Australia developed the Life-Saving Drugs Program (LSDP) in 1995 to complement the Pharmaceutical Benefits Scheme (PBS), expanding access to high-cost drugs for rare diseases (DRD). This program, funded and administered by the Department of Health and Aged Care, permitted sponsors (often pharmaceutical companies) to apply for listing when their clinically effective DRD is rejected for PBS listing on the grounds of effectiveness.

See how it is done in this document.