C13018 | P13018 | CN13018 | Pertuzumab | Metastatic (Stage IV) HER2 positive breast cancer Initial treatment Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion, confirmed through a pathology report from an Approved Pathology Authority; AND Patient must have a WHO performance status of 0 or 1; AND Patient must not have received prior anti-HER2 therapy for this condition; AND Patient must not have received prior chemotherapy for this condition; AND The treatment must be in combination with trastuzumab and a taxane; AND The treatment must not be in combination with nab-paclitaxel; AND 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. Details (date, unique identifying number/code, or provider number) of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) must be provided at the time of application. The pathology report must be documented in the patient's medical records. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval. | Compliance with Authority Required procedures |
C13039 | P13039 | CN13039 | Infliximab | Complex refractory Fistulising Crohn disease Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND Patient must be undergoing treatment with this benefit where:
(i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved; Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The PBS administrator will confirm that (i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient; (ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application. | Compliance with Authority Required procedures |
C13040 | P13040 | CN13040 | Infliximab | Severe psoriatic arthritis Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true:
(i) the most recent authority application did not specify the full quantity of repeat prescriptions available under the relevant PBS listing, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; or Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true:
(i) the most recent authority application was for a different formulation of this benefit, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; Patient must be at least 18 years of age. Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the drug formulation is changing), mark the prescription that is intended for no further supply as 'Cancelled'. | Compliance with Authority Required procedures |
C13045 | P13045 | CN13045 | Infliximab | Moderate to severe ulcerative colitis Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND Patient must be undergoing treatment with this benefit where:
(i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved; Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The PBS administrator will confirm that (i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient; (ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application. | Compliance with Authority Required procedures |
C13049 | P13049 | CN13049 | Paliperidone | Schizophrenia Patient must have previously received and be stabilised on PBS-subsidised paliperidone once-monthly injection for at least 4 consecutive months. or Patient must have previously received and be stabilised on PBS-subsidised paliperidone six-monthly injection for at least one cycle. | Compliance with Authority Required procedures - Streamlined Authority Code 13049 |
C13058 | P13058 | CN13058 | Infliximab | Severe chronic plaque psoriasis Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription Must be treated by a dermatologist; AND Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true:
(i) the most recent authority application did not specify the full quantity of repeat prescriptions available under the relevant PBS listing, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; or Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true:
(i) the most recent authority application was for a different formulation of this benefit, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; Patient must be at least 18 years of age. Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the drug formulation is changing), mark the prescription that is intended for no further supply as 'Cancelled'. | Compliance with Authority Required procedures |
C13077 | P13077 | CN13077 | Infliximab | Ankylosing spondylitis Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND Patient must be undergoing treatment with this benefit where:
(i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved; Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The PBS administrator will confirm that (i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient; (ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application. | Compliance with Authority Required procedures |
C13082 | P13082 | CN13082 | Paliperidone | Schizophrenia Patient must have previously received and be stabilised on PBS-subsidised paliperidone three-monthly injection for at least one cycle. or Patient must have previously received and be stabilised on PBS-subsidised paliperidone once-monthly injection for at least 4 consecutive months. | Compliance with Authority Required procedures - Streamlined Authority Code 13082 |
C13094 | P13094 | CN13094 | Infliximab | Complex refractory Fistulising Crohn disease Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true:
(i) the most recent authority application did not specify the full quantity of repeat prescriptions available under the relevant PBS listing, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; or Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true:
(i) the most recent authority application was for a different formulation of this benefit, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; Patient must be at least 18 years of age. Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the drug formulation is changing), mark the prescription that is intended for no further supply as 'Cancelled'. | Compliance with Authority Required procedures |
C13096 | P13096 | CN13096 | Infliximab | Ankylosing spondylitis Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis; AND Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true:
(i) the most recent authority application did not specify the full quantity of repeat prescriptions available under the relevant PBS listing, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; or Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true:
(i) the most recent authority application was for a different formulation of this benefit, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; Patient must be at least 18 years of age. Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the drug formulation is changing), mark the prescription that is intended for no further supply as 'Cancelled'. | Compliance with Authority Required procedures |
C13097 | P13097 | CN13097 | Infliximab | Severe psoriatic arthritis Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND Patient must be undergoing treatment with this benefit where:
(i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved; Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The PBS administrator will confirm that (i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient; (ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application. | Compliance with Authority Required procedures |
C13122 | P13122 | CN13122 | Ciclosporin | Severe psoriasis Management (initiation, stabilisation and review of therapy) The condition must be ineffective to other systemic therapies; or The condition must be inappropriate for other systemic therapies; AND The condition must have caused significant interference with quality of life; AND Must be treated by a medical practitioner who is either:
(i) a dermatologist, (ii) an accredited dermatology registrar in consultation with a dermatologist. | Compliance with Authority Required procedures - Streamlined Authority Code 13122 |
C13152 | P13152 | CN13152 | Sunitinib | Metastatic or unresectable malignant gastrointestinal stromal tumour Initial treatment The condition must not be resectable; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND Patient must have a WHO performance status of 2 or less; AND Patient must have previously failed or be intolerant to imatinib mesilate. Applications for authorisation must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it must include (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS-subsidised imatinib. | Compliance with Written Authority Required procedures |
C13165 | P13165 | CN13165 | Decitabine with cedazuridine | Chronic Myelomonocytic Leukaemia Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have progressive disease. Up to 6 cycles will be authorised. | Compliance with Authority Required procedures |
C13168 | P13168 | CN13168 | Ciclosporin | Severe psoriasis Management (initiation, stabilisation and review of therapy) The condition must be ineffective to other systemic therapies; or The condition must be inappropriate for other systemic therapies; AND The condition must have caused significant interference with quality of life; AND Must be treated by a medical practitioner who is either:
(i) a dermatologist, (ii) an accredited dermatology registrar in consultation with a dermatologist. | Compliance with Authority Required procedures - Streamlined Authority Code 13168 |
C13181 | P13181 | CN13181 | Brentuximab vedotin | CD30 positive cutaneous T-cell lymphoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have achieved an objective response with this drug; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The treatment must not exceed 12 cycles under this restriction in a lifetime. An objective response is defined as the demonstration of response by clinical observation of skin lesions, or response by positron-emission tomography (PET) and/or computed tomography (CT) standard criteria. | Compliance with Authority Required procedures |
C13186 | P13186 | CN13186 | Entrectinib Repotrectinib | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures |
C13207 | P13207 | CN13207 | Cabazitaxel | Castration resistant metastatic carcinoma of the prostate The treatment must be in combination with prednisone or prednisolone; AND The condition must be resistant to treatment with docetaxel; or Patient must have a documented intolerance necessitating permanent treatment withdrawal or a contraindication to docetaxel; AND The treatment must not be used in combination with a novel hormonal drug; AND Patient must have a WHO performance status of 2 or less; AND Patient must not receive PBS-subsidised cabazitaxel if progressive disease develops while on cabazitaxel. | Compliance with Authority Required procedures - Streamlined Authority Code 13207 |
C13212 | P13212 | CN13212 | Brentuximab vedotin | CD30 positive peripheral T-cell lymphoma, non-cutaneous type Continuing treatment The treatment must be in combination with cyclophosphamide, doxorubicin and prednisone; AND Patient must have completed 6 initial cycles of PBS-subsidised treatment with this drug for this indication; AND Patient must have achieved at least a partial response to the 6 initial cycles of treatment with a combination of this drug and cyclophosphamide, doxorubicin and prednisone for this indication; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must not be more than 2 treatment cycles under this restriction in a lifetime. Partial response is defined using Lugano Response Criteria for Non-Hodgkin Lymphoma as (a) Positron emission tomography-based response lymph nodes and extralymphatic sites - a score of 4 (uptake moderately > liver), or 5 (uptake markedly higher than liver and/or new lesions), with reduced uptake compared with baseline and residual mass(es) of any size; nonmeasured lesions - not applicable; organ enlargement - not applicable; new lesions - none; bone marrow - residual uptake higher than uptake in normal marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed). If there are persistent focal changes in the marrow in the context of a nodal response, consideration should be given to further evaluation with MRI or biopsy or an interval scan; OR (b) Computed tomography-based response lymph nodes and extralymphatic sites - greater than or equal to 50% decrease in the sum of the product of the perpendicular diameters for multiple lesions, of up to six (6) target measurable nodes and extranodal sites; non-measured lesions - absent/normal, regressed but no increase; new lesions - none; bone marrow - not applicable. | Compliance with Authority Required procedures |
C13237 | P13237 | CN13237 | Vedolizumab | Moderate to severe ulcerative colitis Balance of supply - subcutaneous form Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have received insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks Initial treatment (intravenous and subcutaneous inclusive); or Patient must have received insufficient therapy with this drug under the Continuing treatment to complete 24 weeks of treatment; AND The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment - subcutaneous form. or The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment - subcutaneous form. | Compliance with Authority Required procedures |
C13241 | P13241 | CN13241 | Decitabine with cedazuridine | Acute Myeloid Leukaemia Initial treatment The condition must be acute myeloid leukaemia confirmed through a bone marrow biopsy report and full blood examination; AND The condition must have 20% to 30% marrow blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) Classification. The following reports must be documented in the patient's medical records (a) bone marrow biopsy report demonstrating that the patient has acute myeloid leukaemia; and (b) full blood examination report. | Compliance with Authority Required procedures |
C13246 | P13246 | CN13246 | Mogamulizumab Vorinostat | Cutaneous T-cell lymphoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. | Compliance with Authority Required procedures |
C13257 | P13257 | CN13257 | Decitabine with cedazuridine | Myelodysplastic syndrome Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have progressive disease. Up to 6 cycles will be authorised. | Compliance with Authority Required procedures |
C13258 | P13258 | CN13258 | Decitabine with cedazuridine | Acute Myeloid Leukaemia Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have progressive disease. | Compliance with Authority Required procedures - Streamlined Authority Code 13258 |
C13261 | P13261 | CN13261 | Brentuximab vedotin | CD30 positive systemic anaplastic large cell lymphoma Continuing treatment Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must not exceed 12 cycles under this restriction in a lifetime. | Compliance with Authority Required procedures |
C13267 | P13267 | CN13267 | Decitabine with cedazuridine | Myelodysplastic syndrome Initial treatment The condition must be myelodysplastic syndrome confirmed through a bone marrow biopsy report and full blood examination; AND The condition must be classified as Intermediate-2 according to the International Prognostic Scoring System (IPSS); or The condition must be classified as high risk according to the International Prognostic Scoring System (IPSS); AND The condition must have up to 20% marrow blasts according to World Health Organisation (WHO) Classification. Classification of the condition as Intermediate-2 requires a score of 1.5 to 2.0 on the IPSS, achieved with the possible combinations (a) 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 0 to 1 cytopenias; OR (b) 11% to 20% marrow blasts with good karyotypic status (normal, -Y alone, del(5q) alone, del(20q) alone), and 2 to 3 cytopenias; OR (c) 5% to 10% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR (d) 5% to 10% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias; OR (e) Less than 5% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), and 2 to 3 cytopenias. Classification of the condition as high risk requires a score of 2.5 or more on the IPSS, achieved with the possible combinations (a) 11% to 20% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR (b) 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias. The following information must be provided by the prescriber at the time of application (a) The patient's International Prognostic Scoring System (IPSS) score. The following reports must be documented in the patient's medical records (a) bone marrow biopsy report demonstrating that the patient has myelodysplastic syndrome; and (b) full blood examination report; and (c) pathology report detailing the cytogenetics demonstrating intermediate-2 or high-risk disease according to the International Prognostic Scoring System (IPSS). No more than 3 cycles will be authorised under this restriction in a patient's lifetime. | Compliance with Authority Required procedures |
C13290 | P13290 | CN13290 | Avelumab | Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer Maintenance therapy - Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 13290 |
C13321 | P13321 | CN13321 | Trientine | Chelation of elevated copper levels Patient must have a diagnosis of Wilson disease; AND Patient must be intolerant to penicillamine; AND Must be treated by a specialist medical practitioner, where this authority application is to initiate treatment with this drug, of the following type:
(i) gastroenterologist, (ii) hepatologist, (iii) neurologist; the authority prescription must be completed by the specialist prescriber. or Must be treated by a medical practitioner (of any type), where this authority application is continuing established trientine treatment (of any specified salt) initiated by one of the above mentioned specialist types. or Must be treated by a nurse practitioner where this authority application is continuing established trientine treatment (of any specified salt) initiated by one of the above mentioned specialist types. Prior to seeking the initial authority approval, establish evidence of excess copper levels based on at least one of (i) clinical symptoms, (ii) measured serum copper levels, (iii) measured urinary copper levels. Document what these findings were in the patient's medical records. Do not supply them in this authority application. Refer to the following definitions if in doubt over what constitutes an acceptable intolerance to penicillamine Side effects of penicillamine occurring soon after initiation (within first few weeks/months) (i) fever, (ii) rash, (iii) enlarged lymph nodes, (iv) neutropenia, (v) thrombocytopenia, (vi) proteinuria, (vii) severe, persistent nausea. (i) nephrotic syndrome, (ii) glomerulonephritis, (iii) total bone marrow aplasia, (iv) skin changes (cutis laxa, elastosis perforans serpiginosa, pemphigus), (v) myasthenia gravis, (vi) polymyositis, (vii) Goodpasture syndrome, (viii) optic neuritis, (ix) proteinuria (1-2 grams/day or equivalent in children, depending on specialist Wilson disease and renal review), (x) haematuria (if cause unknown), (xi) thrombocytopenia/leukopenia, (xii) bleeding related to thromobocytopenia/leukopenia, (xiii) lupus-like syndrome (haematuria, proteinuria, positive antinuclear antibody), (xiv) arthralgia. Side effects of penicillamine developing later (i) nephrotic syndrome, (ii) glomerulonephritis, (iii) total bone marrow aplasia, (iv) skin changes (cutis laxa, elastosis perforans serpiginosa, pemphigus), (v) myasthenia gravis, (vi) polymyositis, (vii) Goodpasture syndrome, (viii) optic neuritis, (ix) proteinuria (1-2 grams/day or equivalent in children, depending on specialist Wilson disease and renal review), (x) haematuria (if cause unknown), (xi) thrombocytopenia/leukopenia, (xii) bleeding related to thromobocytopenia/leukopenia, (xiii) lupus-like syndrome (haematuria, proteinuria, positive antinuclear antibody), (xiv) arthralgia. At the time of the first authority application for this drug, document the details (date of reaction, severity of reaction, dose of penicillamine, etc) of the penicillamine intolerance, if not already done, in the patient's medical records. Do not supply these details in this authority application. | Compliance with Authority Required procedures |
C13336 | P13336 | CN13336 | Aflibercept Dexamethasone Faricimab Ranibizumab | Central retinal vein occlusion with macular oedema Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND The treatment must be the sole PBS-subsidised therapy for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 13336 |
C13340 | P13340 | CN13340 | Ranibizumab | Subfoveal choroidal neovascularisation (CNV) Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND The condition must not be due to pathologic myopia; AND The condition must not be due to age-related macular degeneration; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye. | Compliance with Authority Required procedures - Streamlined Authority Code 13340 |
C13387 | P13387 | CN13387 | Aflibercept Dexamethasone Faricimab Ranibizumab | Branch retinal vein occlusion with macular oedema Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND The treatment must be the sole PBS-subsidised therapy for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 13387 |
C13392 | P13392 | CN13392 | Aflibercept Ranibizumab | Subfoveal choroidal neovascularisation (CNV) Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND The condition must be due to pathologic myopia (PM); AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye. | Compliance with Authority Required procedures - Streamlined Authority Code 13392 |
C13402 | P13402 | CN13402 | Aflibercept Faricimab | Diabetic macular oedema (DMO) Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND The treatment must be as monotherapy; or The treatment must be in combination with laser photocoagulation; AND The treatment must be the sole PBS-subsidised therapy for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 13402 |
C13406 | P13406 | CN13406 | Aflibercept Faricimab Ranibizumab | Subfoveal choroidal neovascularisation (CNV) Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND The condition must be due to age-related macular degeneration (AMD); AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye. | Compliance with Authority Required procedures - Streamlined Authority Code 13406 |
C13411 | P13411 | CN13411 | Cemiplimab | Metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) Continuing treatment Patient must have previously received PBS-subsidised therapy with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not be undergoing treatment with this drug as a PBS benefit where the treatment duration extends beyond the following, whichever comes first:
(i) disease progression despite treatment with this drug, (ii) 24 months from treatment initiation; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs. | Compliance with Authority Required procedures |
C13419 | P13419 | CN13419 | Cemiplimab | Metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) Initial treatment covering the first 3 treatment cycles The condition must be unsuitable for each of:
(i) curative surgical resection, (ii) curative radiotherapy; AND Patient must have had a WHO performance status of 0 or 1; AND The treatment must be the sole PBS-subsidised therapy for this condition. | Compliance with Authority Required procedures |
C13426 | P13426 | CN13426 | Brolucizumab | Subfoveal choroidal neovascularisation (CNV) Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND The condition must be due to age-related macular degeneration (AMD); AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye. | Compliance with Authority Required procedures |
C13428 | P13428 | CN13428 | Dexamethasone | Diabetic macular oedema (DMO) Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND Patient must have had a cataract removed in the treated eye; or Patient must be scheduled for cataract surgery in the treated eye; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND The treatment must be as monotherapy; or The treatment must be in combination with laser photocoagulation; AND The treatment must be the sole PBS-subsidised therapy for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 13428 |
C13432 | P13432 | CN13432 | Pembrolizumab | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment - 3 weekly treatment regimen Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under both initial and continuing treatment restrictions, whichever comes first. | Compliance with Authority Required procedures - Streamlined Authority Code 13432 |
C13434 | P13434 | CN13434 | Tepotinib | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have a WHO performance status of 2 or less; AND Patient must have evidence of MET exon 14 skipping alterations in tumour material. | Compliance with Authority Required procedures - Streamlined Authority Code 13434 |
C13437 | P13437 | CN13437 | Pembrolizumab | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment - 6 weekly treatment regimen Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND The treatment must not exceed a total of 18 cycles or up to 24 months of treatment under both initial and continuing treatment restrictions, whichever comes first. | Compliance with Authority Required procedures - Streamlined Authority Code 13437 |
C13441 | P13441 | CN13441 | Tepotinib | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 13441 |
C13442 | P13442 | CN13442 | Atezolizumab | Resected early stage (Stage II to IIIA) non-small cell lung cancer (NSCLC) 1,200 mg administered once every 3 weeks Patient must be both:
(i) initiating treatment, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy; or Patient must be continuing existing PBS-subsidised treatment with this drug; or Patient must be both:
(i) transitioning from existing non-PBS to PBS subsidised supply of this drug, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy at the time this drug was initiated; Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug; AND The treatment must be for the purpose of adjuvant therapy following all of:
(i) surgical resection, (ii) platinum-based chemotherapy; AND The condition must have/have had, at treatment commencement, an absence of each of the following gene abnormalities confirmed via tumour material sampling:
(i) an activating epidermal growth factor receptor (EGFR) gene mutation, (ii) an anaplastic lymphoma kinase (ALK) gene rearrangement; AND The condition must have/have had, at treatment commencement, confirmation of programmed cell death ligand 1 (PD-L1) expression on at least 50% of tumour cells; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND Patient must be undergoing treatment that does not occur beyond the following, whichever comes first:
(i) the first instance of disease progression/recurrence, (ii) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words 'cancelled' where (i)/(ii) has occurred. | Compliance with Authority Required procedures - Streamlined Authority Code 13442 |
C13451 | P13451 | CN13451 | Atezolizumab | Resected early stage (Stage II to IIIA) non-small cell lung cancer (NSCLC) 1,680 mg administered once every 4 weeks, or 840 mg every 2 weeks Patient must be both:
(i) initiating treatment, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy; or Patient must be continuing existing PBS-subsidised treatment with this drug; or Patient must be both:
(i) transitioning from existing non-PBS to PBS subsidised supply of this drug, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy at the time this drug was initiated; Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug; AND The treatment must be for the purpose of adjuvant therapy following all of:
(i) surgical resection, (ii) platinum-based chemotherapy; AND The condition must have/have had, at treatment commencement, an absence of each of the following gene abnormalities confirmed via tumour material sampling:
(i) an activating epidermal growth factor receptor (EGFR) gene mutation, (ii) an anaplastic lymphoma kinase (ALK) gene rearrangement; AND The condition must have/have had, at treatment commencement, confirmation of programmed cell death ligand 1 (PD-L1) expression on at least 50% of tumour cells; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND Patient must be undergoing treatment that does not occur beyond the following, whichever comes first:
(i) the first instance of disease progression/recurrence, (ii) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words 'cancelled' where (i)/(ii) has occurred. | Compliance with Authority Required procedures - Streamlined Authority Code 13451 |
C13561 | P13561 | CN13561 | Vericiguat | Chronic heart failure Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated. or The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated. or The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated. | Compliance with Authority Required procedures - Streamlined Authority Code 13561 |
C13624 | P13624 | CN13624 | Leuprorelin | Central precocious puberty Initial treatment Must be treated by a paediatric endocrinologist; or Must be treated by an endocrinologist specialising in paediatrics; Patient must be of an age that is prior to their 10th birthday if female; or Patient must be of an age that is prior to their 11th birthday if male; Patient must have had onset of signs/symptoms of central precocious puberty prior to their 8th birthday if female. or Patient must have had onset of signs/symptoms of central precocious puberty prior to their 9th birthday if male. | |
C13625 | P13625 | CN13625 | Natalizumab | Clinically definite relapsing-remitting multiple sclerosis Must be treated by a neurologist; AND The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND Patient must be ambulatory (without assistance or support); AND Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord. or Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient. The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient. Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug. For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug. | Compliance with Authority Required procedures - Streamlined Authority Code 13625 |
C13650 | P13650 | CN13650 | Adalimumab | Severe psoriatic arthritis Initial treatment - Initial 1 (new patient) Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age. Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application. Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and either (a) an active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment. 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. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
C13694 | P13694 | CN13694 | Adalimumab | Severe psoriatic arthritis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age. Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. 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. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
C13718 | P13718 | CN13718 | Natalizumab | Clinically definite relapsing-remitting multiple sclerosis Must be treated by a neurologist; AND The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND Patient must be ambulatory (without assistance or support); AND Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord. or Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient. The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient. Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug. For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug. | Compliance with Authority Required procedures - Streamlined Authority Code 13718 |
C13726 | P13726 | CN13726 | Pembrolizumab | Relapsed or Refractory Hodgkin lymphoma Initial treatment Patient must have undergone an autologous stem cell transplant (ASCT) for this condition and have experienced relapsed or refractory disease post ASCT; or Patient must not be suitable for ASCT for this condition and have experienced relapsed or refractory disease following at least 2 prior treatments for this condition; AND Patient must not have received prior treatment with a PD-1 (programmed cell death-1) inhibitor for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions. or Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions. | Compliance with Authority Required procedures - Streamlined Authority Code 13726 |
C13727 | P13727 | CN13727 | Pembrolizumab | Relapsed or refractory primary mediastinal B-cell lymphoma Initial treatment The condition must be diagnosed as primary mediastinal B-cell lymphoma through histological investigation combined with at least one of:
(i) positron emission tomography - computed tomography (PET-CT) scan, (ii) PET scan, (iii) CT scan; AND Patient must have been treated with rituximab-based chemotherapy for this condition; AND Patient must be experiencing relapsed/refractory disease; AND Patient must be autologous stem cell transplant (ASCT) ineligible following a single line of treatment; or Patient must have undergone an autologous stem cell transplant (ASCT); or Patient must have been treated with at least 2 chemotherapy treatment lines for this condition, one of which must include rituximab-based chemotherapy; AND 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 this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions. or Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions. | Compliance with Authority Required procedures - Streamlined Authority Code 13727 |
C13728 | P13728 | CN13728 | Pembrolizumab | Unresectable or metastatic deficient mismatch repair (dMMR) colorectal cancer Initial treatment Patient must be untreated for this PBS indication (i.e untreated for each of:
(i) unresectable disease, (ii) metastatic disease); AND Patient must not have received prior treatment for colorectal cancer with each of:
(i) a programmed cell death-1 (PD-1) inhibitor, (ii) a programmed cell death ligand-1 (PD-L1) inhibitor; AND Patient must have a WHO performance status of 0 or 1; AND Patient must have deficient mismatch repair (dMMR) colorectal cancer, as determined by immunohistochemistry test; AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions. or Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions. | Compliance with Authority Required procedures |
C13730 | P13730 | CN13730 | Pembrolizumab | Unresectable or metastatic deficient mismatch repair (dMMR) colorectal cancer Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition; AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime. | Compliance with Authority Required procedures |
C13731 | P13731 | CN13731 | Pembrolizumab | Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime. | Compliance with Authority Required procedures - Streamlined Authority Code 13731 |
C13732 | P13732 | CN13732 | Pembrolizumab | Relapsed or refractory primary mediastinal B-cell lymphoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime. | Compliance with Authority Required procedures - Streamlined Authority Code 13732 |
C13736 | P13736 | CN13736 | Pembrolizumab | Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime. | Compliance with Authority Required procedures - Streamlined Authority Code 13736 |
C13739 | P13739 | CN13739 | Pembrolizumab | Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND The condition must have progressed on or after prior platinum based chemotherapy; or The condition must have progressed on or within 12 months of completion of adjuvant platinum-containing chemotherapy following cystectomy for localised muscle-invasive urothelial cancer; or The condition must have progressed on or within 12 months of completion of neoadjuvant platinum-containing chemotherapy prior to cystectomy for localised muscle-invasive urothelial cancer; AND Patient must have a WHO performance status of 2 or less; AND 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 this condition; AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions. or Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions. | Compliance with Authority Required procedures - Streamlined Authority Code 13739 |
C13741 | P13741 | CN13741 | Pembrolizumab | Relapsed or Refractory Hodgkin lymphoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime. | Compliance with Authority Required procedures - Streamlined Authority Code 13741 |
C13745 | P13745 | CN13745 | Bortezomib | Newly diagnosed systemic light chain amyloidosis Administration on Days 1, 8, 15 and 22 of six treatment cycles (28 days per cycle) in total Patient must be undergoing concurrent treatment with PBS-subsidised daratumumab for this PBS indication. | |
C13753 | P13753 | CN13753 | Leflunomide | Severe active rheumatoid arthritis Patient must have previously received, and failed to achieve an adequate response to, one or more disease modifying anti-rheumatic drugs including methotrexate; or Patient must be clinically inappropriate for treatment with one or more disease modifying anti-rheumatic drugs including methotrexate; AND The treatment must be initiated by a physician. | |
C13771 | P13771 | CN13771 | Leflunomide | Severe active psoriatic arthritis Patient must have previously received, and failed to achieve an adequate response to, one or more disease modifying anti-rheumatic drugs including methotrexate; or Patient must be clinically inappropriate for treatment with one or more disease modifying anti-rheumatic drugs including methotrexate; AND The treatment must be initiated by a physician. | |
C13774 | P13774 | CN13774 | Daratumumab | Newly diagnosed systemic light chain amyloidosis Continuing treatment from week 25 onwards (administered once every four weeks) Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Must be treated by a haematologist (this does not exclude treatment via a multidisciplinary team, but the PBS authority application must be sought by the treating haematologist); AND Patient must be undergoing continuing treatment that does not extend treatment duration beyond whichever comes first:
(i) disease progression, (ii) 96 cumulative weeks from the first administered dose, once in a lifetime. | Compliance with Authority Required procedures |
C13867 | P13867 | CN13867 | Ruxolitinib | Moderate to severe chronic graft versus host disease (cGVHD) Continuing treatment Patient must have received initial PBS-subsidised treatment with this drug for this condition; AND Patient must have responding disease at 24 weeks compared with baseline, demonstrated by either a:
(i) partial response, (ii) complete response; AND The treatment must be the sole PBS-subsidised treatment for this condition with the exception of:
(i) corticosteroids, (ii) calcineurin inhibitors; AND Must be treated by a haematologist. or Must be treated by an oncologist with allogeneic bone marrow transplantation experience. or Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types. Response is defined as attaining a complete or partial response as defined by the National Institutes of Health (NIH) criteria (Lee et al., 2015). Note that response is relative to the assessment of organ function affected by cGVHD prior to commencing initial treatment with ruxolitinib. (a) complete response is defined as complete resolution of all signs and symptoms of cGVHD in all evaluable organs without initiation or addition of new systemic therapy. (b) partial response is defined as an improvement in at least one organ (e.g. improvement of 1 or more points on a 4-to-7-point scale, or an improvement of 2 or more points on a 10-to-12-point scale) without progression in other organs or sites, initiation or addition of new systemic therapies. The assessment of response must be documented in the patient's medical records. Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting. | Compliance with Authority Required procedures - Streamlined Authority Code 13867 |
C13868 | P13868 | CN13868 | Sapropterin | Maternal hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU) Initial treatment - responsiveness testing The treatment must be for the purpose of ascertaining the patient's response to treatment over a period of 7 days, with the intent to then use the drug to control phenylalanine levels under the treatment phase:
First continuing treatment, Indication: Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU); AND Patient must have a baseline blood phenylalanine level above 250 micromol/L prior to commencing treatment with this drug despite best efforts to rely on dietary modifications to control phenylalanine levels; AND Must be treated by a metabolic physician; AND Patient must be undergoing treatment with this drug for the first time; AND Patient must not be undergoing treatment with this drug under this Treatment phase, more than once per lifetime following completion of this authority application; AND Patient must not be undergoing simultaneous treatment with this drug under another PBS-listing (apply under either listing type, but not both simultaneously); Patient must be one of:
(i) planning conception, (ii) pregnant. | Compliance with Authority Required procedures |
C13876 | P13876 | CN13876 | Ruxolitinib | Grade II to IV acute graft versus host disease (aGVHD) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have responding disease compared with baseline after 14 days of treatment demonstrated by either a:
(i) partial response (ii) complete response; AND Must be treated by a haematologist. or Must be treated by an oncologist with allogeneic bone marrow transplantation experience. or Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types. Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib. (a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD. (b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD. The assessment of response must be documented in the patient's medical records. Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting. | Compliance with Authority Required procedures - Streamlined Authority Code 13876 |
C13880 | P13880 | CN13880 | Sapropterin | Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU) First continuing treatment Must be treated by a metabolic physician; or Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND Patient must have previously received PBS-subsidised treatment under the Initial treatment - responsiveness testing restriction with this drug for this condition; AND Patient must have demonstrated a response to treatment with this drug of greater than or equal to a 30% reduction in phenylalanine levels from baseline during initial responsiveness testing. Blood phenylalanine levels must be based on measurements taken during stable periods of the condition. Dietary phenylalanine intake must be maintained at a constant level. | Compliance with Authority Required procedures |
C13885 | P13885 | CN13885 | Sapropterin | Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU) Initial treatment - responsiveness testing Must be treated by a metabolic physician; AND Patient must be untreated with this drug; or Patient must have completed prior responsiveness testing on only 1 occasion - this occurred when the patient was less than 1 month of age, but this benefit is for a second attempt at responsiveness testing in a patient aged at least 1 month old; AND Patient must have a baseline blood phenylalanine level above 360 micromole per L and be less than one month of age; or Patient must have a baseline blood phenylalanine level above 600 micromole per L and be more than one month of age; AND The treatment must be for the purpose of initial responsiveness testing for a period of 24 hours in a patient less than one month of age. or The treatment must be for the purpose of initial responsiveness testing for a period of 7 days in a patient aged more than one month. Dietary phenylalanine intake must be maintained at a constant level. Patients or their parent/guardian should be assessed for their ability to comply with the sapropterin protocol and PKU diet prior to conducting initial responsiveness testing. | Compliance with Authority Required procedures |
C13892 | P13892 | CN13892 | Ruxolitinib | Grade II to IV acute graft versus host disease (aGVHD) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have responding disease compared with baseline after 14 days of treatment demonstrated by either a:
(i) partial response (ii) complete response; AND Must be treated by a haematologist. or Must be treated by an oncologist with allogeneic bone marrow transplantation experience. or Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types. Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib. (a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD. (b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD. The assessment of response must be documented in the patient's medical records. Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting. | Compliance with Authority Required procedures - Streamlined Authority Code 13892 |
C13900 | P13900 | CN13900 | Nivolumab | Adjuvant treatment of stage II or III oesophageal cancer or gastro-oesophageal junction cancer The condition must have histological evidence confirming a diagnosis of a least one of:
(i) adenocarcinoma, (ii) squamous cell cancer; document this evidence in the patient's medical records; AND The condition must have been treated with neoadjuvant platinum-based chemoradiotherapy; AND The treatment must be for the purposes of adjuvant use following complete surgical resection that occurred within 16 weeks prior to initiating this drug; AND The condition must have evidence, through resected specimen, that residual disease meets the Tumour Nodes Metastases (TNM) staging system (as published by the Union for International Cancer Control) of either:
(i) at least ypT1, (ii) at least ypN1; document this evidence in the patient's medical records; AND Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must be undergoing treatment with a dosing regimen as set out in the drug's approved Australian Product Information; AND Patient must not be undergoing PBS-subsidised treatment with this drug where this prescription extends treatment beyond whichever comes first:
(i) 12 months from treatment initiation, irrespective of whether initial treatment was PBS-subsidised/non-PBS-subsidised, (ii) disease recurrence despite treatment with this drug; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs. | Compliance with Authority Required procedures |
C13906 | P13906 | CN13906 | Ruxolitinib | Moderate to severe chronic graft versus host disease (cGVHD) Initial treatment Patient must have received prior systemic steroid treatment for this condition; AND Patient must be one of the following:
(i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment; AND The treatment must be the sole PBS-subsidised treatment for this condition with the exception of:
(i) corticosteroids, (ii) calcineurin inhibitors; AND Must be treated by a haematologist; or Must be treated by an oncologist with allogeneic bone marrow transplantation experience; or Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; AND Patient must be undergoing treatment with this drug following allogeneic haematopoietic stem cell transplantation. The severity of cGVHD is defined by the National Institutes of Health (NIH) criteria (Jagasia et al., 2015) (a) Moderate cGVHD at least one organ (not lung) with a score of 2, 3 or more organs involved with a score of 1 in each organ, or lung score of 1 (b) Severe cGVHD at least 1 organ with a score of 3, or lung score of 2 or 3 Steroid-refractory disease is defined as (a) a lack of response or disease progression after administration of a minimum prednisone dose of 1 mg/kg/day for at least 1 week (or equivalent); or (b) disease persistence without improvement despite continued treatment with prednisone at greater than 0.5 mg/kg/day or 1 mg/kg/every other day for at least 4 weeks (or equivalent). Steroid-dependent disease is defined as an increased prednisone dose to greater than 0.25 mg/kg/day after two unsuccessful attempts to taper the dose (or equivalent). Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal. Details of prior steroid use should be documented in the patient's medical records. A patient must demonstrate a response 24 weeks after initiating treatment with ruxolitinib to be eligible for continuing treatment. Response is defined as attaining a complete or partial response as defined by the National Institutes of Health (NIH) criteria (Lee et al., 2015). Note that response is relative to the assessment of organ function affected by cGVHD prior to commencing initial treatment with ruxolitinib. (a) complete response is defined as complete resolution of all signs and symptoms of cGVHD in all evaluable organs without initiation or addition of new systemic therapy. (b) partial response is defined as an improvement in at least one organ (e.g. improvement of 1 or more points on a 4-to-7-point scale, or an improvement of 2 or more points on a 10-to-12-point scale) without progression in other organs or sites, initiation or addition of new systemic therapies. The assessment of response must be documented in the patient's medical records. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting. | Compliance with Authority Required procedures - Streamlined Authority Code 13906 |
C13907 | P13907 | CN13907 | Ruxolitinib | Grade II to IV acute graft versus host disease (aGVHD) Initial treatment Patient must have received prior systemic steroid treatment for this condition; AND Patient must be one of the following:
(i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment; AND Must be treated by a haematologist. or Must be treated by an oncologist with allogeneic bone marrow transplantation experience. or Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types. The severity of aGVHD is defined by the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Steroid-refractory disease is defined as (a) progression after at least 3 days of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD; or (b) failure to achieve a partial response after 5 days at the time of initiation of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD. (a) an increase in the corticosteroid dose to methylprednisolone of at least 2 mg/kg/day (or equivalent prednisone dose of at least 2.5 mg/kg/day); or (b) failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum of 7 days. Steroid-dependent disease is defined as failed corticosteroid taper involving either one of the following criteria (a) an increase in the corticosteroid dose to methylprednisolone of at least 2 mg/kg/day (or equivalent prednisone dose of at least 2.5 mg/kg/day); or (b) failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum of 7 days. Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal. Details of prior steroid use should be documented in the patient's medical records. A patient must demonstrate a response 14 days after initiating treatment with ruxolitinib to be eligible for continuing treatment. Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib. (a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD. (b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD. The assessment of response must be documented in the patient's medical records. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting. | Compliance with Authority Required procedures - Streamlined Authority Code 13907 |
