Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p238
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 238/381)
Character Range: 13069212–13075614

8 years.
                                                                                                                                                                    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. (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; AND
                                                                                                                                                                    4. Confirmation that the patient has an estimated glomerular filtration rate less than 30ml/minute/1.73m2 ; AND
                                                                                                                                                                    5. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; 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; AND
                                                                                                                                                                    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.
C12752              P12752         CN12752          Somatropin                                                                                                      Short stature associated with chronic renal insufficiency                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Written Authority Required procedures
                                                                                                                                                                    Recommencement of treatment
                                                                                                                                                                    Patient must have previously received treatment under the PBS