Document ID: chunk:federal_register_of_legislation:F2024L01524:schedule:1:p34
Version: federal_register_of_legislation:F2024L01524
Segment Type: schedule
Provision Reference: sch 1 (pt 34/38)
Character Range: 126419–131040

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 not have an established pituitary or testicular disorder; AND
                                                       The condition must not be due to age, obesity, cardiovascular diseases, infertility or drugs.
                                                       Patient must be aged 40 years or older.
                                                       Must be treated by a 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.
                                                       Androgen deficiency is defined as:
                                                       (i) testosterone level of less than 6 nmol per litre; OR
                                                       (ii) testosterone level between 6 and 15 nmol per litre with high luteinising hormone (LH) (greater than 1.5 times the upper limit of the eugonodal reference range for young men, or greater than 14 IU per litre, whichever is higher).
                                                       Androgen deficiency must be confirmed by at least two morning blood samples taken on different mornings.
                                                       The dates and levels of the qualifying testosterone and LH measurements must be, or must have been provided in the authority application when treatment with this drug is or was initiated.
                                                       The name of the specialist must be included in the authority application.
C16215  P16215  CN16215  Belzutifan                    Von Hippel-Lindau (VHL) disease                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                       Initiating or recommencing treatment
                                                       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 be at least one of: (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 tumour(s) that require immediate surgery as assessed by the treating clinician; AND
                                                       Patient must be untreated with this drug for this condition; OR
                                                       Patient must have previously received PBS-subsidised treatment with this drug for this condition for a different tumour type; OR
                                                       Patient must have previously received PBS-subsidised treatment with this drug for this condition and ceased previous treatment for family planning purposes; AND
                                                       Patient must have WHO performance status no higher than 1; OR
                                                       The condition must be VHL-associated brainstem tumour(s), or brain herniation, which temporarily affected the patient's WHO performance status to be higher than 1; AND
                                                       The treatment must be the sole PBS-subsidised therapy for VHL disease associated tumours.
                                                       Must be treated by a physician with expertise in the management of VHL disease associated tumours.
                                                       Patients who cease therapy for reasons