Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p67
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 67/69)
Character Range: 653172–660036

be either: (i) internal tandem duplication (ITD); (ii) tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3), mutation positive; AND
                                                                                                                Patient must not have favourable cytogenetic risk acute myeloid leukaemia (AML); AND
                                                                                                                Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND
                                                                                                                The treatment must not exceed two cycles of induction therapy under this restriction.
                                                                                                                This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.
                                                                                                                The prescriber must confirm whether the patient has newly diagnosed therapy-related AML or AML-MRC. The test result and date of testing must be provided at the time of application and documented in the patient's file.
                                                                                                                The prescribed dose must be according to the Therapeutic Goods Administration (TGA) Product Information.

                                                                                                                Each prescription must include the amount of daunorubicin with cytarabine (Vyxeos) that is appropriate to be prescribed for the patient. For the purposes of the authority application, the maximum amount requested is based on the daunorubicin dose only. The prescribed amount of daunorubicin must be expressed in milligrams.
C16188              P16188         Nivolumab with relatlimab                                                    Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 16188
                                                                                                                Initial treatment
                                                                                                                Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND
                                                                                                                Patient must not have experienced disease progression whilst on adjuvant PD-1 inhibitor treatment or disease recurrence within 6 months of completion of adjuvant PD-1 inhibitor treatment if treated for resected Stage IIIB, IIIC, IIID or IV melanoma; AND
                                                                                                                Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
                                                                                                                The condition must not be uveal melanoma; AND
                                                                                                                The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                                Patient must weigh 40 kg or more; AND
                                                                                                                Patient must be at least 12 years of age.
                                                                                                                Patients must only receive a maximum of 480 mg nivolumab and 160 mg relatlimab every four weeks under a flat dosing regimen.
                                                                                                                The prescribed dose must be according to the Therapeutic Goods Administration (TGA) Product Information.

                                                                                                                The prescription must include the amount of nivolumab with relatlimab (Opdualag) that is appropriate to be prescribed for the patient. For the purposes of PBS subsidy, the maximum amount requested is based on the nivolumab dose only. The prescribed amount of nivolumab must be expressed in milligrams.
C16197              P16197         Daunorubicin with cytarabine                                                 Acute Myeloid Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                Consolidation therapy
                                                                                                                The treatment must be for consolidation treatment following induction treatment with this product; AND
                                                                                                                The condition must be either: (i) newly diagnosed therapy-related acute myeloid leukaemia (AML), (ii)