Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p40
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 40/161)
Character Range: 14063683–14069939

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 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.
C13290              P13290         CN13290          Avelumab                       Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures - Streamlined Authority Code 13290
                                                                                   Maintenance therapy - Continuing treatment
                                                                                   Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                   Patient must not have developed disease progression while being treated with this drug for this condition; AND
                                                                                   The treatment must be the sole PBS-subsidised therapy for this condition.
C13292              P13292         CN13292          Somatrogon                     Short stature associated with biochemical growth hormone deficiency                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                   Initial treatment
                                                                                   Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or
                                                                                   Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or
                                                                                   Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth