Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p332
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 332/381)
Character Range: 13554901–13561907

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.
                                                                                                                                                                    The maximum duration of each continuing treatment phase is 26 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 13 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 continuing treatment as a reclassified patient; AND
                                                                                                                                                                    3. Confirmation that the patient has precocious puberty; AND
                                                                                                                                                                    4. Confirmation that the patient is undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND
                                                                                                                                                                    5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
                                                                                                                                                                    6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
                                                                                                                                                                    7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
                                                                                                                                                                    8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 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.
                                                                                                                                                                    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.
C12860              P12860         CN12860          Somatropin                                                                                                      Short stature associated with Turner syndrome                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Written Authority Required procedures
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    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 have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; or
                                                                                                                                                                    Patient must have diagnostic results consistent with Turner syndrome (the