Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p4
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 4/161)
Character Range: 13845511–13851041

form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
C13025              P13025         CN13025          Ponatinib                      Chronic Myeloid Leukaemia (CML)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                   Initial treatment
                                                                                   The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                   Patient must have failed an adequate trial of dasatinib confirmed through a pathology report from an Approved Pathology Authority; or
                                                                                   Patient must have developed intolerance to dasatinib of a severity necessitating permanent treatment withdrawal; AND
                                                                                   Patient must have failed an adequate trial of nilotinib confirmed through a pathology report from an Approved Pathology Authority.  or
                                                                                   Patient must have developed intolerance to nilotinib of a severity necessitating permanent treatment withdrawal.  or
                                                                                   Patient must not be eligible for PBS-subsidised treatment with nilotinib because the patient has a blast crisis.
                                                                                   Failure of an adequate trial of dasatinib or nilotinib is defined as
                                                                                   1. Lack of response to dasatinib or nilotinib therapy, defined as either
                                                                                   (i) failure to achieve a haematological response after a minimum of 3 months therapy with dasatinib or nilotinib; or
                                                                                   (ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy with dasatinib or nilotinib as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or
                                                                                   (iii) 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 dasatinib or nilotinib; OR
                                                                                   2. 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 dasatinib or nilotinib therapy; OR
                                                                                   3. 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 or nilotinib therapy; OR
                                                                                   4. Development of accelerated phase or blast crisis in a patient previously prescribed dasatinib or nilotinib for any phase of chronic myeloid leukaemia; OR
                                                                                   5. 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 or nilotinib therapy in patients with accelerated phase or blast crisis 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