C13911 | P13911 | CN13911 | Ruxolitinib | Grade II to IV acute graft versus host disease (aGVHD) Initial treatment Patient must have received prior systemic steroid treatment for this condition; AND Patient must be one of the following:
(i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment; AND Must be treated by a haematologist. or Must be treated by an oncologist with allogeneic bone marrow transplantation experience. or Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types. The severity of aGVHD is defined by the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Steroid-refractory disease is defined as (a) progression after at least 3 days of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD; or (b) failure to achieve a partial response after 5 days at the time of initiation of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD. (a) an increase in the corticosteroid dose to methylprednisolone of at least 2 mg/kg/day (or equivalent prednisone dose of at least 2.5 mg/kg/day); or (b) failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum of 7 days. Steroid-dependent disease is defined as failed corticosteroid taper involving either one of the following criteria (a) an increase in the corticosteroid dose to methylprednisolone of at least 2 mg/kg/day (or equivalent prednisone dose of at least 2.5 mg/kg/day); or (b) failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum of 7 days. Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal. Details of prior steroid use should be documented in the patient's medical records. A patient must demonstrate a response 14 days after initiating treatment with ruxolitinib to be eligible for continuing treatment. Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib. (a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD. (b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD. The assessment of response must be documented in the patient's medical records. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting. | Compliance with Authority Required procedures - Streamlined Authority Code 13911 |
C13912 | P13912 | CN13912 | Sapropterin | Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU) Subsequent continuing Must be treated by a metabolic physician; or Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND Patient must be undergoing regular phenylalanine testing and assessment of adherence to dietary modifications. | Compliance with Authority Required procedures |
C13920 | P13920 | CN13920 | Abacavir | Human immunodeficiency virus (HIV) infection Patient must be less than 13.00 years of age; Patient must be unable to take a solid dose form of this drug; AND The treatment must be in combination with other antiretroviral agents. | Compliance with Authority Required procedures |
C13923 | P13923 | CN13923 | Asciminib | Chronic Myeloid Leukaemia (CML) Continuing treatment for patients without T315I mutation The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have received initial PBS-subsidised treatment with this drug for this condition; AND Patient must be undergoing first continuing treatment with this drug, demonstrating either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%. or Patient must be undergoing subsequent continuing treatment with this drug, demonstrating a 12-month response of either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%. A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 13923 |
C13936 | P13936 | CN13936 | Memantine | Moderately severe Alzheimer disease Initial Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less; AND The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND The treatment must be the sole PBS-subsidised therapy for this condition. A patient who is unable to register a score of 10 to 14 for reasons other than their Alzheimer disease, as specified below. Such patients will need to be assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale. The authority application must include the result of the baseline (S)MMSE and specify to which group(s) (see below) the patient belongs. Patients who qualify under this criterion are from 1 or more of the following groups (1) Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background; (2) Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate; (3) Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an (S)MMSE test; (4) Intellectual (developmental or acquired) disability, eg Down's syndrome; (5) Significant sensory impairment despite best correction, which precludes completion of an (S)MMSE test; (6) Prominent dysphasia, out of proportion to other cognitive and functional impairment. Up to a maximum of 6 months' initial therapy will be authorised for this drug, for this strength under this treatment restriction. | Compliance with Authority Required procedures |
C13938 | P13938 | CN13938 | Donepezil Galantamine Rivastigmine | Mild to moderately severe Alzheimer disease Continuing Patient must have received six months of sole PBS-subsidised initial therapy with this drug; AND Patient must demonstrate a clinically meaningful response to the initial treatment; AND The treatment must be the sole PBS-subsidised therapy for this condition. Prior to continuing treatment, a comprehensive assessment must be undertaken and documented, involving the patient, the patient's family or carer and the treating physician to establish agreement that treatment is continuing to produce worthwhile benefit. Treatment should cease if there is no agreement of benefit as there is always the possibility of harm from unnecessary use. Re-assessments for a clinically meaningful response are to be undertaken and documented every six months. Clinically meaningful response to treatment is demonstrated in the following areas Patient's quality of life including but not limited to level of independence and happiness; Patient's cognitive function including but not limited to memory, recognition and interest in environment; Patient's behavioural symptoms, including but not limited to hallucination, delusions, anxiety, marked agitation or associated aggressive behaviour. | Compliance with Authority Required procedures - Streamlined Authority Code 13938 |
C13940 | P13940 | CN13940 | Donepezil Galantamine Rivastigmine | Mild to moderately severe Alzheimer disease Initial Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less; AND The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND The treatment must be the sole PBS-subsidised therapy for this condition. A patient who is unable to register a score of 10 or more for reasons other than their Alzheimer disease, as specified below. Such patients will need to be assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale. The authority application must include the result of the baseline (S)MMSE and specify to which group(s) (see below) the patient belongs. Patients who qualify under this criterion are from 1 or more of the following groups (1) Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background; (2) Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate; (3) Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an (S)MMSE test; (4) Intellectual (developmental or acquired) disability, eg Down's syndrome; (5) Significant sensory impairment despite best correction, which precludes completion of an (S)MMSE test; (6) Prominent dysphasia, out of proportion to other cognitive and functional impairment. Up to a maximum of 6 months' initial therapy will be authorised for this drug, for this strength under this treatment restriction. | Compliance with Authority Required procedures |
C13941 | P13941 | CN13941 | Donepezil Galantamine Rivastigmine | Mild to moderately severe Alzheimer disease Initial Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more; AND The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND The treatment must be the sole PBS-subsidised therapy for this condition. The authority application must include the result of the baseline MMSE or SMMSE. If this score is 25 - 30 points, the result of a baseline Alzheimer Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) may also be specified. Up to a maximum of 6 months' initial therapy will be authorised for this drug, for this strength under this treatment restriction. | Compliance with Authority Required procedures |
C13946 | P13946 | CN13946 | Ozanimod | Moderate to severe ulcerative colitis Continuing treatment - balance of supply Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction. | Compliance with Authority Required procedures |
C13949 | P13949 | CN13949 | Pembrolizumab | Stage IV clear cell variant renal cell carcinoma (RCC) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND Patient must be undergoing combination therapy consisting of:
(i) pembrolizumab, (ii) lenvatinib; or Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records; AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime. | Compliance with Authority Required procedures - Streamlined Authority Code 13949 |
C13950 | P13950 | CN13950 | Asciminib | Chronic Myeloid Leukaemia (CML) Initial PBS-subsidised treatment for patients without T315I mutation The treatment must be the sole PBS-subsidised therapy for this condition; AND The condition must not be in the blast phase; AND The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; or The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND Patient must have failed an adequate trial of at least two tyrosine kinase inhibitors. or Patient must have experienced intolerance, not failure to respond, to at least two tyrosine kinase inhibitors. or Patient must have failed an adequate trial of at least one tyrosine kinase inhibitor with intolerance to at least another tyrosine kinase inhibitor. Failure of an adequate trial of a tyrosine kinase inhibitor is defined as 1. Lack of response defined as either (i) failure to achieve a haematological response after a minimum of 3 months therapy; or (ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive (Ph+) cells; or (iii) failure to achieve or maintain a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy; OR 2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph+ cells on bone marrow biopsy), during ongoing tyrosine kinase inhibitor (TKI) therapy; OR 3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing tyrosine kinase inhibitor (TKI) therapy; OR 4. Development of accelerated phase in a patient previously prescribed a TKI inhibitor for any phase of chronic myeloid leukaemia; OR 5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during TKI therapy in patients with accelerated phase chronic myeloid leukaemia. Accelerated phase is defined by the presence of 1 or more of the following 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or 2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or 3. Peripheral basophils greater than or equal to 20%; or 4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or 5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome). | Compliance with Authority Required procedures |
C13958 | P13958 | CN13958 | Upadacitinib | Moderate to severe ulcerative colitis Continuing treatment - balance of supply Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND The treatment must have been prescribed most recently through the Continuing treatment phase in a quantity which did not seek the full number available in regards to any of:
(i) the quantity per dispensing, (ii) repeat prescriptions; AND The treatment must provide no more than the balance of 24 weeks treatment. | Compliance with Authority Required procedures |
C13959 | P13959 | CN13959 | Upadacitinib | Moderate to severe ulcerative colitis Dose modification Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must be undergoing existing PBS-subsidised treatment with this therapy. | Compliance with Authority Required procedures |
C13966 | P13966 | CN13966 | Memantine | Moderately severe Alzheimer disease Continuing Patient must have received six months of sole PBS-subsidised initial therapy with this drug; AND Patient must demonstrate a clinically meaningful response to the initial treatment; AND The treatment must be the sole PBS-subsidised therapy for this condition. Prior to continuing treatment, a comprehensive assessment must be undertaken and documented, involving the patient, the patient's family or carer and the treating physician to establish agreement that treatment is continuing to produce worthwhile benefit. Treatment should cease if there is no agreement of benefit as there is always the possibility of harm from unnecessary use. Re-assessments for a clinically meaningful response are to be undertaken and documented every six months. Clinically meaningful response to treatment is demonstrated in the following areas Patient's quality of life including but not limited to level of independence and happiness; Patient's cognitive function including but not limited to memory, recognition and interest in environment; Patient's behavioural symptoms, including but not limited to hallucination, delusions, anxiety, marked agitation or associated aggressive behaviour. | Compliance with Authority Required procedures - Streamlined Authority Code 13966 |
C13967 | P13967 | CN13967 | Naltrexone | Alcohol dependence The treatment must be part of a comprehensive treatment program with the goal of maintaining abstinence/controlled consumption. | Compliance with Authority Required procedures - Streamlined Authority Code 13967 |
C13977 | P13977 | CN13977 | Vosoritide | Achondroplasia Initial treatment Patient must have a diagnosis of achondroplasia, confirmed by appropriate genetic testing; AND Patient must not have evidence of growth plate closure demonstrated by at least one of the following:
i) bilateral lower extremity X-rays (proximal tibia, distal femur) taken within 6 months of this application if puberty has commenced; ii) bilateral lower extremity X-rays (proximal tibia, distal femur) taken within 2 years of commencing treatment if puberty has not commenced; iii) an annual growth velocity of greater than 1.5 cm/year as assessed over a period of at least 6 months; AND Must be treated by a medical specialist, experienced in the management of achondroplasia. or Must be treated by a paediatrician in consultation with a medical specialist experienced in the management of achondroplasia. At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised. Appropriate genetic testing constitutes testing for FGFR3 gene mutation. In patients where puberty has not commenced, radiographic evidence that epiphyses have not closed must be obtained within 2 years of commencing treatment with vosoritide. X-rays and dates (date commenced treatment and date of X-ray) must be documented in the patient's medical records. Additional radiographic evidence is not required until patient has begun puberty. In patients where puberty has commenced, radiographic evidence that epiphyses have not closed must be obtained within 6 months of completing an authority application for vosoritide. X-ray and date taken must be documented in the patient's medical records. | Compliance with Authority Required procedures |
C13990 | P13990 | CN13990 | Upadacitinib | Moderate to severe ulcerative colitis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND Patient must have a Mayo clinic score greater than or equal to 6; or Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment. The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application. An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy. 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. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A maximum of 16 weeks of treatment with this drug will be approved under this criterion. | Compliance with Written Authority Required procedures |
C13995 | P13995 | CN13995 | Ozanimod | Moderate to severe ulcerative colitis Initial treatment - Initial 1 (new patient) Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND Patient must have a Mayo clinic score greater than or equal to 6; or Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and (ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]. All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment. The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application. An assessment of a patient's response to this initial course of treatment must be conducted between 9 and 17 weeks of therapy. 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. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application. A maximum of 16 weeks of treatment with this drug will be approved under this criterion. | Compliance with Written Authority Required procedures |
C13998 | P13998 | CN13998 | Vosoritide | Achondroplasia Continuing treatment Patient must have received PBS subsidised vosoritide treatment for this condition; AND Patient must not have evidence of growth plate closure demonstrated by at least one of the following:
i) bilateral lower extremity X-rays (proximal tibia, distal femur) taken within 6 months of this application if puberty has commenced; ii) bilateral lower extremity X-rays (proximal tibia, distal femur) taken within 2 years of commencing treatment if puberty has not commenced; iii) an annual growth velocity of greater than 1.5 cm/year as assessed over a period of at least 6 months; AND Must be treated by a medical specialist, experienced in the management of achondroplasia. or Must be treated by a paediatrician in consultation with a medical specialist experienced in the management of achondroplasia. At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised. In patients where puberty has not commenced, radiographic evidence that epiphyses have not closed must be obtained within 2 years of commencing treatment with vosoritide. X-rays and dates (date commenced treatment and date of X-ray) must be documented in the patient's medical records. Additional radiographic evidence is not required until patient has begun puberty. In patients where puberty has commenced, radiographic evidence that epiphyses have not closed must be obtained within 6 months of completing an authority application for vosoritide. X-ray and date taken must be documented in the patient's medical records. | Compliance with Authority Required procedures |
C13999 | P13999 | CN13999 | Upadacitinib | Moderate to severe ulcerative colitis Initial treatment - Initial 1 (new patient - untreated with biological medicine) Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND Patient must have a Mayo clinic score greater than or equal to 6; or Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and (ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]. All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment. The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application. An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy. 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. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application. A maximum of 16 weeks of treatment with this drug will be approved under this criterion. | Compliance with Written Authority Required procedures |
C14000 | P14000 | CN14000 | Memantine | Moderately severe Alzheimer disease Initial Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 to 14; AND The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND The treatment must be the sole PBS-subsidised therapy for this condition. The authority application must include the result of the baseline MMSE or SMMSE of 10 to 14. Up to a maximum of 6 months' initial therapy will be authorised for this drug, for this strength under this treatment restriction. | Compliance with Authority Required procedures |
C14002 | P14002 | CN14002 | Ozanimod | Moderate to severe ulcerative colitis Continuing treatment Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; Patient must be at least 18 years of age. Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug. Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response. At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction. 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. 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. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 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. | Compliance with Authority Required procedures |
C14003 | P14003 | CN14003 | Ozanimod | Moderate to severe ulcerative colitis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment. An assessment of a patient's response to this initial course of treatment must be conducted between 9 and 17 weeks of therapy. 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. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction. A maximum of 16 weeks of treatment with this drug will be approved under this criterion. | Compliance with Written Authority Required procedures |
C14004 | P14004 | CN14004 | Ozanimod | Moderate to severe ulcerative colitis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND Patient must have a Mayo clinic score greater than or equal to 6; or Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment. The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application. An assessment of a patient's response to this initial course of treatment must be conducted between 9 and 17 weeks of therapy. 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. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A maximum of 16 weeks of treatment with this drug will be approved under this criterion. | Compliance with Written Authority Required procedures |
C14005 | P14005 | CN14005 | Ozanimod | Moderate to severe ulcerative colitis Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
C14011 | P14011 | CN14011 | Upadacitinib | Moderate to severe ulcerative colitis Continuing treatment Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; Patient must be at least 18 years of age. Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug. Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response. At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction. 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. 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. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 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. | Compliance with Authority Required procedures |
C14014 | P14014 | CN14014 | Upadacitinib | Moderate to severe ulcerative colitis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition if relevant; and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment. An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy. 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. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction. A maximum of 16 weeks of treatment with this drug will be approved under this criterion. | Compliance with Written Authority Required procedures |
C14017 | P14017 | CN14017 | Ozanimod | Moderate to severe ulcerative colitis Dose escalation occurring at initial treatment or re-initiation of treatment Must be treated by a gastroenterologist (code 87). or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]. or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. | Compliance with Authority Required procedures - Streamlined Authority Code 14017 |
C14021 | P14021 | CN14021 | Selinexor | Relapsed and/or refractory multiple myeloma Initial treatment - Dose requirement of 80 mg, 60 mg or 40 mg per week The condition must be confirmed by a histological diagnosis; AND Patient must be undergoing triple combination therapy limited to:
(i) this drug, (ii) bortezomib, (iii) dexamethasone; or Patient must be undergoing dual combination therapy limited to:
(i) this drug, (ii) dexamethasone; AND Patient must have progressive disease after at least one prior therapy; AND Patient must not have previously received this drug for this condition. Progressive disease is defined as at least 1 of the following (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. Details of the histological diagnosis of multiple myeloma; prior treatments including name(s) of drug(s) and date of most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response, must be documented in the patient's medical records. Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records (a) the level of serum monoclonal protein; or (b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or (c) the serum level of free kappa and lambda light chains; or (d) bone marrow aspirate or trephine; or (e) if present, the size and location of lytic bone lesions (not including compression fractures); or (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or (g) if present, the level of hypercalcaemia, corrected for albumin concentration. As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records. Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy | Compliance with Authority Required procedures |
C14022 | P14022 | CN14022 | Selinexor | Relapsed and/or refractory multiple myeloma Grandfather treatment - Transitioning from non-PBS to PBS-subsidised supply - Dose requirement of 80 mg, 60 mg or 40 mg per week Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 June 2023; AND Patient must have met all initial treatment PBS eligibility criteria applying to a non-grandfathered patient prior to having commenced treatment with this drug, which are:
(a) the condition was confirmed by histological diagnosis, (b) the treatment is/was being used as part of combination therapy limited to this drug in combination with either: (i) dexamethasone, (ii) dexamethasone plus bortezomib, (c) the condition progressed (see definition of progressive disease below) after at least one prior therapy, (d) the patient had never been treated with this drug; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition. Progressive disease is defined as at least 1 of the following (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
C14023 | P14023 | CN14023 | Selinexor | Relapsed and/or refractory multiple myeloma Continuing treatment - Dose requirement of 100 mg per week Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must be undergoing triple combination therapy limited to:
(i) this drug, (ii) bortezomib, (iii) dexamethasone; or Patient must be undergoing dual combination therapy limited to:
(i) this drug, (ii) dexamethasone; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition. Progressive disease is defined as at least 1 of the following (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
C14024 | P14024 | CN14024 | Selinexor | Relapsed and/or refractory multiple myeloma Initial treatment - Dose requirement of 100 mg per week The condition must be confirmed by a histological diagnosis; AND Patient must be undergoing triple combination therapy limited to:
(i) this drug, (ii) bortezomib, (iii) dexamethasone; or Patient must be undergoing dual combination therapy limited to:
(i) this drug, (ii) dexamethasone; AND Patient must have progressive disease after at least one prior therapy; AND Patient must not have previously received this drug for this condition. Progressive disease is defined as at least 1 of the following (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy | Compliance with Authority Required procedures |
C14026 | P14026 | CN14026 | Ciclosporin | Chronic severe dry eye disease with keratitis Initial treatment for up to the first 180 days of treatment Patient must have a corneal fluorescein staining (CFS) grade of 4 at treatment initiation, using at least one of:
(i) the Oxford scale, (ii) the modified Oxford scale, (iii) an equivalent scale to the Oxford scale as determined by the prescriber; AND Patient must have an ocular surface disease index (OSDI) score of at least 23 at treatment initiation; AND The condition must be inadequately controlled by monotherapy with a preservative free artificial tears substitute; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must be undergoing simultaneous treatment with a preservative free artificial tears substitute; AND Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; or Must be treated by an optometrist in accordance with Optometry Board of Australia guidelines; AND Patient must not be undergoing treatment with this drug under this treatment phase beyond day 180 of treatment; Patient must be at least 18 years of age. Prescribing instruction State in the first authority application for this drug, for the purpose of having a baseline measurement to assess response to treatment under the Continuing treatment listing, each of (i) the qualifying corneal fluorescein staining grade (a numerical value no less than 4), (ii) the qualifying ocular surface disease index score (a numerical value no less than 23). | Compliance with Authority Required procedures |
C14027 | P14027 | CN14027 | Pembrolizumab | Advanced, metastatic or recurrent endometrial carcinoma Initial treatment Patient must have received prior treatment with platinum-based chemotherapy; AND The condition must be untreated with each of:
(i) programmed cell death-1/ligand-1 (PD-1/PDL-1) inhibitor therapy, (ii) tyrosine kinase inhibitor therapy; AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND Patient must be undergoing combination therapy consisting of:
(i) pembrolizumab, (ii) lenvatinib; or Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records; AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions. or Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions. | Compliance with Authority Required procedures - Streamlined Authority Code 14027 |
C14031 | P14031 | CN14031 | Selinexor | Relapsed and/or refractory multiple myeloma Continuing treatment - Dose requirement of 160 mg per week Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must be undergoing dual combination therapy limited to:
(i) this drug, (ii) dexamethasone; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition. Progressive disease is defined as at least 1 of the following (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
C14032 | P14032 | CN14032 | Ciclosporin | Chronic severe dry eye disease with keratitis Continuing treatment Patient must have received PBS-subsidised treatment with this drug for this condition; AND The condition must have improved to an extent that corneal fluorescein staining, using the same scale used at the time of the first authority application, shows an improvement (reduction) by at least 3 grades from baseline (the grade stated in the first authority application) - the improvement need only be demonstrated by staining once only with the first Continuing treatment authority application; AND The condition must have improved to an extent that the patient's ocular surface disease index score at the time of this authority application, has improved (reduced) by at least 30% compared to the value stated in the first authority application (i.e. baseline); AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. or Must be treated by an optometrist in accordance with Optometry Board of Australia guidelines. Prescribing instructions State in the first continuing treatment authority application for this drug (i) an improved corneal fluorescein staining grade (a numerical value that has improved by 3 grades from that provided in the first Initial 1 treatment authority application). (ii) the ocular surface disease index score at the time of this authority application (a numerical value that is at least 30% lower than that stated in the first Initial 1 treatment authority application). State in all continuing treatment authority applications (ii) the ocular surface disease index score at the time of this authority application (a numerical value that is at least 30% lower than that stated in the first Initial 1 treatment authority application). | Compliance with Authority Required procedures |
C14037 | P14037 | CN14037 | Selinexor | Relapsed and/or refractory multiple myeloma Grandfather treatment - Transitioning from non-PBS to PBS-subsidised supply - Dose requirement of 100 mg per week Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 June 2023; AND Patient must have met all initial treatment PBS eligibility criteria applying to a non-grandfathered patient prior to having commenced treatment with this drug, which are:
(a) the condition was confirmed by histological diagnosis, (b) the treatment is/was being used as part of combination therapy limited to this drug in combination with either: (i) dexamethasone, (ii) dexamethasone plus bortezomib, (c) the condition progressed (see definition of progressive disease below) after at least one prior therapy, (d) the patient had never been treated with this drug; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition. Progressive disease is defined as at least 1 of the following (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
C14039 | P14039 | CN14039 | Selinexor | Relapsed and/or refractory multiple myeloma Initial treatment - Dose requirement of 160 mg per week The condition must be confirmed by a histological diagnosis; AND Patient must be undergoing dual combination therapy limited to:
(i) this drug, (ii) dexamethasone; AND Patient must have progressive disease after at least one prior therapy; AND Patient must not have previously received this drug for this condition. Progressive disease is defined as at least 1 of the following (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy | Compliance with Authority Required procedures |
C14040 | P14040 | CN14040 | Nicotine | Nicotine dependence The treatment must be as an aid to achieving abstinence from smoking; AND The treatment must not be a PBS-benefit with other non-nicotine drugs that are PBS indicated for smoking cessation; AND Patient must have indicated they are ready to cease smoking; AND Patient must not receive more than 2 x 12-week PBS-subsidised treatment courses per 12 month period; AND Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program or is about to enter such a program at the time PBS-subsidised treatment is initiated. Details of the support and counselling program must be documented in the patient's medical records at the time treatment is initiated. | |
C14044 | P14044 | CN14044 | Pembrolizumab | Advanced, metastatic or recurrent endometrial carcinoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND Patient must be undergoing combination therapy consisting of:
(i) pembrolizumab, (ii) lenvatinib; or Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records; AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime. | Compliance with Authority Required procedures - Streamlined Authority Code 14044 |
C14045 | P14045 | CN14045 | Selinexor | Relapsed and/or refractory multiple myeloma Continuing treatment - Dose requirement of 80 mg, 60 mg or 40 mg per week Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must be undergoing triple combination therapy limited to:
(i) this drug, (ii) bortezomib, (iii) dexamethasone; or Patient must be undergoing dual combination therapy limited to:
(i) this drug, (ii) dexamethasone; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition. Progressive disease is defined as at least 1 of the following (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
C14080 | P14080 | CN14080 | Tocilizumab | Systemic juvenile idiopathic arthritis Initial treatment - Initial 1 (new patient weighing at least 30 kg) Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have polyarticular course disease which has failed to respond adequately to oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or Patient must have polyarticular course disease and have demonstrated severe intolerance of, or toxicity due to, methotrexate; or Patient must have refractory systemic symptoms, demonstrated by an inability to decrease and maintain the dose of prednisolone (or equivalent) below 0.5 mg per kg per day following a minimum of 2 months of therapy; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be under 18 years of age; Must be treated by a rheumatologist. or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. The following criteria indicate failure to achieve an adequate response to prior methotrexate therapy in a patient with polyarticular course disease and must be demonstrated in the patient at the time of the initial application (a) an active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to prior treatment must be documented in the patient's medical records. The following criteria indicate failure to achieve an adequate response to prior therapy in a patient with refractory systemic symptoms and must be demonstrated in the patient at the time of the initial application (a) an active joint count of at least 2 active joints; and (b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or (c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN). The assessment of response to prior treatment must be documented in the patient's medical records. The baseline measurements of joint count, fever and/or CRP level and platelet count must be performed preferably whilst on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments. Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. If treatment with methotrexate alone or in combination with other treatments is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient's medical records. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. The following information must be provided by the prescriber at the time of application and documented in the patient's medical records (a) the date of assessment of severe active systemic juvenile idiopathic arthritis; and (b) details of prior treatment including dose and duration of treatment. The following reports must be documented in the patient's medical records where appropriate (a) the date of assessment of severe active systemic juvenile idiopathic arthritis; (b) details of prior treatment including dose and duration of treatment; and (c) the pathology reports detailing CRP and platelet count where appropriate. | Compliance with Authority Required procedures |
C14084 | P14084 | CN14084 | Tocilizumab | Systemic juvenile idiopathic arthritis Continuing treatment in a patient weighing less than 30 kg Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction; AND Must be treated by a rheumatologist. or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. An adequate response to treatment is defined as (a) in a patient with polyarticular course disease (i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (ii) a reduction in the number of the following major active joints, from at least 4, by at least 50% (b) in a patient with refractory systemic symptoms (i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or (ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or (iii) a reduction in the dose of corticosteroid by at least 30% from baseline. - elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or - shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). (b) in a patient with refractory systemic symptoms (i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or (ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or (iii) a reduction in the dose of corticosteroid by at least 30% from baseline. The assessment of response to treatment must be documented in the patient's medical records. Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity provided with the initial treatment application. The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of prescribing and must be documented in the patient's medical records. The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle. 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. If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 14084 |
C14088 | P14088 | CN14088 | Tocilizumab | Systemic juvenile idiopathic arthritis Continuing treatment in a patient weighing at least 30 kg Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction; AND Must be treated by a rheumatologist. or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. An adequate response to treatment is defined as (a) in a patient with polyarticular course disease (i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (ii) a reduction in the number of the following major active joints, from at least 4, by at least 50% (b) in a patient with refractory systemic symptoms (i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or (ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or (iii) a reduction in the dose of corticosteroid by at least 30% from baseline. - elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or - shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). (b) in a patient with refractory systemic symptoms (i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or (ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or (iii) a reduction in the dose of corticosteroid by at least 30% from baseline. The assessment of response to treatment must be documented in the patient's medical records. Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity provided with the initial treatment application. The following reports must be documented in the patient's medical records where appropriate (a) baseline and current pathology reports detailing C-reactive protein (CRP) levels; and (b) baseline and current pathology reports detailing platelet count. The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of prescribing and must be documented in the patient's medical records. The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle. 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. If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 14088 |
C14094 | P14094 | CN14094 | Tocilizumab | Systemic juvenile idiopathic arthritis Initial treatment - Initial 1 (new patient weighing less than 30 kg) Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have polyarticular course disease which has failed to respond adequately to oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or Patient must have polyarticular course disease and have demonstrated severe intolerance of, or toxicity due to, methotrexate; or Patient must have refractory systemic symptoms, demonstrated by an inability to decrease and maintain the dose of prednisolone (or equivalent) below 0.5 mg per kg per day following a minimum of 2 months of therapy; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be under 18 years of age; Must be treated by a rheumatologist. or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. The following criteria indicate failure to achieve an adequate response to prior methotrexate therapy in a patient with polyarticular course disease and must be demonstrated in the patient at the time of the initial application (a) an active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to prior treatment must be documented in the patient's medical records. The following criteria indicate failure to achieve an adequate response to prior therapy in a patient with refractory systemic symptoms and must be demonstrated in the patient at the time of the initial application (a) an active joint count of at least 2 active joints; and (b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or (c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN). The assessment of response to prior treatment must be documented in the patient's medical records. The baseline measurements of joint count, fever and/or CRP level and platelet count must be performed preferably whilst on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments. Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. If treatment with methotrexate alone or in combination with other treatments is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient's medical records. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records. The following information must be provided by the prescriber at the time of application and documented in the patient's medical records (a) the date of assessment of severe active systemic juvenile idiopathic arthritis; and (b) the details of prior treatment including dose and duration of treatment. The following reports must be documented in the patient's medical records where appropriate (a) pathology reports detailing C-reactive protein (CRP) level and platelet count. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. | Compliance with Authority Required procedures |
C14096 | P14096 | CN14096 | Choriogonadotropin alfa | Infertility indications other than that of Assisted Reproductive Technology Patient must not be undergoing treatment with medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule; AND Patient must not be undergoing simultaneous treatment with this drug through another PBS program listing; AND Must be treated by an obstetrician/gynaecologist. or Must be treated by a specialist in reproductive endocrinology/infertility. or Must be treated by a urogynaecologist. or Must be treated by an endocrinologist. or Must be treated by a urologist. The PBS prescription, whether it is to initiate or continue treatment, must be made out under the specialist's prescriber number. | |
C14097 | P14097 | CN14097 | Finerenone | Chronic kidney disease with Type 2 diabetes Patient must have a diagnosis of chronic kidney disease, defined as abnormalities of at least one of:
(i) kidney structure, (ii) kidney function, present for at least 3 months, prior to initiating treatment with this drug; AND Patient must not have known significant non-diabetic renal disease, prior to initiating treatment with this drug; AND Patient must have an estimated glomerular filtration rate of 25 mL/min/1.73 m2 or greater, prior to initiating treatment with this drug; AND Patient must have a urinary albumin-to-creatinine ratio of 200 mg/g (22.6 mg/mmol) or greater, prior to initiating treatment with this drug; AND Patient must discontinue treatment with this drug prior to initiating renal replacement therapy, defined as dialysis or kidney transplant; AND Patient must be stabilised, for at least 4 weeks, on either:
(i) an ACE inhibitor or (ii) an angiotensin II receptor antagonist, unless medically contraindicated, prior to initiation of combination therapy with this drug; AND The treatment must be in combination with an SGLT2i unless medically contraindicated or intolerant; AND Patient must not be receiving treatment with another selective nonsteroidal mineralocorticoid receptor antagonist, a renin inhibitor or a potassium-sparing diuretic; AND Patient must not have established heart failure with reduced ejection fraction with an indication for treatment with a mineralocorticoid receptor antagonist. | Compliance with Authority Required procedures - Streamlined Authority Code 14097 |
C14121 | P14121 | CN14121 | Tocilizumab | Systemic juvenile idiopathic arthritis Initial treatment - Initial 3 (recommencement of a new treatment cycle after a break of more than 12 months in a patient weighing less than 30 kg) Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have had a break in treatment of 12 months or more from this drug for this condition; AND Patient must have polyarticular course disease and the condition must have at least one of:
(a) an active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active joints from the following list of major joints: i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); or Patient must have refractory systemic symptoms and the condition must have (a) an active joint count of at least 2 active joints; and (b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or (c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN); AND Patient must not receive more than 16 weeks of treatment under this restriction; AND Must be treated by a rheumatologist; or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; Patient must be under 18 years of age. The following information must be provided by the prescriber at the time of application and documented in the patient's medical records (a) the date of assessment of severe active systemic juvenile idiopathic arthritis. The following reports must be documented in the patient's medical records where appropriate (a) pathology reports detailing C-reactive protein (CRP) level and platelet count. The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of application. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle. If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Authority Required procedures |
C14124 | P14124 | CN14124 | Choriogonadotropin alfa | Assisted Reproductive Technology Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule; AND Patient must not be undergoing simultaneous treatment with this drug through another PBS program listing. | Compliance with Authority Required procedures - Streamlined Authority Code 14124 |
C14147 | P14147 | CN14147 | Tocilizumab | Systemic juvenile idiopathic arthritis Initial treatment - Initial 3 (recommencement of treatment after a break of more than 12 months in a patient weighing at least 30 kg) Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have had a break in treatment of 12 months or more from this drug for this condition; AND Patient must have polyarticular course disease and the condition must have at least one of:
