Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p260
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 260/381)
Character Range: 13178004–13183440

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.
                                                                                                                                                                    An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
                                                                                                                                                                    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 minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND
                                                                                                                                                                    4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
                                                                                                                                                                    5. (a) Confirmation that the patient has a structural lesion that is not neoplastic; OR
                                                                                                                                                                    (b) Confirmation that the patient had a structural lesion that was neoplastic and has undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR
                                                                                                                                                                    (c) Confirmation that the patient has a structural lesion that is neoplastic, has received medical advice that it is unsafe to treat the structural lesion, and has undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND
                                                                                                                                                                    6. Confirmation that the patient has other hypothalamic/pituitary hormone deficits; AND
                                                                                                                                                                    7. Confirmation that the patient has hypothalamic obesity; AND
                                                                                                                                                                    8. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
                                                                                                                                                                    9. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
                                                                                                                                                                    10. The proprietary name (brand), form and strength of somatropin requested,