Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p274
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 274/381)
Character Range: 13251091–13256444

or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND
                                                                                                                                                                    Patient must have a structural lesion that is not neoplastic; or
                                                                                                                                                                    Patient must have had a structural lesion that was neoplastic and have undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); or
                                                                                                                                                                    Patient must have a structural lesion that is neoplastic, have received medical advice that it is unsafe to treat the structural lesion, and have undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND
                                                                                                                                                                    Patient must have other hypothalamic/pituitary hormone deficits (includes ACTH, TSH, GnRH and/or vasopressin/ADH deficiencies); AND
                                                                                                                                                                    Patient must have hypothalamic obesity; AND
                                                                                                                                                                    Patient must have had a growth velocity above the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or
                                                                                                                                                                    Patient must have had an annual growth velocity of greater than 14 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or
                                                                                                                                                                    Patient must have had an annual growth velocity of greater than 8 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; 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 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 recommencement treatment phase is 32 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