Document ID: chunk:federal_register_of_legislation:F2024L01543:reg:14a:p2
Version: federal_register_of_legislation:F2024L01543
Segment Type: reg
Provision Reference: reg 14A (pt 2/3)
Character Range: 7096–11995

C16151  P16151  Nivolumab with relatlimab     Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 16151
                                              Continuing treatment
                                              Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                              The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                              Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.
                                              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.
C16187  P16187  Daunorubicin with cytarabine  Acute Myeloid Leukaemia                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                              Induction therapy
                                              Patient must not have received prior chemotherapy as induction therapy for this condition; 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 condition must not 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