Document ID: chunk:federal_register_of_legislation:F2024L01524:schedule:1:p23
Version: federal_register_of_legislation:F2024L01524
Segment Type: schedule
Provision Reference: sch 1 (pt 23/38)
Character Range: 74968–80521

the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
                                                       The treatment must be in combination with metformin; unless contraindicated/intolerant; AND
                                                       Patient must have cardiovascular disease; OR
                                                       Patient must be at high risk of a cardiovascular event; OR
                                                       Patient must identify as Aboriginal or Torres Strait Islander.
                                                       Patient must not be undergoing concomitant PBS-subsidised treatment for this condition with any of: (i) a GLP-1 receptor agonist, (ii) another SGLT2 inhibitor.
C16166  P16166  CN16166  Testosterone                  Androgen deficiency                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                       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.
C16180  P16180  CN16180  Belzutifan                    Von Hippel-Lindau (VHL) disease                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                       Continuing treatment
                                                       Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same tumour type; AND
                                                       Patient must not have developed VHL-associated metastatic disease; AND
                                                       Patient must have demonstrated clinical improvement or stabilisation of the condition while being treated with this drug, the details of which must be kept with the patient's record; 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 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, clinical improvement or stabilisation of the patient's condition includes but is not limited 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,