Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p282
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 282/381)
Character Range: 13290533–13296565

a reclassified patient; AND
                                                                                                                                                                    3. 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 (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND
                                                                                                                                                                    4. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND
                                                                                                                                                                    5. If the patient's condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient's increased risk of gonadoblastoma is in place; 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; 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.
                                                                                                                                                                    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.
C12791              P12791         CN12791          Somatropin                                                                                                      Short stature associated with chronic renal insufficiency                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Written Authority Required procedures
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; or
                                                                                                                                                                    Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND
                                                                                                                                                                    Patient must have a current height at or below the 1st percentile for age and sex; or
                                                                                                                                                                    Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and a growth velocity less than or equal to the 25th percentile for bone age