Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p201
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 201/381)
Character Range: 12853256–12861613

Chronic Myeloid Leukaemia (CML)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment - first-line therapy
                                                                                                                                                                    Patient must have a primary diagnosis of chronic myeloid leukaemia; AND
                                                                                                                                                                    The condition must be in the chronic 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 first-line treatment with this drug for this condition; or
                                                                                                                                                                    Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with imatinib as a first-line therapy for this condition; or
                                                                                                                                                                    Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with nilotinib as a first-line therapy for this condition; AND
                                                                                                                                                                    The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                                                                                    Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved.
                                                                                                                                                                    Patients should be commenced on a dose of dasatinib of 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to dasatinib therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter.
                                                                                                                                                                    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.
C12572              P12572         CN12572          Nilotinib                                                                                                       Chronic Myeloid Leukaemia (CML)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 12572
                                                                                                                                                                    Continuing treatment - first-line therapy
                                                                                                                                                                    The condition must be in the chronic phase; AND
                                                                                                                                                                    Patient must have received initial PBS-subsidised treatment with this drug as a first-line therapy for this condition; or
                                                                                                                                                                    Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised first-line treatment with imatinib for this condition; or
                                                                                                                                                                    Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised first-line treatment with dasatinib for this condition; AND
                                                                                                                                                                    Patient must have demonstrated