(a) an active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active joints from the following list of major joints: i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); or Patient must have refractory systemic symptoms and the condition must have (a) an active joint count of at least 2 active joints; and (b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or (c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN); AND Patient must not receive more than 16 weeks of treatment under this restriction; AND Must be treated by a rheumatologist; or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; Patient must be under 18 years of age. The following information must be provided by the prescriber at the time of application and documented in the patient's medical records (a) the date of assessment of severe active systemic juvenile idiopathic arthritis. The following reports must be documented in the patient's medical records where appropriate (a) pathology reports detailing C-reactive protein (CRP) level and platelet count. The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of application. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle. If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Authority Required procedures |
C14175 | P14175 | CN14175 | Tocilizumab | Systemic juvenile idiopathic arthritis Initial treatment - Initial 2 (retrial or recommencement of treatment after a break of less than 12 months in a patient weighing at least 30 kg) Patient must have received prior PBS-subsidised treatment with this drug for this condition in the previous 12 months; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be under 18 years of age; Must be treated by a rheumatologist. or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. An adequate response to treatment is defined as (a) in a patient with polyarticular course disease (i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (ii) a reduction in the number of the following major active joints, from at least 4, by at least 50% (b) in a patient with refractory systemic symptoms (i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or (ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or (iii) a reduction in the dose of corticosteroid by at least 30% from baseline. - elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or - shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). (b) in a patient with refractory systemic symptoms (i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or (ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or (iii) a reduction in the dose of corticosteroid by at least 30% from baseline. The assessment of response to treatment must be documented in the patient's medical records. The following reports must be documented in the patient's medical records where appropriate (a) pathology reports detailing C-reactive protein (CRP) level and platelet count. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to retrial or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle. If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures |
C14180 | P14180 | CN14180 | Fluticasone propionate | Asthma The treatment must not be a PBS benefit where this 50 microgram strength is being initiated in a patient over the age of 6.00 years. | Compliance with Authority Required procedures - Streamlined Authority Code 14180 |
C14182 | P14182 | CN14182 | Tocilizumab | Systemic juvenile idiopathic arthritis Initial treatment - Initial 2 (retrial or recommencement of treatment after a break of less than 12 months in a patient weighing less than 30 kg) Patient must have received prior PBS-subsidised treatment with this drug for this condition in the previous 12 months; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be under 18 years of age; Must be treated by a rheumatologist. or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. An adequate response to treatment is defined as (a) in a patient with polyarticular course disease (i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (ii) a reduction in the number of the following major active joints, from at least 4, by at least 50% (b) in a patient with refractory systemic symptoms (i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or (ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or (iii) a reduction in the dose of corticosteroid by at least 30% from baseline. - elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or - shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). (b) in a patient with refractory systemic symptoms (i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or (ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or (iii) a reduction in the dose of corticosteroid by at least 30% from baseline. The assessment of response to treatment must be documented in the patient's medical records. The following reports must be documented in the patient's medical records where appropriate (a) pathology reports detailing C-reactive protein (CRP) level and platelet count. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to retrial or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle. If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures |
C14195 | P14195 | CN14195 | Tocilizumab | Active giant cell arteritis Initial treatment Must be treated by a rheumatologist, clinical immunologist or neurologist experienced in the management of giant cell arteritis; AND Patient must have clinical symptoms of active giant cell arteritis in the absence of any other identifiable cause; AND Patient must have an ESR equal to or greater than 30 mm/hour within the past 6 weeks; or Patient must have a CRP equal to or greater than 10 mg/L within the past 6 weeks; or Patient must have active giant cell arteritis confirmed by positive temporal artery biopsy or imaging; AND Patient must have had a history of an ESR equal to or greater than 50 mm/hour or a CRP equal to or greater than 24.5 mg/L at diagnosis; AND Patient must have had temporal artery biopsy revealing features of giant cell arteritis at diagnosis; or Patient must have had evidence of large-vessel vasculitis by magnetic resonance (MR) or computed tomography (CT) angiography or PET/CT at diagnosis; or Patient must have had evidence of positive temporal artery halo sign by ultrasound (US) at diagnosis; AND The treatment must be in combination with a tapering course of corticosteroids; AND The treatment must not exceed 52 weeks in total including initial and continuing applications; Patient must be aged 50 years or older. Clinical symptoms of giant cell arteritis at diagnosis include unequivocal cranial symptoms of giant cell arteritis (new onset localized headache, scalp tenderness, temporal artery tenderness or decreased pulsation, ischemia related vision loss, or otherwise unexplained mouth or jaw pain upon mastication); or symptoms of polymyalgia rheumatica, defined as shoulder and/or hip girdle pain associated with inflammatory morning stiffness. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS and must include (a) details (dates, results, and unique identifying number/code or provider number) of evidence that the patient has active giant cell arteritis including pathology reports outlining the patient's ESR or CRP levels within the last 6 weeks, or positive temporal artery biopsy or imaging; and (b) details (dates, results, and unique identifying number/code or provider number) of evidence that the patient has been diagnosed with giant cell arteritis with a history of an ESR equal to or greater than 50 mm/hour or a CRP equal to or greater than 24.5 mg/L at diagnosis. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Authority Required procedures |
C14196 | P14196 | CN14196 | Trabectedin | Advanced (unresectable and/or metastatic) leiomyosarcoma or liposarcoma Initial treatment Patient must have an ECOG performance status of 2 or less; AND Patient must have received prior chemotherapy treatment including an anthracycline; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The condition must be one of the following subtypes for patients with liposarcoma:
(i) dedifferentiated, (ii) myxoid, (iii) round-cell, (iv) pleomorphic. This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting. | Compliance with Authority Required procedures - Streamlined Authority Code 14196 |
C14197 | P14197 | CN14197 | Trabectedin | Advanced (unresectable and/or metastatic) leiomyosarcoma or liposarcoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition. This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting. | Compliance with Authority Required procedures - Streamlined Authority Code 14197 |
C14202 | P14202 | CN14202 | Mifepristone and misoprostol | Termination of an intra-uterine pregnancy The condition must be an intra-uterine pregnancy of up to 63 days of gestation. | Compliance with Authority Required procedures - Streamlined Authority Code 14202 |
C14217 | P14217 | CN14217 | Bimekizumab Upadacitinib | Non-radiographic axial spondyloarthritis Initial 1 (New patient), Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment; AND Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis. | Compliance with Authority Required procedures |
C14228 | P14228 | CN14228 | Calcium | Hyperphosphataemia The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must be associated with chronic renal failure. | Compliance with Authority Required procedures - Streamlined Authority Code 14228 |
C14231 | P14231 | CN14231 | Calcitriol | Hypophosphataemic rickets The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | Compliance with Authority Required procedures - Streamlined Authority Code 14231 |
C14234 | P14234 | CN14234 | Risedronic acid | Corticosteroid-induced osteoporosis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition. The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated. | |
C14235 | P14235 | CN14235 | Risedronic acid | Osteoporosis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; Patient must be aged 70 years or older; Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition. The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated. | |
C14236 | P14236 | CN14236 | Calcipotriol with betamethasone | Chronic stable plaque type psoriasis vulgaris The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must be inadequately controlled by potent topical corticosteroid monotherapy. | |
C14238 | P14238 | CN14238 | Acarbose Allopurinol Amlodipine Amlodipine with atorvastatin Amlodipine with valsartan Atenolol Atorvastatin Baclofen Beclometasone Bimatoprost Brimonidine Brinzolamide Budesonide Candesartan Candesartan with hydrochlorothiazide Chlortalidone Ciclesonide Ciclosporin Clonidine Clopidogrel Clopidogrel with aspirin Colestyramine Cyproterone Dexamethasone Diltiazem Dorzolamide Enalapril Enalapril with hydrochlorothiazide Eprosartan Eprosartan with hydrochlorothiazide Estradiol Estradiol and estradiol with dydrogesterone Estradiol and estradiol with norethisterone Estradiol with norethisterone Estriol Everolimus Ezetimibe Ezetimibe and rosuvastatin Ezetimibe with atorvastatin Ezetimibe with simvastatin Famotidine Felodipine Fenofibrate Fluticasone furoate Fluticasone propionate Furosemide Gemfibrozil Glibenclamide Gliclazide Glimepiride Glipizide Glyceryl trinitrate Hydrochlorothiazide Hydrochlorothiazide with amiloride Indapamide Irbesartan Irbesartan with hydrochlorothiazide Isosorbide dinitrate Isosorbide mononitrate Labetalol Latanoprost Lercanidipine Lercanidipine with enalapril Lisinopril Medroxyprogesterone Metformin Methenamine Methotrexate Metoprolol Mycophenolic acid Nicorandil Nifedipine Nizatidine Norethisterone Olmesartan Olmesartan with amlodipine Olmesartan with hydrochlorothiazide Paraffin Perindopril Perindopril with amlodipine Perindopril with indapamide Pilocarpine Pizotifen Potassium chloride Potassium chloride with potassium bicarbonate Pravastatin Prazosin Prednisolone Prednisone Probenecid Progesterone Progesterone and estradiol Propranolol Pyridostigmine Ramipril Ramipril with felodipine Rosuvastatin Simvastatin Sirolimus Sodium bicarbonate Spironolactone Tacrolimus Telmisartan Telmisartan with amlodipine Telmisartan with hydrochlorothiazide Timolol Trandolapril Trandolapril with verapamil Tranylcypromine Travoprost Valsartan Valsartan with hydrochlorothiazide Verapamil | The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C14240 | P14240 | CN14240 | Ticagrelor | Acute coronary syndrome (myocardial infarction or unstable angina) The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must be in combination with aspirin. | Compliance with Authority Required procedures - Streamlined Authority Code 14240 |
C14242 | P14242 | CN14242 | Alendronic acid | Osteoporosis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; Patient must be aged 70 years or older; Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition. The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated. | |
C14251 | P14251 | CN14251 | Bisoprolol Carvedilol Metoprolol succinate Nebivolol | Moderate to severe heart failure The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must be stabilised on conventional therapy, which must include an ACE inhibitor or Angiotensin II antagonist, if tolerated. | |
C14259 | P14259 | CN14259 | Calcitriol | Established osteoporosis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have fracture due to minimal trauma. The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated. A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body. | Compliance with Authority Required procedures - Streamlined Authority Code 14259 |
C14263 | P14263 | CN14263 | Risedronic acid | Established osteoporosis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have fracture due to minimal trauma; AND Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition. The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated. A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body. | |
C14264 | P14264 | CN14264 | Rivaroxaban | Deep vein thrombosis Continuing treatment The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have confirmed acute symptomatic deep vein thrombosis; AND Patient must not have symptomatic pulmonary embolism. | Compliance with Authority Required procedures - Streamlined Authority Code 14264 |
C14270 | P14270 | CN14270 | Carvedilol | Patients receiving this drug as a pharmaceutical benefit prior to 1 August 2002 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C14272 | P14272 | CN14272 | Amlodipine with valsartan and hydrochlorothiazide Olmesartan with amlodipine and hydrochlorothiazide | Hypertension The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must not be for the initiation of anti-hypertensive therapy; AND The condition must be inadequately controlled with concomitant treatment with two of the following:
an angiotensin II antagonist, a dihydropyridine calcium channel blocker or a thiazide diuretic. | |
C14274 | P14274 | CN14274 | Raloxifene | Established post-menopausal osteoporosis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have fracture due to minimal trauma; AND Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition. The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated. A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body. | Compliance with Authority Required procedures - Streamlined Authority Code 14274 |
C14275 | P14275 | CN14275 | Adapalene with benzoyl peroxide | Severe acne vulgaris The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must be maintenance therapy. | |
C14287 | P14287 | CN14287 | Calcitriol | Hypoparathyroidism The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | Compliance with Authority Required procedures - Streamlined Authority Code 14287 |
C14289 | P14289 | CN14289 | Moxonidine | Hypertension The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must be receiving concurrent antihypertensive therapy. | |
C14291 | P14291 | CN14291 | Alendronic acid | Established osteoporosis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have fracture due to minimal trauma; AND Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition. The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated. A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body. | |
C14296 | P14296 | CN14296 | Calcitriol | Vitamin D-resistant rickets The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | Compliance with Authority Required procedures - Streamlined Authority Code 14296 |
C14298 | P14298 | CN14298 | Rivaroxaban | Chronic stable atherosclerotic disease Continuing treatment The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with aspirin, but not with any other anti-platelet therapy. | Compliance with Authority Required procedures - Streamlined Authority Code 14298 |
C14300 | P14300 | CN14300 | Apixaban Rivaroxaban | Prevention of recurrent venous thromboembolism Continuing treatment The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have a history of venous thromboembolism. | Compliance with Authority Required procedures - Streamlined Authority Code 14300 |
C14301 | P14301 | CN14301 | Apixaban Dabigatran etexilate Rivaroxaban | Prevention of stroke or systemic embolism The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have non-valvular atrial fibrillation; AND Patient must have one or more risk factors for developing stroke or systemic embolism. Risk factors for developing stroke or systemic ischaemic embolism are (i) Prior stroke (ischaemic or unknown type), transient ischaemic attack or non-central nervous system (CNS) systemic embolism; (ii) age 75 years or older; (iii) hypertension; (iv) diabetes mellitus; (v) heart failure and/or left ventricular ejection fraction 35% or less. | Compliance with Authority Required procedures - Streamlined Authority Code 14301 |
C14305 | P14305 | CN14305 | Atenolol | For a patient who is unable to take a solid dose form of atenolol. The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C14309 | P14309 | CN14309 | Alendronic acid | Corticosteroid-induced osteoporosis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition. The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated. | |
C14313 | P14313 | CN14313 | Febuxostat | Chronic gout The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must be either chronic gouty arthritis or chronic tophaceous gout; AND Patient must have a medical contraindication to allopurinol. or Patient must have a documented history of allopurinol hypersensitivity syndrome. or Patient must have an intolerance to allopurinol necessitating permanent treatment discontinuation. | Compliance with Authority Required procedures - Streamlined Authority Code 14313 |
C14318 | P14318 | CN14318 | Rivaroxaban | Pulmonary embolism Continuing treatment The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have confirmed acute symptomatic pulmonary embolism. | Compliance with Authority Required procedures - Streamlined Authority Code 14318 |
C14319 | P14319 | CN14319 | Thiamine | Thiamine deficiency The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must be for prophylaxis; Patient must be an Aboriginal or a Torres Strait Islander person. | Compliance with Authority Required procedures - Streamlined Authority Code 14319 |
C14322 | P14322 | CN14322 | Calcitriol | Hypocalcaemia The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must be due to renal disease. | Compliance with Authority Required procedures - Streamlined Authority Code 14322 |
C14324 | P14324 | CN14324 | Pembrolizumab | Recurrent, unresectable or metastatic triple negative breast cancer The condition must have been (up until this drug therapy) untreated in the unresectable/metastatic disease stage; AND The condition must have been (up until this drug therapy) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy in breast cancer; AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND The treatment must be in combination with chemotherapy; AND The condition must have both:
(i) programmed cell death ligand 1 (PD-L1) expression confirmed by a validated test, (ii) a Combined Positive Score (CPS) of at least 10 at treatment initiation; AND Patient must be undergoing initial treatment with this drug - this is the first prescription for this drug; or Patient must be undergoing continuing treatment with this drug - both the following are true:
(i) the condition has not progressed on active treatment with this drug, (ii) this prescription does not extend PBS subsidy beyond 24 cumulative months from the first administered dose; AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions. or Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions. | Compliance with Authority Required procedures - Streamlined Authority Code 14324 |
C14326 | P14326 | CN14326 | Obinutuzumab | Chronic lymphocytic leukaemia (CLL) Combination use with chlorambucil only The condition must be CD20 positive; AND The condition must be previously untreated; AND The treatment must be in combination with chlorambucil; AND The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition. Treatment must be discontinued in patients who experience disease progression whilst on this treatment. | Compliance with Authority Required procedures - Streamlined Authority Code 14326 |
C14327 | P14327 | CN14327 | Patiromer | Chronic hyperkalaemia Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must not be in place of emergency treatment of hyperkalaemia; AND Patient must be undergoing treatment with a renin angiotensin aldosterone system inhibitor; AND Patient must not be undergoing dialysis. | Compliance with Authority Required procedures - Streamlined Authority Code 14327 |
C14332 | P14332 | CN14332 | Azacitidine | Acute Myeloid Leukaemia Treatment following intensive induction chemotherapy - Initial treatment Patient must have demonstrated either:
(i) first complete remission, (ii) complete remission with incomplete blood count recovery following intensive induction chemotherapy; AND Patient must not be a candidate for, including those who choose not to proceed to, haematopoietic stem cell transplantation; AND Patient must have, at the time of induction therapy, a cytogenetic risk classified as either:
(i) intermediate-risk, (ii) poor-risk; AND Patient must not have undergone a stem cell transplant; AND Patient must not be receiving concomitant PBS-subsidised treatment with midostaurin. A complete remission is defined as bone marrow blasts of less than 5%, absence of blasts with Auer rods, absence of extramedullary disease, independent of blood transfusions and a recovery of peripheral blood counts with peripheral neutrophil count greater than 1.0 x 109/L and platelet count greater than or equal to 100 x 109/L. A complete remission with incomplete blood count recovery is defined as bone marrow blasts of less than 5%, absence of blasts with Auer rods, absence of extramedullary disease, independent of blood transfusions and a recovery of peripheral blood counts with peripheral neutrophil count less than 1.0 x 109/L or platelet count less than 100 x 109/L. | Compliance with Authority Required procedures |
C14338 | P14338 | CN14338 | Azacitidine | Acute Myeloid Leukaemia Treatment following intensive induction chemotherapy - Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have, for reasons not attributable to any cause other than AML, no more than 15% blasts in either the:
(i) bone marrow, (ii) peripheral blood; AND Patient must not be receiving concomitant PBS-subsidised treatment with midostaurin. | Compliance with Authority Required procedures |
C14342 | P14342 | CN14342 | Patiromer | Chronic hyperkalaemia Initial PBS-subsidised treatment (including grandfathered patients) Patient must have stage 3 to stage 4 chronic kidney disease; The condition must be inadequately controlled by a low potassium diet.; AND Patient must have experienced at least 2 episodes of hyperkalaemia (defined as serum potassium levels of at least 6.0 mmol/L) within the 12 months prior to commencing this drug; AND The treatment must not be in place of emergency treatment of hyperkalaemia; AND Patient must be undergoing treatment with a renin angiotensin aldosterone system inhibitor; or Patient must be indicated for treatment with a renin angiotensin aldosterone system inhibitor, but unable to tolerate this due to prior occurrence of hyperkalaemia; AND Must be treated by a specialist medical practitioner with experience in the diagnosis and management of chronic kidney disease. | Compliance with Authority Required procedures |
C14363 | P14363 | CN14363 | Carfilzomib | Relapsed and/or refractory multiple myeloma Continuing treatment for Cycles 3 to 12 Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with lenalidomide and dexamethasone; AND Patient must not have progressive disease while receiving treatment with this drug for this condition. Progressive disease is defined as at least 1 of the following (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures - Streamlined Authority Code 14363 |
C14364 | P14364 | CN14364 | Carfilzomib | Relapsed and/or refractory multiple myeloma Continuing treatment for Cycles 13 onwards Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with lenalidomide and dexamethasone; AND Patient must not have progressive disease while receiving treatment with this drug for this condition. Progressive disease is defined as at least 1 of the following (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures - Streamlined Authority Code 14364 |
C14366 | P14366 | CN14366 | Somatropin | Severe growth hormone deficiency Continuing treatment in a person with a mature skeleton or aged 18 years or older Must be treated by an endocrinologist; AND Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause in a patient with a mature skeleton. or Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to late onset of growth hormone deficiency secondary to organic hypothalamic or pituitary disease in a patient with chronological age of 18 years or older. or Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to late onset of growth hormone deficiency diagnosed after skeletal maturity (bone age greater than or equal to 15.5 years in males or 13.5 years in females) and before chronological age of 18 years. | Compliance with Authority Required procedures |
C14387 | P14387 | CN14387 | Fosnetupitant with palonosetron | Nausea and vomiting The treatment must be for prevention of nausea and vomiting associated with moderate to highly emetogenic anti-cancer therapy; AND The treatment must be in combination with dexamethasone, unless contraindicated; AND Patient must be unable to swallow. or Patient must be contraindicated to oral anti-emetics. | Compliance with Authority Required procedures |
C14389 | P14389 | CN14389 | Carfilzomib | Relapsed and/or refractory multiple myeloma Initial treatment for Cycles 1 to 3 The condition must be confirmed by a histological diagnosis; AND The treatment must be in combination with lenalidomide and dexamethasone; AND Patient must have progressive disease after at least one prior therapy; AND Patient must not have previously received this drug for this condition. Progressive disease is defined as at least 1 of the following (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. Provide details of the histological diagnosis of multiple myeloma, prior treatments including name(s) of drug(s) and date of the most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response once only through the Authority application for lenalidomide. | Compliance with Authority Required procedures - Streamlined Authority Code 14389 |
C14416 | P14416 | CN14416 | Enfortumab vedotin | Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer The condition must have progressed on/following both:
(i) platinum-based chemotherapy, (ii) programmed cell death 1/ligand 1 (PD-1/PD-L1) inhibitor therapy; or The condition must have progressed on/following platinum-based chemotherapy, whilst PD-1/PD-L1 inhibitor therapy resulted in an intolerance that required treatment cessation; AND Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND Patient must be undergoing treatment with this drug for the first time. or Patient must be undergoing continuing treatment with this drug, with each of the following being true:
(i) all other PBS eligibility criteria in this restriction are met, (ii) disease progression is absent. | Compliance with Authority Required procedures - Streamlined Authority Code 14416 |
C14443 | P14443 | CN14443 | Netupitant with Palonosetron | Nausea and vomiting The treatment must be in combination with dexamethasone, unless contraindicated; AND The treatment must be for prevention of nausea and vomiting associated with moderate to highly emetogenic anti-cancer therapy. | Compliance with Authority Required procedures - Streamlined Authority Code 14443 |
C14449 | P14449 | CN14449 | Bimekizumab | Severe chronic plaque psoriasis Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 24 weeks treatment; or Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 24 weeks treatment; or Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 24 weeks treatment; or Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 24 weeks treatment; or Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 24 weeks treatment; or Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 24 weeks treatment; AND The treatment must be as systemic monotherapy (other than methotrexate); AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND Must be treated by a dermatologist. | Compliance with Authority Required procedures |
C14471 | P14471 | CN14471 | Dapagliflozin Empagliflozin | Chronic heart failure Patient must be symptomatic with NYHA classes II, III or IV prior to initiating treatment with this drug; AND Patient must have a documented left ventricular ejection fraction (LVEF) of greater than 40%; AND Patient must have documented evidence of structural changes in the heart on echocardiography that would be expected to cause diastolic dysfunction (e.g. left ventricular hypertrophy); AND Patient must have documented evidence of at least one of the following:
(i) diastolic dysfunction with high filling pressure on echocardiography, stress echocardiography or cardiac catheterisation; (ii) hospitalisation for heart failure in the 12 months prior to initiating treatment with this drug; (iii) requirement for intravenous diuretic therapy in the 12 months prior to initiating treatment with this drug; (iv) elevated N-terminal pro brain natriuretic peptide (NT-proBNP) levels in the absence of another cause; AND Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 14471 |
C14488 | P14488 | CN14488 | Etanercept | Severe active rheumatoid arthritis Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supply Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or 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 24 months) restriction to complete 16 weeks treatment; or 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 24 months) to complete 16 weeks of treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
C14496 | P14496 | CN14496 | Adalimumab | Severe active rheumatoid arthritis Initial treatment - Initial 1 (new patient) Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following:
(i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs:
(i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of:
(i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or Patient must have a contraindication/severe intolerance to each of:
(i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details of the contraindications/severe intolerances; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age. If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, details of the contraindication or intolerance including severity to methotrexate must be provided at the time of application and documented in the patient's medical records. The maximum tolerated dose of methotrexate must be provided at the time of the application, if applicable, and documented in the patient's medical records. The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity. The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months. If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided at the time of application and documented in the patient's medical records. The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to prior treatment must be documented in the patient's medical records. The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application. If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient's medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. The following information must be provided by the prescriber at the time of application and documented in the patient's medical records (a) the active joint count, ESR and/or CRP result and date of results; (b) details of prior treatment, including dose and date/duration of treatment. (c) If applicable, details of any contraindications/intolerances. (d) If applicable, the maximum tolerated dose of methotrexate. An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment. 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. 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. | Compliance with Authority Required procedures |
C14499 | P14499 | CN14499 | Adalimumab Baricitinib Certolizumab pegol Etanercept Tocilizumab Tofacitinib Upadacitinib | Severe active rheumatoid arthritis Subsequent continuing treatment Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction; Patient must be at least 18 years of age. An adequate response to treatment is defined as an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50% (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition. 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. | Compliance with Authority Required procedures - Streamlined Authority Code 14499 |
C14507 | P14507 | CN14507 | Abatacept Adalimumab Baricitinib Certolizumab pegol Etanercept Golimumab Infliximab Tocilizumab Tofacitinib | Severe active rheumatoid arthritis First continuing treatment - balance of supply Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment. | Compliance with Authority Required procedures |
C14508 | P14508 | CN14508 | Etanercept | Severe chronic plaque psoriasis Completion of course - treatment covering weeks 16 to 24 (Face, hand, foot) Must be treated by a dermatologist; AND Patient must be undergoing current PBS-subsidised treatment with this biological medicine, with the intention to complete the remainder of a 24-week treatment course with this biological medicine; AND The treatment must be as systemic monotherapy; or The treatment must be in combination with methotrexate; AND Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine, but within 8 weeks of the last administered dose; AND Patient must have demonstrated an adequate response to treatment; AND Patient must not receive more than 8 weeks of treatment with etanercept under this restriction. An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing (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 (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. The assessment of response to treatment must be documented in the patient's medical records. The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment. | Compliance with Authority Required procedures - Streamlined Authority Code 14508 |
C14509 | P14509 | CN14509 | Etanercept | Severe chronic plaque psoriasis Completion of course - treatment covering weeks 16 to 24 (Whole body) Must be treated by a dermatologist; AND Patient must be undergoing current PBS-subsidised treatment with this biological medicine, with the intention to complete the remainder of a 24-week treatment course with this biological medicine; AND The treatment must be as systemic monotherapy; or The treatment must be in combination with methotrexate; AND Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine, but within 8 weeks of the last administered dose; AND Patient must have demonstrated an adequate response to treatment; AND Patient must not receive more than 8 weeks of treatment with etanercept under this restriction. An adequate response to treatment is defined as 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. The assessment of response to treatment must be documented in the patient's medical records. The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment. | Compliance with Authority Required procedures - Streamlined Authority Code 14509 |
C14513 | P14513 | CN14513 | Etanercept | Severe chronic plaque psoriasis Initial 1 treatment (Whole body) - biological medicine-naive patient Must be treated by a dermatologist; AND Patient must be undergoing treatment for the first time with PBS-subsidised biological medicine for this PBS indication; AND The treatment must be as systemic monotherapy; or The treatment must be in combination with methotrexate; AND Patient must have lesions present for at least 6 months from the time of initial diagnosis; AND Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND Patient must not receive more than 16 weeks of treatment with this biological medicine under this restriction; Patient must be under 18 years of age. Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be documented in the patient's medical records. Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be documented in the patient's medical records. Details of the accepted toxicities including severity can be found on the Services Australia website. The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy (a) A Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of the last pre-requisite therapy. (i) the name of each prior therapy trialled that meets the above requirements - state at least 2; (ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies); (iii) the PASI score that followed each prior therapy trialled; (iv) the date the PASI scores were determined. A PASI assessment must have been completed for each pre-requisite treatment trialled, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of that pre-requisite treatment. Provide in this authority application, and document in the patient's medical records, each of (i) the name of each prior therapy trialled that meets the above requirements - state at least 2; (ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies); (iii) the PASI score that followed each prior therapy trialled; (iv) the date the PASI scores were determined. Provide a baseline PASI score to be referenced in any future authority applications that continue treatment. This PASI score may be any of (i) a current PASI score, (ii) a PASI score present prior to, or, after a pre-requisite non-biological medicine. | Compliance with Authority Required procedures |
C14542 | P14542 | CN14542 | Certolizumab pegol | Severe active rheumatoid arthritis Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supply Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND 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, depending on the dosage regimen; or 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 24 months) restriction to complete 18 to 20 weeks treatment, depending on the dosage regimen; or 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 24 months) restriction to complete 18 to 20 weeks treatment, depending on the dosage regimen; AND The treatment must provide no more than the balance of up to 18 to 20 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
C14553 | P14553 | CN14553 | Etanercept | Severe chronic plaque psoriasis Initial 4 - Re-treatment (Whole body) Must be treated by a dermatologist; AND The treatment must be as systemic monotherapy; or The treatment must be in combination with methotrexate; AND Patient must have a documented history of severe chronic plaque psoriasis of the whole body; AND Patient must be undergoing re-treatment with this biological medicine for this PBS indication after an initial adequate response to the most recent treatment course, but has since experienced at least one of the following:
(i) a disease flare where the PASI score has worsened (increased) by at least 50%, (ii) the current PASI score has returned above 15; AND Patient must not have failed more than once to achieve an adequate response with etanercept; AND Patient must not receive more than 16 weeks of treatment with etanercept under this restriction; Patient must be under 18 years of age. Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment. | Compliance with Authority Required procedures |
C14554 | P14554 | CN14554 | Etanercept | Severe chronic plaque psoriasis Initial 1 treatment (Face, hand, foot) - biological medicine-naive patient Must be treated by a dermatologist; AND Patient must be undergoing treatment for the first time with PBS-subsidised biological medicine for this PBS indication; AND The treatment must be as systemic monotherapy; or The treatment must be in combination with methotrexate; AND Patient must have the plaque or plaques of the face, or palm of hand or sole of foot present for at least 6 months from the time of initial diagnosis; AND Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND Patient must not receive more than 16 weeks of treatment with etanercept under this restriction; Patient must be under 18 years of age. Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be documented in the patient's medical records. Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be documented in the patient's medical records. Details of the accepted toxicities including severity can be found on the Services Australia website. The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy (a) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling being rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy; or (b) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy (i) the name of each prior therapy trialled that meets the above requirements - state at least 2; (ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies); (iii) whether failure type (a) or (b) as described above occurred for each prior therapy trialled; (iv) the dates that response assessments were determined. (v) for each of erythema, thickness and scaling, which of these are rated as severe or very severe (at least 2 must be rated as severe/very severe); (vi) the percentage area of skin (combined area of face, hands and feet) affected by this condition (must be at least 30%) prior to treatment with biological medicine. Provide in this authority application, and document in the patient's medical records, each of (i) the name of each prior therapy trialled that meets the above requirements - state at least 2; (ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies); (iii) whether failure type (a) or (b) as described above occurred for each prior therapy trialled; (iv) the dates that response assessments were determined. (v) for each of erythema, thickness and scaling, which of these are rated as severe or very severe (at least 2 must be rated as severe/very severe); (vi) the percentage area of skin (combined area of face, hands and feet) affected by this condition (must be at least 30%) prior to treatment with biological medicine. Provide in this authority application at least one of the following to act as a baseline measurement and be referenced in any future authority applications that continue treatment (v) for each of erythema, thickness and scaling, which of these are rated as severe or very severe (at least 2 must be rated as severe/very severe); (vi) the percentage area of skin (combined area of face, hands and feet) affected by this condition (must be at least 30%) prior to treatment with biological medicine. Where a patient has had a 12 month treatment break, the length of the break is measured from the date the most recent treatment was stopped to the date of the application to re-commence treatment. | Compliance with Authority Required procedures |
C14563 | P14563 | CN14563 | Fremanezumab Galcanezumab | Treatment-resistant migraine Continuing treatment Must be treated by a neurologist; or Must be treated by a general practitioner in consultation with a neurologist; AND Patient must not be undergoing concurrent treatment with the following PBS benefits:
(i) botulinum toxin type A listed for this PBS indication, (ii) another drug in the same pharmacological class as this drug listed for this PBS indication; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have achieved and maintained at least 50% reduction from baseline in the number of migraine headache days per month; AND Patient must continue to be appropriately managed for medication overuse headache. Patient must have the number of migraine headache days per month documented in their medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 14563 |
C14567 | P14567 | CN14567 | Adalimumab | Severe active rheumatoid arthritis First continuing treatment Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction; Patient must be at least 18 years of age. An adequate response to treatment is defined as an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50% (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition. 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. | Compliance with Authority Required procedures - Streamlined Authority Code 14567 |
C14568 | P14568 | CN14568 | Adalimumab | Severe active rheumatoid arthritis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND The condition must have either:
(a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age. Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application. If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient's medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. The following information must be provided by the prescriber at the time of application and documented in the patient's medical records (a) the active joint count, ESR and/or CRP result and date of result; (b) the most recent biological agent and the date of the last continuing prescription. (c) If applicable, the new baseline scores. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. 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. 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. | Compliance with Authority Required procedures |
C14576 | P14576 | CN14576 | Etanercept | Severe chronic plaque psoriasis Initial 3 treatment (Whole body, or, face/hand/foot) - Recommencement of treatment after a break in biological medicine of more than 5 years Must be treated by a dermatologist; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition for at least 5 years, if they have previously received PBS-subsidised treatment with a biological medicine for this condition and wish to commence a new treatment cycle; AND The condition must be affecting the whole body - all subsequent authority applications to this application will be made under treatment phases that feature the words 'whole body'; or The condition must be limited to the face/hand/foot - all subsequent authority applications to this application will be made under treatment phases that feature the words 'face, hand, foot'; AND Patient must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; or The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND The treatment must be as systemic monotherapy; or The treatment must be in combination with methotrexate; AND Patient must not receive more than 16 weeks of treatment with this biological medicine under this restriction; Patient must be under 18 years of age. The most recent PASI assessment must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records. | Compliance with Authority Required procedures |
C14577 | P14577 | CN14577 | Etanercept | Severe chronic plaque psoriasis Initial 4 - Re-treatment (face, hand, foot) Must be treated by a dermatologist; AND The treatment must be as systemic monotherapy; or The treatment must be in combination with methotrexate; AND Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; AND Patient must be undergoing re-treatment with this biological medicine for this PBS indication after an initial adequate response to the most recent treatment course, but has since experienced at least one of the following:
(i) all PASI sub-measures (redness, thickness, scaling) are rated as 'moderate' to 'severe', (ii) at least 2 of the 3 PASI sub-measures are rated as 'severe' to 'very severe', (iii) the skin area affected has increased by at least 50% since the last administered dose, (iv) the skin area affected is at least 30% of the total skin area of the face/hand/foot; AND Patient must not have failed more than once to achieve an adequate response with etanercept; AND Patient must not receive more than 16 weeks of treatment with etanercept under this restriction; Patient must be under 18 years of age. Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment. | Compliance with Authority Required procedures |
C14581 | P14581 | CN14581 | Etanercept | Severe active rheumatoid arthritis Initial treatment - Initial 1 (new patient) Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following:
(i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs:
(i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of:
(i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or Patient must have a contraindication/severe intolerance to each of:
(i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details of the contraindications/severe intolerances; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age. If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, details of the contraindication or intolerance including severity to methotrexate must be provided at the time of application and documented in the patient's medical records. The maximum tolerated dose of methotrexate must be provided at the time of the application, if applicable, and documented in the patient's medical records. The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity. The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months. If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided at the time of application and documented in the patient's medical records. The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to prior treatment must be documented in the patient's medical records. The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application. If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient's medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. The following information must be provided by the prescriber at the time of application and documented in the patient's medical records (a) the active joint count, ESR and/or CRP result and date of results; (b) details of prior treatment, including dose and date/duration of treatment. (c) If applicable, details of any contraindications/intolerances. (d) If applicable, the maximum tolerated dose of methotrexate. An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment. 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. 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. | Compliance with Authority Required procedures |
