Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p257
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 257/381)
Character Range: 13164061–13169661

having had an intracranial lesion and is under appropriate observation and management; 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 (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 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.
                                                                                                                                                                    An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
                                                                                                                                                                    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.
C12770              P12770         CN12770          Somatropin                                                                                                      Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  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 hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth; 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 a significant medical illness; 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