Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p182
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 182/381)
Character Range: 12725206–12732854

be documented in the patient's medical records.
C12524              P12524         CN12524          Dasatinib                                                                                                       Chronic Myeloid Leukaemia (CML)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment - second-line therapy
                                                                                                                                                                    The condition must be in the chronic phase; or
                                                                                                                                                                    The condition must be in the accelerated phase; or
                                                                                                                                                                    The condition must be in the blast phase; AND
                                                                                                                                                                    Patient must not have failed PBS-subsidised treatment with this drug for this condition in the first-line setting; AND
                                                                                                                                                                    Patient must have failed an adequate trial of PBS-subsidised first-line treatment with imatinib for this condition; or
                                                                                                                                                                    Patient must have failed an adequate trial of PBS-subsidised first-line treatment with nilotinib for this condition; or
                                                                                                                                                                    Patient must have experienced intolerance, not a failure to respond, to PBS-subsidised second-line treatment with nilotinib for this condition; AND
                                                                                                                                                                    The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                                                                                    Failure of an adequate trial of imatinib or nilotinib is defined as
                                                                                                                                                                    (i) Lack of response to initial imatinib or nilotinib therapy, defined as either
                                                                                                                                                                    (ii) Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or nilotinib 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 imatinib or nilotinib therapy; OR
                                                                                                                                                                    (iv) Development of accelerated phase or blast crisis in a patient previously prescribed imatinib or nilotinib for any phase of chronic myeloid leukaemia.
                                                                                                                                                                    (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);
                                                                                                                                                                    (1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or
                                                                                                                                                                    (2) Extramedullary involvement other than spleen and liver; OR
                                                                                                                                                                    (v) Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell