Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p298
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 298/312)
Character Range: 17365039–17372811

application.
C16207              P16207         CN16207          Testosterone                                                           Pubertal induction                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    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.
                                                                                                                           Patient must be under 18 years of age.
                                                                                                                           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.
C16208              P16208         CN16208          Belzutifan                                                             Von Hippel-Lindau (VHL) disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                                                           Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangement
                                                                                                                           Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 December 2024; AND
                                                                                                                           The condition must have been diagnosed by at least one of: (i) a germline VHL alteration; (ii) at least two manifestations highly characteristic of VHL disease; (iii) at least one manifestation highly characteristic of VHL disease with a documented family history of VHL; AND
                                                                                                                           The condition must have been at least one of the following prior to non-PBS-subsidised treatment with this drug: (i) VHL-associated non-metastatic renal cell carcinoma (RCC); (ii) VHL-associated central nervous system (CNS) haemangioblastoma; (iii) VHL-associated non-metastatic pancreatic neuroendocrine tumour (pNET); AND
                                                                                                                           Patient must not have had tumour(s) that require immediate surgery as assessed by the treating clinician prior to non-PBS-subsidised treatment with this drug; AND
                                                                                                                           Patient must have had a WHO performance status score of no greater than 1 at treatment initiation with this drug; OR
                                                                                                                           The condition must have been VHL-associated brain stem tumour(s), or brain herniation, which temporarily affected the patient's WHO performance status to be higher than 1 at treatment initiation with this drug; AND
                                                                                                                           Patient must not have developed VHL-associated metastatic disease; AND
                                                                                                                           Patient must have demonstrated clinical improvement or stabilisation of the condition, the details of which must be kept with the patient's record. This should be assessed only after a total of 6 months of therapy.
                                                                                                                           Must be treated by a physician with expertise in the management of VHL disease associated tumours.
                                                                                                                           Patients who cease therapy for reasons other than, clinical disease progression or metastasis, may re-initiate PBS-subsidised treatment through the initiating or recommencing treatment phase.
                                                                                                                           For the purpose of administering this restriction, the highly characteristic manifestations of VHL disease include but not limited to:
                                                                                                                           (i) retinal, spinal, or cerebellar haemangioblastoma;
                                                                                                                           (ii) adrenal or extra-adrenal phaeochromocytoma;
                                                                                                                           (iii) renal cell carcinoma;
                                                                                                                           (iv) multiple renal and pancreatic cysts;
                                                                                                                           (v) endolymphatic sac tumours, papillary cystadenomas of the epididymis or broad ligament, or pancreatic neuroendocrine tumours.