Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p12
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 12/69)
Character Range: 259093–266547

factor receptor 2 (HER2) positivity as demonstrated by immunohistochemistry 2+ or more in tumour material; AND
                                                                                                                Patient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on more than 6 copies of HER2 in the same tumour tissue sample; AND
                                                                                                                Patient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on the ratio of HER2 to chromosome 17 being more than 2 in the same tumour tissue sample; AND
                                                                                                                Patient must commence treatment in combination with platinum based chemotherapy and capecitabine; OR
                                                                                                                Patient must commence treatment in combination with platinum based chemotherapy and 5 fluorouracil; AND
                                                                                                                Patient must not have previously received this drug for this condition; AND
                                                                                                                Patient must not have received prior chemotherapy for this condition; AND
                                                                                                                Patient must have a WHO performance status of 2 or less; 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.
                                                                                                                Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.
C9601               P9601          Inotuzumab ozogamicin                                                        Acute lymphoblastic leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures
                                                                                                                Consolidation treatment
                                                                                                                Patient must have previously received PBS‑subsidised induction treatment with this drug for this condition; AND
                                                                                                                Patient must have achieved a complete remission; OR
                                                                                                                Patient must have achieved a complete remission with partial haematological recovery; AND
                                                                                                                The treatment must not be more than 5 treatment cycles under this restriction in a lifetime; AND
                                                                                                                Patient must not receive PBS‑subsidised treatment with this drug if progressive disease develops while on this drug.
                                                                                                                This drug is not PBS‑subsidised if it is administered to an in‑patient in a public hospital setting.
                                                                                                                The treatment must not exceed 0.5mg per m2for all doses within a treatment cycle
                                                                                                                Treatment with this drug for this condition must not exceed 6 treatment cycles in a lifetime.
C10119              P10119         Nivolumab                                                                    Resected Stage IIIB, IIIC, IIID or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                                                Initial treatment
                                                                                                                The treatment must be adjuvant 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 receive more than 12 months of combined PBS‑subsidised and non‑PBS‑subsidised adjuvant therapy.
                                                                                                                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.
C10120              P10120         Nivolumab                                                                    Resected Stage IIIB, IIIC, IIID or Stage IV malignant