Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p197
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 197/381)
Character Range: 12826594–12834970

must have experienced intolerance, not a failure to respond, to PBS-subsidised second-line treatment with dasatinib for this condition; AND
                                                                                                                                                                    Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; or
                                                                                                                                                                    Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                                                                                    A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient's medical records.
C12565              P12565         CN12565          Dasatinib                                                                                                       Chronic Myeloid Leukaemia (CML)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 12565
                                                                                                                                                                    Continuing treatment - first-line therapy
                                                                                                                                                                    The condition must be in the chronic phase; AND
                                                                                                                                                                    Patient must have received initial PBS-subsidised treatment with this drug as a first-line therapy for this condition; or
                                                                                                                                                                    Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised first-line treatment with imatinib for this condition; or
                                                                                                                                                                    Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised first-line treatment with nilotinib for this condition; AND
                                                                                                                                                                    Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; or
                                                                                                                                                                    Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                                                                                    A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient's medical records.
C12566              P12566         CN12566          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 109 cells/L with a