Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p370
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 370/381)
Character Range: 13762168–13768572

most recent data must not be more than three months old at the time of application; AND
                                                                                                                                                                    4. A bone age result performed within the last 12 months; AND
                                                                                                                                                                    5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
                                                                                                                                                                    6. (a) Confirmation that the patient has a structural lesion that is not neoplastic; OR
                                                                                                                                                                    (b) Confirmation that the patient had a structural lesion that was neoplastic and has undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR
                                                                                                                                                                    (c) Confirmation that the patient has a structural lesion that is neoplastic, has received medical advice that it is unsafe to treat the structural lesion, and has undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND
                                                                                                                                                                    7. Confirmation that the patient has other hypothalamic/pituitary hormone deficits; AND
                                                                                                                                                                    8. Confirmation that the patient has hypothalamic obesity; AND
                                                                                                                                                                    9. 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.
                                                                                                                                                                    Testing for biochemical growth hormone deficiency must have been performed at a time when all other pituitary hormone deficits were being adequately replaced.
                                                                                                                                                                    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.
C12928              P12928         CN12928          Somatropin                                                                                                      Growth retardation secondary to an intracranial lesion, or cranial irradiation                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with 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 period and 26 weeks for a continuing treatment period, whichever applies); or
                                                                                                                                                                    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 period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by