Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p53
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 53/161)
Character Range: 14119133–14124555

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.
C13308              P13308         CN13308          Somatrogon                     Short stature and slow growth                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                   Continuing treatment
                                                                                   Patient must be undergoing continuing PBS-subsidised therapy with this drug - subsidy through this treatment phase must not:
                                                                                    (i) initiate treatment, (ii) change the prescribed drug, (iii) recommence treatment, (iv) reclassify the PBS indication; AND
                                                                                   Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and slow growth category; AND
                                                                                   Patient must have achieved the 50th percentile growth velocity for bone age plus sex following the most recent supply; or
                                                                                   Patient must have achieved an increase in height standard deviation score for chronological age plus sex following the most recent supply; or
                                                                                   Patient must have achieved a minimum growth velocity of 4 cm per year following the most recent supply; or
                                                                                   Patient must have achieved a mid-parental height standard deviation score following the most recent supply; or
                                                                                   The treatment must have been administered at a dose that is lower than that recommended in the approved Product Information in the most recent supply; 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 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
                                                                                   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. 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