Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p253
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 253/381)
Character Range: 13145041–13151464

for the patient's current height;
                                                                                                                                                                    Patient must not have a chronological age of equal to or greater than 18 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; AND
                                                                                                                                                                    3. Growth data (height, weight and waist circumference) 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
                                                                                                                                                                    4. The date at which skeletal maturity was achieved (if applicable) [Note In patients whose chronological age is greater than 2.5 years, a bone age reading should be performed at least once every 12 months prior to attainment of skeletal maturity]; AND
                                                                                                                                                                    5. Confirmation that during the initial 32 week treatment period, the patient was re-evaluated via polysomnography for airway obstruction and apnoea, and any sleep disorders that were identified have been addressed; AND
                                                                                                                                                                    6. 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.
                                                                                                                                                                    Maintenance is defined as a value within a 5% tolerance (this allows for seasonal and other measurement variations).
                                                                                                                                                                    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.
C12769              P12769         CN12769          Somatropin                                                                                                      Growth retardation secondary to an intracranial lesion, or cranial irradiation                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                                                                    Continuing treatment as a reclassified patient
                                                                                                                                                                    Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than growth retardation secondary to an intracranial lesion, or cranial irradiation; AND
                                                                                                                                                                    The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment