PBS GROWTH HORMONE PROGRAM
The Australian Government provides subsidised access to growth hormone medicines for eligible paediatric and adult patients through the Pharmaceutical Benefits Scheme (PBS) Growth Hormone Program established under section 100 of the National Health Act 1953. Growth Hormone restriction criteria is clinically complex. Different restriction criteria apply to the writing of a prescription for growth hormone for adults and children respectively. Prescribers should ensure the appropriate restriction criteria are met at the time of prescribing.
On 1 October 2022, two new medicines were listed on the Section 100 Growth Hormone Program – mecasermin and somatrogon. Somatrogon has been listed for the treatment of paediatric patients with (1) short stature associated with biochemical growth hormone deficiency, and (2) short stature and slow growth. Mecasermin has been listed for the long-term treatment of growth failure in children and adolescents from 2 to 18 years with severe primary insulin-like growth factor 1 deficiency (Primary IGFD).
There are a number of prescribers authorised to treat patients for PBS-subsidised treatment with growth hormone medicines. This is dependent upon the appropriate restriction criteria at the time of prescribing. Growth Hormone medicines can be dispensed by a community pharmacy, a participating PBS reform public hospital pharmacy, a private hospital pharmacy and a dispensing doctor.
Prescribers are able to apply to Services Australia for the supply of Growth Hormone. Prescribing information, including Authority Application forms and other relevant documentation (as applicable) are available on the Services Australia website.
On 1 January 2020, changes were made to the Pharmaceutical Benefits Scheme (PBS) restrictions for growth hormone treatment in adults, which set out the eligibility requirements for PBS subsidy, to provide additional clarity and improved access to growth hormone treatment.
On 1 February 2019, revised eligibility restrictions to PBS subsidised paediatric growth hormone treatment took effect. The eligibility restriction changes relate to:
- revised height percentile thresholds;
- growth velocity percentile for bone age and sex;
- clarification of definitions within the restrictions; and
- streamlining the way associated growth data requirements are specified within the prescriber instructions.
