Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p194
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 194/381)
Character Range: 12809194–12815600

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; or
                                                                                                                                                                    Patient must not have failed PBS-subsidised treatment with this drug for this condition in the second-line setting; AND
                                                                                                                                                                    Patient must have documented failure with an adequate trial of PBS-subsidised first-line treatment with imatinib for this condition; AND
                                                                                                                                                                    Patient must have failed an adequate trial of 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 nilotinib is defined as
                                                                                                                                                                    (i) Lack of response to second line nilotinib therapy, defined as either
                                                                                                                                                                    (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 nilotinib therapy; OR
                                                                                                                                                                    (iv) Development of accelerated phase or blast crisis in a patient previously prescribed 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); OR
                                                                                                                                                                    (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 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 nilotinib for patients initially treated in chronic phase; or
                                                                                                                                                                    - failure to achieve any cytogenetic response after a minimum of 6 months therapy with nilotinib for patients initially