C14582 | P14582 | CN14582 | Etanercept | Severe active rheumatoid arthritis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; or Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age. Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores. Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below. An adequate response to treatment is defined as an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50% (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to treatment must be documented in the patient's medical records. An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine, within the timeframes specified below. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. 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. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. 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. A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. | Compliance with Authority Required procedures |
C14590 | P14590 | CN14590 | Adalimumab | Severe active rheumatoid arthritis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; or Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age. Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores. Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below. An adequate response to treatment is defined as an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50% (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to treatment must be documented in the patient's medical records. An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine, within the timeframes specified below. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. 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. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. 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. A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. | Compliance with Authority Required procedures |
C14603 | P14603 | CN14603 | Etanercept | Severe active rheumatoid arthritis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND The condition must have either:
(a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age. Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application. If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient's medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. The following information must be provided by the prescriber at the time of application and documented in the patient's medical records (a) the active joint count, ESR and/or CRP result and date of result; (b) the most recent biological agent and the date of the last continuing prescription. (c) If applicable, the new baseline scores. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. 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. 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. | Compliance with Authority Required procedures |
C14604 | P14604 | CN14604 | Abatacept Golimumab | Severe active rheumatoid arthritis Subsequent continuing treatment Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction; AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; Patient must be at least 18 years of age. An adequate response to treatment is defined as an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50% (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition. 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. If the requirement for concomitant treatment with methotrexate cannot be met because of a contraindication and/or severe intolerance, details must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 14604 |
C14608 | P14608 | CN14608 | Budesonide | Eosinophilic oesophagitis Initial treatment - Induction of remission Patient must have a history of symptoms of oesophageal dysfunction; AND Patient must have eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy confirming the presence of at least 15 eosinophils in at least one high power field (hpf); corresponding to approximately 60 eosinophils per mm2 hpf; AND Patient must not receive more than 90 days of treatment under this restriction; AND Must be treated by a prescriber who is either:
(i) gastroenterologist, (ii) surgeon experienced in the management of patients with eosinophilic oesophagitis, (iii) physician experienced in the management of patients with eosinophilic oesophagitis. Applications for treatment of this condition must be received within 12 weeks of biopsy. Symptoms of oesophageal dysfunction include at least one of the following dysphasia, odynophagia, transient or self-cleared food impaction, chest pain, epigastric discomfort, vomiting/regurgitation. Diagnostic sensitivity increases with the number of biopsies and can be optimised, where necessary, by taking at least eight biopsies (minimum of four collected from each of the mid and distal segments, with the distal segment biopsies taken at least 5 cm above the gastroesophageal junction). After prescribing the Initial induction treatment with budesonide, a histologic assessment must be conducted within 48 weeks of initiating treatment to determine the patient's eligibility for continuing therapy. The histologic assessment should be conducted no later than 2 weeks prior to completing the PBS-subsidised First continuing maintenance treatment course to avoid an interruption of supply for continuing therapy. | Compliance with Authority Required procedures |
C14629 | P14629 | CN14629 | Etanercept | Severe active rheumatoid arthritis First continuing treatment Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction; Patient must be at least 18 years of age. An adequate response to treatment is defined as an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50% (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition. 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. | Compliance with Authority Required procedures - Streamlined Authority Code 14629 |
C14655 | P14655 | CN14655 | Adalimumab Golimumab Ixekizumab Secukinumab Tofacitinib Upadacitinib | Ankylosing spondylitis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed/ceased to respond to PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 5 years, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine within the timeframes specified below. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a patient is changing from PBS-subsidised treatment with a biosimilar medicine for this condition, the prescriber must submit baseline disease severity indicators with this application, in addition to the response assessment outlined below. An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following (a) an ESR measurement no greater than 25 mm per hour; or (b) a CRP measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from baseline. Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment. The assessment of response to treatment must be documented in the patient's medical records. Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 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. | Compliance with Written Authority Required procedures |
C14656 | P14656 | CN14656 | Adalimumab | Ankylosing spondylitis Subsequent continuing treatment Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following (a) an ESR measurement no greater than 25 mm per hour; or (b) a CRP measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from baseline. Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment. The assessment of response to treatment must be documented in the patient's medical records. 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. Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 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. | Compliance with Written Authority Required procedures |
C14659 | P14659 | CN14659 | Certolizumab pegol | Ankylosing spondylitis Initial treatment - Initial 1 (new patient) The condition must be either radiologically (plain X-ray) confirmed:
(i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have at least 2 of the following:
(i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; Patient must be at least 18 years of age; Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The application must include details of the NSAIDs trialled, their doses and duration of treatment. If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used. If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication. If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance. The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L. The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be provided at the time of application and documented in the patient's medical records (i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and (ii) a baseline BASDAI score; and (iii) a completed Exercise Program Self Certification Form included in the supporting information form; and (iv) baseline ESR and/or CRP level. An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment. Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
C14662 | P14662 | CN14662 | Adalimumab Golimumab Ixekizumab Secukinumab Tofacitinib Upadacitinib | Ankylosing spondylitis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of at least 5 years from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must be either radiologically (plain X-ray) confirmed:
(i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND Patient must have at least 2 of the following:
(i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; or Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; or Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be provided at the time of application and documented in the patient's medical records (i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and (ii) a baseline BASDAI score; and (iii) a baseline ESR and/or CRP level. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
C14670 | P14670 | CN14670 | Adalimumab Etanercept Golimumab Ixekizumab Secukinumab Tofacitinib Upadacitinib | Ankylosing spondylitis Initial treatment - Initial 1 (new patient) The condition must be either radiologically (plain X-ray) confirmed:
(i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have at least 2 of the following:
(i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The application must include details of the NSAIDs trialled, their doses and duration of treatment. If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used. If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication. If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance. The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L. The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be provided at the time of application and documented in the patient's medical records (i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and (ii) a baseline BASDAI score; and (iii) a completed Exercise Program Self Certification Form included in the supporting information form; and (iv) baseline ESR and/or CRP level. An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment. Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
C14671 | P14671 | CN14671 | Etanercept | Ankylosing spondylitis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of at least 5 years from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must be either radiologically (plain X-ray) confirmed:
(i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND Patient must have at least 2 of the following:
(i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; or Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; or Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The following must be provided at the time of application and documented in the patient's medical records (i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and (ii) a baseline BASDAI score; and (iii) a baseline ESR and/or CRP level. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Authority Required procedures |
C14672 | P14672 | CN14672 | Adalimumab | Ankylosing spondylitis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must be either radiologically (plain X-ray) confirmed:
(i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND Patient must have at least 2 of the following:
(i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; or Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; or Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The following must be provided at the time of application and documented in the patient's medical records (i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and (ii) a baseline BASDAI score; and (iii) a baseline ESR and/or CRP level. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Authority Required procedures |
C14673 | P14673 | CN14673 | Adalimumab Etanercept | Ankylosing spondylitis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed/ceased to respond to PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 5 years, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine within the timeframes specified below. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a patient is changing from PBS-subsidised treatment with a biosimilar medicine for this condition, the prescriber must submit baseline disease severity indicators with this application, in addition to the response assessment outlined below. An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following (a) an ESR measurement no greater than 25 mm per hour; or (b) a CRP measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from baseline. Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment. The assessment of response to treatment must be documented in the patient's medical records. Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 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. | Compliance with Authority Required procedures |
C14683 | P14683 | CN14683 | Adalimumab Etanercept | Ankylosing spondylitis First continuing treatment Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following (a) an ESR measurement no greater than 25 mm per hour; or (b) a CRP measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from baseline. Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment. The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 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. | Compliance with Authority Required procedures - Streamlined Authority Code 14683 |
C14686 | P14686 | CN14686 | Certolizumab pegol | Ankylosing spondylitis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of at least 5 years from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must be either radiologically (plain X-ray) confirmed:
(i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND Patient must have at least 2 of the following:
(i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; or Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; or Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; Patient must be at least 18 years of age; Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be provided at the time of application and documented in the patient's medical records (i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and (ii) a baseline BASDAI score; and (iii) a baseline ESR and/or CRP level. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
C14692 | P14692 | CN14692 | Certolizumab pegol Golimumab Ixekizumab Secukinumab Tofacitinib Upadacitinib | Ankylosing spondylitis Continuing treatment Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following (a) an ESR measurement no greater than 25 mm per hour; or (b) a CRP measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from baseline. Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment. The assessment of response to treatment must be documented in the patient's medical records. 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. Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 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. | Compliance with Written Authority Required procedures |
C14701 | P14701 | CN14701 | Adalimumab Etanercept | Ankylosing spondylitis Subsequent continuing treatment Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following (a) an ESR measurement no greater than 25 mm per hour; or (b) a CRP measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from baseline. Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment. The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 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. | Compliance with Authority Required procedures - Streamlined Authority Code 14701 |
C14703 | P14703 | CN14703 | Etanercept | Ankylosing spondylitis Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment; AND Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. | Compliance with Authority Required procedures |
C14708 | P14708 | CN14708 | Durvalumab | Locally advanced, metastatic or recurrent biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer) Patient must have either of the following at treatment initiation:
(i) locally advanced biliary tract cancer that is untreated with systemic anti-cancer therapy in the unresectable setting, (ii) metastatic biliary tract cancer that is untreated with systemic anti-cancer therapy in the metastatic setting; Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug; AND The treatment must be/have been initiated with both:
(i) gemcitabine, (ii) cisplatin (refer to Product Information of gemcitabine and cisplatin for dosing information); AND Patient must not have developed disease progression while being treated with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 14708 |
C14713 | P14713 | CN14713 | Adalimumab | Ankylosing spondylitis First continuing treatment Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following (a) an ESR measurement no greater than 25 mm per hour; or (b) a CRP measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from baseline. Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment. The assessment of response to treatment must be documented in the patient's medical records. 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. Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 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. | Compliance with Written Authority Required procedures |
C14714 | P14714 | CN14714 | Certolizumab pegol | Ankylosing spondylitis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed/ceased to respond to PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; Patient must be at least 18 years of age; Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 5 years, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine within the timeframes specified below. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a patient is changing from PBS-subsidised treatment with a biosimilar medicine for this condition, the prescriber must submit baseline disease severity indicators with this application, in addition to the response assessment outlined below. An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following (a) an ESR measurement no greater than 25 mm per hour; or (b) a CRP measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from baseline. Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment. The assessment of response to treatment must be documented in the patient's medical records. Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 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. | Compliance with Written Authority Required procedures |
C14715 | P14715 | CN14715 | Etanercept | Ankylosing spondylitis Continuing treatment - balance of supply Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment; AND Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. | Compliance with Authority Required procedures |
C14727 | P14727 | CN14727 | Pembrolizumab | Stage II or Stage III triple negative breast cancer The treatment must be initiated in combination with neoadjuvant chemotherapy; AND The condition must not have progressed/recurred whilst on treatment with this drug; AND Patient must not be undergoing treatment with this drug beyond 52 cumulative weeks under this restriction; AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 7 repeat prescriptions. or Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 4 repeat prescriptions. | Compliance with Authority Required procedures - Streamlined Authority Code 14727 |
C14729 | P14729 | CN14729 | Zoledronic acid | Adjuvant management of breast cancer Patient must be post-menopausal; Patient must not be undergoing PBS-subsidised treatment with this drug for this indication for more than 36 months. | Compliance with Authority Required procedures - Streamlined Authority Code 14729 |
C14730 | P14730 | CN14730 | Adalimumab | Ankylosing spondylitis Continuing treatment - balance of supply Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. | Compliance with Authority Required procedures |
C14735 | P14735 | CN14735 | Zoledronic acid | Adjuvant management of breast cancer Patient must be post-menopausal; Patient must not be undergoing PBS-subsidised treatment with this drug for this indication for more than 36 months. | Compliance with Authority Required procedures - Streamlined Authority Code 14735 |
C14741 | P14741 | CN14741 | Olaparib | High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer Initial first-line maintenance therapy (BRCA1/2 gene mutation) The condition must be associated with a pathogenic variant (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 gene(s) - this has been confirmed by a validated test; AND Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must be undergoing treatment with this drug class for the first time. or Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal. A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines. Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing. | Compliance with Authority Required procedures |
C14761 | P14761 | CN14761 | Olaparib | High grade epithelial ovarian, fallopian tube or primary peritoneal cancer Initial subsequent-line maintenance therapy (BRCA1/2 gene mutation) The condition must be associated with a pathogenic variant (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 gene(s) - this has been confirmed by a validated test; AND The condition must be platinum sensitive; AND Patient must have received at least two previous platinum-containing regimens; AND Patient must have relapsed following a previous platinum-containing regimen; AND Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition. Platinum sensitivity is defined as disease progression greater than 6 months after completion of the penultimate platinum regimen. A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines. Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing. | Compliance with Authority Required procedures |
C14770 | P14770 | CN14770 | Pembrolizumab | Stage IIIB, Stage IIIC or Stage IIID malignant melanoma Initial treatment - 3 weekly treatment regimen The treatment must be in addition to complete surgical resection; AND Patient must have a WHO performance status of 1 or less; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not have received prior PBS-subsidised treatment for this condition; AND The treatment must commence within 12 weeks of complete resection; AND Patient must not have received more than 12 months of therapy (irrespective of whether therapy has been partly PBS-subsidised/non-PBS-subsidised). | Compliance with Authority Required procedures |
C14776 | P14776 | CN14776 | Venetoclax | Chronic lymphocytic leukaemia (CLL) Dose titration for relapsed/refractory disease The condition must have relapsed or be refractory to at least one prior therapy; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND Patient must not be undergoing retreatment with this drug where any of:
(i) prior treatment of CLL/SLL with this same drug was unable to prevent disease progression; (ii) 24 months of PBS-subsidised treatment has been administered with this drug for this condition. | Compliance with Authority Required procedures |
C14786 | P14786 | CN14786 | Pembrolizumab | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma Continuing treatment - 3 weekly treatment regimen Patient must be undergoing continuing PBS-subsidised treatment commenced through an 'Initial treatment' listing; AND Patient must not have experienced disease recurrence; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not have received more than 12 months of therapy (irrespective of whether therapy has been partly PBS-subsidised/non-PBS-subsidised). | Compliance with Authority Required procedures |
C14801 | P14801 | CN14801 | Ustekinumab | Complex refractory Fistulising Crohn disease Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) - balance of supply Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; or Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break of less than 5 years) restriction to complete 16 weeks treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND Must be treated by a gastroenterologist (code 87). or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]. or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. | Compliance with Authority Required procedures |
C14813 | P14813 | CN14813 | Tebentafusp | Advanced (unresectable or metastatic) uveal melanoma Initial treatment - day 1 Patient must have HLA-A*02:
01-positive disease; AND Patient must have uveal melanoma that has been confirmed either (i) histologically, (ii) cytologically; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not have received prior systemic therapy for metastatic disease; Patient must be at least 18 years of age. According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 doses (on Days 1, 8 and 15) and for at least 16 hours after each infusion is completed. If the patient does not experience hypotension that is Grade 2 or worse (requiring medical intervention) with the third dose, subsequent doses can be administered in an appropriate outpatient/ambulatory care setting. Supervision by a health care professional is recommended for a minimum of 30 minutes following each infusion. This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting. Positive HLA-A*02 01 assessment must be documented in the patient's medical records. | Compliance with Authority Required procedures |
C14821 | P14821 | CN14821 | Tebentafusp | Advanced (unresectable or metastatic) uveal melanoma Initial treatment - day 8 Patient must have HLA-A*02:
01-positive disease; AND Patient must have previously received PBS-subsidised initial day 1 treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 doses (on Days 1, 8 and 15) and for at least 16 hours after each infusion is completed. If the patient does not experience hypotension that is Grade 2 or worse (requiring medical intervention) with the third dose, subsequent doses can be administered in an appropriate outpatient/ambulatory care setting. Supervision by a health care professional is recommended for a minimum of 30 minutes following each infusion. This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting. Positive HLA-A*02 01 assessment must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 14821 |
C14825 | P14825 | CN14825 | Tebentafusp | Advanced (unresectable or metastatic) uveal melanoma Initial treatment - day 15 Patient must have HLA-A*02:
01-positive disease; AND Patient must have previously received PBS-subsidised initial day 8 treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 doses (on Days 1, 8 and 15) and for at least 16 hours after each infusion is completed. If the patient does not experience hypotension that is Grade 2 or worse (requiring medical intervention) with the third dose, subsequent doses can be administered in an appropriate outpatient/ambulatory care setting. Supervision by a health care professional is recommended for a minimum of 30 minutes following each infusion. This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting. Positive HLA-A*02 01 assessment must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 14825 |
C14837 | P14837 | CN14837 | Olmesartan with amlodipine and hydrochlorothiazide | Hypertension The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must not be for the initiation of anti-hypertensive therapy; AND The condition must be inadequately controlled with concomitant treatment with two of the following:
an angiotensin II antagonist, a dihydropyridine calcium channel blocker or a thiazide diuretic. | |
C14841 | P14841 | CN14841 | Eprosartan | Drug interactions expected to occur with all of the base-priced drugs The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | Compliance with Authority Required procedures |
C14842 | P14842 | CN14842 | Desmopressin | Primary nocturnal enuresis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; Patient must be 6 years of age or older; Patient must be one in whom an enuresis alarm is contraindicated. | Compliance with Authority Required procedures - Streamlined Authority Code 14842 |
C14847 | P14847 | CN14847 | Perampanel | Idiopathic generalised epilepsy with primary generalised tonic-clonic seizures Continuing treatment The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; Patient must be aged 12 years or older. | Compliance with Authority Required procedures - Streamlined Authority Code 14847 |
C14868 | P14868 | CN14868 | Cyproterone | Moderate to severe androgenisation The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must not be indicated by acne alone, as this is not a sufficient indication of androgenisation; Patient must be female; Patient must not be pregnant. | Compliance with Authority Required procedures - Streamlined Authority Code 14868 |
C14872 | P14872 | CN14872 | Lanthanum Sevelamer Sucroferric oxyhydroxide | Hyperphosphataemia Maintenance following initiation and stabilisation The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must not be adequately controlled by calcium; AND Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; or The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND The treatment must not be used in combination with any other non-calcium phosphate binding agents; AND Patient must be undergoing dialysis for chronic kidney disease. | Compliance with Authority Required procedures - Streamlined Authority Code 14872 |
C14874 | P14874 | CN14874 | Sodium acid phosphate | Hypophosphataemic rickets The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | Compliance with Authority Required procedures - Streamlined Authority Code 14874 |
C14895 | P14895 | CN14895 | Anastrozole Exemestane Letrozole Tamoxifen | Breast cancer The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must be hormone receptor positive. | |
C14898 | P14898 | CN14898 | Alendronic acid with colecalciferol | Osteoporosis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; Patient must be aged 70 years or older; Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition. The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated. | Compliance with Authority Required procedures - Streamlined Authority Code 14898 |
C14901 | P14901 | CN14901 | Topiramate | Migraine The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must be for prophylaxis; AND Patient must have experienced an average of 3 or more migraines per month over a period of at least 6 months; AND Patient must have a contraindication to beta-blockers, as described in the relevant TGA-approved Product Information; or Patient must have experienced intolerance of a severity necessitating permanent withdrawal during treatment with a beta-blocker; AND Patient must have a contraindication to pizotifen because the weight gain associated with this drug poses an unacceptable risk. or Patient must have experienced intolerance of a severity necessitating permanent withdrawal during treatment with pizotifen. Details of the contraindication and/or intolerance(s) must be documented in the patient's medical records when treatment is initiated. | Compliance with Authority Required procedures - Streamlined Authority Code 14901 |
C14912 | P14912 | CN14912 | Testosterone | Androgen deficiency The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must not have an established pituitary or testicular disorder; AND The condition must not be due to age, obesity, cardiovascular diseases, infertility or drugs; Patient must be aged 40 years or older; Must be treated by a specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. Androgen deficiency is defined as (i) testosterone level of less than 6 nmol per litre; OR (ii) testosterone level between 6 and 15 nmol per litre with high luteinising hormone (LH) (greater than 1.5 times the upper limit of the eugonodal reference range for young men, or greater than 14 IU per litre, whichever is higher). Androgen deficiency must be confirmed by at least two morning blood samples taken on different mornings. The dates and levels of the qualifying testosterone and LH measurements must be, or must have been provided in the authority application when treatment with this drug is or was initiated. The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C14913 | P14913 | CN14913 | Testosterone | Micropenis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; Patient must be under 18 years of age; Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C14914 | P14914 | CN14914 | Bromocriptine | Acromegaly The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C14915 | P14915 | CN14915 | Oxybutynin Propantheline | Detrusor overactivity The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C14918 | P14918 | CN14918 | Cabergoline | Pathological hyperprolactinaemia The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must be one in whom surgery is not indicated. | |
C14921 | P14921 | CN14921 | Sodium acid phosphate | Familial hypophosphataemia The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | Compliance with Authority Required procedures - Streamlined Authority Code 14921 |
C14922 | P14922 | CN14922 | Sodium acid phosphate | Hypercalcaemia The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | Compliance with Authority Required procedures - Streamlined Authority Code 14922 |
C14941 | P14941 | CN14941 | Leflunomide | Severe active psoriatic arthritis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have previously received, and failed to achieve an adequate response to, one or more disease modifying anti-rheumatic drugs including methotrexate; or Patient must be clinically inappropriate for treatment with one or more disease modifying anti-rheumatic drugs including methotrexate; AND The treatment must be initiated by a physician. | |
C14942 | P14942 | CN14942 | Leflunomide | Severe active rheumatoid arthritis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have previously received, and failed to achieve an adequate response to, one or more disease modifying anti-rheumatic drugs including methotrexate; or Patient must be clinically inappropriate for treatment with one or more disease modifying anti-rheumatic drugs including methotrexate; AND The treatment must be initiated by a physician. | |
C14945 | P14945 | CN14945 | Desmopressin | Primary nocturnal enuresis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; Patient must be 6 years of age or older; Patient must be refractory to an enuresis alarm. | Compliance with Authority Required procedures - Streamlined Authority Code 14945 |
C14947 | P14947 | CN14947 | Phenoxymethylpenicillin | Recurrent streptococcal infections (including rheumatic fever) The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must be for prophylaxis. | |
C14955 | P14955 | CN14955 | Testosterone | Pubertal induction The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; Patient must be under 18 years of age; Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C14956 | P14956 | CN14956 | Testosterone | Constitutional delay of growth or puberty The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; Patient must be under 18 years of age; Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C14959 | P14959 | CN14959 | Cabergoline | Pathological hyperprolactinaemia The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must be one in whom radiotherapy is not indicated. | |
C14962 | P14962 | CN14962 | Sodium acid phosphate | Vitamin D-resistant rickets The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | Compliance with Authority Required procedures - Streamlined Authority Code 14962 |
C14969 | P14969 | CN14969 | Eprosartan | Adverse effects occurring with all of the base-priced drugs The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | Compliance with Authority Required procedures |
C14970 | P14970 | CN14970 | Eprosartan | Drug interactions occurring with all of the base-priced drugs The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | Compliance with Authority Required procedures |
C14972 | P14972 | CN14972 | Desmopressin | Primary nocturnal enuresis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; Patient must be 6 years of age or older; Patient must be refractory to an enuresis alarm. | Compliance with Authority Required procedures - Streamlined Authority Code 14972 |
C14981 | P14981 | CN14981 | Bromocriptine | Pathological hyperprolactinaemia The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have had surgery for this condition with incomplete resolution. | |
C14983 | P14983 | CN14983 | Cabergoline | Pathological hyperprolactinaemia The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have had radiotherapy for this condition with incomplete resolution. | |
C14993 | P14993 | CN14993 | Alendronic acid with colecalciferol | Established osteoporosis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have fracture due to minimal trauma; AND Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition. The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated. A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body. | Compliance with Authority Required procedures - Streamlined Authority Code 14993 |
C14994 | P14994 | CN14994 | Minoxidil | Severe refractory hypertension The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must be initiated by a consultant physician. | |
C15004 | P15004 | CN15004 | Dutasteride with tamsulosin | Benign prostatic hyperplasia The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have lower urinary tract symptoms; AND Patient must have moderate to severe benign prostatic hyperplasia. | Compliance with Authority Required procedures - Streamlined Authority Code 15004 |
C15005 | P15005 | CN15005 | Cabergoline | Pathological hyperprolactinaemia The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have had surgery for this condition with incomplete resolution. | |
C15006 | P15006 | CN15006 | Oxybutynin | Detrusor overactivity The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must be unable to tolerate oral oxybutynin. or Patient must be unable to swallow oral oxybutynin. | |
C15009 | P15009 | CN15009 | Eprosartan | Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | Compliance with Authority Required procedures |
C15011 | P15011 | CN15011 | Alendronic acid with colecalciferol | Osteoporosis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; Patient must be aged 70 years or older; Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition. The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated. | Compliance with Authority Required procedures - Streamlined Authority Code 15011 |
C15012 | P15012 | CN15012 | Desmopressin | Cranial diabetes insipidus The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | Compliance with Authority Required procedures - Streamlined Authority Code 15012 |
C15015 | P15015 | CN15015 | Testosterone | Androgen deficiency The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have an established pituitary or testicular disorder; AND Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C15017 | P15017 | CN15017 | Bromocriptine | Pathological hyperprolactinaemia The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have had radiotherapy for this condition with incomplete resolution. | |
C15018 | P15018 | CN15018 | Dutasteride | Benign prostatic hyperplasia The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have lower urinary tract symptoms; AND Patient must have moderate to severe benign prostatic hyperplasia; AND The treatment must be in combination with an alpha-antagonist. | Compliance with Authority Required procedures - Streamlined Authority Code 15018 |
C15024 | P15024 | CN15024 | Alendronic acid with colecalciferol | Corticosteroid-induced osteoporosis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition. The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated. | Compliance with Authority Required procedures - Streamlined Authority Code 15024 |
C15025 | P15025 | CN15025 | Desmopressin | Primary nocturnal enuresis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; Patient must be 6 years of age or older; Patient must be one in whom an enuresis alarm is contraindicated. | Compliance with Authority Required procedures - Streamlined Authority Code 15025 |
C15028 | P15028 | CN15028 | Bromocriptine | Parkinson disease The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C15030 | P15030 | CN15030 | Medroxyprogesterone | Endometriosis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C15032 | P15032 | CN15032 | Alendronic acid with colecalciferol | Corticosteroid-induced osteoporosis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition. The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated. | Compliance with Authority Required procedures - Streamlined Authority Code 15032 |
C15035 | P15035 | CN15035 | Alendronic acid with colecalciferol | Established osteoporosis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have fracture due to minimal trauma; AND Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition. The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated. A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body. | Compliance with Authority Required procedures - Streamlined Authority Code 15035 |
C15043 | P15043 | CN15043 | Bromocriptine | Pathological hyperprolactinaemia The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must be one in whom surgery is not indicated. | |
C15044 | P15044 | CN15044 | Bromocriptine | Pathological hyperprolactinaemia The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must be one in whom radiotherapy is not indicated. | |
C15047 | P15047 | CN15047 | Dapagliflozin Empagliflozin | Chronic heart failure Patient must be symptomatic with NYHA classes II, III or IV prior to initiating treatment with this drug; AND Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; or The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; or The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 15047 |
C15051 | P15051 | CN15051 | Dapagliflozin Empagliflozin | Chronic heart failure The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must be symptomatic with NYHA classes II, III or IV prior to initiating treatment with this drug; AND Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; or The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; or The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 15051 |
C15063 | P15063 | CN15063 | Cemiplimab | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment - 3 weekly treatment regimen Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under both initial and continuing treatment restrictions, whichever comes first. | Compliance with Authority Required procedures - Streamlined Authority Code 15063 |
C15068 | P15068 | CN15068 | Methotrexate | Severe active juvenile idiopathic arthritis Patient must be unsuitable for administration of an oral form of methotrexate for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 15068 |
C15071 | P15071 | CN15071 | Golimumab | Non-radiographic axial spondyloarthritis Initial treatment - Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND Patient must have one or more of the following:
(a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND The treatment must not exceed a maximum of 16 weeks duration under this restriction; AND Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis. The following must be provided at the time of application and documented in the patient's medical records (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and (b) C-reactive protein (CRP) level greater than 10 mg per L. The BASDAI score and CRP level must be no more than 4 weeks old at the time of this application. If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. | Compliance with Authority Required procedures |
C15085 | P15085 | CN15085 | Tebentafusp | Advanced (unresectable or metastatic) uveal melanoma Continuing treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; or Patient must have previously received inpatient treatment with this drug for this condition in the public hospital setting; AND Patient must not receive PBS-subsidised treatment with this drug for this condition if it is no longer determined to be clinically beneficial by the treating clinician. According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 doses (on Days 1, 8 and 15) and for at least 16 hours after each infusion is completed. If the patient does not experience hypotension that is Grade 2 or worse (requiring medical intervention) with the third dose, subsequent doses can be administered in an appropriate outpatient/ambulatory care setting. Supervision by a health care professional is recommended for a minimum of 30 minutes following each infusion. | Compliance with Authority Required procedures - Streamlined Authority Code 15085 |
C15103 | P15103 | CN15103 | Certolizumab pegol | Non-radiographic axial spondyloarthritis Initial treatment - Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND Patient must have one or more of the following:
(a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis. The following must be provided at the time of application and documented in the patient's medical records (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and (b) C-reactive protein (CRP) level greater than 10 mg per L. The BASDAI score and CRP level must be no more than 4 weeks old at the time of this application. If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. | Compliance with Authority Required procedures |
C15118 | P15118 | CN15118 | Fluticasone propionate with salmeterol | Asthma Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids. | Compliance with Authority Required procedures - Streamlined Authority Code 15118 |
C15125 | P15125 | CN15125 | Golimumab | Non-radiographic axial spondyloarthritis Continuing treatment Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND The treatment must not exceed a maximum of 24 weeks with this drug per authorised course under this restriction; AND Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis. 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 (a) a CRP measurement no greater than 10 mg per L; or (b) a CRP measurement reduced by at least 20% from baseline. 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. 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. | Compliance with Authority Required procedures |
C15126 | P15126 | CN15126 | Certolizumab pegol | Non-radiographic axial spondyloarthritis Initial treatment - Initial 2 (Change or re-commencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND The condition must not have responded inadequately to biological medicine on 4 occasions within the same treatment cycle; AND Patient must not have failed PBS-subsidised therapy with this biological medicine for this PBS indication more than once in the current treatment cycle; AND Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis. An application for Initial 2 treatment must indicate whether the patient has demonstrated an adequate response (an absence of treatment failure), failed or experienced an intolerance to the most recent supply of biological medicine treatment. A new baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and C-reactive protein (CRP) level may be provided at the time of this application. 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 (a) a CRP measurement no greater than 10 mg per L; or (b) a CRP measurement reduced by at least 20% from baseline. The assessment of the patient's response to the most recent supply of biological medicine must be conducted following a minimum of 12 weeks of treatment. BASDAI scores and CRP levels must be documented in the patient's medical records. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. The following must be provided at the time of application and documented in the patient's medical records (a) the BASDAI score; and (b) the C-reactive protein (CRP) level. | Compliance with Authority Required procedures |
C15135 | P15135 | CN15135 | Golimumab | Non-radiographic axial spondyloarthritis Initial treatment - Initial 2 (Change or re-commencement of treatment after a break of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND The condition must not have responded inadequately to biological medicine on 4 occasions within the same treatment cycle; AND The treatment must not exceed a maximum of 16 weeks with this drug under this restriction; AND Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis; AND Patient must not have failed PBS-subsidised therapy with this biological medicine for this PBS indication more than once in the current treatment cycle. An application for Initial 2 treatment must indicate whether the patient has demonstrated an adequate response (an absence of treatment failure), failed or experienced an intolerance to the most recent supply of biological medicine treatment. A new baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and C-reactive protein (CRP) level may be provided at the time of this application. 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 (a) a CRP measurement no greater than 10 mg per L; or (b) a CRP measurement reduced by at least 20% from baseline. The assessment of the patient's response to the most recent supply of biological medicine must be conducted following a minimum of 12 weeks of treatment. BASDAI scores and CRP levels must be documented in the patient's medical records. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. The following must be provided at the time of application and documented in the patient's medical records (a) the BASDAI score; and (b) the C-reactive protein (CRP) level. | Compliance with Authority Required procedures |
