Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p80
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 80/312)
Character Range: 15949026–15957607

T-score of -2.5 or less; AND
                                                                                                                           Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
                                                                                                                           The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.
C14901              P14901         CN14901          Topiramate                                                             Migraine                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 14901
                                                                                                                           The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
                                                                                                                           The treatment must be for prophylaxis; AND
                                                                                                                           Patient must have experienced an average of 3 or more migraines per month over a period of at least 6 months; AND
                                                                                                                           Patient must have a contraindication to beta-blockers, as described in the relevant TGA-approved Product Information; or
                                                                                                                           Patient must have experienced intolerance of a severity necessitating permanent withdrawal during treatment with a beta-blocker; AND
                                                                                                                           Patient must have a contraindication to pizotifen because the weight gain associated with this drug poses an unacceptable risk.  or
                                                                                                                           Patient must have experienced intolerance of a severity necessitating permanent withdrawal during treatment with pizotifen.
                                                                                                                           Details of the contraindication and/or intolerance(s) must be documented in the patient's medical records when treatment is initiated.
C14903              P14903         CN14903          Vigabatrin                                                             Epileptic seizures                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 14903
                                                                                                                           The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
                                                                                                                           The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs.
C14912              P14912         CN14912          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 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.
                                                                                                                           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