Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p240
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 240/381)
Character Range: 13079545–13086578

30mL/min/1.73m2; 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 167.7cm; or
                                                                                                                                                                    Patient must be female and must not have a height greater than or equal to 155.0cm; 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;
                                                                                                                                                                    Patient must be aged 3 years or older.
                                                                                                                                                                    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; AND
                                                                                                                                                                    3. Recent growth data (height and weight, not older than three months); AND
                                                                                                                                                                    4. A bone age result performed within the last 12 months; AND
                                                                                                                                                                    5. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m2 ; AND
                                                                                                                                                                    6. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; 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.
                                                                                                                                                                    If a patient receiving treatment under the indication 'short stature associated with chronic renal insufficiency' undergoes a renal transplant and 12 months post-transplant has an eGFR of equal to or greater than 30mL/min/1.73m2 prescribers should seek reclassification to the indication short stature and slow growth.
                                                                                                                                                                    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.
C12755              P12755         CN12755          Somatropin                                                                                                      Growth retardation secondary to an intracranial lesion, or cranial irradiation                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with