Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p200
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 200/381)
Character Range: 12848553–12855091

of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing dasatinib therapy; OR
                                                                                                                                                                    (iii) Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing dasatinib therapy; OR
                                                                                                                                                                    (iv) Development of accelerated phase in a patient previously prescribed dasatinib for the chronic phase of chronic myeloid leukaemia.
                                                                                                                                                                    Accelerated phase is defined by the presence of 1 or more of the following:
                                                                                                                                                                    (1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or
                                                                                                                                                                    (2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or
                                                                                                                                                                    (3) Peripheral basophils greater than or equal to 20%; or
                                                                                                                                                                    (4) Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or
                                                                                                                                                                    (5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); OR
                                                                                                                                                                    (v) Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during dasatinib therapy in patients with accelerated phase chronic myeloid leukaemia, provided that blast crisis has been excluded on bone marrow biopsy.
                                                                                                                                                                    Patients should be commenced on a dose of nilotinib of 400 mg twice daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to nilotinib therapy or a peripheral blood BCR-ABL level of less than 1% within 18 months and thereafter at 12 monthly intervals.
                                                                                                                                                                    A bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale either on peripheral blood or bone marrow must be documented in the patient's medical records.
                                                                                                                                                                    Pathology report(s) confirming a loss of response to imatinib and dasatinib, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement must be documented in the patient's medical records.
C12570              P12570         CN12570          Dasatinib                                                                                                       Chronic Myeloid Leukaemia (CML)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment - first-line therapy
                                                                                                                                                                    Patient must have a primary diagnosis of chronic myeloid leukaemia; AND
                                                                                                                                                                    The condition must be in the chronic phase; AND
                                                                                                                                                                    The condition must be expressing the