Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p67
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 67/161)
Character Range: 14188641–14192685

insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND
                                                                                   Patient must have a current height at or below the 1st percentile for age and sex; or
                                                                                   Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and a growth velocity below 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 a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; or
                                                                                   Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological 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; 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; 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 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) A minimum