Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p158
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 158/161)
Character Range: 14644186–14649860

patients without T315I mutation
                                                                                   The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                   Patient must have received initial PBS-subsidised treatment with this drug for this condition; AND
                                                                                   Patient must be undergoing first continuing treatment with this drug, demonstrating either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%.  or
                                                                                   Patient must be undergoing subsequent continuing treatment with this drug, demonstrating a 12-month response of either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%.
                                                                                   A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient's medical records.
C13925              P13925         CN13925          Asciminib                      Chronic Myeloid Leukaemia (CML)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                   Initial PBS-subsidised treatment for patients with T315I mutation
                                                                                   The condition must not be in the blast phase; AND
                                                                                   The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                   Patient must be expressing the T315I mutation confirmed through a bone marrow biopsy pathology report; 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 one tyrosine kinase inhibitor as confirmed through a pathology report from an Approved Pathology Authority.  or
                                                                                   Patient must have experienced intolerance, not failure to respond, to at least one tyrosine kinase inhibitor as confirmed through a pathology report from an Approved Pathology Authority.
                                                                                   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