Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p267
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 267/476)
Character Range: 2498508–2509208

8 weeks ago, (ii) a subsequent trial of systemic corticosteroids at therapeutic doses has been completed.
                                                                                                                                            Patient must be undergoing treatment with this drug that is being administered within at least one of: (i) the first 12 weeks of a treatment episode, (ii) the first 25 doses (inclusive of the 25thdose) of a treatment episode; AND
                                                                                                                                            Must be treated by a haematologist; OR
                                                                                                                                            Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR
                                                                                                                                            Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; AND
                                                                                                                                            Patient must be undergoing treatment with this drug following allogeneic haematopoietic stem cell transplantation; AND
                                                                                                                                            Patient must be undergoing concurrent treatment with extracorporeal photopheresis as described in the Medicare Benefits Schedule for this condition.
Methoxy polyethylene glycol‑epoetin beta                               C6294                                                                Anaemia associated with intrinsic renal disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures ‑ Streamlined Authority Code 6294
                                                                                                                                            Patient must require transfusion; AND
                                                                                                                                            Patient must have a haemoglobin level of less than 100 g per L; AND
                                                                                                                                            Patient must have intrinsic renal disease, as assessed by a nephrologist.
                                                                       C9688                                                                Anaemia associated with intrinsic renal disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures ‑ Streamlined Authority Code 9688
                                                                                                                                            Patient must require transfusion; AND
                                                                                                                                            Patient must have a haemoglobin level of less than 100 g per L; AND
                                                                                                                                            Patient must have intrinsic renal disease, as assessed by a nephrologist.
Midostaurin                                                            C11699                                                               Acute Myeloid Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                                            Maintenance therapy ‑ Continuing treatment
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the initial maintenance treatment restriction; AND
                                                                                                                                            Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must not be undergoing or have undergone a stem cell transplant.
                                                                                                                                            A maximum of 9 cycles will be authorised under this restriction in a lifetime.
                                                                                                                                            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.
                                                                       C13001                                                               Acute Myeloid Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                                            Induction / Consolidation therapy
                                                                                                                                            Patient must not have