Document ID: chunk:federal_register_of_legislation:F2024L01543:reg:14a:p3
Version: federal_register_of_legislation:F2024L01543
Segment Type: reg
Provision Reference: reg 14A (pt 3/3)
Character Range: 11627–15238

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) newly diagnosed AML with myelodysplasia-related changes (MRC) (prior myelodysplastic syndromes (MDS) or MDS-related cytogenetic or molecular abnormality); AND
                                              The treatment must not exceed two cycles of consolidation therapy under this restriction.
                                              This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.
                                              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.