Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p97
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 97/191)
Character Range: 10608200–10621125

eligible for PBS-subsidised treatment with this drug.
C8622               P8622          CN8622           Everolimus                                                                                                                                                                 Stage IV clear cell variant renal cell carcinoma (RCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               Patient must have progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) following prior treatment with a tyrosine kinase inhibitor; 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.
                                                                                                                                                                                                                               Patients who have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised everolimus.
                                                                                                                                                                                                                               Patients who have progressive disease with everolimus are no longer eligible for PBS-subsidised everolimus.
C8624               P8624          CN8624           Safinamide                                                                                                                                                                 Parkinson disease
                                                                                                                                                                                                                               The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination.
C8667               P8667          CN8667           Filgrastim                                                                                                                                                                 Chemotherapy-induced neutropenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 8667
                                                                                                                                                                                                                               Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
                                                                                                                                                                                                                               Patient must have had a prior episode of febrile neutropenia.  or
                                                                                                                                                                                                                               Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.
C8668               P8668          CN8668           Filgrastim                                                                                                                                                                 Mobilisation of peripheral blood progenitor cells                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 8668
                                                                                                                                                                                                                               The treatment must be in a normal volunteer for use in allogeneic transplantation.
C8669               P8669          CN8669           Filgrastim                                                                                                                                                                 Severe congenital neutropenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 8669
                                                                                                                                                                                                                               Patient must have an absolute neutrophil count of less than 100 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; AND
                                                                                                                                                                                                                               Patient must have had a bone marrow examination that has shown evidence of maturational arrest of the neutrophil lineage.
C8670               P8670          CN8670           Filgrastim                                                                                                                                                                 Severe chronic neutropenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 8670
                                                                                                                                                                                                                               Patient must have an absolute neutrophil count of less than 1,000 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; or
                                                                                                                                                                                                                               Patient must have neutrophil dysfunction; AND
                                                                                                                                                                                                                               Patient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics in the previous 12 months.  or
                                                                                                                                                                                                                               Patient must have had at least 3 recurrent clinically significant infections in the previous 12 months.
C8671               P8671          CN8671           Filgrastim                                                                                                                                                                 Assisting bone marrow transplantation                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 8671
                                                                                                                                                                                                                               Patient must be receiving marrow-ablative chemotherapy prior to the transplantation.
C8672               P8672          CN8672           Filgrastim                                                                                                                                                                 Mobilisation of peripheral blood progenitor cells                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 8672
                                                                                                                                                                                                                               The treatment must be to facilitate harvest of peripheral blood progenitor cells for autologous transplantation into a patient with a non-myeloid malignancy who has had myeloablative or