Document ID: chunk:federal_register_of_legislation:F2024L01524:schedule:1:p24
Version: federal_register_of_legislation:F2024L01524
Segment Type: schedule
Provision Reference: sch 1 (pt 24/38)
Character Range: 80221–85090

endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
                                                       The treatment must be applied to the scrotum, where possible.
                                                       The name of the specialist must be included in the authority application.
C16187  P16187  CN16187  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  CN16188  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