Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p145
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 145/191)
Character Range: 11004823–11017707

weeks or 480 mg every four weeks under a weight based or flat dosing regimen.
C9302               P9302          CN9302           Deferasirox                                                                                                                                                                Chronic iron overload                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 9302
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must be transfusion dependent; AND
                                                                                                                                                                                                                               Patient must not have a malignant disorder of erythropoiesis; AND
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.
C9303               P9303          CN9303           Pegfilgrastim                                                                                                                                                              Chemotherapy-induced neutropenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 9303
                                                                                                                                                                                                                               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.
C9304               P9304          CN9304           Zoledronic acid                                                                                                                                                            Bone metastases                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 9304
                                                                                                                                                                                                                               The condition must be due to castration-resistant prostate cancer.
C9312               P9312          CN9312           Nivolumab                                                                                                                                                                  Stage IV clear cell variant renal cell carcinoma (RCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures - Streamlined Authority Code 9312
                                                                                                                                                                                                                               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 progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) following prior treatment with a tyrosine kinase inhibitor; or
                                                                                                                                                                                                                               Patient must have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal; 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.
                                                                                                                                                                                                                               The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
                                                                                                                                                                                                                               Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.
C9313               P9313          CN9313           Octreotide                                                                                                                                                                 Functional carcinoid tumour                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 9313
                                                                                                                                                                                                                               Patient must have achieved symptom control on octreotide immediate release injections; 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 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
                                                                                                                                                                                                                               Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.
C9315               P9315          CN9315           Pamidronic acid                                                                                                                                                            Bone metastases                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 9315
                                                                                                                                                                                                                               The condition must be due to breast cancer.
C9317               P9317          CN9317           Zoledronic acid                                                                                                                                                            Hypercalcaemia of malignancy                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority