Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p268
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 268/476)
Character Range: 2507502–2516072

Extramedullary leukaemia.
                                                                                                                                            A patient who has progressive disease when treated with this drug is no longer eligible for PBS‑subsidised treatment with this drug.
                                                                       C13001                                                               Acute Myeloid Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                                            Induction / Consolidation therapy
                                                                                                                                            Patient must not have received prior chemotherapy as induction therapy for this condition; OR
                                                                                                                                            The treatment must be for consolidation treatment following induction treatment with midostaurin in combination with chemotherapy and the patient must not have progressive disease; AND
                                                                                                                                            The condition must be internal tandem duplication (ITD) or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition confirmed through a pathology report from an Approved Pathology Authority; AND
                                                                                                                                            The condition must not be acute promyelocytic leukaemia; AND
                                                                                                                                            The treatment must be in combination with standard intensive remission induction or consolidation chemotherapy for this condition.
                                                                                                                                            A maximum of 6 cycles will be authorised under this restriction in a lifetime.
                                                                                                                                            Standard intensive remission induction combination chemotherapy must include cytarabine and an anthracycline.
                                                                                                                                            The prescriber must confirm whether the patient has FLT3 ITD or TKD mutation. The test result and date of testing must be provided at the time of application and documented in the patient's file.
                                                                                                                                            This drug is not PBS‑subsidised if it is prescribed to an in‑patient in a public hospital setting.
                                                                                                                                            Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.
                                                                                                                                            If abnormal blood counts suggest the potential for relapsed AML, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.
                                                                                                                                            Progressive disease is defined as the presence of any of the following:
                                                                                                                                            Leukaemic cells in the CSF;
                                                                                                                                            Re‑appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;
                                                                                                                                            Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;
                                                                                                                                            Extramedullary leukaemia.
                                                                                                                                            A patient who has progressive disease when treated with this drug is no longer eligible for PBS‑subsidised treatment with this drug.
                                                                       C13013                                                               Acute Myeloid Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Written Authority Required procedures
                                                                                                                                            Maintenance therapy ‑ Initial treatment
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must have demonstrated complete remission after induction and consolidation chemotherapy in combination with midostaurin confirmed through a bone marrow biopsy pathology report; AND
                                                                                                                                            Patient must not be undergoing or have undergone a stem cell transplant; AND
                                                                                                                                            The condition must be internal tandem duplication (ITD) or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for