Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p193
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 193/381)
Character Range: 12801192–12809916

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 nilotinib of 300 mg twice daily. Continuing therapy is dependent on patients demonstrating a response to nilotinib 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.
C12559              P12559         CN12559          Gemtuzumab ozogamicin                                                                                           Acute Myeloid Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                                                                                                    Induction treatment
                                                                                                                                                                    Patient must have confirmed CD33-positive AML prior to initiation of treatment; AND
                                                                                                                                                                    The condition must be de novo; AND
                                                                                                                                                                    The condition must be previously untreated at the time of initiation (except for prior essential treatment with hydroxyurea or leukapheresis for patients with hyperleukocytic AML); AND
                                                                                                                                                                    Patient must have confirmed intermediate/favourable cytogenetic risk; or
                                                                                                                                                                    Patient must have unknown cytogenetic risk due to inconclusive test results; AND
                                                                                                                                                                    Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND
                                                                                                                                                                    The condition must not be acute promyelocytic leukaemia; AND
                                                                                                                                                                    The treatment must be in combination with standard intensive remission induction chemotherapy for this condition, which must include cytarabine and an anthracycline; AND
                                                                                                                                                                    The treatment must not be used in combination with a tyrosine kinase inhibitor; AND
                                                                                                                                                                    The condition must not be internal tandem duplication (ITD) or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive; AND
                                                                                                                                                                    Patient must not receive more than 1 induction cycle under this restriction in a lifetime.
                                                                                                                                                                    This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.
C12561              P12561         CN12561          Dasatinib                                                                                                       Chronic Myeloid Leukaemia (CML)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment - third-line therapy
                                                                                                                                                                    The condition must be in the chronic phase; or
                                                                                                                                                                    The condition must be in the accelerated phase; or
                                                                                                                                                                    The condition must be in the blast phase; AND
                                                                                                                                                                    Patient must not have failed PBS-subsidised treatment with this drug for this condition in