Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p290
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 290/312)
Character Range: 17308777–17317293

to:
                                                                                                                           (i) avoidance of surgery;
                                                                                                                           (ii) avoidance of renal replacement therapy such as dialysis or renal transplantation in patients with VHL- associated renal cell carcinoma (RCC);
                                                                                                                           (iii) experiencing clinical benefit in at least one of the VHL associated conditions, as determined by the treating clinician(s).
C16186              P16186         CN16186          Testosterone                                                           Androgen deficiency                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                                                           The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
                                                                                                                           Patient must have an established pituitary or testicular disorder.
                                                                                                                           Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist 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