Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p108
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 108/161)
Character Range: 14369652–14373704

pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); 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 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 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 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; 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; AND
                                                                                   Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
                                                                                   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 recommencement 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 recommencement of treatment as a reclassified patient; AND
                                                                                   3. (a) 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