Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p51
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 51/161)
Character Range: 14110208–14115482

assessment) or in writing via HPOS form upload or mail and must include
                                                                                   1. (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 where a patient had a chronological age greater than 2.5 years 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 plus sex immediately prior to commencing treatment.
                                                                                   2. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations.
                                                                                   3. 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.
                                                                                   4. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.
                                                                                   If the application is submitted through HPOS form upload or mail, it must include
                                                                                   (i) A completed authority prescription form; and
                                                                                   (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                                   Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
                                                                                   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.
                                                                                   Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.
                                                                                   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.
C13304              P13304         CN13304          Somatrogon                     Short stature and slow growth                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                   Recommencement of treatment
                                                                                   Patient must be undergoing recommencing treatment following a temporary treatment break (i.e. a lapse) from this drug for the stated indication above - subsidy through this treatment phase must not:
                                                                                    (i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication; AND
                                                                                   Patient must have had a lapse in growth hormone treatment; AND
                                                                                   The