Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p211
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 211/381)
Character Range: 12930736–12936974

results consistent with Prader-Willi syndrome (the condition must be genetically proven); or
                                                                                                                                                                    Patient must have a clinical diagnosis of Prader-Willi syndrome, confirmed by a clinical geneticist; AND
                                                                                                                                                                    Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with no sleep disorders identified; or
                                                                                                                                                                    Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with sleep disorders identified which are not of sufficient severity to require treatment; or
                                                                                                                                                                    Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with sleep disorders identified for which the patient is currently receiving ameliorative treatment; AND
                                                                                                                                                                    Patient must not have uncontrolled morbid obesity, defined as a body weight greater than 200% of ideal body weight for height and sex, with ideal body weight derived by calculating the 50th percentile weight for the patient's current height; AND
                                                                                                                                                                    Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
                                                                                                                                                                    Patient must not have an active tumour or evidence of tumour growth or activity; AND
                                                                                                                                                                    Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
                                                                                                                                                                    Patient must not have a chronological age of 18 years or greater; AND
                                                                                                                                                                    Must be treated by a specialist or consultant physician in paediatric endocrinology.  or
                                                                                                                                                                    Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
                                                                                                                                                                    The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
                                                                                                                                                                    The authority application must be in writing and must include
                                                                                                                                                                    1. A completed authority prescription form; AND
                                                                                                                                                                    2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
                                                                                                                                                                    3. A minimum of 6 months of recent growth data (height, weight and waist circumference). The most recent data must not be older than three months; AND
                                                                                                                                                                    4. The date at which skeletal maturity was achieved (if applicable) [Note In patients whose chronological age is greater than 2.5 years, a bone age reading should be performed at least once every 12 months prior to attainment of 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