Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p231
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 231/381)
Character Range: 13034051–13040296

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. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
                                                                                                                                                                    5. (a) Confirmation that the patient has had an intracranial lesion which is under appropriate observation and management; OR
                                                                                                                                                                    (b) Confirmation that the patient has received cranial irradiation without having had an intracranial lesion and is under appropriate observation and management; AND
                                                                                                                                                                    6. Recent growth data (height and weight, not 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 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.
                                                                                                                                                                    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.
C12731              P12731         CN12731          Somatropin                                                                                                      Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Written Authority Required procedures
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth category; AND
                                                                                                                                                                    Patient must not have been on the maximum 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
                                                                                                                                                                    Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum 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
                                                                                                                                                                    Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum 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
                                                                                                                                                                    Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or