Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p212
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 212/381)
Character Range: 12936200–12942302

skeletal maturity]; AND
                                                                                                                                                                    5. (a) Confirmation that the patient has diagnostic results consistent with Prader-Willi syndrome; OR
                                                                                                                                                                    (b) Confirmation that the patient has a clinical diagnosis of Prader-Willi syndrome, confirmed by a clinical geneticist
                                                                                                                                                                    6. Confirmation that the patient has been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months and any sleep disorders identified via polysomnography that required treatment have been addressed; AND
                                                                                                                                                                    7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with 1 repeat allowed)
                                                                                                                                                                    Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
                                                                                                                                                                    In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.
C12711              P12711         CN12711          Somatropin                                                                                                      Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
                                                                                                                                                                    Recommencement of treatment
                                                                                                                                                                    Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants category; AND
                                                                                                                                                                    Patient must have had a lapse in growth hormone treatment; AND
                                                                                                                                                                    The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or
                                                                                                                                                                    The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or
                                                                                                                                                                    The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or
                                                                                                                                                                    The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies),