Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p299
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 299/312)
Character Range: 17371879–17381005

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.
                                                                                                                           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).
                                                                                                                           A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
C16211              P16211         CN16211          Testosterone                                                           Androgen deficiency                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                                                           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.
C16212              P16212         CN16212          Testosterone                                                           Pubertal induction                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                                                                                           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.
C16214              P16214         CN16214          Testosterone                                                           Androgen deficiency                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                                                           The condition must be stable for the prescriber to consider the listed