Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p55
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 55/161)
Character Range: 14129281–14133903

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 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; AND
                                                                                   Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
                                                                                   Definition
                                                                                   An adequate response to the preceding supply of growth hormone for which the patient is changing from is one where the patient, for their sex, has achieved at least one of
                                                                                   (a) the 50th percentile growth velocity for bone age;
                                                                                   (b) an increase in height standard deviation score for chronological age;
                                                                                   (c) a minimum growth velocity of 4 cm per year;
                                                                                   (d) a mid-parental height standard deviation score.
                                                                                   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. 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.
                                                                                   2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.
                                                                                   Where growth data has been supplied within 3 months of this authority application, do not resupply this data.
                                                                                   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 that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which