Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p59
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 59/161)
Character Range: 14146912–14152060

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.
C13318              P13318         CN13318          Somatrogon                     Short stature and slow growth                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                   Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
                                                                                   Patient must be undergoing privately funded treatment (e.g. through a clinical trial, a sponsor compassionate access program, supply from an overseas jurisdiction) with this drug at the time of this authority application - subsidy through this treatment phase must only occur once per lifetime; 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 reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; AND
                                                                                   Patient must have had a height no higher than the 1st percentile for age plus sex at the time treatment first commenced; AND
                                                                                   Patient must have had a growth velocity below the 25th percentile for bone age plus sex measured over a 12 month interval (or a 6 month interval for an older child) prior to having commenced treatment; or
                                                                                   Patient must have had an annual growth velocity of no higher than 8 cm per year where the patient had either a bone/chronological age no higher than 2.5 years prior to having commenced 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