Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p81
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 81/161)
Character Range: 14245276–14249111

due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND
                                                                                   Patient must have previously received treatment under the indication short stature associated with chronic renal insufficiency, have undergone a renal transplant and a 12 month period of observation following the transplant, and have an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; or
                                                                                   Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment and a growth velocity below 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 both:
                                                                                    (i) a height no higher than the 1st percentile for age plus sex at the time of having commenced treatment with this drug, (ii) over the 12 month interval immediately prior to having commenced treatment, a growth velocity no greater than 8 cm/year where the patient had a bone/chronological age of no greater than 2.5 years; 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
                                                                                   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
                                                                                   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; AND
                                                                                   Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
                                                                                   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