Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p6
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 6/162)
Character Range: 14687573–14693461

to 3 repeat prescriptions; AND
                                                                                                         Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime.
C13950              P13950         CN13950          Asciminib                                            Chronic Myeloid Leukaemia (CML)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures
                                                                                                         Initial PBS-subsidised treatment for patients without T315I mutation
                                                                                                         The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                         The condition must not be in the blast phase; 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 condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; or
                                                                                                         The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND
                                                                                                         Patient must have failed an adequate trial of at least two tyrosine kinase inhibitors.  or
                                                                                                         Patient must have experienced intolerance, not failure to respond, to at least two tyrosine kinase inhibitors.  or
                                                                                                         Patient must have failed an adequate trial of at least one tyrosine kinase inhibitor with intolerance to at least another tyrosine kinase inhibitor.
                                                                                                         Failure of an adequate trial of a tyrosine kinase inhibitor is defined as
                                                                                                         1. Lack of response defined as either
                                                                                                         (i) failure to achieve a haematological response after a minimum of 3 months therapy; or
                                                                                                         (ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive (Ph+) cells; or
                                                                                                         (iii) failure to achieve or maintain a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy; OR
                                                                                                         2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph+ cells on bone marrow biopsy), during ongoing tyrosine kinase inhibitor (TKI) 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 tyrosine kinase inhibitor (TKI) therapy; OR
                                                                                                         4. Development of accelerated phase in a patient previously prescribed a TKI inhibitor 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 TKI therapy in patients with accelerated phase 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.