Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p159
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 159/161)
Character Range: 14649535–14653893

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. 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).
                                                                                   The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include
                                                                                   (i) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; or
                                                                                   (ii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale; and
                                                                                   (iii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating evidence of the T315I mutation; and
                                                                                   (iv) where there has been a loss of response to imatinib or dasatinib or nilotinib, details (date, unique identifying number/code or provider number) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement.
                                                                                   All reports must be documented in the patient's medical records.
                                                                                   If the application is submitted through HPOS form upload or mail, it must include
                                                                                   (i) A completed authority prescription form; and
                                                                                   (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                                   Patients are eligible for PBS-subsidised treatment with only one of