Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p359
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 359/381)
Character Range: 13701256–13707214

weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; 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 non-compliance due to social/family problems; AND
                                                                                                                                                                    Patient must have diagnostic 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 whilst on growth hormone treatment and any sleep disorders identified that required treatment must have been addressed; 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 a chronological age of 18 years or greater; AND
                                                                                                                                                                    Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology.  or
                                                                                                                                                                    Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
                                                                                                                                                                    The maximum duration of each continuing treatment phase is 26 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 13 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 continuing treatment as a reclassified patient; AND
                                                                                                                                                                    3. (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; AND
                                                                                                                                                                    4. Confirmation that the patient has been evaluated via polysomnography for airway obstruction and apnoea whilst on growth hormone treatment, and any sleep disorders identified via the polysomnography that required treatment have been addressed; AND
                                                                                                                                                                    5. Growth data (height and weight) for the most recent 6 month