Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p62
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 62/191)
Character Range: 10206489–10216135

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.
C6319               P6319          CN6319           Alendronic acid with colecalciferol                                                                                                                                        Established osteoporosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 6319
                                                                                                                                                                                                                               Patient must have fracture due to minimal trauma; AND
                                                                                                                                                                                                                               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.
C6320               P6320          CN6320           Alendronic acid with colecalciferol                                                                                                                                        Osteoporosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 6320
                                                                                                                                                                                                                               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.
C6321               P6321          CN6321           Follitropin alfa                                                                                                                                                           Infertility
                                                                                                                                                                                                                               The condition must be due to hypogonadotrophic hypogonadism; AND
                                                    Follitropin beta                                                                                                                                                           The treatment must be following failure of 6 months' treatment with human chorionic gonadotrophin to achieve adequate spermatogenesis; AND
                                                                                                                                                                                                                               The treatment must be administered with human chorionic gonadotrophin.
C6323               P6323          CN6323           Alendronic acid                                                                                                                                                            Corticosteroid-induced osteoporosis
                                                                                                                                                                                                                               Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND
                                                    Risedronic acid                                                                                                                                                            Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND
                                                                                                                                                                                                                               Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
                                                                                                                                                                                                                               The duration and dose of corticosteroid therapy together with 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.
C6324               P6324          CN6324           Testosterone                                                                                                                                                               Androgen deficiency                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures
                                                                                                                                                                                                                               Patient must not have an established pituitary or testicular disorder; AND
                                                                                                                                                                                                                               The