Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p191
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 191/381)
Character Range: 12784705–12793457

condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR).
C12543              P12543         CN12543          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 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); 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.
                                                                                                                                                                    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.
                                                                                                                                                                    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 (FISH) with BCR-ABL specific probe must be documented in the patient's medical records.
C12546              P12546         CN12546          Methoxsalen                                                                                                     Chronic graft versus host disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 12546
                                                                                                                                                                    Initial treatment in a treatment episode
                                                                                                                                                                    The condition must be inadequately responsive to systemic corticosteroid treatment at a therapeutic dose, but has never been treated with this drug; or
                                                                                                                                                                    The condition must have relapsed within 8 weeks of prior PBS-subsidised treatment with this drug administered via extracorporeal photopheresis; or
                                                                                                                                                                    The condition must have relapsed with each of the following conditions being met:
                                                                                                                                                                     (i) prior PBS-subsidised treatment with this drug administered via extracorporeal photopheresis last occurred at least 8 weeks ago, (ii) a subsequent trial of systemic corticosteroids at therapeutic doses has been completed; AND
                                                                                                                                                                    Patient must be undergoing treatment with this drug that is being administered within at least one of:
                                                                                                                                                                     (i) the first 12 weeks of a treatment episode, (ii) the first 25 doses (inclusive of the 25th dose) of a treatment episode; AND
                                                                                                                                                                    Must be treated by a haematologist; or
                                                                                                                                                                    Must be treated by an oncologist with allogeneic bone marrow transplantation experience; or
                                                                                                                                                                    Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types;