | N | N | IMMEDIATE | ALL | Y | 2020-10-01 | 3,671 |
10757_10758_R | null | RESTRICTED | 10,758 | 10,757 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>The treatment must be for short term therapy of acute severe pain; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>The treatment must be for short term therapy of acute severe pain; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-10-01 | 3,671 |
10759_10839_R | null | RESTRICTED | 10,839 | 10,759 | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; or</p> <p>The treatment must be part of pre-operative care; or</p> <p>The treatment must be used as an analgesic adjunct in general anaesthesia.</p> | <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; or</p> <p>The treatment must be part of pre-operative care; or</p> <p>The treatment must be used as an analgesic adjunct in general anaesthesia.</p> | N | N | N | IMMEDIATE | ALL | N | 2020-10-01 | 3,671 |
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