C15137 | P15137 | CN15137 | Secukinumab | Non-radiographic axial spondyloarthritis Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND The condition must not have responded inadequately to biological medicine on 4 occasions within the same treatment cycle; AND Patient must not have failed PBS-subsidised therapy with this biological medicine for this PBS indication more than once in the current treatment cycle; AND Patient must not receive more than 20 weeks of treatment under this restriction; AND Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis. An application for Initial 2 treatment must indicate whether the patient has demonstrated an adequate response (an absence of treatment failure), failed or experienced an intolerance to the most recent supply of biological medicine treatment. A new baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and C-reactive protein (CRP) level may be provided at the time of this application. 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 (a) a CRP measurement no greater than 10 mg per L; or (b) a CRP measurement reduced by at least 20% from baseline. The assessment of the patient's response to the most recent supply of biological medicine must be conducted following a minimum of 12 weeks of treatment. BASDAI scores and CRP levels must be documented in the patient's medical records. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. The following must be provided at the time of application and documented in the patient's medical records (a) the BASDAI score; and (b) the C-reactive protein (CRP) level. The stated maximum quantity of 5 with zero repeats is intended for a patient undergoing the loading dose regimen of 150 mg administered at weeks 0, 1, 2, 3, and 4 (a total of 5 doses) followed by monthly administration thereafter. State in the application whether a loading dose regimen is intended or not. Where a loading dose regimen is intended, request a maximum quantity of 5 and zero repeats to cover doses at weeks 0, 1, 2, 3 and 4. Doses at week 8, 12, and 16 can be sought under the relevant 'Balance of supply' listing. Where no loading dose regimen is intended, request a maximum quantity of 1 and seek an increase in the number of repeats from zero to 4 repeats to cover dosing at weeks 4, 8, 12 and 16. Where increased repeats are sought, the maximum quantity sought must not be greater than 1. | Compliance with Authority Required procedures |
C15138 | P15138 | CN15138 | Fluticasone propionate with salmeterol | Asthma Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids. | Compliance with Authority Required procedures - Streamlined Authority Code 15138 |
C15140 | P15140 | CN15140 | Bimekizumab Upadacitinib | Non-radiographic axial spondyloarthritis Continuing treatment Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND The treatment must not exceed a maximum of 24 weeks with this drug per authorised course under this restriction; AND Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis. 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 (a) a CRP measurement no greater than 10 mg per L; or (b) a CRP measurement reduced by at least 20% from baseline. 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. 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. | Compliance with Authority Required procedures |
C15141 | P15141 | CN15141 | Olaparib | High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer Initial first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) The condition must be associated with homologous recombination deficiency (HRD) positive status defined by genomic instability, which has been confirmed by a validated test; AND The condition must not be associated with pathogenic variants (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 genes - this has been confirmed by a validated test; AND Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; or The condition must have both:
(i) been in a partial/complete response to the immediately preceding platinum-based chemotherapy regimen prior to having commenced non-PBS-subsidised treatment with this drug for this condition, (ii) not progressed since the commencement of non-PBS-subsidised supply of this drug; AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must be undergoing treatment with this drug class for the first time. or Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal. A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines. Evidence of homologous recombination deficiency (genomic instability) must be derived through a test that has been validated against the Myriad MyChoice HRD assay, which uses a score of 42 or greater as the threshold for HRD (genomic instability) positivity. Evidence that BRCA1/2 gene mutations are absent must also be derived through a validated test as described above. | Compliance with Authority Required procedures |
C15149 | P15149 | CN15149 | Bimekizumab Upadacitinib | Non-radiographic axial spondyloarthritis Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND The condition must not have responded inadequately to biological medicine on 4 occasions within the same treatment cycle; AND Patient must not have failed PBS-subsidised therapy with this biological medicine for this PBS indication more than once in the current treatment cycle; AND The treatment must not exceed a maximum of 16 weeks with this drug under this restriction; AND Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis. An application for Initial 2 treatment must indicate whether the patient has demonstrated an adequate response (an absence of treatment failure), failed or experienced an intolerance to the most recent supply of biological medicine treatment. A new baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and C-reactive protein (CRP) level may be provided at the time of this application. 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 (a) a CRP measurement no greater than 10 mg per L; or (b) a CRP measurement reduced by at least 20% from baseline. The assessment of the patient's response to the most recent supply of biological medicine must be conducted following a minimum of 12 weeks of treatment. BASDAI scores and CRP levels must be documented in the patient's medical records. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. The following must be provided at the time of application and documented in the patient's medical records (a) the BASDAI score; and (b) the C-reactive protein (CRP) level. | Compliance with Authority Required procedures |
C15150 | P15150 | CN15150 | Bimekizumab Upadacitinib | Non-radiographic axial spondyloarthritis Initial treatment - Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND Patient must have one or more of the following:
(a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND The treatment must not exceed a maximum of 16 weeks with this drug under this restriction; AND Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis. The following must be provided at the time of application and documented in the patient's medical records (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and (b) C-reactive protein (CRP) level greater than 10 mg per L. The BASDAI score and CRP level must be no more than 4 weeks old at the time of this application. If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. | Compliance with Authority Required procedures |
C15158 | P15158 | CN15158 | Secukinumab | Non-radiographic axial spondyloarthritis Initial treatment - Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND Patient must have one or more of the following:
(a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND Patient must not receive more than 20 weeks of treatment under this restriction; AND Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis. The following must be provided at the time of application and documented in the patient's medical records (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and (b) C-reactive protein (CRP) level greater than 10 mg per L. The BASDAI score and CRP level must be no more than 4 weeks old at the time of this application. If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. The stated maximum quantity of 5 with zero repeats is intended for a patient undergoing the loading dose regimen of 150 mg administered at weeks 0, 1, 2, 3, and 4 (a total of 5 doses) followed by monthly administration thereafter. State in the application whether a loading dose regimen is intended or not. Where a loading dose regimen is intended, request a maximum quantity of 5 and zero repeats to cover doses at weeks 0, 1, 2, 3 and 4. Doses at week 8, 12, and 16 can be sought under the relevant 'Balance of supply' listing. Where no loading dose regimen is intended, request a maximum quantity of 1 and seek an increase in the number of repeats from zero to 4 repeats to cover dosing at weeks 4, 8, 12 and 16. Where increased repeats are sought, the maximum quantity sought must not be greater than 1. | Compliance with Authority Required procedures |
C15163 | P15163 | CN15163 | Dostarlimab | Advanced, metastatic or recurrent endometrial carcinoma Initial treatment covering the first 6 treatment cycles Patient must have deficient mismatch repair (dMMR) endometrial cancer, as determined by immunohistochemistry test; AND The condition must be unsuitable for at least one of the following: (i) curative surgical resection, (ii) curative radiotherapy; AND The treatment must be initiated in combination with platinum-containing chemotherapy; AND The condition must be, at treatment initiation with this drug, either: (i) untreated with systemic therapy, (ii) treated with neoadjuvant/adjuvant systemic therapy, but the cancer has recurred or progressed after more than 6 months from the last dose of systemic therapy; AND 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 this condition; AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation. | Compliance with Authority Required procedures - Streamlined Authority Code 15163 |
C15193 | P15193 | CN15193 | Ondansetron | Nausea and vomiting The condition must be associated with radiotherapy being used to treat malignancy; OR The condition must be associated with chemotherapy (including methotrexate) being used in the treatment of malignancy and juvenile autoimmune conditions. | Compliance with Authority Required procedures - Streamlined Authority Code 15193 |
C15205 | P15205 | CN15205 | Dostarlimab | Advanced, metastatic or recurrent endometrial carcinoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition. Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 36 cumulative months from the first administered dose, once in a lifetime. | Compliance with Authority Required procedures - Streamlined Authority Code 15205 |
C15261 | P15261 | CN15261 | Alogliptin Linagliptin Saxagliptin Sitagliptin Vildagliptin | Diabetes mellitus type 2 The treatment must be used in combination with at least one of: metformin, a sulfonylurea, insulin; AND The condition must be inadequately responsive to at least one of: metformin, a sulfonylurea, insulin. Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another DPP4 inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 15261 |
C15263 | P15263 | CN15263 | Dulaglutide Semaglutide | Diabetes mellitus type 2 Subsequent PBS-prescriptions for any GLP-1 receptor agonist Patient must not be undergoing concomitant PBS-subsidised treatment for type 2 diabetes mellitus with any of: an SGLT2 inhibitor, a DPP4 inhibitor, another GLP-1 receptor agonist. | Compliance with Authority Required procedures - Streamlined Authority Code 15263 |
C15265 | P15265 | CN15265 | Dapagliflozin Empagliflozin | Diabetes mellitus type 2 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must be used in combination with at least one of: metformin, a sulfonylurea, insulin; AND The condition must be inadequately responsive to at least one of: metformin, a sulfonylurea, insulin. Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another SGLT2 inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 15265 |
C15267 | P15267 | CN15267 | Dapagliflozin with metformin Empagliflozin with metformin | Diabetes mellitus type 2 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must be inadequately responsive to metformin. Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another SGLT2 inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 15267 |
C15269 | C15269 | CN15269 | Dapagliflozin with sitagliptin Empagliflozin with linagliptin | Diabetes mellitus type 2 The treatment must be in combination with at least metformin; AND The condition must be inadequately responsive to dual therapy consisting of metformin with either: a DDP-4 inhibitor, an SGLT2 inhibitor. Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another SGLT2 inhibitor, another DPP4 inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 15269 |
C15270 | C15270 | CN15270 | Dapagliflozin with sitagliptin Empagliflozin with linagliptin | Diabetes mellitus type 2 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must be in combination with at least metformin; AND The condition must be inadequately responsive to dual therapy consisting of metformin with either: a DDP-4 inhibitor, an SGLT2 inhibitor. Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another SGLT2 inhibitor, another DPP4 inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 15270 |
C15276 | P15276 | CN15276 | Alogliptin with metformin Linagliptin with metformin Saxagliptin with metformin Sitagliptin with metformin Vildagliptin with metformin | Diabetes mellitus type 2 The condition must be inadequately responsive to metformin. Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another DPP4 inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 15276 |
C15287 | P15287 | CN15287 | Alogliptin Linagliptin Saxagliptin Sitagliptin Vildagliptin | Diabetes mellitus type 2 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must be used in combination with at least one of: metformin, a sulfonylurea, insulin; AND The condition must be inadequately responsive to at least one of: metformin, a sulfonylurea, insulin. Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another DPP4 inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 15287 |
C15288 | P15288 | CN15288 | Alogliptin with metformin Linagliptin with metformin Saxagliptin with metformin Sitagliptin with metformin Vildagliptin with metformin | Diabetes mellitus type 2 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must be inadequately responsive to metformin. Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another DPP4 inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 15288 |
C15289 | P15289 | CN15289 | Dapagliflozin with metformin Empagliflozin with metformin | Diabetes mellitus type 2 The condition must be inadequately responsive to metformin. Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another SGLT2 inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 15289 |
C15290 | P15290 | CN15290 | Pioglitazone | Diabetes mellitus type 2 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C15301 | P15301 | CN15301 | Dulaglutide Semaglutide | Diabetes mellitus type 2 First PBS-prescription for this drug The treatment must be used in combination with at least one of: metformin, a sulfonylurea, insulin; AND The condition must be inadequately responsive to at least one of: metformin, a sulfonylurea, insulin; AND Patient must not have achieved a clinically meaningful glycaemic response with an SGLT2 inhibitor; OR Patient must have a contraindication/intolerance requiring treatment discontinuation of an SGLT2 inhibitor. Patient must not be undergoing concomitant PBS-subsidised treatment for type 2 diabetes mellitus with any of: an SGLT2 inhibitor, a DPP4 inhibitor, another GLP-1 receptor agonist. | Compliance with Authority Required procedures |
C15303 | P15303 | CN15303 | Tafamidis | Transthyretin amyloid cardiomyopathy Second and subsequent PBS-subsidised prescriptions for this drug Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have an estimated glomerular filtration rate (eGFR) greater than 25 mL/minute/1.73 m2; AND The treatment must be ceased where the patient's heart failure has worsened to persistent New York Heart Association (NYHA) Class III/IV heart failure; AND The treatment must be ceased where the patient has received any of: (i) a heart transplant, (ii) a liver transplant, (iii) an implanted ventricular assist device. Must be treated by a medical practitioner who is any of the following: (i) a cardiologist, (ii) a consultant physician with experience in the management of amyloid disorders; this authority application must be sought by the same medical practitioner providing treatment. Confirm whether heart failure has worsened to NYHA Class III/IV since the last authority application (yes/no). If 'no', continued PBS subsidy is available. If 'yes', continued PBS subsidy is available, but the prescriber must undertake a review of the patient within 3 months to determine whether the worsening heart failure was transient or persistent. Where this subsequent clinical review finds that the heart failure persists as NYHA Class III/IV heart failure despite active treatment with this drug, then PBS subsidy is not available. | Compliance with Authority Required procedures |
C15311 | P15311 | CN15311 | Dapagliflozin Empagliflozin | Diabetes mellitus type 2 The treatment must be used in combination with at least one of: metformin, a sulfonylurea, insulin; AND The condition must be inadequately responsive to at least one of: metformin, a sulfonylurea, insulin. Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another SGLT2 inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 15311 |
C15321 | P15321 | CN15321 | Pioglitazone | Diabetes mellitus type 2 | |
C15333 | P15333 | CN15333 | Melatonin | Insomnia Initial Patient must have Smith-Magenis Syndrome confirmed by genetic testing; AND The condition must be inadequately responsive to sleep hygiene measures, resulting in the patient experiencing a period of at least 12 consecutive weeks of impaired sleep (see definition of impaired sleep below). Must be treated by a medical practitioner identifying as at least one of: (i) a paediatrician, (ii) a sleep physician, (iii) neurologist, (iv) a psychiatrist, (v) a developmental specialist (see NOTE); this authority approval is being sought by one of these 5 prescriber types. Patient must be at least 2 years of age, but yet to turn 18 years of age, at treatment initiation with this drug. Definition: For the purposes of administering this restriction, Smith-Magenis Syndrome is confirmed by the deletion or variation of the retinoic acid induced 1 (RAI1) gene on chromosome 17p11.2 Definition:For the purposes of administering this restriction, impaired sleep is at least one of:(i) less than 6 hours of continuous sleep on at least 3 occasions over a given 5-day interval; (ii) taking at least half an hour to fall asleep on at least 3 occasions over a given 5-day interval. Prior to seeking authorisation for this pharmaceutical benefit, document the amount of continuous sleep/sleep latency in the patient's medical records for a period of 2 consecutive weeks, but ensure the impairment has been observed for at least 12 consecutive weeks. The documented values (averages) will form baseline measurements upon which the extent of response to treatment is to be considered under the Continuing treatment listing. The observations of continuous sleep/sleep latency may be based on any of the following, including a mix of: patient self-reporting, parental observation, documented medical history, sleep studies conducted by health professionals. | Compliance with Authority Required procedures |
C15363 | P15363 | CN15363 | Melatonin | Insomnia Continuing Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have experienced/maintained a clinically meaningful response (as defined below) to the preceding supply of this drug - document the response improvement in the patient's medical records; AND The treatment must have commenced between the ages of 2 to 17 years inclusive. Must be treated by a medical practitioner identifying as at least one of: (i) a paediatrician, (ii) a sleep physician, (iii) neurologist, (iv) a psychiatrist, (v) a developmental specialist (see NOTE); this authority approval is being sought by one of these 5 prescriber types; OR Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion. Treatment must cease if a patient is unable to achieve a clinically meaningful response on the maximum dose of melatonin specified in the Product Information. Definition: A clinically meaningful response to this drug is defined as at least one of: (i) an increase in total sleep time of at least 45 minutes per night on average from baseline; (ii) a decrease in the time it takes to fall asleep by at least 15 minutes per night on average from baseline. | Compliance with Authority Required procedures |
C15408 | P15408 | CN15408 | Niraparib | High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer Initial first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tablets The condition must be associated with homologous recombination deficiency (HRD) positive status defined by genomic instability, which has been confirmed by a validated test; AND The condition must not be associated with pathogenic variants (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 genes - this has been confirmed by a validated test; AND Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; OR The condition must have both: (i) been in a partial/complete response to the immediately preceding platinum-based chemotherapy regimen prior to having commenced non-PBS-subsidised treatment with this drug for this condition, (ii) not progressed since the commencement of non-PBS-subsidised supply of this drug; AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition. Patient must be undergoing treatment with this drug class for the first time; OR Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal. A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines. Evidence of homologous recombination deficiency (genomic instability) must be derived through a test that has been validated against the Myriad MyChoice HRD assay, which uses a score of 42 or greater as the threshold for HRD (genomic instability) positivity. Evidence that BRCA1/2 gene mutations are absent must also be derived through a validated test as described above. | Compliance with Authority Required procedures |
C15414 | P15414 | CN15414 | Niraparib | High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer Initial first-line maintenance therapy (BRCA1/2 gene mutation) in a patient requiring a daily dose of up to 2 tablets The condition must be associated with a pathogenic variant (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 gene(s) - this has been confirmed by a validated test; AND Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition. Patient must be undergoing treatment with this drug class for the first time; OR Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal. A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines. Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing. | Compliance with Authority Required procedures |
C15440 | P15440 | CN15440 | Niraparib | High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer Initial first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) in a patient requiring a daily dose of up to 2 tablets The condition must be associated with homologous recombination deficiency (HRD) positive status defined by genomic instability, which has been confirmed by a validated test; AND The condition must not be associated with pathogenic variants (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 genes - this has been confirmed by a validated test; AND Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; OR The condition must have both: (i) been in a partial/complete response to the immediately preceding platinum-based chemotherapy regimen prior to having commenced non-PBS-subsidised treatment with this drug for this condition, (ii) not progressed since the commencement of non-PBS-subsidised supply of this drug; AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition. Patient must be undergoing treatment with this drug class for the first time; OR Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal. A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines. Evidence of homologous recombination deficiency (genomic instability) must be derived through a test that has been validated against the Myriad MyChoice HRD assay, which uses a score of 42 or greater as the threshold for HRD (genomic instability) positivity. Evidence that BRCA1/2 gene mutations are absent must also be derived through a validated test as described above. | Compliance with Authority Required procedures |
C15441 | P15441 | CN15441 | Niraparib | High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer Initial first-line maintenance therapy (BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tablets The condition must be associated with a pathogenic variant (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 gene(s) - this has been confirmed by a validated test; AND Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition. Patient must be undergoing treatment with this drug class for the first time; OR Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal. A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines. Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing. | Compliance with Authority Required procedures |
C15445 | P15445 | CN15445 | Adalimumab | Vision threatening non-infectious uveitis Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND The treatment must not exceed 24 weeks under this restriction per authority application. Must be treated by an ophthalmologist, rheumatologist or immunologist with expertise in uveitis; OR Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion. An adequate response to treatment is defined as: (a) Sustained reduction in inflammation defined as a 2-step decrease from baseline in Standardisation of Uveitis Nomenclature (SUN) criteria for anterior chamber or vitreous haze; or (b) Sustained quiescence of inflammation defined as Standardisation of Uveitis Nomenclature (SUN) criteria less than or equal to 0.5+ anterior chamber or vitreous haze, absence of active vitreous or retinal lesions or vitreous cells; or (c) Sustained corticosteroid sparing effect, allowing reduction in prednisone to less than 7.5 mg daily; or (d) Reduction in frequency of ocular attacks to less than or equal to 1 per year (patients with Behcet's disease only) 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. | Compliance with Authority Required procedures - Streamlined Authority Code 15445 |
C15446 | P15446 | CN15446 | Adalimumab | Vision threatening non-infectious uveitis Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must demonstrated or sustained an adequate response to treatment with this drug for this condition; AND The treatment must not exceed 24 weeks under this restriction per authority application. Must be treated by an ophthalmologist, rheumatologist or immunologist with expertise in uveitis; OR Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion. An adequate response to treatment is defined as: (a) Sustained reduction in inflammation defined as a 2-step decrease from baseline in Standardisation of Uveitis Nomenclature (SUN) criteria for anterior chamber or vitreous haze; or (b) Sustained quiescence of inflammation defined as Standardisation of Uveitis Nomenclature (SUN) criteria less than or equal to 0.5+ anterior chamber or vitreous haze, absence of active vitreous or retinal lesions or vitreous cells; or (c) Sustained corticosteroid sparing effect, allowing reduction in prednisone to less than 7.5 mg daily; or (d) Reduction in frequency of ocular attacks to less than or equal to 1 per year (patients with Behcet's disease only) 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. | Compliance with Authority Required procedures |
C15454 | P15454 | CN15454 | Cabozantinib | Locally advanced or metastatic differentiated thyroid cancer Initial treatment The condition must be refractory to radioactive iodine; OR Patient must be deemed ineligible for treatment with radioactive iodine; AND Patient must have progressive disease according to Response Evaluation Criteria in Solid Tumours (RECIST) whilst on treatment with a vascular endothelial growth factor (VEGF)-targeted tyrosine kinase inhibitor (TKI) for this indication; OR Patient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression, to prior VEGF-targeted TKI therapy; AND Patient must have a WHO performance status of no higher than 2; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have thyroid stimulating hormone adequately suppressed. Radioactive iodine refractory is defined as: (i) a lesion without iodine uptake on a radioactive iodine (RAI) scan; or (ii) having received a cumulative RAI dose of greater than or equal to 600 mCi; or (iii) progression within 12 months of a single RAI treatment; or (iv) progression after two RAI treatments administered within 12 months of each other. | Compliance with Authority Required procedures - Streamlined Authority Code 15454 |
C15455 | P15455 | CN15455 | Atezolizumab | Resected early stage (Stage II to IIIA) non-small cell lung cancer (NSCLC) 1,875 mg administered once every 3 weeks Patient must be both: (i) initiating treatment, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy; OR Patient must be continuing existing PBS-subsidised treatment with this drug; OR Patient must be both: (i) transitioning from existing non-PBS to PBS subsidised supply of this drug, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy at the time this drug was initiated. Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug. The treatment must be for the purpose of adjuvant therapy following all of: (i) surgical resection, (ii) platinum-based chemotherapy; AND The condition must have/have had, at treatment commencement, an absence of each of the following gene abnormalities confirmed via tumour material sampling: (i) an activating epidermal growth factor receptor (EGFR) gene mutation, (ii) an anaplastic lymphoma kinase (ALK) gene rearrangement; AND The condition must have/have had, at treatment commencement, confirmation of programmed cell death ligand 1 (PD-L1) expression on at least 50% of tumour cells; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition. Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words 'cancelled' where (i)/(ii) has occurred. | Compliance with Authority Required procedures - Streamlined Authority Code 15455 |
C15456 | P15456 | CN15456 | Midazolam | Generalized convulsive status epilepticus Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures |
C15467 | P15467 | CN15467 | Larotrectinib | Solid tumours (of certain specified types) with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion Initial treatment The condition must be confirmed to be positive for a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion prior to treatment initiation with this drug through a pathology report from an Approved Pathology Authority - provide the following evidence: (i) the date of the pathology report substantiating the positive NTRK gene fusion, (ii) the name of the pathology service provider, (iii) the unique identifying number/code linking the pathology test result to the patient; the recency of the pathology report may be of any date; AND The condition must be non-small cell lung cancer confirmed through a pathology report from an Approved Pathology Authority (of any date); OR The condition must be soft tissue sarcoma confirmed through a pathology report from an Approved Pathology Authority (of any date); OR The condition must be confirmed through a pathology report from an Approved Pathology Authority (of any date) as either: (i) glioma, (ii) glioneuronal tumour, (iii) glioblastoma; AND The condition must be metastatic disease; OR The condition must be both: (i) locally advanced, (ii) unresectable; OR The condition must be locally advanced where surgical resection is likely to result in severe morbidity; AND Patient must have received prior systemic treatment for this disease; OR Patient must have a condition that predisposes them to an unacceptable risk of intolerance to other systemic therapies; AND The treatment must be the sole PBS-subsidised anti-cancer therapy for this condition; AND Patient must not receive more than 3 months of treatment under this restriction. Patient must not be undergoing treatment through this Initial treatment phase listing where the patient has developed disease progression while receiving this drug for this condition. Patient must be at least 18 years of age. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail, and must include: (a) details of the pathology report substantiating the positive NTRK gene fusion. The recency of the pathology report may be of any date. (b) details of the pathology report establishing the carcinoma type (non-small cell lung cancer, soft tissue sarcoma or either glioma/ glioneuronal tumour/ glioblastoma) being treated, if different to the pathology report provided to substantiate the NTRK gene fusion. (c) details of prior systemic treatment for this disease or details of the condition that predisposes the patient to an unacceptable risk of intolerance to other systemic therapies. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include: (i) details of the proposed prescription; and (ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
C15469 | P15469 | CN15469 | Beclometasone with formoterol | Asthma Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; OR Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; OR Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy. Patient must be at least 18 years of age. | Compliance with Authority Required procedures - Streamlined Authority Code 15469 |
C15471 | P15471 | CN15471 | Nivolumab | Resectable non-small cell lung cancer (NSCLC) The condition must be at least one of: (i) node positive, (ii) at least 4 cm in size; AND The treatment must be for neoadjuvant use in a patient preparing for surgical resection; AND Patient must have a WHO performance status of 0 or 1; AND The treatment must be in combination with platinum-based chemotherapy. Patient must not be undergoing treatment with more than 3 PBS-subsidised doses of this drug per lifetime for this indication. In non-squamous type NSCLC where any of the following is known to be present, this drug must not be a PBS benefit: (i) activating epidermal growth factor receptor (EGFR) gene mutation, (ii) anaplastic lymphoma kinase (ALK) gene rearrangement. | Compliance with Authority Required procedures - Streamlined Authority Code 15471 |
C15473 | P15473 | CN15473 | Adalimumab | Vision threatening non-infectious uveitis Balance of Supply Patient must have received PBS-subsidised treatment with this drug for this condition; AND Patient must have received insufficient therapy with this drug for this condition to complete one of the following: (i) 25 weeks for initial treatment; (ii) 25 weeks for recommencement treatment; (iii) 24 weeks for continuing treatment; (iv) 24 weeks for transitioning from non-PBS to PBS-subsidised treatment. | Compliance with Authority Required procedures |
C15474 | P15474 | CN15474 | Adalimumab | Vision threatening non-infectious uveitis Initial treatment Patient must have non-infectious uveitis that is vision threatening with the diagnosis confirmed by an ophthalmologist, rheumatologist, or immunologist; AND Patient must have failed to achieve an adequate response to corticosteroid therapy in combination with at least 1 immunosuppressive agent; OR Patient must have flared when corticosteroid therapy was tapered to a dose of less than or equal to 7.5 mg per day of prednisone or equivalent while on immunomodulatory therapy; OR Patient must have failed to achieve an adequate response to at least one immunosuppressive agent in patients for whom corticosteroids are not clinically appropriate; OR Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contraindication to corticosteroid and immunomodulatory therapy; AND The treatment must not exceed 25 weeks under this restriction. Must be treated by an ophthalmologist, rheumatologist or immunologist with expertise in uveitis; OR Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion. Vision threatening disease is defined as at least 1 of the following: (a) A decrease in visual acuity of at least 10 letters using an ETDRS chart or equivalent; (b) A 2-step increase in anterior chamber cells or vitreous haze; (c) New retinal vasculitis; (d) New retinal or choroidal lesions; (e) Other signs of disease progression including visual field changes or electroretinogram changes A failure to achieve an adequate response is defined as failure to meet one or more of the below criteria: (a) Sustained reduction in inflammation defined as a 2-step decrease from baseline in Standardisation of Uveitis Nomenclature (SUN) criteria for anterior chamber or vitreous haze; or (b) Sustained quiescence of inflammation defined as Standardisation of Uveitis Nomenclature (SUN) criteria less than or equal to 0.5+ anterior chamber or vitreous haze, absence of active vitreous or retinal lesions or vitreous cells; or (c) Sustained corticosteroid sparing effect, allowing reduction in prednisone to less than 7.5 mg daily; or (d) Reduction in frequency of ocular attacks to less than or equal to 1 per year (patients with Behcet's disease only) Details of prior immunomodulatory agent and corticosteroid treatment, or details of contraindications or developed intolerances necessitating treatment withdrawal, must be documented in the patient's medical record. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include details of vision threatening disease. If the application is submitted through HPOS form upload or mail, it must include: (i) details of the proposed prescription; and (ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
C15477 | P15477 | CN15477 | Selumetinib | Neurofibromatosis type 1 Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must be tolerating treatment; AND Patient must have achieved either: (i) stabilisation of disease, (ii) adequate response to treatment, if have received at least 12 months of treatment with this drug. Must be treated by a prescriber who is either: (i) a specialist physician with expertise in neurofibromatosis, (ii) a medical practitioner in consultation with a specialist physician with expertise in neurofibromatosis if attendance is not possible due to geographic isolation. At the time of the authority application, medical practitioners must request the appropriate number of packs of appropriate strength(s) to provide sufficient drug, based on the body surface area (BSA) of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised. Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records. For the purpose of administering this restriction, adequate response is defined as: 1. stability or improvement of the initial baseline measurements prior to initiating treatment with this drug; 2. relevant imaging has not shown an increase in tumour size of 20% or more. | Compliance with Authority Required procedures |
C15485 | P15485 | CN15485 | Avelumab | Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer Maintenance therapy - Initial treatment Patient must have received first-line platinum-based chemotherapy; AND Patient must not have progressive disease following first-line platinum-based chemotherapy; AND Patient must have a WHO performance status of 0 or 1; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND 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 this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 15485 |
C15489 | P15489 | CN15489 | Adalimumab | Vision threatening non-infectious uveitis Recommencement of treatment Patient must have a documented history of non-infectious uveitis that is vision threatening; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated or sustained an adequate response to treatment prior to having a break in therapy with this drug for this condition; AND The treatment must not exceed 25 weeks under this restriction. Must be treated by an ophthalmologist, rheumatologist or immunologist with expertise in uveitis; OR Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion. An adequate response to treatment is defined as: (a) Sustained reduction in inflammation defined as a 2-step decrease from baseline in Standardisation of Uveitis Nomenclature (SUN) criteria for anterior chamber or vitreous haze; or (b) Sustained quiescence of inflammation defined as Standardisation of Uveitis Nomenclature (SUN) criteria less than or equal to 0.5+ anterior chamber or vitreous haze, absence of active vitreous or retinal lesions or vitreous cells; or (c) Sustained corticosteroid sparing effect, allowing reduction in prednisone to less than 7.5 mg daily; or (d) Reduction in frequency of ocular attacks to less than or equal to 1 per year (patients with Behcet's disease only) 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. | Compliance with Authority Required procedures |
C15490 | P15490 | CN15490 | Selumetinib | Neurofibromatosis type 1 Initial treatment Patient must have plexiform neurofibroma(s) (PN) that is causing/likely to cause at least one of: (i) significant symptoms/morbidity, (ii) disability, (iii) disfigurement, (iv) impairment of normal body function; AND Patient must have PN for which complete resection cannot be performed; AND Patient must have either a: (i) Karnofsky, (ii) Lansky Performance Score of at least 70%. Must be treated by a prescriber who is either: (i) a specialist physician with expertise in neurofibromatosis, (ii) a medical practitioner in consultation with a specialist physician with expertise in neurofibromatosis if attendance is not possible due to geographic isolation. Patient must be aged between 2 to 18 years; AND Patient must be able to swallow the whole capsule form of this drug. At the time of the authority application, medical practitioners must request the appropriate number of packs of appropriate strength(s) to provide sufficient drug, based on the body surface area (BSA) of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised. Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records. For the purpose of administering this restriction, significant symptoms/morbidity are defined as, but not limited to: 1. head and neck PN that can compromise the airway or great vessels; 2. paraspinal PN that can cause myelopathy; 3. brachial or lumbar plexus PN that can cause nerve compression and loss of function; 4. PN that can result in major deformity or significant disfiguring (e.g. orbital PN); 5. PN of the extremity that can cause limb hypertrophy or loss of function; and 6. painful PN. The authority application must be made in writing and must include: (1) details of the proposed prescription; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
C15491 | P15491 | CN15491 | Selumetinib | Neurofibromatosis type 1 Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements Patient must have previously received treatment with this drug for this condition prior to 1 August 2024; OR Patient must have previously received treatment with another mitogen-activated protein kinase (MEK) inhibitor for this condition prior to 1 August 2024; AND Patient must have met all other PBS eligibility criteria that a non-'Grandfather' patient would ordinarily be required to meet, meaning that at the time non-PBS-subsidised supply of a MEK inhibitor (including selumetinib) was commenced, the patient: (i) had PN that caused/was likely to cause at least one of: (a) significant symptoms/morbidity, (b) disability, (c) disfigurement, (d) impairment of normal body function; (ii) had PN for which complete PN resection could not be performed either: (a) safely, (b) without causing unacceptable morbidity; (iii) had either a: (a) Karnofsky, (b) Lansky Performance Score of at least 70%; (iv) was aged between 2 to 18 years; (v) was able to swallow the whole capsule form if received non-PBS supply with selumetinib; AND Patient must be tolerating treatment; AND Patient must have achieved either: (i) stabilisation of disease, (ii) adequate response to treatment, if have received at least 12 months of treatment. Must be treated by a prescriber who is either: (i) a specialist physician with expertise in neurofibromatosis, (ii) a medical practitioner in consultation with a specialist physician with expertise in neurofibromatosis if attendance is not possible due to geographic isolation. At the time of the authority application, medical practitioners must request the appropriate number of packs of appropriate strength(s) to provide sufficient drug, based on the body surface area (BSA) of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised. Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records. For the purpose of administering this restriction, significant symptoms/morbidity are defined as, but not limited to: 1. head and neck PN that can compromise the airway or great vessels; 2. paraspinal PN that can cause myelopathy; 3. brachial or lumbar plexus PN that can cause nerve compression and loss of function; 4. PN that can result in major deformity or significant disfiguring (e.g. orbital PN); 5. PN of the extremity that can cause limb hypertrophy or loss of function; and 6. painful PN. For the purpose of administering this restriction, adequate response is defined as: 1. stability or improvement of the initial baseline measurements prior to initiating treatment with this drug; 2. relevant imaging has not shown an increase in tumour size of 20% or more. The authority application must be made in writing and must include: (1) details of the proposed prescription; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
C15500 | P15500 | CN15500 | Durvalumab | Unresectable Stage III non-small cell lung cancer Initial treatment Patient must have received platinum based chemoradiation therapy; AND The condition must not have progressed following platinum based chemoradiation therapy; AND Patient must have a WHO performance status of 0 or 1; AND Patient must be untreated with immunotherapy at commencement of this drug; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 15500 |
C15509 | P15509 | CN15509 | Larotrectinib | Solid tumours (of certain specified types) with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The condition must be either: (i) non-small cell lung cancer, (ii) soft tissue sarcoma, (iii) glioma, (iv), glioneuronal tumour, (v) glioblastoma; AND The treatment must cease to be a PBS benefit upon radiographic progression; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition. Patient must be at least 18 years of age. Where radiographic progression is observed, mark any remaining repeat prescriptions with the word 'cancelled'. | Compliance with Authority Required procedures |
C15526 | P15526 | CN15526 | Gilteritinib | Relapsed or refractory Acute Myeloid Leukaemia Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND The condition must not be acute promyelocytic leukaemia; AND The condition must be internal tandem duplication (ITD) and/or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition, confirmed through a pathology report from an Approved Pathology Authority; AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 prior to treatment initiation; AND The treatment must not be for maintenance therapy post-transplant. The prescriber must confirm whether the patient has FLT3 ITD or TKD mutation. The test result and date of testing must be provided at the time of application and documented in the patient's file. | Compliance with Authority Required procedures |
C15530 | P15530 | CN15530 | Esomeprazole Lansoprazole Omeprazole Pantoprazole Rabeprazole | Gastro-oesophageal reflux disease The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must be for long-term maintenance of gastro-oesophageal reflux disease in a patient with symptoms inadequately controlled using a low dose proton pump inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 15530 |
C15535 | P15535 | CN15535 | Bisacodyl | Terminal malignant neoplasia The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. Patient must identify as Aboriginal or Torres Strait Islander. | |
C15536 | P15536 | CN15536 | Teriparatide | Severe established osteoporosis Continuing treatment The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have previously been issued with an authority prescription for this drug; AND The treatment must not exceed a lifetime maximum of 18 months therapy. Must be treated by a specialist; OR Must be treated by a consultant physician. | Compliance with Authority Required procedures - Streamlined Authority Code 15536 |
C15539 | P15539 | CN15539 | Macrogol 3350 | Chronic constipation The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must be inadequately controlled with first line interventions such as bulk-forming agents. | |
C15542 | P15542 | CN15542 | Apomorphine | Parkinson disease Maintenance therapy The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND Patient must have been commenced on treatment in a specialist unit in a hospital setting. | Compliance with Authority Required procedures - Streamlined Authority Code 15542 |
C15543 | P15543 | CN15543 | Beclometasone with formoterol and glycopyrronium Budesonide with glycopyrronium and formoterol Fluticasone furoate with umeclidinium and vilanterol | Chronic obstructive pulmonary disease (COPD) The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have experienced at least one severe COPD exacerbation, which required hospitalisation, or two or more moderate exacerbations in the previous 12 months, with significant symptoms despite regular bronchodilator therapy with a long acting muscarinic antagonist (LAMA) and a long acting beta-2 agonist (LABA) or an inhaled corticosteroid (ICS) and a LABA; OR Patient must have been stabilised on a combination of a LAMA, LABA and an ICS for this condition. Patient must not be undergoing treatment with this product in each of the following circumstances: (i) treatment of asthma in the absence of a COPD diagnosis, (ii) initiation of bronchodilator therapy in COPD, (iii) use as reliever therapy for asthma, (iv) dosed at an interval/frequency that differs to that recommended in the approved Product Information. | Compliance with Authority Required procedures - Streamlined Authority Code 15543 |
C15546 | P15546 | CN15546 | Fluticasone furoate with vilanterol | Asthma The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids. Patient must be aged 12 years or over. | Compliance with Authority Required procedures - Streamlined Authority Code 15546 |
C15548 | P15548 | CN15548 | Budesonide with formoterol Fluticasone furoate with vilanterol Fluticasone propionate with salmeterol | Chronic obstructive pulmonary disease (COPD) The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have significant symptoms despite regular beta-2 agonist bronchodilator therapy; AND Patient must have experienced at least one severe COPD exacerbation, which required hospitalisation, or two or more moderate exacerbations in the previous 12 months. | Compliance with Authority Required procedures - Streamlined Authority Code 15548 |
C15550 | P15550 | CN15550 | Escitalopram | Moderate to severe generalised anxiety disorder (GAD) The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND Patient must not have responded to non-pharmacological therapy; AND Patient must have been assessed by a psychiatrist. | |
C15551 | P15551 | CN15551 | Escitalopram | Moderate to severe social anxiety disorder (social phobia, SAD) The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND Patient must not have responded to non-pharmacological therapy; AND Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared. | |
C15553 | P15553 | CN15553 | Desvenlafaxine Duloxetine Mirtazapine Moclobemide Reboxetine Venlafaxine | Major depressive disorders The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C15556 | P15556 | CN15556 | Carbomer Hypromellose Hypromellose with dextran Polyethylene glycol 400 with propylene glycol Propylene glycol | Severe dry eye syndrome The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C15558 | P15558 | CN15558 | Bimatoprost with timolol Brimonidine with timolol Brinzolamide with brimonidine Brinzolamide with timolol Dorzolamide with timolol Latanoprost with timolol Travoprost with timolol | Elevated intra-ocular pressure The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must have been inadequately controlled with monotherapy; AND Patient must have open-angle glaucoma; OR Patient must have ocular hypertension. | |
C15559 | P15559 | CN15559 | Carbomer Carmellose Hyaluronic acid Hypromellose Paraffin Perfluorohexyloctane Polyethylene glycol 400 with propylene glycol | Severe dry eye syndrome The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must be sensitive to preservatives in multi-dose eye drops. | Compliance with Authority Required procedures - Streamlined Authority Code 15559 |
C15560 | P15560 | CN15560 | Carbomer Hypromellose Hypromellose with dextran Polyethylene glycol 400 with propylene glycol | Severe dry eye syndrome | |
C15566 | P15566 | CN15566 | Tiotropium | Severe asthma The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have experienced at least one severe asthma exacerbation in the 12 months prior to having first commenced treatment for severe asthma, which required systemic corticosteroid treatment despite each of: (i) receiving optimised asthma therapy, (ii) being assessed for adherence to therapy, (iii) being assessed for correct inhaler technique; AND The treatment must be used in combination with a maintenance combination of an inhaled corticosteroid (ICS) and a long acting beta-2 agonist (LABA) unless a LABA is contraindicated. Patient must be at least 18 years of age. Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta-2 agonist. | |
C15572 | P15572 | CN15572 | Bisacodyl Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate | Terminal malignant neoplasia The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C15574 | P15574 | CN15574 | Lansoprazole Omeprazole Pantoprazole Rabeprazole | Gastro-oesophageal reflux disease The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C15575 | P15575 | CN15575 | Omeprazole Pantoprazole | Zollinger-Ellison syndrome The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C15577 | P15577 | CN15577 | Budesonide with formoterol | Asthma The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have failed PBS-subsidised fluticasone proprionate and salmeterol as a fixed dose combination for this condition. Must be treated by a respiratory physician; OR Must be treated by a paediatrician. | Compliance with Authority Required procedures - Streamlined Authority Code 15577 |
C15578 | P15578 | CN15578 | Budesonide | Severe chronic asthma The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must require long-term steroid therapy; AND Patient must not be able to use other forms of inhaled steroid therapy. | Compliance with Authority Required procedures - Streamlined Authority Code 15578 |
C15580 | P15580 | CN15580 | Mianserin | Severe depression The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C15582 | P15582 | CN15582 | Fluoxetine Fluvoxamine Paroxetine Sertraline | Obsessive-compulsive disorder The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C15583 | P15583 | CN15583 | Sertraline | Panic disorder The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must be for use when other treatments have failed; OR The treatment must be for use when other treatments are inappropriate. | |
C15585 | P15585 | CN15585 | Bisacodyl Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate | Constipation The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must be paraplegic or quadriplegic or have severe neurogenic impairment of bowel function. | |
C15586 | P15586 | CN15586 | Bisacodyl Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate | Constipation The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must be receiving palliative care. | |
C15587 | P15587 | CN15587 | Bisacodyl | Constipation The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult. Patient must identify as Aboriginal or Torres Strait Islander. | |
C15593 | P15593 | CN15593 | Macrogol 3350 | Constipation The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must be receiving palliative care. | |
C15596 | P15596 | CN15596 | Doxycycline | Bronchiectasis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. Patient must be aged 8 years or older. | |
C15599 | P15599 | CN15599 | Beclometasone with formoterol | Asthma The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; OR Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; OR Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy. Patient must be at least 18 years of age. | Compliance with Authority Required procedures - Streamlined Authority Code 15599 |
C15600 | P15600 | CN15600 | Beclometasone | Asthma The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must be unable to achieve co-ordinated use of other metered dose inhalers containing this drug | |
C15601 | P15601 | CN15601 | Fluticasone furoate with umeclidinium and vilanterol Indacaterol with glycopyrronium and mometasone | Severe asthma The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have experienced at least one severe asthma exacerbation in the 12 months prior to having first commenced treatment for severe asthma, which required systemic corticosteroid treatment despite each of: (i) receiving optimised asthma therapy, (ii) being assessed for adherence to therapy, (iii) being assessed for correct inhaler technique. Patient must be at least 18 years of age. Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta-2 agonist. | Compliance with Authority Required procedures - Streamlined Authority Code 15601 |
C15604 | P15604 | CN15604 | Fluticasone propionate with salmeterol | Asthma The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids. Patient must be aged 4 years or older. | Compliance with Authority Required procedures - Streamlined Authority Code 15604 |
C15606 | P15606 | CN15606 | Escitalopram | Moderate to severe generalised anxiety disorder (GAD) The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND Patient must not have responded to non-pharmacological therapy; AND Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared. | |
C15607 | P15607 | CN15607 | Formoterol Salmeterol | Asthma The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must experience frequent episodes of the condition; AND Patient must be currently receiving treatment with oral corticosteroids; OR Patient must be currently receiving treatment with optimal doses of inhaled corticosteroids. | |
C15611 | P15611 | CN15611 | Tiotropium | Chronic obstructive pulmonary disease (COPD) The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C15615 | P15615 | CN15615 | Budesonide with formoterol | Asthma The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids. Patient must be aged 12 years or over. | Compliance with Authority Required procedures - Streamlined Authority Code 15615 |
C15617 | P15617 | CN15617 | Budesonide with formoterol | Asthma The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids. | Compliance with Authority Required procedures - Streamlined Authority Code 15617 |
C15625 | P15625 | CN15625 | Doxycycline | Severe acne The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C15629 | P15629 | CN15629 | Bisacodyl Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate | Constipation The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult. | |
C15633 | P15633 | CN15633 | Lansoprazole Omeprazole Pantoprazole Rabeprazole | Scleroderma oesophagus The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C15634 | P15634 | CN15634 | Aclidinium Glycopyrronium Umeclidinium | Chronic obstructive pulmonary disease (COPD) The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C15635 | P15635 | CN15635 | Fluticasone propionate with formoterol | Asthma The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids. Patient must be aged 12 years or over. | Compliance with Authority Required procedures - Streamlined Authority Code 15635 |
C15639 | P15639 | CN15639 | Escitalopram | Major depressive disorders The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C15642 | P15642 | CN15642 | Montelukast | Asthma First-line prevention The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. Patient must be aged 2 to 5 years inclusive. The condition must be frequent intermittent; OR The condition must be mild persistent; AND The treatment must be the single preventer agent; AND The treatment must be an alternative to sodium cromoglycate; OR The treatment must be an alternative to nedocromil sodium. | Compliance with Authority Required procedures - Streamlined Authority Code 15642 |
C15643 | P15643 | CN15643 | Montelukast | Asthma First-line prevention The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must be frequent intermittent; OR The condition must be mild persistent; AND The treatment must be the single preventer agent; AND The treatment must be an alternative to sodium cromoglycate; OR The treatment must be an alternative to nedocromil sodium. Patient must be aged 6 to 14 years inclusive. | Compliance with Authority Required procedures - Streamlined Authority Code 15643 |
C15644 | P15644 | CN15644 | Montelukast | Asthma Prevention of condition The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must be exercise-induced; AND The treatment must be as an alternative to adding salmeterol xinafoate; OR The treatment must be an alternative to adding formoterol fumarate; AND The condition must be otherwise well controlled while receiving optimal dose inhaled corticosteroid; AND Patient must require short-acting beta-2 agonist 3 or more times per week for prevention or relief of residual exercise-related symptoms. Patient must be aged 6 to 14 years inclusive. | Compliance with Authority Required procedures - Streamlined Authority Code 15644 |
C15648 | C15648 | CN15648 | Rasagiline | Parkinson disease The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C15653 | P15653 | CN15653 | Indacaterol with mometasone | Asthma The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids. Patient must be aged 12 years or over. | Compliance with Authority Required procedures - Streamlined Authority Code 15653 |
C15656 | P15656 | CN15656 | Beclometasone with formoterol | Asthma The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids. Patient must be aged 18 years or older. | Compliance with Authority Required procedures - Streamlined Authority Code 15656 |
C15657 | P15657 | CN15657 | Minocycline | Severe acne The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must not be responding to other tetracyclines. | |
C15658 | P15658 | CN15658 | Esomeprazole Lansoprazole Omeprazole Pantoprazole Rabeprazole | Scleroderma oesophagus The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | Compliance with Authority Required procedures - Streamlined Authority Code 15658 |
C15659 | P15659 | CN15659 | Doxycycline | Chronic bronchitis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. Patient must be aged 8 years or older. | |
C15661 | P15661 | CN15661 | Macrogol 3350 | Constipation The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must be paraplegic, quadriplegic or have severe neurogenic impairment of bowel function; AND The condition must be unresponsive to other oral therapies. | |
C15666 | P15666 | CN15666 | Citalopram Escitalopram Fluoxetine Fluvoxamine Paroxetine Sertraline | Major depressive disorders The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C15669 | P15669 | CN15669 | Escitalopram | Moderate to severe generalised anxiety disorder (GAD) The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND Patient must not have responded to non-pharmacological therapy; AND Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared. | |
C15670 | P15670 | CN15670 | Escitalopram | Moderate to severe generalised anxiety disorder (GAD) The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND Patient must not have responded to non-pharmacological therapy; AND Patient must have been assessed by a psychiatrist. | |
C15678 | P15678 | CN15678 | Omeprazole Pantoprazole | Zollinger-Ellison syndrome The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | Compliance with Authority Required procedures - Streamlined Authority Code 15678 |
C15680 | P15680 | CN15680 | Budesonide with formoterol | Asthma The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; OR Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; OR Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy. | Compliance with Authority Required procedures - Streamlined Authority Code 15680 |
C15682 | P15682 | CN15682 | Esomeprazole | Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | Compliance with Authority Required procedures - Streamlined Authority Code 15682 |
C15686 | P15686 | CN15686 | Doxycycline | Severe acne The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C15691 | P15691 | CN15691 | Aclidinium with formoterol Indacaterol with glycopyrronium Tiotropium with olodaterol Umeclidinium with vilanterol | Chronic obstructive pulmonary disease (COPD) The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have COPD symptoms that persist despite regular bronchodilator treatment with a long acting muscarinic antagonist (LAMA); OR Patient must have COPD symptoms that persist despite regular bronchodilator treatment with a long acting beta 2 agonist (LABA); OR Patient must have been stabilised on a combination of a LAMA and a LABA. | Compliance with Authority Required procedures - Streamlined Authority Code 15691 |
C15692 | P15692 | CN15692 | Fluticasone furoate with vilanterol | Asthma The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids. Patient must be aged 12 years or over. | Compliance with Authority Required procedures - Streamlined Authority Code 15692 |
C15693 | P15693 | CN15693 | Fluticasone propionate with salmeterol | Asthma The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids. | Compliance with Authority Required procedures - Streamlined Authority Code 15693 |
C15696 | P15696 | CN15696 | Escitalopram | Moderate to severe social anxiety disorder (social phobia, SAD) The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND Patient must not have responded to non-pharmacological therapy; AND Patient must have been assessed by a psychiatrist. | |
C15698 | P15698 | CN15698 | Escitalopram | Moderate to severe social anxiety disorder (social phobia, SAD) The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND Patient must not have responded to non-pharmacological therapy; AND Patient must have been assessed by a psychiatrist. | |
C15699 | P15699 | CN15699 | Safinamide | Parkinson disease The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination. | |
C15702 | P15702 | CN15702 | Budesonide with formoterol | Asthma The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; OR Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; OR Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist. Patient must be aged 12 years or over. | Compliance with Authority Required procedures - Streamlined Authority Code 15702 |
C15707 | P15707 | CN15707 | Bisacodyl Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate | Anorectal congenital abnormalities The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C15708 | P15708 | CN15708 | Bisacodyl | Constipation The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility. Patient must identify as Aboriginal or Torres Strait Islander. | |
C15709 | P15709 | CN15709 | Macrogol 3350 | Faecal impaction The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must be inadequately controlled with first line interventions such as bulk-forming agents. | |
C15710 | P15710 | CN15710 | Erythromycin | Severe acne The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must be one in which tetracycline therapy is inappropriate. | Compliance with Authority Required procedures - Streamlined Authority Code 15710 |
C15714 | P15714 | CN15714 | Fluticasone propionate with salmeterol | Asthma The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids. | Compliance with Authority Required procedures - Streamlined Authority Code 15714 |
C15715 | P15715 | CN15715 | Fluticasone propionate with salmeterol | Asthma The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids. Patient must be aged 4 years or older. | Compliance with Authority Required procedures - Streamlined Authority Code 15715 |
C15719 | P15719 | CN15719 | Riluzole | Amyotrophic lateral sclerosis Continuing treatment The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must be ambulatory; OR Patient must not be ambulatory, and must be able to either use upper limbs or to swallow; AND Patient must not have undergone a tracheostomy; AND Patient must not have experienced respiratory failure. | Compliance with Authority Required procedures |
C15722 | P15722 | CN15722 | Paroxetine | Panic disorder The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C15726 | P15726 | CN15726 | Bisacodyl | Anorectal congenital abnormalities The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. Patient must identify as Aboriginal or Torres Strait Islander. | |
C15727 | P15727 | CN15727 | Bisacodyl | Megacolon The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. Patient must identify as Aboriginal or Torres Strait Islander. | |
C15729 | P15729 | CN15729 | Macrogol 3350 | Constipation The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have malignant neoplasia. | |
C15734 | P15734 | CN15734 | Bisacodyl Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate | Constipation The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility. | |
C15735 | P15735 | CN15735 | Bisacodyl Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate | Megacolon The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C15736 | P15736 | CN15736 | Indacaterol | Chronic obstructive pulmonary disease (COPD) The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C15751 | P15751 | CN15751 | Escitalopram | Moderate to severe social anxiety disorder (social phobia, SAD) The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND Patient must not have responded to non-pharmacological therapy; AND Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared. | |
C15753 | P15753 | CN15753 | Tiotropium | Bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease Long-term maintenance treatment The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C15754 | P15754 | CN15754 | Tiotropium | Severe asthma The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. Must be treated by a respiratory physician, paediatric respiratory physician, clinical immunologist, allergist, paediatrician or general physician experienced in the management of patients with severe asthma; or in consultation with one of these specialists. Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND Patient must have experienced at least one severe exacerbation prior to receiving PBS-subsidised treatment with this drug for this condition, which has required documented use of systemic corticosteroids in the previous 12 months while receiving optimised asthma therapy; OR Patient must have experienced frequent episodes of moderate asthma exacerbations prior to receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must be used in combination with a maintenance combination of an inhaled corticosteroid (ICS) and a long acting beta-2 agonist (LABA) unless a LABA is contraindicated. Patient must be aged 6 to 17 years inclusive. Optimised asthma therapy includes adherence to the maintenance combination of a medium to high dose ICS and a LABA. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative | Compliance with Authority Required procedures - Streamlined Authority Code 15754 |
C15755 | P15755 | CN15755 | Budesonide with formoterol | Asthma The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; OR Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; OR Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy. Patient must be aged 12 years or over. | Compliance with Authority Required procedures - Streamlined Authority Code 15755 |
C15759 | P15759 | CN15759 | Brigatinib | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment The treatment must be as monotherapy; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND Patient must have a WHO performance status of 2 or less; AND Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing. | Compliance with Authority Required procedures |
C15774 | P15774 | CN15774 | Cabozantinib | Stage IV renal cell carcinoma (RCC) Initial treatment The condition must be each of: (i) classified as having an intermediate to poor survival risk score according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC), (ii) untreated with a tyrosine kinase inhibitor; OR Patient must have progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) despite treatment with a tyrosine kinase inhibitor, irrespective of the current IMDC survival risk score; AND Patient must have a WHO performance status of 2 or less; AND The treatment must be the sole PBS-subsidised therapy for this condition. Patient must be undergoing treatment with this drug for the first time at the time of the first PBS prescription. | Compliance with Authority Required procedures - Streamlined Authority Code 15774 |
C15776 | C15776 | CN15776 | Entrectinib | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND Patient must have a WHO performance status of 2 or less; AND Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing; AND Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition; OR Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it must include: (a) details of the proposed prescription; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be documented in the patient's medical records: (a) evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material. | Compliance with Written Authority Required procedures |
C15781 | C15781 | CN15781 | Larotrectinib | Solid tumours with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion Continuing treatment Patient must be undergoing continuing PBS-subsidised treatment commenced through an 'Initial treatment' listing for solid tumours (of any type) with confirmed NTRK gene fusion where treatment with this drug is/was initiated in a child; OR Patient must be undergoing continuing PBS-subsidised treatment commenced through an 'Initial treatment' listing for solid tumours (of certain specified types) with confirmed NTRK gene fusion which either includes: (i) mammary analogue secretory carcinoma of the salivary gland, (ii) secretory breast carcinoma. The treatment must cease to be a PBS benefit upon radiographic progression; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition. Where radiographic progression is observed, mark any remaining repeat prescriptions with the word 'cancelled'. | Compliance with Authority Required procedures |
C15782 | P15782 | CN15782 | Ganciclovir Valganciclovir | Cytomegalovirus infection and disease Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures - Streamlined Authority Code 15782 |
C15784 | P15784 | CN15784 | Ganciclovir Valganciclovir | Cytomegalovirus infection and disease Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures - Streamlined Authority Code 15784 |
C15787 | P15787 | CN15787 | Migalastat | Fabry disease Grandfather arrangement (transition from LSDP-funded Fabry disease therapy) Patient must have previously received treatment with this drug for this condition funded under the Australian Government's Life Saving Drugs Program (LSDP) prior to 1 September 2024; OR Patient must have previously received treatment with Enzyme Replacement Therapy for this condition funded under the Australian Government's Life Saving Drugs Program (LSDP) prior to 1 September 2024; AND Patient must have a documented migalastat amenable galactosidase alpha (GLA) gene variant prior to commencing treatment with this drug; AND Patient must have/have had an estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m2prior to commencing treatment with this drug. Must be treated by a physician with expertise in the management of Fabry disease. Patient must be at least 12 years of age. A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. Confirmation of eligibility for treatment with diagnostic reports including the confirmed mutations must be documented in the patient's medical records. The authority application must be made in writing and must include: (1) details of the proposed prescription; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
C15788 | P15788 | CN15788 | Adalimumab | Moderate to severe hidradenitis suppurativa Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years), or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment. Must be treated by a dermatologist. A maximum of 12 weeks of treatment will be authorised under this restriction. | Compliance with Authority Required procedures |
C15800 | P15800 | CN15800 | Ganciclovir Valganciclovir | Cytomegalovirus infection and disease Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures - Streamlined Authority Code 15800 |
C15801 | P15801 | CN15801 | Migalastat | Fabry disease Continuing treatment Patient must have received prior PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient's record; AND Patient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by migalastat. Must be treated by a physician with expertise in the management of Fabry disease. | Compliance with Authority Required procedures |
C15807 | P15807 | CN15807 | Secukinumab | Moderate to severe hidradenitis suppurativa Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 20 weeks treatment; OR 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 20 weeks treatment; OR 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 20 weeks treatment; AND The treatment must provide no more than the balance of up to 20 weeks treatment. Must be treated by a dermatologist. | Compliance with Authority Required procedures |
C15814 | P15814 | CN15814 | Ganciclovir Valganciclovir | Cytomegalovirus infection and disease Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures - Streamlined Authority Code 15814 |
C15818 | P15818 | CN15818 | Trastuzumab emtansine | Early HER2 positive breast cancer Initial adjuvant treatment The treatment must be prescribed within 12 weeks after surgery; AND Patient must have, prior to commencing treatment with this drug, evidence of residual invasive cancer in the breast and/or axillary lymph nodes following completion of surgery, as demonstrated by a pathology report; AND Patient must have completed systemic neoadjuvant therapy that included trastuzumab and taxane-based chemotherapy prior to surgery; AND 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 The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined. Authority applications for initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include: (a) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of surgery. The pathology report must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include: (i) details of the proposed prescription; and (ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
C15819 | P15819 | CN15819 | Trastuzumab emtansine | Early HER2 positive breast cancer Continuing adjuvant treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND 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 The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined. | Compliance with Authority Required procedures |
C15820 | P15820 | CN15820 | Trastuzumab | Early HER2 positive breast cancer Initial treatment (3 weekly regimen) Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND 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 Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; OR 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. HER2 positivity must be demonstrated by in situ hybridisation (ISH). Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 15820 |
C15826 | P15826 | CN15826 | Trastuzumab deruxtecan | Metastatic (Stage IV) HER2 positive breast cancer Patient must have evidence of human epidermal growth factor (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) in either the primary tumour/a metastatic lesion - establish this finding once only with the first PBS prescription; AND The condition must have progressed following treatment with at least one prior HER2 directed regimen for metastatic breast cancer; OR The condition must have, at the time of treatment initiation with this drug, progressed during/within 6 months following adjuvant treatment with a HER2 directed therapy; AND Patient must have, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND The treatment must not be prescribed where any of the following is present: (i) left ventricular ejection fraction of less than 50%, (ii) symptomatic heart failure; confirm cardiac function testing for the first PBS prescription only. Patient must be undergoing initial treatment with this drug - the following are true: (i) this is the first prescription for this drug, (ii) this prescription seeks no more than 3 repeat prescriptions; OR Patient must be undergoing continuing treatment with drug - the following are true: (i) there has been an absence of further disease progression whilst on active treatment with this drug, (ii) this prescription does not seek to re-treat after disease progression, (iii) this prescription seeks no more than 8 repeat prescriptions. Confirm that the following information is documented/retained in the patient's medical records once only with the first PBS prescription: 1) Evidence of HER2 gene amplification (evidence obtained in relation to past PBS treatment is acceptable). 2) Details of prior HER2 directed drug regimens prescribed for the patient. 3) Cardiac function test results (evidence obtained in relation to past PBS treatment is acceptable). | Compliance with Authority Required procedures |
C15827 | P15827 | CN15827 | Trastuzumab emtansine | Metastatic (Stage IV) HER2 positive breast cancer Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for metastatic (Stage IV) HER2 positive breast cancer; AND Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND 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. A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. The treatment must not exceed a lifetime total of one continuous course for this PBS indication. | Compliance with Authority Required procedures |
C15828 | P15828 | CN15828 | Trastuzumab emtansine | Metastatic (Stage IV) HER2 positive breast cancer Initial treatment Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion, confirmed through a pathology report from an Approved Pathology Authority; AND The condition must have progressed following treatment with pertuzumab and trastuzumab in combination; OR The condition must have progressed during or within 6 months of completing adjuvant therapy with trastuzumab; AND Patient must have a WHO performance status of 0 or 1; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND 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. The following information must be provided by the prescriber at the time of application: (a) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH). (b) dates of treatment with trastuzumab and pertuzumab; (c) date of demonstration of progression following treatment with trastuzumab and pertuzumab; or (d) date of demonstration of progression and date of completion of adjuvant trastuzumab treatment. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application. All reports must be documented in the patient's medical records. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval. | Compliance with Authority Required procedures |
C15831 | P15831 | CN15831 | Trastuzumab | Early HER2 positive breast cancer Initial treatment (weekly regimen) Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND 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 Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; OR 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. HER2 positivity must be demonstrated by in situ hybridisation (ISH). Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 15831 |
C15832 | P15832 | CN15832 | Trastuzumab deruxtecan | Unresectable and/or metastatic HER2-low breast cancer Patient must have evidence of human epidermal growth factor receptor 2 (HER2)-low disease; AND Patient must have received prior chemotherapy in the metastatic setting; OR Patient must have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy; AND Patient must have received or be ineligible for endocrine therapy in the metastatic setting, if hormone receptor positive; AND Patient must have, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND The treatment must not be prescribed where any of the following is present: (i) left ventricular ejection fraction of less than 50%, (ii) symptomatic heart failure; confirm cardiac function testing for the first PBS prescription only. Patient must be undergoing initial treatment with this drug - the following are true: (i) this is the first prescription for this drug, (ii) this prescription seeks no more than 3 repeat prescriptions; OR Patient must be undergoing continuing treatment with drug - the following are true: (i) there has been an absence of further disease progression whilst on active treatment with this drug, (ii) this prescription does not seek to re-treat after disease progression, (iii) this prescription seeks no more than 8 repeat prescriptions. HER2-low is defined as an immunohistochemical (IHC) score of 1+ or an IHC score of 2+ and a negative result on in situ hybridization (ISH). Confirm that the following information is documented/retained in the patient's medical records once only with the first PBS prescription: 1) Evidence of HER2-low status 2) Details of prior drug regimens prescribed for the patient 3) Cardiac function test results | Compliance with Authority Required procedures |
C15851 | P15851 | CN15851 | Etrasimod | Moderate to severe ulcerative colitis Initial treatment - Initial 1 (new patient) Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND Patient must have a Mayo clinic score greater than or equal to 6; OR Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score). Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. The authority application must be made in writing and must include: (1) details of the proposed prescription; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes: (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and (ii) details of prior systemic drug therapy (dosage, date of commencement and duration of therapy). All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment. The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application. An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy. 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. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application. A maximum of 16 weeks of treatment with this drug will be approved under this criterion. | Compliance with Written Authority Required procedures |
C15854 | P15854 | CN15854 | Fluticasone propionate | Asthma The treatment must not be a PBS benefit where this 50 microgram strength is being initiated in a patient over the age of 6.00 years; AND The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | Compliance with Authority Required procedures - Streamlined Authority Code 15854 |
C15856 | P15856 | CN15856 | Esomeprazole Lansoprazole Omeprazole Pantoprazole Rabeprazole | Complex gastro-oesophageal reflux disease (GORD) One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. Must be treated by a gastroenterologist; OR Must be treated by a surgeon with expertise in the upper gastrointestinal tract; OR Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialists in relation to this current PBS benefit being sought, with the specialist's name documented in the patient's medical records for auditing purposes; OR Must be treated by a medical practitioner who has not consulted a specialist, but only if treatment continues therapy initiated under this restriction with involvement by a specialist (i.e. continuing treatment initiated for non-complex GORD does not meet this criterion), with the specialist's name documented in the patient's medical records for auditing purposes. The treatment must be: (i) the sole PBS-subsidised proton pump inhibitor (PPI) for this condition, (ii) the sole strength of this PPI, (iii) the sole form of PPI; AND Patient must must have symptoms inadequately controlled with each of: (i) a standard dose proton pump inhibitor (PPI) administered once daily, (ii) a low dose PPI administered twice daily; treatment is for: (1) establishment of symptom control; OR Patient must be assessed for the risks/benefits of a step-down in dosing from standard dose PPI administered twice daily, with the determination being that the risks outweigh the benefits; treatment is for: (2) maintenance treatment; OR Patient must have trialled a step-down in dosing, yet symptoms have re-emerged/worsened; treatment is for: (3) re-establishment of symptom control; OR Patient must have trialled a step-down in dosing, with symptoms adequately managed with once daily dosing; treatment is for: (2) maintenance treatment, but with the quantity sought in this authority application being up to 2 packs per dispensing. Check patient adherence to any preceding PPI treatment regimen. Exclude non-adherence as a cause of inadequate control before accessing treatment under this restriction. | Compliance with Authority Required procedures |
C15857 | P15857 | CN15857 | Bimekizumab | Ankylosing spondylitis Initial 1 (new patient) The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be at least 18 years of age. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The application must include details of the NSAIDs trialled, their doses and duration of treatment. If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used. If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication. If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance. The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application: (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L. The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied. The authority application must be made in writing and must include: (1) details of the proposed prescription; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be provided at the time of application and documented in the patient's medical records: (i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and (ii) a baseline BASDAI score; and (iii) a completed Exercise Program Self Certification Form included in the supporting information form; and (iv) baseline ESR and/or CRP level. An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment. Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
C15864 | P15864 | CN15864 | Ibrutinib | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) Initial treatment in first-line therapy (treatment cycles 1 to 3 inclusive) The condition must be untreated with drug treatment at the time of the first dose of this drug; OR Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL; AND The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND The treatment must be in combination with venetoclax (refer to Product Information for timing of ibrutinib and venetoclax doses). There are more ibrutinib capsules (or tablets) in a pack than is required for the completion of a treatment cycle. The patient must not discard any remaining capsules (or tablets) after the completion of any treatment cycle as these capsules (or tablets) will be required for the doses in the final treatment cycle (i.e. treatment cycle 15). | Compliance with Authority Required procedures |
C15874 | P15874 | CN15874 | Bimekizumab | Ankylosing spondylitis Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of at least 5 years from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; OR Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; OR Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be at least 18 years of age. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The authority application must be made in writing and must include: (1) details of the proposed prescription; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be provided at the time of application and documented in the patient's medical records: (i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and (ii) a baseline BASDAI score; and (iii) a baseline ESR and/or CRP level. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
C15886 | P15886 | CN15886 | Dupilumab | Uncontrolled severe asthma Initial treatment - Initial 2 (Change of treatment) Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma. Patient must be under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND Patient must have had a blood eosinophil count of at least 300 cells per microlitre and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; OR Patient must have had a blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; OR Patient must have had a total serum human immunoglobulin E of at least 30 IU/mL, measured no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma, that has past or current evidence of atopy, documented by either: (i) skin prick testing; (ii) an in vitro measure of specific IgE; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma. Patient must be aged 12 years or older. An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient's most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine. An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment at around 28 weeks, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this biological medicine. At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy, at a dose of 400 mg as an initial dose, followed by 200 mg every 2 weeks thereafter. A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts. A multidisciplinary severe asthma clinic team comprises of: (i) A respiratory physician; and (ii) A pharmacist, nurse or asthma educator. The authority application must be made in writing and must include: (1) details of the proposed prescription; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be provided at the time of application and documented in the patient's medical records: (a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and (b) details (treatment, date of commencement, duration of therapy) of prior biological medicine treatment; and (c) if applicable, the eosinophil count and date; and (d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and (e) if applicable, the IgE result and date; and (f) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy). | Compliance with Written Authority Required procedures |
C15887 | P15887 | CN15887 | Etrasimod | Moderate to severe ulcerative colitis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND Patient must have a Mayo clinic score greater than or equal to 6; OR Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score). Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. The authority application must be made in writing and must include: (1) details of the proposed prescription; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes: (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment. The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application. An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy. 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. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A maximum of 16 weeks of treatment with this drug will be approved under this criterion. | Compliance with Written Authority Required procedures |
C15888 | P15888 | CN15888 | Etrasimod | Moderate to severe ulcerative colitis Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug. Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug. Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response. At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction. 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. 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. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 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. | Compliance with Authority Required procedures |
C15889 | P15889 | CN15889 | Icosapent ethyl | Established atherosclerotic cardiovascular disease with hypertriglyceridaemia Initial treatment The treatment must be in conjunction with dietary therapy and exercise; AND Patient must have at least one of (i) coronary artery disease, (ii) cerebrovascular or carotid disease, (iii) peripheral arterial disease; AND Patient must be treated with a stable dose of a HMG CoA reductase inhibitor (statin) to achieve target secondary prevention LDL-c levels for at least 12 consecutive weeks; OR Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment; OR Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND Patient must have LDL cholesterol level between 1.0 millimoles per litre and 2.6 millimoles per litre; OR Patient must have a non-HDL cholesterol between 1.5 millimoles per litre and 3.5 millimoles per litre if LDL cannot be measured/detected; AND Patient must have fasting triglyceride level between 1.7 millimoles per litre and 5.6 millimoles per litre. The qualifying fasting triglyceride level and LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, dietary therapy and exercise should be documented in the patient's medical records and must be no more than 8 weeks old. A clinically important product-related adverse event is defined as follows: (i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or (ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or (iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin. Atherosclerotic cardiovascular disease is defined as: (i) Documented coronary artery disease (CAD); one or more of the following primary criteria must have been satisfied: a) Documented multi-vessel CAD (at least 50% stenosis in at least two major epicardial coronary arteries, with or without antecedent revascularisation). b) Documented prior MI. c) Hospitalisation for high-risk non-ST-segment elevation acute coronary syndrome, with objective evidence of ischemia: ST-segment deviation or biomarker positivity. (ii) Documented cerebrovascular or carotid disease; one of the following primary criteria must have been satisfied: a) Documented prior ischemic stroke. b) Symptomatic carotid artery disease with at least 50% carotid arterial stenosis. c) Asymptomatic carotid artery disease with at least 70% carotid arterial stenosis per angiography or duplex ultrasound. d) History of carotid revascularisation (catheter-based or surgical). (iii) Documented peripheral arterial disease; one or more of the following primary criteria must have been satisfied: a) Ankle brachial index (ABI) less than 0.9 with symptoms of intermittent claudication. b) History of aorto-iliac or peripheral arterial intervention (catheter-based or surgical). | Compliance with Authority Required procedures - Streamlined Authority Code 15889 |
