Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p48
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 48/161)
Character Range: 14098451–14103802

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. Recent growth data (height and weight, not older than three months).
                                                                                   2. A bone age result performed within the last 12 months where a patient has a 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 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 the records relate is written.
                                                                                   In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.
C13298              P13298         CN13298          Somatrogon                     Short stature associated with biochemical growth hormone deficiency                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                   Recommencement of treatment as a reclassified patient
                                                                                   Patient must be undergoing treatment that is simultaneously:
                                                                                    (a) recommencing treatment following a temporary break in treatment (i.e. a lapse), plus (b) reclassifying the PBS indication whilst continuing with the same growth hormone; subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication where the most recent authority approval was for a different growth hormone; AND
                                                                                   Patient must have had a lapse in growth hormone treatment; AND
                                                                                   The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following:
                                                                                    (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse