Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p250
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 250/381)
Character Range: 13132648–13138323

deficits; AND
                                                                                                                                                                    8. Confirmation that the patient has hypothalamic obesity; AND
                                                                                                                                                                    9. 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 up to 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.
                                                                                                                                                                    Testing for biochemical growth hormone deficiency must have been performed at a time when all other pituitary hormone deficits were being adequately replaced.
                                                                                                                                                                    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.
C12768              P12768         CN12768          Somatropin                                                                                                      Short stature and poor body composition due to Prader-Willi syndrome                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Written Authority Required procedures
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and poor body composition due to Prader-Willi syndrome category; AND
                                                                                                                                                                    Patient must have been re-evaluated via polysomnography for airway obstruction and apnoea during the initial 32 week treatment period and any sleep disorders identified that required treatment must have been addressed; AND
                                                                                                                                                                    Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must not have been on the maximum 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
                                                                                                                                                                    Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must have maintained or improved height percentile for age and sex while on the maximum 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
                                                                                                                                                                    Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must have maintained or improved body mass index SDS for age and sex while on the maximum dose of 7.5mg/m2/week or greater for