Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p39
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 39/161)
Character Range: 14058382–14063996

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.
C13288              P13288         CN13288          Somatrogon                     Short stature associated with biochemical growth hormone deficiency                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                   Change of drug
                                                    Somatropin                     Patient must be undergoing existing PBS-subsidised growth hormone treatment where the prescribed drug is changing within the same PBS indication - subsidy through this treatment phase must not:
                                                                                    (i) initiate treatment, (ii) recommence treatment, (iii) reclassify the PBS indication; AND
                                                                                   Patient must have been treated with PBS-subsidised growth hormone for less than 32 weeks; or
                                                                                   Patient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) having been demonstrated; or
                                                                                   Patient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) not demonstrated due to at least one of:
                                                                                    (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance to treatment arising from social/family problems, (v) sub-optimal dosing (i.e. the dose was less than the permitted upper dose range); 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
                                                                                   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