Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p60
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 60/161)
Character Range: 14151663–14155868

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 167.7 cm; or
                                                                                   Patient must be female and must not have a height greater than or equal to 155.0 cm; 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; AND
                                                                                   Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
                                                                                   Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include
                                                                                   1. (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 where a patient had a chronological age greater than 2.5 years at commencement of treatment; OR
                                                                                   (b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age plus sex immediately prior to commencing treatment.
                                                                                   2. 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.
                                                                                   3. A bone age result performed within the last 12 months where the patient has chronological age greater than 2.5 years.
                                                                                   If the application is submitted through HPOS form upload or mail, it must include
                                                                                   (i) A completed authority prescription form; and
                                                                                   (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                                   Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
                                                                                   Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate