Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p22
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 22/69)
Character Range: 346517–354916

PBS‑subsidised encorafenib for this condition.
C12559              P12559         Gemtuzumab ozogamicin                                                        Acute Myeloid Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                Induction treatment
                                                                                                                Patient must have confirmed CD33‑positive AML prior to initiation of treatment; AND
                                                                                                                The condition must be de novo; AND
                                                                                                                The condition must be previously untreated at the time of initiation (except for prior essential treatment with hydroxyurea or leukapheresis for patients with hyperleukocytic AML); AND
                                                                                                                Patient must have confirmed intermediate/favourable cytogenetic risk; OR
                                                                                                                Patient must have unknown cytogenetic risk due to inconclusive test results; AND
                                                                                                                Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND
                                                                                                                The condition must not be acute promyelocytic leukaemia; AND
                                                                                                                The treatment must be in combination with standard intensive remission induction chemotherapy for this condition, which must include cytarabine and an anthracycline; AND
                                                                                                                The treatment must not be used in combination with a tyrosine kinase inhibitor; AND
                                                                                                                The condition must not be internal tandem duplication (ITD) or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive; AND
                                                                                                                Patient must not receive more than 1 induction cycle under this restriction in a lifetime.
                                                                                                                This drug is not PBS‑subsidised if it is prescribed to an in‑patient in a public hospital setting.
C12566              P12566         Gemtuzumab ozogamicin                                                        Acute Myeloid Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                Consolidation treatment
                                                                                                                Patient must have achieved a complete remission following induction treatment with this drug for this condition; AND
                                                                                                                The treatment must be in combination with standard intensive remission consolidation chemotherapy for this condition, which must include cytarabine and an anthracycline; AND
                                                                                                                Patient must not receive more than 2 consolidation cycles under this restriction in a lifetime.
                                                                                                                This drug is not PBS‑subsidised if it is prescribed to an in‑patient in a public hospital setting.
                                                                                                                A patient who has progressive disease when treated with this drug is no longer eligible for PBS‑subsidised treatment with this drug.
                                                                                                                Complete remission following induction is defined as fewer than 5% blasts in a normocellular marrow and an absolute neutrophil count of more than 1.0 x 109cells/L with a platelet count of 100 x 109/L or more in the peripheral blood in the absence of transfusion.
                                                                                                                Progressive disease is defined as the presence of any of the following:
                                                                                                                a) Leukaemic cells in the CSF;
                                                                                                                b) Re‑appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;
                                                                                                                c) Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;
                                                                                                                d) Extramedullary leukaemia.
C12656              P12656         Sacituzumab govitecan                                                        Unresectable locally advanced or metastatic triple‑negative breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures ‑ Streamlined Authority Code 12656
                                                                                                                Initial treatment
                                                                                                                Patient must have progressive disease following two or more prior systemic