Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p222
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 222/381)
Character Range: 12989135–12994203

either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or
                                                                                                                                                                    Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or
                                                                                                                                                                    Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; 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 percentile for age and sex and a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or
                                                                                                                                                                    Patient must have a current height above the 1st percentile for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; or
                                                                                                                                                                    Patient must have a current height above the 1st percentile for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; 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 not have previously received treatment under the PBS S100 Growth Hormone Program; 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 specialist or consultant physician in paediatric endocrinology.  or
                                                                                                                                                                    Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
                                                                                                                                                                    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 the initial treatment phase is 32 weeks. Prescribers must