Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p302
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 302/312)
Character Range: 17395750–17402544

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.
C16224              P16224         CN16224          Talazoparib                                                            Castration resistant metastatic carcinoma of the prostate                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                                                           The condition must be associated with a class 4 or 5 BRCA1 or BRCA2 gene mutation; AND
                                                                                                                           Patient must not have received prior PBS-subsidised novel hormonal drug in any non-metastatic setting of prostate cancer prior to commencing treatment with this drug for this condition; AND
                                                                                                                           Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance score no higher than 1 prior to treatment initiation; AND
                                                                                                                           Patient must be undergoing concurrent treatment with enzalutamide, unless an intolerance to enzalutamide requires either a:
                                                                                                                           (i) temporary cessation, (ii) permanent discontinuation; AND
                                                                                                                           The treatment must not be a PBS-subsidised benefit beyond disease progression.