Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p75
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 75/161)
Character Range: 14220453–14225677

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 prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR
                                                                                   (b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; OR
                                                                                   (c) Confirmation that the patient has previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and has reached or surpassed 5 years of age (chronological); AND
                                                                                   4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
                                                                                   5. Recent growth data (height and weight, not older than three months); AND
                                                                                   6. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
                                                                                   7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
                                                                                   Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
                                                                                   Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.
                                                                                   In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.
C13355              P13355         CN13355          Somatropin                     Short stature and slow growth                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                   Recommencement of treatment as a reclassified patient
                                                                                   Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature and slow growth; AND
                                                                                   Patient must have had a lapse in treatment; AND
                                                                                   The treatment must not have lapsed due to failure to respond to growth hormone