Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p185
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 185/381)
Character Range: 12742437–12750968

patient's medical records.
                                                                                                                                                                    Pathology report(s) confirming a loss of response to imatinib or nilotinib, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement must be documented in the patient's medical records.
C12525              P12525         CN12525          Imatinib                                                                                                        Chronic Myeloid Leukaemia (CML)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 12525
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have received initial PBS-subsidised treatment with this drug as a first-line therapy for this condition; AND
                                                                                                                                                                    The condition must be in the blast phase; 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).
C12527              P12527         CN12527          Imatinib                                                                                                        Chronic Myeloid Leukaemia (CML)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment - first-line therapy
                                                                                                                                                                    The condition must be a primary diagnosis of chronic myeloid leukaemia; AND
                                                                                                                                                                    The condition must be in the accelerated phase; 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 not have previously experienced a failure to respond to PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                                                                                    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).
                                                                                                                                                                    A pathology cytogenetic report from an Approved Pathology Authority conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient's medical records.
                                                                                                                                                                    The expression of the Philadelphia chromosome should be confirmed through cytogenetic analysis by standard karyotyping; or if standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation