Growth hormone deficiency - paediatric patients Program in Pharmaceutical Benefits Scheme (PBS) 012-63030010

The administration of the GH Program transferred from the Department of Health and Aged Care to Services Australia (the agency) on 1 September 2015 as a prescription based program. PBS-subsidised GH remains as a special arrangement under Section 100 of the National Health Act 1953.

Listing dates:

• somatropin – 1 September 2015
• somatrogon – 1 October 2022

Conditions treated by somatropin under the GH Program (paediatric use):

• short stature and slow growth (SSSG)
• short stature associated with biochemical growth hormone deficiency (BGHD)
• growth retardation secondary to an intracranial lesion, or cranial irradiation (CL/CI)
• hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth (HO)
• risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants (N)
• biochemical growth hormone deficiency and precocious puberty (PP)
• short stature associated with Turner syndrome (TS)
• short stature due to short stature homeobox gene disorders (SHOX)
• short stature associated with chronic renal insufficiency (CR)
• short stature and poor body composition due to Prader-Willi syndrome (PW)

Conditions treated by somatrogon under the GH Program (paediatric use):

• short stature and slow growth (SSSG)
• short stature associated with biochemical growth hormone deficiency (BGHD)

All GH applications will be assessed and processed by a Complex Drugs Pharmaceutical Adviser (PA).

Processing in Online PBS Authorities (OPA) system

All paediatric Growth Hormone applications can be processed using the OPA system regardless of the treatment and condition combination.

Telephone authority approvals for replacement of previously approved prescriptions may be processed using the Mainframe system.

From 1 September 2020, prescribers can submit their PBS GH authority applications in OPA and receive a real time assessment result.

The OPA system will:

• provide prescribers with a real time assessment result
• help patients get their approved authority prescriptions sooner, and
• remove the need for prescribers to post supporting documentation

To use the OPA system or the form upload in HPOS, prescribers must register for a Provider Digital Access (PRODA) account.

Patients can take their GH approved PBS authority prescription to a pharmacy of their choice.