Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p10
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 10/69)
Character Range: 243353–252663

IV) HER2 positive breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 9353
                                                                                                                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; 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.
                                                                                                                Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.
C9369               P9369          Blinatumomab                                                                 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 3 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.
C9462               P9462          Trastuzumab                                                                  Metastatic (Stage IV) HER2 positive breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 9462
                                                                                                                Continuing treatment
                                                                                                                Patient must have previously received PBS‑subsidised treatment 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.
C9470               P9470          Inotuzumab ozogamicin                                                        Acute lymphoblastic leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Written Authority Required procedures
                                                                                                                Induction treatment
                                                                                                                The condition must be relapsed or refractory B‑precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND
                                                                                                                Patient must have received intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; AND
                                                                                                                Patient must not have received more than 1 line of salvage therapy; AND
                                                                                                                Patient must have previously received a tyrosine kinase inhibitor (TKI) if the condition is Philadelphia chromosome positive; AND
                                                                                                                The condition must be CD22‑positive; AND
                                                                                                                The condition must have more than 5% blasts in bone marrow; AND
                                                                                                                The treatment must not be more than 3 treatment cycles under this restriction in a lifetime.
                                                                                                                This drug is not PBS‑subsidised if it is administered to an in‑patient in a public hospital setting.
                                                                                                                The authority application must be made in writing and must include:
                                                                                                                (1) two completed authority prescription forms;
                                                                                                                (2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application ‑ Supporting Information Form; and
                                                                                                                (3) evidence that the condition is CD22‑positive; and
                                                                                                                (4) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy, including what line of salvage; and
                                                                                                                (5)