Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p79
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 79/161)
Character Range: 14236961–14241197

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
                                                                                   Patient must be male and must not have a height greater than or equal to 167.7 cm; or
                                                                                   Patient must be female and must not have a height greater than or equal to 155.0 cm; AND
                                                                                   Patient must be male and must not have maturational or constitutional delay in combination with an estimated mature height equal to or above 160.1 cm; or
                                                                                   Patient must be female and must not have maturational or constitutional delay in combination with an estimated mature height equal to or above 148.0 cm; 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 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 (except for a patient whose chronological age is 2.5 years or less); AND
                                                                                   5. Confirmation of the patient's maturational or constitutional delay status; AND
                                                                                   6. If the patient has maturational or constitutional delay, confirmation that the patient has an estimated mature height below the 1st adult height percentile; AND
                                                                                   7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges