Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p302
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 302/381)
Character Range: 13391590–13396986

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 not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
                                                                                                                                                                    Patient must not have an active tumour or evidence of tumour growth or activity; AND
                                                                                                                                                                    Patient must be male and must not have a height greater than or equal to 167.7cm; or
                                                                                                                                                                    Patient must be female and must not have a height greater than or equal to 155.0cm; AND
                                                                                                                                                                    Patient must be male and must not have a bone age of 15.5 years or more; or
                                                                                                                                                                    Patient must be female and must not have a bone age of 13.5 years or more; AND
                                                                                                                                                                    Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology.  or
                                                                                                                                                                    Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
                                                                                                                                                                    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.
                                                                                                                                                                    The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
                                                                                                                                                                    The authority application must be in writing and must include
                                                                                                                                                                    1. A completed authority prescription form; AND
                                                                                                                                                                    2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
                                                                                                                                                                    3. (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 (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR
                                                                                                                                                                    (b) Height and