C15891 | P15891 | CN15891 | Bimekizumab | Non-radiographic axial spondyloarthritis Initial treatment - Initial 1 (New patient) Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND The treatment must not exceed a maximum of 16 weeks with this drug under this restriction. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis. The application must include details of the NSAIDs trialled, their doses and duration of treatment. If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used. If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication. If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance. The following criteria indicate failure to achieve an adequate response to NSAIDs and must be demonstrated at the time of the initial application: (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and (b) C-reactive protein (CRP) level greater than 10 mg per L. The baseline BASDAI score and CRP level must be determined at the completion of the 3-month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measures must be no more than 4 weeks old at the time of initial application. If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. The authority application must be made in writing and must include: (a) details of the proposed prescription(s); and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The baseline BASDAI score and CRP level must also be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
C15894 | P15894 | CN15894 | Avacopan | Anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis Induction treatment The condition must be severe granulomatosis with polyangiitis; OR The condition must be severe microscopic polyangiitis; AND The condition must be active at the time of the first prescription for this drug per treatment cycle; AND Patient must have ANCA associated vasculitis that is either: (i) organ-threatening, (ii) life-threatening disease; AND Patient must be undergoing concomitant therapy with at least another drug therapy as part of a regimen specified in this drug's approved Product Information; AND Patient must not receive more than 12 months of PBS-subsidised treatment with this drug per induction. A prescriber may apply for more than one induction treatment for their patient | Compliance with Authority Required procedures |
C15902 | P15902 | CN15902 | Bimekizumab Risankizumab | Severe psoriatic arthritis Continuing treatment Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. Patient must be at least 18 years of age. An adequate response to treatment is defined as: an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following major active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments. The authority application must be made in writing and must include: (1) details of the proposed prescription; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). 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. 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. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 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. | Compliance with Written Authority Required procedures |
C15903 | P15903 | CN15903 | Bimekizumab Risankizumab | Severe psoriatic arthritis Continuing treatment - balance of supply Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. | Compliance with Authority Required procedures |
C15904 | P15904 | CN15904 | Venetoclax | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) Second and final continuing treatment prescription (treatment cycles 10 to 15 inclusive) of first-line therapy Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with ibrutinib (refer to Product Information for timing of ibrutinib and venetoclax doses); AND The treatment must cease upon disease progression; OR The treatment must cease upon completion of 12 cycles of treatment with this drug for this condition, whichever comes first. | Compliance with Authority Required procedures |
C15905 | P15905 | CN15905 | Venetoclax | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) Initial treatment in first-line therapy with ibrutinib - Dose titration (cycle 4) The condition must be untreated with venetoclax at the time of the first dose of this drug; AND The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND The treatment must be in combination with ibrutinib (refer to Product Information for timing of ibrutinib and venetoclax doses). | Compliance with Authority Required procedures |
C15907 | P15907 | CN15907 | Venetoclax | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) First continuing treatment (treatment cycles 5 to 9 inclusive) of first-line therapy Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with ibrutinib (refer to Product Information for timing of ibrutinib and venetoclax doses); AND The treatment must cease upon disease progression. | Compliance with Authority Required procedures |
C15916 | P15916 | CN15916 | Bimekizumab | Severe psoriatic arthritis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND Patient must not receive more than 16 weeks of treatment under this restriction. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. Patient must be at least 18 years of age. Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include: (1) details of the proposed prescription; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. 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. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
C15918 | P15918 | CN15918 | Aflibercept Ranibizumab | Subfoveal choroidal neovascularisation (CNV) Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. The condition must be due to age-related macular degeneration (AMD); AND The condition must be diagnosed by optical coherence tomography; OR The condition must be diagnosed by fluorescein angiography; AND The treatment must be the sole PBS-subsidised therapy for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include: (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report. If the application is submitted through HPOS form upload or mail, it must include: (a) details of the proposed prescription; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
C15926 | P15926 | CN15926 | Etrasimod | Moderate to severe ulcerative colitis Continuing treatment - balance of supply Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction. Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. | Compliance with Authority Required procedures |
C15927 | P15927 | CN15927 | Icosapent ethyl | Established atherosclerotic cardiovascular disease with hypertriglyceridaemia Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in conjunction with dietary therapy and exercise; AND The treatment must be co-administered with a HMG CoA reductase inhibitor (statin), unless the patient is contraindicated to statins or has developed statin related adverse events necessitating withdrawal of statin treatment. | Compliance with Authority Required procedures - Streamlined Authority Code 15927 |
C15936 | P15936 | CN15936 | Esomeprazole | Complex gastro-oesophageal reflux disease (GORD) One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. Must be treated by a gastroenterologist; OR Must be treated by a surgeon with expertise in the upper gastrointestinal tract. The treatment must be: (i) the sole PBS-subsidised proton pump inhibitor (PPI) for this condition, (ii) the sole strength of this PPI, (iii) the sole form of PPI; AND Patient must have symptoms inadequately controlled with each of: (i) a high dose proton pump inhibitor (PPI) administered once daily, (ii) a standard dose PPI administered twice daily; treatment is for: (1) establishment of symptom control; OR Patient must be assessed for the risks/benefits of a step-down in dosing from a high dose PPI administered twice daily, with the determination being that the risks outweigh the benefits; treatment is for: (2) maintenance treatment; OR Patient must have trialled a step-down in dosing, yet symptoms have re-emerged/worsened; treatment is for: (3) re-establishment of symptom control; OR Patient must have trialled a step-down in dosing, with symptoms adequately managed with once daily dosing; treatment is for: (2) maintenance treatment, but with the quantity sought in this authority application being up to 2 packs per dispensing. Check patient adherence to any preceding PPI treatment regimen. Exclude non-adherence as a cause of inadequate control before accessing treatment under this restriction. | Compliance with Authority Required procedures |
C15937 | P15937 | CN15937 | Bimekizumab | Ankylosing spondylitis Continuing treatment Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be at least 18 years of age. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The authority application must be made in writing and must include: (1) details of the proposed prescription; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following: (a) an ESR measurement no greater than 25 mm per hour; or (b) a CRP measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from baseline. Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment. The assessment of response to treatment must be documented in the patient's medical records. 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. Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 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. | Compliance with Written Authority Required procedures |
C15938 | P15938 | CN15938 | Bimekizumab | Ankylosing spondylitis Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed/ceased to respond to PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be at least 18 years of age. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The authority application must be made in writing and must include: (1) details of the proposed prescription; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 5 years, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine within the timeframes specified below. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a patient is changing from PBS-subsidised treatment with a biosimilar medicine for this condition, the prescriber must submit baseline disease severity indicators with this application, in addition to the response assessment outlined below. An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following: (a) an ESR measurement no greater than 25 mm per hour; or (b) a CRP measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from baseline. Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment. The assessment of response to treatment must be documented in the patient's medical records. Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 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. | Compliance with Written Authority Required procedures |
C15939 | P15939 | CN15939 | Bimekizumab | Ankylosing spondylitis Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. | Compliance with Authority Required procedures |
C15940 | P15940 | CN15940 | Bimekizumab | Severe psoriatic arthritis Initial treatment - Initial 1 (new patient) Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND Patient must not receive more than 16 weeks of treatment under this restriction. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. Patient must be at least 18 years of age. Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application. Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and either (a) an active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. The authority application must be made in writing and must include: (1) details of the proposed prescription; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment. 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. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
C15943 | P15943 | CN15943 | Vedolizumab | Moderate to severe ulcerative colitis Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; OR Patient must have received this drug in the intravenous form as their most recent course of PBS-subsidised biological medicine for this condition under the vedolizumab intravenous form continuing treatment restriction; AND Patient must not receive more than 24 weeks of treatment under this restriction; AND Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR Patient must have demonstrated an adequate response to treatment with this drug in the intravenous form. Patient must be at least 18 years of age. Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug. Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response. At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction. Up to a maximum of 5 repeats will be authorised. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. 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. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 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. | Compliance with Authority Required procedures |
C15944 | P15944 | CN15944 | Vedolizumab | Moderate to severe ulcerative colitis Initial treatment with subcutaneous form Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 6 under Initial 1 (new patient); OR Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 6 under Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years); OR Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 6 under Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years); OR Patient must have a concurrent authority application for the intravenous infusion for this condition under either Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years). Patient must be at least 18 years of age. Where two initial doses of vedolizumab (at weeks 0 and 2) are administered via intravenous infusion, initial treatment with subcutaneous form will commence at week 6. The maximum listed quantity and 2 repeats should be requested to provide for weeks 6, 8, 10, 12, 14 and 16. Where three initial doses of vedolizumab (at weeks 0, 2 and 6) is administered via intravenous infusion, initial treatment with subcutaneous form will commence at week 14 (8 weeks after the third dose). A maximum quantity with no repeats should be requested to provide for weeks 14 and 16. The authority application must be made in writing and must include: (a) details of the proposed prescription(s); and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. 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. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
C15946 | P15946 | CN15946 | Etrasimod | Moderate to severe ulcerative colitis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle. Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. The authority application must be made in writing and must include: (1) details of the proposed prescription; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes: (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment. An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy. 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. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction. A maximum of 16 weeks of treatment with this drug will be approved under this criterion. | Compliance with Written Authority Required procedures |
C15947 | P15947 | CN15947 | Etrasimod | Moderate to severe ulcerative colitis Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. | Compliance with Authority Required procedures |
C15949 | P15949 | CN15949 | Bimekizumab | Ankylosing spondylitis Continuing treatment - balance of supply Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. | Compliance with Authority Required procedures |
C15955 | P15955 | CN15955 | Lanreotide | Functional carcinoid tumour Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The condition must be causing intractable symptoms; AND Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 120 mg every 28 days. Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures - Streamlined Authority Code 15955 |
C15956 | P15956 | CN15956 | Auranofin Chlorpromazine Digoxin Disopyramide Isoniazid Lidocaine Penicillamine Periciazine Zuclopenthixol decanoate | For prescribing by certain health practitioners Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | |
C15964 | P15964 | CN15964 | Cefazolin Ceftriaxone | Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | |
C15965 | P15965 | CN15965 | Flecainide | Serious supra-ventricular cardiac arrhythmias Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | |
C15966 | P15966 | CN15966 | Flecainide | Serious ventricular cardiac arrhythmias The treatment must be initiated in a hospital; AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | |
C15967 | P15967 | CN15967 | Amiodarone Sotalol | Severe cardiac arrhythmias Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | |
C15973 | P15973 | CN15973 | Rifampicin | Leprosy Patient must be an adult; Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures |
C15975 | P15975 | CN15975 | Fluconazole | Cryptococcal meningitis The treatment must be maintenance therapy; AND Patient must be immunosuppressed; AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 15975 |
C15978 | P15978 | CN15978 | Itraconazole | Systemic sporotrichosis Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 15978 |
C15979 | P15979 | CN15979 | Voriconazole | Serious Candida infections Treatment and maintenance therapy The condition must be caused by species not susceptible to fluconazole; or The condition must be resistant to fluconazole; or Patient must be unable to tolerate fluconazole; AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures |
C15981 | P15981 | CN15981 | Voriconazole | Serious invasive mycosis infections Treatment and maintenance therapy The treatment must be for invasive mycosis infections other than definite or probable invasive aspergillosis; AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures |
C15984 | P15984 | CN15984 | Fluconazole | Cryptococcal meningitis Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 15984 |
C15994 | P15994 | CN15994 | Fentanyl Methadone | Chronic severe disabling pain Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months The condition must require daily, continuous, long term opioid treatment; AND Patient must not be opioid naive; AND Patient must have cancer pain; or Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 15994 |
C15996 | P15996 | CN15996 | Fentanyl Methadone | Chronic severe disabling pain Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months The condition must require daily, continuous, long term opioid treatment; AND Patient must not be opioid naive; AND Patient must have cancer pain; or Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 15996 |
C16000 | P16000 | CN16000 | Fentanyl Methadone | Chronic severe disabling pain Continuing PBS treatment after 1 June 2020 Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020; AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 16000 |
C16009 | P16009 | CN16009 | Buprenorphine Buprenorphine with naloxone | Opioid dependence The treatment must be within a framework of medical, social and psychological treatment. The prescriber must request a quantity sufficient for up to 28 days of supply per dispensing according to the patient's daily dose. Up to 5 repeats will be authorised. The maximum listed quantity or number of repeats must not be prescribed if lesser quantity or repeats are sufficient for the patient's needs. | Compliance with Authority Required procedures - Streamlined Authority Code 16009 |
C16015 | P16015 | CN16015 | Buprenorphine | Opioid dependence Must be treated by a health care professional; AND The treatment must be within a framework of medical, social and psychological treatment; AND Patient must be stabilised on one of the following prior to commencing treatment with this drug for this condition: (i) weekly prolonged release buprenorphine (Buvidal Weekly) (ii) sublingual buprenorphine (iii) buprenorphine/naloxone. The prescriber must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs. | Compliance with Authority Required procedures - Streamlined Authority Code 16015 |
C16018 | P16018 | CN16018 | Eptinezumab | Chronic migraine Initial treatment Must be treated by a neurologist; or Must be treated by a general practitioner in consultation with a neurologist; AND Patient must not be undergoing concurrent treatment with the following PBS benefits: (i) botulinum toxin type A listed for this PBS indication, (ii) another drug in the same pharmacological class as this drug listed for this PBS indication; AND Patient must have experienced an average of 15 or more headache days per month, with at least 8 days of migraine, over a period of at least 6 months, prior to commencement of treatment with this medicine for this condition; AND Patient must have experienced an inadequate response, intolerance or a contraindication to at least three prophylactic migraine medications prior to commencement of treatment with this drug for this condition; AND Patient must be appropriately managed by their practitioner for medication overuse headache, prior to initiation of treatment with this drug; Patient must be at least 18 years of age. Prophylactic migraine medications are propranolol, amitriptyline, pizotifen, candesartan, verapamil, nortriptyline, sodium valproate or topiramate. Patient must have the number of migraine days per month documented in their medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 16018 |
C16022 | P16022 | CN16022 | Romosozumab | Severe established osteoporosis Continuing treatment - First-line therapy Patient must have previously received PBS-subsidised treatment with this drug for this condition as first-line therapy; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a lifetime maximum of 12 months of PBS and non-PBS-subsidised therapy; AND Must be treated by a medical practitioner identifying as either: (i) a consultant physician, (ii) a general practitioner. | Compliance with Authority Required procedures |
C16023 | P16023 | CN16023 | Romosozumab | Severe established osteoporosis Continuing treatment - Second-line therapy Patient must have previously received PBS-subsidised treatment with this drug for this condition as second-line therapy; AND The treatment must not exceed a lifetime maximum of 12 months of PBS and non-PBS-subsidised therapy; AND Must be treated by a medical practitioner identifying as either: (i) a consultant physician, (ii) a general practitioner. | Compliance with Authority Required procedures |
C16024 | P16024 | CN16024 | Lanreotide | Acromegaly Initial treatment Must be treated by a specialist practicing in a hospital who is either: (i) an endocrinologist, (ii) an oncologist; or Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types within a hospital setting; AND The condition must be active; AND Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND The treatment must be after failure of other therapy including dopamine agonists; or The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND The treatment must cease if IGF1 is not lower after 3 months of treatment; AND The treatment must not be given concomitantly with PBS-subsidised pegvisomant. In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission. | Compliance with Authority Required procedures - Streamlined Authority Code 16024 |
C16029 | P16029 | CN16029 | Cefazolin Ceftriaxone | Septicaemia, proven Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | |
C16030 | P16030 | CN16030 | Cefazolin Ceftriaxone | Septicaemia, suspected Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | |
C16034 | P16034 | CN16034 | Fluconazole | Fungal infection The condition must be serious or life-threatening; AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 16034 |
C16035 | P16035 | CN16035 | Itraconazole | Systemic histoplasmosis Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 16035 |
C16037 | P16037 | CN16037 | Rifampicin | Haemophilus influenzae type B The treatment must be for prophylaxis; AND Patient must be in contact with people who have the disease; AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | |
C16042 | P16042 | CN16042 | Voriconazole | Definite or probable invasive aspergillosis Treatment and maintenance therapy Patient must be immunocompromised; AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures |
C16043 | P16043 | CN16043 | Rifampicin | Mycobacterium ulcerans infection (Buruli ulcer) The treatment must be used in combination with another antibiotic for the treatment of Buruli ulcer; AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures |
C16048 | P16048 | CN16048 | Risperidone | Severe behavioural disturbances Continuing treatment Patient must have autism spectrum disorder; AND Patient must have been commenced on PBS-subsidised treatment with risperidone prior to turning 18 years of age; AND The treatment must be under the supervision of a paediatrician or psychiatrist; AND The treatment must be in combination with non-pharmacological measures; Patient must be at least 18 years of age. Behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful. 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. | Compliance with Authority Required procedures - Streamlined Authority Code 16048 |
C16050 | P16050 | CN16050 | Buprenorphine | Opioid dependence Must be treated by a health care professional; AND The treatment must be within a framework of medical, social and psychological treatment; AND Patient must be stabilised on sublingual buprenorphine or buprenorphine/naloxone prior to commencing treatment with this drug for this condition. The prescriber must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs. | Compliance with Authority Required procedures - Streamlined Authority Code 16050 |
C16051 | P16051 | CN16051 | Buprenorphine | Opioid dependence Must be treated by a health care professional; AND The treatment must be within a framework of medical, social and psychological treatment. The prescriber must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs. | Compliance with Authority Required procedures - Streamlined Authority Code 16051 |
C16053 | P16053 | CN16053 | Avelumab | Stage IV (metastatic) Merkel Cell Carcinoma Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a total of 9 doses at a maximum dose of 10 mg per kg every 2 weeks under this restriction. or The treatment must not exceed a dose of 800 mg every 2 weeks under this restriction. The patient's body weight must be documented in the patient's medical records at the time treatment is initiated. | Compliance with Authority Required procedures - Streamlined Authority Code 16053 |
C16054 | P16054 | CN16054 | Chlormethine | Mycosis fungoides cutaneous T-cell lymphoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND Patient must be treated by at least one of the following prescriber types (i) dermatologist, (ii) haematologist; AND The treatment must be approved for 1 unit if the condition is no more than 10% of the patient's body surface area to provide 4 weeks of treatment per script. or The treatment must be approved for 2 units if the condition is no more than 25% of the patient's body surface area to provide 4 weeks of treatment per script. | Compliance with Authority Required procedures |
C16055 | P16055 | CN16055 | Lanreotide | Acromegaly Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The condition must be active; AND Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND The treatment must be after failure of other therapy including dopamine agonists; or The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND The treatment must cease if IGF1 is not lower after 3 months of treatment; AND The treatment must not be given concomitantly with PBS-subsidised pegvisomant. In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission. | Compliance with Authority Required procedures - Streamlined Authority Code 16055 |
C16057 | P16057 | CN16057 | Lanreotide | Functional carcinoid tumour Initial treatment Must be treated by a specialist practicing in a hospital who is either: (i) an endocrinologist, (ii) an oncologist; or Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types within a hospital setting; AND The condition must be causing intractable symptoms; AND Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 120 mg every 28 days. Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures - Streamlined Authority Code 16057 |
C16063 | P16063 | CN16063 | Tirofiban | Non-Q-wave myocardial infarction Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 16063 |
C16072 | P16072 | CN16072 | Posaconazole | Invasive aspergillosis Patient must be unable to tolerate alternative therapy; or Patient must have disease refractory to alternative therapy; AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures |
C16073 | P16073 | CN16073 | Itraconazole | Oropharyngeal candidiasis Patient must be immunosuppressed; AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 16073 |
C16075 | P16075 | CN16075 | Rifampicin | Meningococcal disease The treatment must be for prophylaxis; AND Patient must be a carrier of the disease; or Patient must be in close contact with people who have the disease; AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | |
C16078 | P16078 | CN16078 | Penicillamine | The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | |
C16083 | P16083 | CN16083 | Methadone | Opioid dependence The treatment must be within a framework of medical, social and psychological treatment. The prescriber must request a quantity (in millilitres) sufficient for up to 28 days of supply per dispensing according to the patient's daily dose. Up to 5 repeats will be authorised. The maximum listed quantity or number of repeats must not be prescribed if lesser quantity or repeats are sufficient for the patient's needs. | Compliance with Authority Required procedures - Streamlined Authority Code 16083 |
C16085 | P16085 | CN16085 | Avelumab | Stage IV (metastatic) Merkel Cell Carcinoma Continuing treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND The treatment must not exceed a maximum dose of 10 mg per kg every 2 weeks under this restriction. or The treatment must not exceed a dose of 800 mg every 2 weeks under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 16085 |
C16087 | P16087 | CN16087 | Romosozumab | Severe established osteoporosis Initial treatment - Second-line therapy Patient must be at very high risk of fracture; AND Patient must have a bone mineral density (BMD) T-score of -3.0 or less; AND Patient must have had 2 or more fractures due to minimal trauma; AND Patient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a lifetime maximum of 12 months of PBS and non-PBS-subsidised therapy; AND Patient must not have received treatment with PBS-subsidised teriparatide; or Patient must have developed intolerance to teriparatide of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy; AND Must be treated by a consultant physician. A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body. If treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be documented in the patient's medical record at the time treatment with this drug is initiated. If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details must be documented in the patient's medical record at the time treatment with this drug is initiated. Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months and zoledronic acid 5 mg per annum. Details of prior anti-resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s) which developed after at least 12 months continuous anti-resorptive therapy and the score of the qualifying BMD measurement must be provided at the time of application. | Compliance with Authority Required procedures |
C16094 | P16094 | CN16094 | Voriconazole | Serious fungal infections Treatment and maintenance therapy The condition must be caused by Scedosporium species; OR The condition must be caused by Fusarium species. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures |
C16096 | P16096 | CN16096 | Posaconazole | Fungal infection The condition must be fusariosis; or The condition must be zygomycosis; or The condition must be coccidioidomycosis; or The condition must be chromoblastomycosis; or The condition must be mycetoma; AND Patient must be unable to tolerate alternative therapy; or Patient must have disease refractory to alternative therapy; AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures |
C16099 | P16099 | CN16099 | Itraconazole | Disseminated pulmonary histoplasmosis infection Treatment and maintenance therapy Patient must be diagnosed with acquired immunodeficiency syndrome (AIDS); AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 16099 |
C16101 | P16101 | CN16101 | Itraconazole | Chronic pulmonary histoplasmosis infection Treatment and maintenance therapy Patient must be diagnosed with acquired immunodeficiency syndrome (AIDS); AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 16101 |
C16102 | P16102 | CN16102 | Itraconazole | Oesophageal candidiasis Patient must be immunosuppressed; AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 16102 |
C16104 | P16104 | CN16104 | Fremanezumab Galcanezumab | Treatment-resistant migraine Initial treatment Must be treated by a neurologist; or Must be treated by a general practitioner in consultation with a neurologist; AND Patient must not be undergoing concurrent treatment with the following PBS benefits: (i) botulinum toxin type A listed for this PBS indication, (ii) another drug in the same pharmacological class as this drug listed for this PBS indication; AND Patient must have experienced at least 8 migraine headache days per month, over a period of at least 6 months, prior to commencement of treatment with this medicine for this condition; AND Patient must have experienced an inadequate response, intolerance or a contraindication to at least three prophylactic migraine medications prior to commencement of treatment with this drug for this condition; AND Patient must be appropriately managed by their practitioner for medication overuse headache, prior to initiation of treatment with this drug; Patient must be at least 18 years of age. Prophylactic migraine medications are propranolol, amitriptyline, pizotifen, candesartan, verapamil, nortriptyline, sodium valproate or topiramate. Patient must have the number of migraine headache days per month documented in their medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 16104 |
C16111 | P16111 | CN16111 | Perhexiline | Angina The condition must not be responding to other therapy; AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 16111 |
C16114 | P16114 | CN16114 | Fluconazole | Fungal infection The condition must be serious or life-threatening; AND Patient must be unable to take a solid dose form of fluconazole; AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 16114 |
C16115 | P16115 | CN16115 | Voriconazole | Prophylaxis of invasive fungal infections including both yeasts and moulds Patient must be considered at high risk of developing an invasive fungal infection due to anticipated neutropenia (an absolute neutrophil count less than 500 cells per cubic millimetre) for at least 10 days whilst receiving chemotherapy for acute myeloid leukaemia or myelodysplastic syndrome; or Patient must be considered at high risk of developing an invasive fungal infection due to having acute graft versus host disease (GVHD) grade II, III or IV, or, extensive chronic GVHD, whilst receiving intensive immunosuppressive therapy after allogeneic haematopoietic stem cell transplant; or Patient must be undergoing allogeneic haematopoietic stem cell transplant using either bone marrow from an unrelated donor or umbilical cord blood (related or unrelated), and, be considered to be at high risk of developing an invasive fungal infection during the neutropenic phase prior to engraftment; AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures |
C16117 | P16117 | CN16117 | Posaconazole | Prophylaxis of invasive fungal infections including both yeasts and moulds Patient must be considered at high risk of developing an invasive fungal infection due to anticipated neutropenia (an absolute neutrophil count less than 500 cells per cubic millimetre), for at least 10 days whilst receiving chemotherapy for acute myeloid leukaemia or myelodysplastic syndrome; or Patient must be considered at high risk of developing an invasive fungal infection due to having acute graft versus host disease (GVHD) grade II, III or IV, or extensive chronic GVHD, and receiving intensive immunosuppressive therapy after allogeneic haematopoietic stem cell transplant; AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. Treatment of neutropenia should continue until recovery of the neutrophil count to at least 500 cells per cubic millimetre. Patients who have had a previous invasive fungal infection should have secondary prophylaxis during subsequent episodes of neutropenia. No more than 6 months therapy per episode will be PBS-subsidised | Compliance with Authority Required procedures |
C16119 | P16119 | CN16119 | Itraconazole | Systemic aspergillosis Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 16119 |
C16123 | P16123 | CN16123 | Tirofiban | High risk of unstable angina Patient must have new transient or persistent ST-T ischaemic changes; AND Patient must have pain lasting longer than 20 minutes; AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 16123 |
C16132 | P16132 | CN16132 | Romosozumab | Severe established osteoporosis Initial treatment - First-line therapy Patient must not have received PBS-subsidised treatment with any of: (i) anti-resorptive therapy, (ii) teriparatide, (iii) romosozumab; AND Patient must be at very high risk of fracture; AND Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND Patient must have had a symptomatic fracture due to minimal trauma; AND Patient must have had at least 1 hip or symptomatic vertebral fracture in the previous 24 months; or Patient must have had at least 2 fractures including 1 symptomatic new fracture in the previous 24 months; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a lifetime maximum of 12 months of PBS and non-PBS-subsidised therapy; AND Must be treated by a consultant physician. Details of fracture history including the date(s), site(s), the symptoms associated with the fracture(s) and the score of the qualifying BMD measurement must be provided at the time of application. A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body. Anti-resorptive therapies for osteoporosis include alendronate sodium, risedronate sodium, raloxifene hydrochloride, denosumab and zoledronic acid. | Compliance with Authority Required procedures |
C16141 | P16141 | CN16141 | Fluconazole | Cryptococcal meningitis Patient must be unable to take a solid dose form of fluconazole; AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 16141 |
C16145 | P16145 | CN16145 | Chlormethine | Mycosis fungoides cutaneous T-cell lymphoma Initial treatment The condition must be any of: (i) Stage IA, (ii) IIA, (iii) IB mycosis fungoides cutaneous T-cell lymphoma; AND The condition must have been confirmed through a diagnostic lesion biopsy from an Approved Pathology Authority; AND The condition must cover either of which: (i) no more than 10% of the patient's body surface area, (ii) no more than 25% of the patient's body surface area; AND Patient must be treated by at least one of the following prescriber types (i) dermatologist, (ii) haematologist; AND The treatment must be approved for 1 unit if the condition is no more than 10% of the patient's body surface area to provide 4 weeks of treatment per script; or The treatment must be approved for 2 units if the condition is no more than 25% of the patient's body surface area to provide 4 weeks of treatment per script; Patient must be at least 18 years of age. Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records. | Compliance with Authority Required procedures |
C16147 | P16147 | CN16147 | Tirofiban | High risk of unstable angina Patient must have new transient or persistent ST-T ischaemic changes; AND Patient must have repetitive episodes of angina at rest or during minimal exercise in the previous 12 hours; AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 16147 |
C16148 | P16148 | CN16148 | Fluconazole | Cryptococcal meningitis The treatment must be maintenance therapy; AND Patient must be immunosuppressed; AND Patient must be unable to take a solid dose form of fluconazole; AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. | Compliance with Authority Required procedures - Streamlined Authority Code 16148 |
C16151 | P16151 | CN16151 | Nivolumab with relatlimab | Unresectable Stage III or Stage IV malignant melanoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition. Patients must only receive a maximum of 480 mg nivolumab and 160 mg relatlimab every four weeks under a flat dosing regimen. The prescribed dose must be according to the Therapeutic Goods Administration (TGA) Product Information. The prescription must include the amount of nivolumab with relatlimab (Opdualag) that is appropriate to be prescribed for the patient. For the purposes of PBS subsidy, the maximum amount requested is based on the nivolumab dose only. The prescribed amount of nivolumab must be expressed in milligrams. | Compliance with Authority Required procedures - Streamlined Authority Code 16151 |
C16155 | P16155 | CN16155 | Nirmatrelvir and ritonavir | SARS-CoV-2 infection Patient must have received a positive nucleic acid test result; OR Patient must have received a positive rapid antigen test (RAT) result; AND Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND The treatment must be initiated within 5 days of symptom onset; OR The treatment must be initiated as soon as possible after a diagnosis is confirmed where asymptomatic. Patient must be at least 70 years of age. Access to this drug through this restriction is permitted irrespective of vaccination status. Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record. Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record. This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. | Compliance with Authority Required procedures - Streamlined Authority Code 16155 |
C16156 | P16156 | CN16156 | Nirmatrelvir and ritonavir | SARS-CoV-2 infection Patient must have received a positive nucleic acid test result; OR Patient must have received a positive rapid antigen test (RAT) result; AND Patient must have at least one sign or symptom attributable to COVID-19; AND Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND The treatment must be initiated within 5 days of symptom onset. Patient must be both: (i) at least 50 years of age, (ii) at high risk. For the purpose of administering this restriction, high risk is defined as either a past COVID-19 infection episode resulting in hospitalisation, or the presence of at least two of the following conditions: 1. The patient is in residential aged care, 2. The patient has disability with multiple comorbidities and/or frailty, 3. Neurological conditions, including stroke and dementia and demyelinating conditions, 4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease, 5. Heart failure, coronary artery disease, cardiomyopathies, 6. Obesity (BMI greater than 30 kg/m 2), 7. Diabetes type I or II, requiring medication for glycaemic control, 8. Renal impairment (eGFR less than 60mL/min), 9. Cirrhosis, or 10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above. Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records. For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell. Access to this drug through this restriction is permitted irrespective of vaccination status. Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record. Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record. This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. | Compliance with Authority Required procedures - Streamlined Authority Code 16156 |
C16158 | P16158 | CN16158 | Dapagliflozin with metformin Empagliflozin with metformin | Diabetes mellitus type 2 Patient must have cardiovascular disease; OR Patient must be at high risk of a cardiovascular event; OR Patient must identify as Aboriginal or Torres Strait Islander. Patient must not be undergoing concomitant PBS-subsidised treatment for this condition with any of: (i) a GLP-1 receptor agonist, (ii) another SGLT2 inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 16158 |
C16162 | P16162 | CN16162 | Dapagliflozin with metformin Empagliflozin with metformin | Diabetes mellitus type 2 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have cardiovascular disease; OR Patient must be at high risk of a cardiovascular event; OR Patient must identify as Aboriginal or Torres Strait Islander. Patient must not be undergoing concomitant PBS-subsidised treatment for this condition with any of: (i) a GLP-1 receptor agonist, (ii) another SGLT2 inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 16162 |
C16164 | P16164 | CN16164 | Dapagliflozin Empagliflozin | Diabetes mellitus type 2 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must be in combination with metformin; unless contraindicated/intolerant; AND Patient must have cardiovascular disease; OR Patient must be at high risk of a cardiovascular event; OR Patient must identify as Aboriginal or Torres Strait Islander. Patient must not be undergoing concomitant PBS-subsidised treatment for this condition with any of: (i) a GLP-1 receptor agonist, (ii) another SGLT2 inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 16164 |
C16166 | P16166 | CN16166 | Testosterone | Androgen deficiency Patient must have an established pituitary or testicular disorder. Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The treatment must be applied to the scrotum, where possible. The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C16180 | P16180 | CN16180 | Belzutifan | Von Hippel-Lindau (VHL) disease Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same tumour type; AND Patient must not have developed VHL-associated metastatic disease; AND Patient must have demonstrated clinical improvement or stabilisation of the condition while being treated with this drug, the details of which must be kept with the patient's record; AND The treatment must be the sole PBS-subsidised therapy for VHL disease associated tumours. Must be treated by a physician with expertise in the management of VHL disease associated tumours. Patients who cease therapy for reasons other than, clinical disease progression or metastasis, may re-initiate PBS-subsidised treatment through the initiating or recommencing treatment phase. For the purpose of administering this restriction, clinical improvement or stabilisation of the patient's condition includes but is not limited to: (i) avoidance of surgery; (ii) avoidance of renal replacement therapy such as dialysis or renal transplantation in patients with VHL- associated renal cell carcinoma (RCC); (iii) experiencing clinical benefit in at least one of the VHL associated conditions, as determined by the treating clinician(s). | Compliance with Authority Required procedures |
C16186 | P16186 | CN16186 | Testosterone | Androgen deficiency The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have an established pituitary or testicular disorder. Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The treatment must be applied to the scrotum, where possible. The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C16187 | P16187 | CN16187 | Daunorubicin with cytarabine | Acute Myeloid Leukaemia Induction therapy Patient must not have received prior chemotherapy as induction therapy for this condition; AND The condition must be either: (i) newly diagnosed therapy-related acute myeloid leukaemia (AML), (ii) newly diagnosed AML with myelodysplasia-related changes (MRC) (prior myelodysplastic syndromes (MDS) or MDS-related cytogenetic or molecular abnormality); AND The condition must not be either: (i) internal tandem duplication (ITD); (ii) tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3), mutation positive; AND Patient must not have favourable cytogenetic risk acute myeloid leukaemia (AML); AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND The treatment must not exceed two cycles of induction therapy under this restriction. This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting. The prescriber must confirm whether the patient has newly diagnosed therapy-related AML or AML-MRC. The test result and date of testing must be provided at the time of application and documented in the patient's file. The prescribed dose must be according to the Therapeutic Goods Administration (TGA) Product Information. Each prescription must include the amount of daunorubicin with cytarabine (Vyxeos) that is appropriate to be prescribed for the patient. For the purposes of the authority application, the maximum amount requested is based on the daunorubicin dose only. The prescribed amount of daunorubicin must be expressed in milligrams. | Compliance with Authority Required procedures |
C16190 | P16190 | CN16190 | Molnupiravir | SARS-CoV-2 infection The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND Patient must have received a positive nucleic acid test result; OR Patient must have received a positive rapid antigen test (RAT) result; AND Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND The treatment must be initiated within 5 days of symptom onset; OR The treatment must be initiated as soon as possible after a diagnosis is confirmed where asymptomatic. Patient must be at least 70 years of age. Access to this drug through this restriction is permitted irrespective of vaccination status. Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record. Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record. This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. For the purpose of administering this restriction, the contraindications to nirmatrelvir (&) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid. Details/reasons of contraindications to nirmatrelvir (&) ritonavir must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 16190 |
