Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p63
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 63/191)
Character Range: 10214626–10224174

of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.
C6324               P6324          CN6324           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.
                                                                                                                                                                                                                               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.
C6325               P6325          CN6325           Alendronic acid with colecalciferol                                                                                                                                        Osteoporosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 6325
                                                                                                                                                                                                                               Patient must be aged 70 years or older;
                                                                                                                                                                                                                               Patient must have a Bone Mineral Density (BMD) 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.
C6327               P6327          CN6327           Alendronic acid                                                                                                                                                            Established osteoporosis
                                                                                                                                                                                                                               Patient must have fracture due to minimal trauma; AND
                                                    Risedronic acid                                                                                                                                                            Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
                                                                                                                                                                                                                               The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated.
                                                                                                                                                                                                                               A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.
C6328               P6328          CN6328           Eprosartan                                                                                                                                                                 Drug interactions expected to occur with all of the base-priced drugs                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures

C6329               P6329          CN6329           Eprosartan                                                                                                                                                                 Transfer to a base-priced drug