Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p369
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 369/381)
Character Range: 13756908–13762721

stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or
                                                                                                                                                                    Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND
                                                                                                                                                                    Patient must have other hypothalamic/pituitary hormone deficits (includes ACTH, TSH, GnRH and/or vasopressin/ADH deficiencies); AND
                                                                                                                                                                    Patient must have hypothalamic obesity; AND
                                                                                                                                                                    Patient must have a growth velocity above the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or
                                                                                                                                                                    Patient must have an annual growth velocity of greater than 8 cm per year if the patient has a bone age of 2.5 years or less; 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 be male and must not have a bone age of 15.5 years or more; or
                                                                                                                                                                    Patient must be female and must not have a bone age of 13.5 years or more;
                                                                                                                                                                    Patient must be aged 3 years or older.
                                                                                                                                                                    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 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 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; AND
                                                                                                                                                                    4. A bone age result performed within the last 12 months; AND
                                                                                                                                                                    5. Evidence of biochemical growth hormone deficiency, including the type of