C16191 | P16191 | CN16191 | Molnupiravir | SARS-CoV-2 infection The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND Patient must have received a positive nucleic acid test result; OR Patient must have received a positive rapid antigen test (RAT) result; AND Patient must have at least one sign or symptom attributable to COVID-19; AND Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND Patient must satisfy at least one of the following criteria: (i) be moderately to severely immunocompromised with risk of progression to severe COVID-19 disease due to the immunocompromised status, (ii) has experienced past COVID-19 infection resulting in hospitalisation; AND The treatment must be initiated within 5 days of symptom onset. Patient must be at least 18 years of age. For the purpose of administering this restriction, 'moderately to severely immunocompromised' patients are those with: 1. Any primary or acquired immunodeficiency including: a. Haematologic neoplasms: leukaemias, lymphomas, myelodysplastic syndromes, multiple myeloma and other plasma cell disorders, b. Post-transplant: solid organ (on immunosuppressive therapy), haematopoietic stem cell transplant (within 24 months), c. Immunocompromised due to primary or acquired (HIV/AIDS) immunodeficiency; OR 2. Any significantly immunocompromising condition(s) where, in the last 3 months the patient has received: a. Chemotherapy or whole body radiotherapy, b. High-dose corticosteroids (at least 20 mg of prednisone per day, or equivalent) for at least 14 days in a month, or pulse corticosteroid therapy, c. Biological agents and other treatments that deplete or inhibit B cell or T cell function (abatacept, anti-CD20 antibodies, BTK inhibitors, JAK inhibitors, sphingosine 1-phosphate receptor modulators, anti-CD52 antibodies, anti-complement antibodies, anti-thymocyte globulin), d. Selected conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) including mycophenolate, methotrexate, leflunomide, azathioprine, 6-mercaptopurine (at least 1.5mg/kg/day), alkylating agents (e.g. cyclophosphamide, chlorambucil), and systemic calcineurin inhibitors (e.g. cyclosporin, tacrolimus); OR 3. Any significantly immunocompromising condition(s) where, in the last 12 months the patient has received an anti-CD20 monoclonal antibody treatment, but criterion 2c above is not met; OR 4. Others with very high-risk conditions including Down Syndrome, cerebral palsy, congenital heart disease, thalassemia, sickle cell disease and other haemoglobinopathies; OR 5. People with disability with multiple comorbidities and/or frailty. Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell. Access to this drug through this restriction is permitted irrespective of vaccination status. Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record. Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record. This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. For the purpose of administering this restriction, the contraindications to nirmatrelvir (&) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid. Details/reasons of contraindications to nirmatrelvir (&) ritonavir must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 16191 |
C16192 | P16192 | CN16192 | Nirmatrelvir and ritonavir | SARS-CoV-2 infection Patient must have received a positive nucleic acid test result; OR Patient must have received a positive rapid antigen test (RAT) result; AND Patient must have at least one sign or symptom attributable to COVID-19; AND Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND The treatment must be initiated within 5 days of symptom onset. Patient must be each of: (i) identify as Aboriginal or Torres Strait Islander, (ii) at least 30 years of age, (iii) at high risk. For the purpose of administering this restriction, high risk is defined as the presence of at least one of the following conditions: 1. The patient is in residential aged care 2. The patient has disability with multiple comorbidities and/or frailty 3. Neurological conditions, including stroke and dementia and demyelinating conditions 4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease 5. Heart failure, coronary artery disease, cardiomyopathies 6. Obesity (BMI greater than 30 kg/m 2) 7. Diabetes type I or II, requiring medication for glycaemic control 8. Renal impairment (eGFR less than 60mL/min) 9. Cirrhosis 10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above 11. Past COVID-19 infection episode resulting in hospitalisation. Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records. For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell. Access to this drug through this restriction is permitted irrespective of vaccination status. Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record. Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record. This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. | Compliance with Authority Required procedures - Streamlined Authority Code 16192 |
C16194 | P16194 | CN16194 | Testosterone | Constitutional delay of growth or puberty Patient must be under 18 years of age. Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The treatment must be applied to the scrotum, where possible. The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C16195 | P16195 | CN16195 | Testosterone | Constitutional delay of growth or puberty The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. Patient must be under 18 years of age. Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The treatment must be applied to the scrotum, where possible. The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C16197 | P16197 | CN16197 | Daunorubicin with cytarabine | Acute Myeloid Leukaemia Consolidation therapy The treatment must be for consolidation treatment following induction treatment with this product; AND The condition must be either: (i) newly diagnosed therapy-related acute myeloid leukaemia (AML), (ii) newly diagnosed AML with myelodysplasia-related changes (MRC) (prior myelodysplastic syndromes (MDS) or MDS-related cytogenetic or molecular abnormality); AND The treatment must not exceed two cycles of consolidation therapy under this restriction. This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting. The prescribed dose must be according to the Therapeutic Goods Administration (TGA) Product Information. Each prescription must include the amount of daunorubicin with cytarabine (Vyxeos) that is appropriate to be prescribed for the patient. For the purposes of the authority application, the maximum amount requested is based on the daunorubicin dose only. The prescribed amount of daunorubicin must be expressed in milligrams. | Compliance with Authority Required procedures |
C16200 | P16200 | CN16200 | Molnupiravir | SARS-CoV-2 infection The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND Patient must have received a positive nucleic acid test result; OR Patient must have received a positive rapid antigen test (RAT) result; AND Patient must have at least one sign or symptom attributable to COVID-19; AND Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND The treatment must be initiated within 5 days of symptom onset. Patient must be each of: (i) identify as Aboriginal or Torres Strait Islander, (ii) at least 30 years of age, (iii) at high risk. For the purpose of administering this restriction, high risk is defined as the presence of at least one of the following conditions: 1. The patient is in residential aged care 2. The patient has disability with multiple comorbidities and/or frailty 3. Neurological conditions, including stroke and dementia and demyelinating conditions 4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease 5. Heart failure, coronary artery disease, cardiomyopathies 6. Obesity (BMI greater than 30 kg/m 2) 7. Diabetes type I or II, requiring medication for glycaemic control 8. Renal impairment (eGFR less than 60mL/min) 9. Cirrhosis 10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above 11. Past COVID-19 infection episode resulting in hospitalisation. Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records. For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell. Access to this drug through this restriction is permitted irrespective of vaccination status. Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record. Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record. This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. For the purpose of administering this restriction, the contraindications to nirmatrelvir (&) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid. Details/reasons of contraindications to nirmatrelvir (&) ritonavir must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 16200 |
C16201 | P16201 | CN16201 | Molnupiravir | SARS-CoV-2 infection The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND Patient must have received a positive nucleic acid test result; OR Patient must have received a positive rapid antigen test (RAT) result; AND Patient must have at least one sign or symptom attributable to COVID-19; AND Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND The treatment must be initiated within 5 days of symptom onset. Patient must be both: (i) at least 50 years of age, (ii) at high risk. For the purpose of administering this restriction, high risk is defined as either a past COVID-19 infection episode resulting in hospitalisation, or the presence of at least two of the following conditions: 1. The patient is in residential aged care, 2. The patient has disability with multiple comorbidities and/or frailty, 3. Neurological conditions, including stroke and dementia and demyelinating conditions, 4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease, 5. Heart failure, coronary artery disease, cardiomyopathies, 6. Obesity (BMI greater than 30 kg/m 2), 7. Diabetes type I or II, requiring medication for glycaemic control, 8. Renal impairment (eGFR less than 60mL/min), 9. Cirrhosis, or 10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above. Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records. For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell. Access to this drug through this restriction is permitted irrespective of vaccination status. Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record. Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record. This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. For the purpose of administering this restriction, the contraindications to nirmatrelvir (&) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid. Details/reasons of contraindications to nirmatrelvir (&) ritonavir must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 16201 |
C16204 | P16204 | CN16204 | Testosterone | Micropenis Patient must be under 18 years of age. Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The treatment must be applied to the scrotum, where possible. The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C16206 | P16206 | CN16206 | Testosterone | Micropenis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. Patient must be under 18 years of age. Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The treatment must be applied to the scrotum, where possible. The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C16207 | P16207 | CN16207 | Testosterone | Pubertal induction The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. Patient must be under 18 years of age. Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The treatment must be applied to the scrotum, where possible. The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C16211 | P16211 | CN16211 | Testosterone | Androgen deficiency Patient must not have an established pituitary or testicular disorder; AND The condition must not be due to age, obesity, cardiovascular diseases, infertility or drugs. Patient must be aged 40 years or older. Must be treated by a specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The treatment must be applied to the scrotum, where possible. Androgen deficiency is defined as: (i) testosterone level of less than 6 nmol per litre; OR (ii) testosterone level between 6 and 15 nmol per litre with high luteinising hormone (LH) (greater than 1.5 times the upper limit of the eugonodal reference range for young men, or greater than 14 IU per litre, whichever is higher). Androgen deficiency must be confirmed by at least two morning blood samples taken on different mornings. The dates and levels of the qualifying testosterone and LH measurements must be, or must have been provided in the authority application when treatment with this drug is or was initiated. The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C16212 | P16212 | CN16212 | Testosterone | Pubertal induction Patient must be under 18 years of age. Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The treatment must be applied to the scrotum, where possible. The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C16214 | P16214 | CN16214 | Testosterone | Androgen deficiency The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must not have an established pituitary or testicular disorder; AND The condition must not be due to age, obesity, cardiovascular diseases, infertility or drugs. Patient must be aged 40 years or older. Must be treated by a specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The treatment must be applied to the scrotum, where possible. Androgen deficiency is defined as: (i) testosterone level of less than 6 nmol per litre; OR (ii) testosterone level between 6 and 15 nmol per litre with high luteinising hormone (LH) (greater than 1.5 times the upper limit of the eugonodal reference range for young men, or greater than 14 IU per litre, whichever is higher). Androgen deficiency must be confirmed by at least two morning blood samples taken on different mornings. The dates and levels of the qualifying testosterone and LH measurements must be, or must have been provided in the authority application when treatment with this drug is or was initiated. The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C16215 | P16215 | CN16215 | Belzutifan | Von Hippel-Lindau (VHL) disease Initiating or recommencing treatment The condition must have been diagnosed by at least one of: (i) a germline VHL alteration; (ii) at least two manifestations highly characteristic of VHL disease; (iii) at least one manifestation highly characteristic of VHL disease with a documented family history of VHL; AND The condition must be at least one of: (i) VHL-associated non-metastatic renal cell carcinoma (RCC); (ii) VHL-associated central nervous system (CNS) haemangioblastoma; (iii) VHL-associated non-metastatic pancreatic neuroendocrine tumour (pNET); AND Patient must not have tumour(s) that require immediate surgery as assessed by the treating clinician; AND Patient must be untreated with this drug for this condition; OR Patient must have previously received PBS-subsidised treatment with this drug for this condition for a different tumour type; OR Patient must have previously received PBS-subsidised treatment with this drug for this condition and ceased previous treatment for family planning purposes; AND Patient must have WHO performance status no higher than 1; OR The condition must be VHL-associated brainstem tumour(s), or brain herniation, which temporarily affected the patient's WHO performance status to be higher than 1; AND The treatment must be the sole PBS-subsidised therapy for VHL disease associated tumours. Must be treated by a physician with expertise in the management of VHL disease associated tumours. Patients who cease therapy for reasons other than, clinical disease progression or metastasis, may re-initiate PBS-subsidised treatment through the initiating or recommencing treatment phase. For the purpose of administering this restriction, the highly characteristic manifestations of VHL disease include but not limited to: (i) retinal, spinal, or cerebellar haemangioblastoma; (ii) adrenal or extra-adrenal phaeochromocytoma; (iii) renal cell carcinoma; (iv) multiple renal and pancreatic cysts; (v) endolymphatic sac tumours, papillary cystadenomas of the epididymis or broad ligament, or pancreatic neuroendocrine tumours. | Compliance with Authority Required procedures |
C16220 | P16220 | CN16220 | Dapagliflozin Empagliflozin | Diabetes mellitus type 2 The treatment must be in combination with metformin; unless contraindicated/intolerant; AND Patient must have cardiovascular disease; OR Patient must be at high risk of a cardiovascular event; OR Patient must identify as Aboriginal or Torres Strait Islander. Patient must not be undergoing concomitant PBS-subsidised treatment for this condition with any of: (i) a GLP-1 receptor agonist, (ii) another SGLT2 inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 16220 |
C16222 | P16222 | CN16222 | Dienogest | Endometriosis | Compliance with Authority Required procedures - Streamlined Authority Code 16222 |
C16223 | P16223 | CN16223 | Nirmatrelvir and ritonavir | SARS-CoV-2 infection Patient must have received a positive nucleic acid test result; OR Patient must have received a positive rapid antigen test (RAT) result; AND Patient must have at least one sign or symptom attributable to COVID-19; AND Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND Patient must satisfy at least one of the following criteria: (i) be moderately to severely immunocompromised with risk of progression to severe COVID-19 disease due to the immunocompromised status, (ii) has experienced past COVID-19 infection resulting in hospitalisation; AND The treatment must be initiated within 5 days of symptom onset. Patient must be at least 18 years of age. For the purpose of administering this restriction, 'moderately to severely immunocompromised' patients are those with: 1. Any primary or acquired immunodeficiency including: a. Haematologic neoplasms: leukaemias, lymphomas, myelodysplastic syndromes, multiple myeloma and other plasma cell disorders, b. Post-transplant: solid organ (on immunosuppressive therapy), haematopoietic stem cell transplant (within 24 months), c. Immunocompromised due to primary or acquired (HIV/AIDS) immunodeficiency; OR 2. Any significantly immunocompromising condition(s) where, in the last 3 months the patient has received: a. Chemotherapy or whole body radiotherapy, b. High-dose corticosteroids (at least 20 mg of prednisone per day, or equivalent) for at least 14 days in a month, or pulse corticosteroid therapy, c. Biological agents and other treatments that deplete or inhibit B cell or T cell function (abatacept, anti-CD20 antibodies, BTK inhibitors, JAK inhibitors, sphingosine 1-phosphate receptor modulators, anti-CD52 antibodies, anti-complement antibodies, anti-thymocyte globulin), d. Selected conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) including mycophenolate, methotrexate, leflunomide, azathioprine, 6-mercaptopurine (at least 1.5mg/kg/day), alkylating agents (e.g. cyclophosphamide, chlorambucil), and systemic calcineurin inhibitors (e.g. cyclosporin, tacrolimus); OR 3. Any significantly immunocompromising condition(s) where, in the last 12 months the patient has received an anti-CD20 monoclonal antibody treatment, but criterion 2c above is not met; OR 4. Others with very high-risk conditions including Down Syndrome, cerebral palsy, congenital heart disease, thalassemia, sickle cell disease and other haemoglobinopathies; OR 5. People with disability with multiple comorbidities and/or frailty. Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell. Access to this drug through this restriction is permitted irrespective of vaccination status. Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record. Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record. This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. | Compliance with Authority Required procedures - Streamlined Authority Code 16223 |
C16231 | P16231 | CN16231 | Risperidone | Schizophrenia For a patient switching from oral risperidone, the prescriber must determine the patient dosage of this drug based on the current dose of oral risperidone according to the dose transition table in the Therapeutic Goods Administration (TGA) approved Product Information. | Compliance with Authority Required procedures - Streamlined Authority Code 16231 |
C16238 | P16238 | CN16238 | Imatinib | Acute lymphoblastic leukaemia Induction and Consolidation therapy Patient must be newly diagnosed; AND The condition must be expressing the Philadelphia chromosome; or The condition must have the transcript BCR-ABL; AND The treatment must be in combination with chemotherapy or corticosteroids; AND Patient must not have previously experienced a failure to respond to PBS-subsidised first-line treatment with this drug for this condition. or Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with dasatinib as a first-line therapy for this condition. A pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient's medical records. | Compliance with Authority Required procedures |
C16261 | P16261 | CN16261 | Enoxaparin Labetalol Levothyroxine Metformin | For prescribing by certain health practitioners Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife who is each of: (a) sharing patient care with a medical practitioner for the current pregnancy episode, (b) continuing existing treatment with this drug that was initiated by a medical practitioner. | |
C16269 | P16269 | CN16269 | Hydroxocobalamin | Anaemias associated with vitamin B12 deficiency Patient must have had a gastrectomy; AND The treatment must be for prophylaxis; Patient must identify as Aboriginal or Torres Strait Islander; Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife where patient care is being shared with a medical practitioner. | |
C16270 | P16270 | CN16270 | Selpercatinib | Locally advanced or metastatic non-small cell lung cancer The condition must have evidence of rearranged during transfection (RET) gene fusion in tumour material - this evidence has been obtained prior to commencing treatment with this drug; AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 at treatment initiation; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND Patient must be initiating treatment with this drug. or Patient must be continuing treatment with this drug, with an absence of further disease progression while being treated with this drug. Medical practitioners must prescribe the appropriate quantities of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks per dispensing, according to the specified dosage in the approved Therapeutic Goods Administration (TGA) Product Information (PI). A separate authority prescription form must be completed for each strength requested. | Compliance with Authority Required procedures - Streamlined Authority Code 16270 |
C16273 | P16273 | CN16273 | Methyldopa | Hypertension Patient must be pregnant; Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, an endorsed midwife who is each of: (a) sharing patient care with a medical practitioner for the current pregnancy episode, (b) continuing existing treatment with this drug that was initiated by a medical practitioner. | Compliance with Authority Required procedures |
C16276 | P16276 | CN16276 | Oxycodone Tramadol | Severe pain The treatment must be for short term therapy of acute severe pain; AND Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; or Patient must be unable to use non-opioid analgesics due to contraindications or intolerance; AND Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife who is sharing the post-operative care of the patient with a medical practitioner. | |
C16279 | P16279 | CN16279 | Temazepam | For prescribing by certain health practitioners Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife where patient care is being shared with a medical practitioner. | |
C16282 | P16282 | CN16282 | Selpercatinib | Locally advanced or metastatic non-small cell lung cancer The condition must have evidence of rearranged during transfection (RET) gene fusion in tumour material - this evidence has been obtained prior to commencing treatment with this drug; AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 at treatment initiation; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND Patient must be initiating treatment with this drug. or Patient must be continuing treatment with this drug, with an absence of further disease progression while being treated with this drug. Medical practitioners must prescribe the appropriate quantities of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks per dispensing, according to the specified dosage in the approved Therapeutic Goods Administration (TGA) Product Information (PI). A separate authority prescription form must be completed for each strength requested. Medical practitioners may prescribe selpercatinib 80 mg with a quantity of up to 56 units where the dose does not exceed 120 mg twice daily (i.e., in combination with selpercatinib 40 mg). Selpercatinib 80 mg with a quantity of 112 units must be prescribed only where the dose is 160 mg twice daily to provide 28 days of treatment per dispensing. Prescribers should refer to the TGA PI for dosing and dose adjustments regimens. | Compliance with Authority Required procedures - Streamlined Authority Code 16282 |
C16288 | P16288 | CN16288 | Hydroxocobalamin | Pernicious anaemia Patient must identify as Aboriginal or Torres Strait Islander; Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife where patient care is being shared with a medical practitioner. | |
C16289 | P16289 | CN16289 | Hydroxocobalamin | Proven vitamin B12 deficiencies other than pernicious anaemia Patient must identify as Aboriginal or Torres Strait Islander; Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife where patient care is being shared with a medical practitioner. | |
C16294 | P16294 | CN16294 | Evolocumab | Familial heterozygous hypercholesterolaemia Initial treatment The treatment must be in conjunction with dietary therapy and exercise; AND The condition must have been confirmed by genetic testing; OR The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 6; AND Patient must have an LDL cholesterol level in excess of 1.8 millimoles per litre in the presence of symptomatic atherosclerotic cardiovascular disease; OR Patient must have an LDL cholesterol level in excess of 5 millimoles per litre; AND Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; OR Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; OR Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise; OR Patient must have developed clinically important product-related adverse event/contraindication as defined in the TGA approved Product Information necessitating withdrawal of ezetimibe; AND Patient must not be receiving concomitant PBS-subsidised treatment with any of: (i) another monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9), (ii) inclisiran, for this PBS indication. Must be treated by a specialist physician; OR Must be treated by an authorised prescriber in consultation with a specialist physician. Symptomatic atherosclerotic cardiovascular disease is defined as: (i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or (ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or (iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)). The qualifying LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be documented in the patient's medical records and must be no more than 8 weeks old. A clinically important product-related adverse event is defined as follows: (i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or (ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or (iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin. If treatment with atorvastatin or rosuvastatin results in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must be treated with the alternative statin (atorvastatin or rosuvastatin) unless there is a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should occur after a washout period of at least 4 weeks, or if the creatine kinase (CK) level is elevated, retrial should not occur until CK has returned to normal. In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved. The following must be documented in the patient's medical records: (i) the qualifying Dutch Lipid Clinic Network Score; or (ii) the result of genetic testing confirming a diagnosis of familial heterozygous hypercholesterolaemia One of the following must be documented in the patient's medical records regarding prior statin treatment: (i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or (ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or (iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information. Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre. | Compliance with Authority Required procedures - Streamlined Authority Code 16294 |
C16295 | P16295 | CN16295 | Inclisiran | Familial heterozygous hypercholesterolaemia Initial treatment The treatment must be in conjunction with dietary therapy and exercise; AND The condition must have been confirmed by genetic testing; OR The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 6; AND Patient must have an LDL cholesterol level in excess of 1.8 millimoles per litre in the presence of symptomatic atherosclerotic cardiovascular disease; OR Patient must have an LDL cholesterol level in excess of 5 millimoles per litre; AND Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; OR Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; OR Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise; OR Patient must have developed clinically important product-related adverse event/contraindication as defined in the TGA approved Product Information necessitating withdrawal of ezetimibe; AND Patient must not be receiving concomitant PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication. Must be treated by a specialist physician; OR Must be treated by an authorised prescriber in consultation with a specialist physician. Symptomatic atherosclerotic cardiovascular disease is defined as: (i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or (ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or (iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)). The qualifying LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be documented in the patient's medical records and must be no more than 8 weeks old. A clinically important product-related adverse event is defined as follows: (i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or (ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or (iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin. If treatment with atorvastatin or rosuvastatin results in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must be treated with the alternative statin (atorvastatin or rosuvastatin) unless there is a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should occur after a washout period of at least 4 weeks, or if the creatine kinase (CK) level is elevated, retrial should not occur until CK has returned to normal. In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved. The following must be documented in the patient's medical records: (i) the qualifying Dutch Lipid Clinic Network Score; or (ii) the result of genetic testing confirming a diagnosis of familial heterozygous hypercholesterolaemia One of the following must be documented in the patient's medical records regarding prior statin treatment: (i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or (ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or (iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information. Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre. | Compliance with Authority Required procedures - Streamlined Authority Code 16295 |
C16297 | P16297 | CN16297 | Glatiramer Interferon beta-1b Peginterferon beta-1a | Multiple sclerosis Continuing treatment The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not show continuing progression of disability while on treatment with this drug; AND Patient must have demonstrated compliance with, and an ability to tolerate this therapy. Must be treated by a medical practitioner; OR Must be treated by a nurse practitioner in consultation with a specialist physician. | Compliance with Authority Required procedures - Streamlined Authority Code 16297 |
C16299 | P16299 | CN16299 | Cladribine | Relapsing remitting multiple sclerosis Continuing treatment The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; AND The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not show continuing progression of disability while on treatment with this drug; AND Patient must have demonstrated compliance with, and an ability to tolerate, this therapy. Must be treated by a medical practitioner; OR Must be treated by a nurse practitioner in consultation with a specialist physician. The prescriber should request authority approval for the appropriate combination of packs (1, 4 or 6 tablets) to provide sufficient drug for a treatment week based on the weight of the patient in accordance with the TGA approved Product Information. Separate authority prescriptions may be required where the dose for treatment week 5 is different to the dose for treatment week 1. | Compliance with Authority Required procedures - Streamlined Authority Code 16299 |
C16301 | P16301 | CN16301 | Fingolimod Ofatumumab Ozanimod | Multiple sclerosis Continuing treatment The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not show continuing progression of disability while on treatment with this drug; AND Patient must have demonstrated compliance with, and an ability to tolerate this therapy. Must be treated by a medical practitioner; OR Must be treated by a nurse practitioner in consultation with a specialist physician. | Compliance with Authority Required procedures - Streamlined Authority Code 16301 |
C16303 | P16303 | CN16303 | Siponimod | Multiple sclerosis Continuing treatment (including recommencement of treatment) The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not show continuing progression of disability while on treatment with this drug; AND Patient must be ambulatory, with/without assistance/support; AND Patient must have demonstrated compliance with, and an ability to tolerate this therapy. Must be treated by a medical practitioner; OR Must be treated by a nurse practitioner in consultation with a specialist physician. | Compliance with Authority Required procedures - Streamlined Authority Code 16303 |
C16306 | P16306 | CN16306 | Osilodrostat | Endogenous Cushing's syndrome Initial treatment The condition must be at least one of: (i) persistent hypercortisolism after surgery, (ii) recurrent hypercortisolism after surgery, (iii) inappropriate for surgery; AND Patient must have active endogenous Cushing's Syndrome determined by a mean urinary free cortisol (UFC) level greater than 1.3 times the upper limit of normal (ULN); OR Patient must have undergone treatment for this condition with conventional therapies to control cortisol production resulting in an improved UFC level prior to applying for the initial authority application of this drug. Must be treated by an endocrinologist. Patient must be at least 18 years of age. For the purposes of administering this restriction, the mean UFC is the average of at least two values being 1.3 times greater than the ULN. Patient must undergo a dose titration period whereby responses must be assessed every 1-2 weeks until the mean UFC levels are within the normal range. At the time of authority application, medical practitioners must request the appropriate number of packs to provide sufficient drug, based on the prescribed dose of the patient, for 4 weeks of treatment. A separate authority prescription form must be completed for each strength requested. The dose must not exceed 30 mg twice daily. Up to a maximum of 6 repeats will be authorised. Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the dose is changing), mark the prescription that is intended for no further supply as 'Cancelled'. The condition is inappropriate for surgery if the patient: (i) has a medical contraindication for surgery; (ii) has inoperable tumours; (iii) has been determined that surgery is unlikely to reduce hypercortisolism; (iv) refuses surgery; (v) cannot access surgical treatment. | Compliance with Authority Required procedures |
C16309 | P16309 | CN16309 | Faricimab | Central retinal vein occlusion with macular oedema Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND The condition must be diagnosed by optical coherence tomography; OR The condition must be diagnosed by fluorescein angiography; AND The treatment must be the sole PBS-subsidised therapy for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include: (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report. If the application is submitted through HPOS form upload or mail, it must include: (a) details of the proposed prescription; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
C16315 | P16315 | CN16315 | Dimethyl fumarate Diroximel fumarate Teriflunomide | Multiple sclerosis Continuing treatment The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not show continuing progression of disability while on treatment with this drug. Must be treated by a medical practitioner; OR Must be treated by a nurse practitioner in consultation with a specialist physician. Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 16315 |
C16317 | P16317 | CN16317 | Osilodrostat | Endogenous Cushing's syndrome Continuing treatment Patient must have received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated a complete response after at least 26 weeks of treatment with this drug; OR Patient must have demonstrated a partial response after at least 26 weeks of treatment with this drug. Must be treated by an endocrinologist. Patient must be at least 18 years of age. For the purposes of administering this restriction, a complete response is defined as a mean urinary free cortisol (UFC) level of less than or equal to the upper limit of normal (ULN). A partial response is defined as mean UFC level of greater than ULN but with at least 50% reduction from the baseline value. The mean UFC should be the average of at least two urine samples. At the time of authority application, medical practitioners must request the appropriate number of packs to provide sufficient drug, based on the prescribed dose of the patient, for 4 weeks of treatment. A separate authority prescription form must be completed for each strength requested. The dose must not exceed 30 mg twice daily. Up to a maximum of 5 repeats will be authorised. Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the dose is changing), mark the prescription that is intended for no further supply as 'Cancelled'. An application for the continuing treatment must be accompanied with the assessment of response conducted after 26 weeks from the first dose of osilodrostat and no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for patients who meet the continuing restriction for PBS-subsidised treatment. | Compliance with Authority Required procedures |
C16319 | P16319 | CN16319 | Faricimab | Branch retinal vein occlusion with macular oedema Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND The condition must be diagnosed by optical coherence tomography; OR The condition must be diagnosed by fluorescein angiography; AND The treatment must be the sole PBS-subsidised therapy for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include: (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report. If the application is submitted through HPOS form upload or mail, it must include: (a) details of the proposed prescription; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
C16320 | P16320 | CN16320 | Inclisiran | Familial heterozygous hypercholesterolaemia Continuing treatment with this drug or switching treatment from a monoclonal antibody inhibiting proprotein coverase subtilisin kexin type 9 (PSCK9) for this PBS indication Patient must have previously received PBS-subsidised treatment with this drug for this condition; OR Patient must have previously received PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication; AND The treatment must be in conjunction with dietary therapy and exercise; AND Patient must not be receiving concomitant PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication. Must be treated by a medical practitioner; OR Must be treated by a nurse practitioner in consultation with a specialist physician. | Compliance with Authority Required procedures - Streamlined Authority Code 16320 |
C16321 | P16321 | CN16321 | Glatiramer Interferon beta-1b Peginterferon beta-1a | Multiple sclerosis Initial treatment The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis, with written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND Patient must be ambulatory (without assistance or support). Must be treated by a medical practitioner; OR Must be treated by a nurse practitioner in consultation with a specialist physician. Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 16321 |
C16323 | P16323 | CN16323 | Dimethyl fumarate Diroximel fumarate Fingolimod Ofatumumab Ozanimod Teriflunomide | Multiple sclerosis Initial treatment The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND Patient must be ambulatory (without assistance or support). Must be treated by a medical practitioner; OR Must be treated by a nurse practitioner in consultation with a specialist physician. Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 16323 |
C16325 | P16325 | CN16325 | Fingolimod | Multiple sclerosis Initial treatment The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND Patient must be ambulatory (without assistance or support). Must be treated by a medical practitioner; OR Must be treated by a nurse practitioner in consultation with a specialist physician. Patient must weigh 40 kg or less. Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 16325 |
C16331 | P16331 | CN16331 | Inclisiran | Non-familial hypercholesterolaemia Initial treatment The treatment must be in conjunction with dietary therapy and exercise; AND Patient must have symptomatic atherosclerotic cardiovascular disease; AND Patient must have an LDL cholesterol level in excess of 1.8 millimoles per litre; AND Patient must have atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); OR Patient must have severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; OR Patient must have had at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; OR Patient must have diabetes mellitus with microalbuminuria; OR Patient must have diabetes mellitus and be aged 60 years or more; OR Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus; OR Patient must have a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher; AND Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; OR Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; OR Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise; OR Patient must have developed clinically important product-related adverse event/contraindication as defined in the TGA approved Product Information necessitating withdrawal of ezetimibe; AND Patient must not be receiving concomitant PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication. Must be treated by a specialist physician; OR Must be treated by an authorised prescriber in consultation with a specialist physician. Symptomatic atherosclerotic cardiovascular disease is defined as: (i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or (ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or (iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)). The qualifying LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be documented in the patient's medical records and must be no more than 8 weeks old. A clinically important product-related adverse event is defined as follows: (i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or (ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or (iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin. If treatment with atorvastatin or rosuvastatin results in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must be treated with the alternative statin (atorvastatin or rosuvastatin) unless there is a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should occur after a washout period of at least 4 weeks, or if the creatine kinase (CK) level is elevated, retrial should not occur until CK has returned to normal. In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved. One of the following must be documented in the patient's medical records regarding prior statin treatment: (i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or (ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or (iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information. One or more of the following must be documented in the patient's medical records regarding the presence of cardiovascular disease or high risk of experiencing a cardiovascular event: (i) atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); or (ii) severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; or (iii) history of at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; or (iv) diabetes mellitus with microalbuminuria; or (v) diabetes mellitus and age 60 years or more; or (vi) Aboriginal or Torres Strait Islander with diabetes mellitus; or (vii) a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher. Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre. | Compliance with Authority Required procedures - Streamlined Authority Code 16331 |
C16336 | P16336 | CN16336 | Evolocumab | Non-familial hypercholesterolaemia Continuing treatment with this drug or switching treatment from any of: (i) another drug that belongs to the same pharmacological class as this drug, (ii) inclisiran Patient must have previously received PBS-subsidised treatment with this drug for this condition; OR Patient must have received PBS-subsidised treatment for this PBS indication with any of: (i) a drug from the same pharmacological class as this drug (ii) inclisiran; AND The treatment must be in conjunction with dietary therapy and exercise; AND Patient must not be receiving concomitant PBS-subsidised treatment with any of: (i) another drug that belongs to the same pharmacological class as this drug, (ii) inclisiran, for this PBS indication. Must be treated by a medical practitioner; OR Must be treated by a nurse practitioner in consultation with a specialist physician. | Compliance with Authority Required procedures - Streamlined Authority Code 16336 |
C16338 | P16338 | CN16338 | Risankizumab | Severe psoriatic arthritis Initial treatment - Initial 1 (new patient) Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND Patient must not receive more than 28 weeks of treatment under this restriction. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. Patient must be at least 18 years of age. Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application. Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and either (a) an active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. The authority application must be made in writing and must include: (1) details of the proposed prescription; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment. 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. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
C16339 | P16339 | CN16339 | Risankizumab | Severe psoriatic arthritis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND Patient must not receive more than 28 weeks of treatment under this restriction. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. Patient must be at least 18 years of age. Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include: (1) details of the proposed prescription; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. 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. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
C16340 | P16340 | CN16340 | Risankizumab | Severe psoriatic arthritis Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply Patient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete 28 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 28 weeks treatment; OR 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 28 weeks treatment; AND The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restriction. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. | Compliance with Authority Required procedures |
C16345 | P16345 | CN16345 | Cladribine | Relapsing remitting multiple sclerosis Initial treatment The condition must be diagnosed by a neurologist; AND The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis, with written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND Patient must be ambulatory (without assistance or support). Must be treated by a medical practitioner; OR Must be treated by a nurse practitioner in consultation with a specialist physician. Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. The prescriber should write authority prescriptions for the appropriate combination of packs (1, 4 or 6 tablets) to provide sufficient drug for a treatment week based on the weight of the patient in accordance with the TGA approved Product Information. Separate authority prescriptions may be required where the dose for treatment week 5 is different to the dose for treatment week 1. | Compliance with Authority Required procedures - Streamlined Authority Code 16345 |
C16346 | P16346 | CN16346 | Fingolimod | Multiple sclerosis Continuing treatment The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not show continuing progression of disability while on treatment with this drug; AND Patient must have demonstrated compliance with, and an ability to tolerate this therapy. Patient must weigh 40 kg or less. Must be treated by a medical practitioner; OR Must be treated by a nurse practitioner in consultation with a specialist physician. | Compliance with Authority Required procedures - Streamlined Authority Code 16346 |
C16347 | P16347 | CN16347 | Siponimod | Multiple sclerosis Initial treatment The condition must be/have previously been diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of at least one of the brain/spinal cord; OR The condition must be/have previously been diagnosed as clinically definite relapsing-remitting multiple sclerosis supported by written certification, which is documented in the patient's medical records, from a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND Patient must be ambulatory, with/without assistance/support; AND Patient must have mild disability in at least 3 functional systems; OR Patient must have moderate disability in at least 1 functional system. Must be treated by a medical practitioner; OR Must be treated by a nurse practitioner in consultation with a specialist physician. Functional systems referred to in this restriction are the: visual, brain stem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral/cognitive systems. Select a dose and pack size appropriate for the patient's CYP2C9 metabolising enzyme status. | Compliance with Authority Required procedures - Streamlined Authority Code 16347 |
