Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p183
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 183/381)
Character Range: 12732288–12737873

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 count, blast count, basophils or platelets) during first-line imatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia.
                                                                                                                                                                    - failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or nilotinib for patients initially treated in chronic phase; or
                                                                                                                                                                    - failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or nilotinib for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or
                                                                                                                                                                    - failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or nilotinib; OR
                                                                                                                                                                    (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 count, blast count, basophils or platelets) during first-line imatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia.
                                                                                                                                                                    Accelerated phase is defined