Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p5
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 5/161)
Character Range: 13850651–13856336

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).
                                                                                   Blast crisis is defined as either
                                                                                   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.
                                                                                   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) where there has been a loss of response to 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).
                                                                                   Up to a maximum of 18 months of treatment may be authorised under this initial restriction.
C13030              P13030         CN13030          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 be expressing the T315I mutation confirmed through a bone marrow biopsy pathology report; AND
                                                                                   Patient must have failed an adequate trial of imatinib confirmed through a pathology report from an Approved Pathology Authority.  or
                                                                                   Patient must have failed an adequate trial of dasatinib confirmed through a pathology report from an Approved Pathology Authority.  or
                                                                                   Patient must have failed an adequate trial of nilotinib confirmed through a pathology report from an