The listing process
If a company wishes to have a product included on the PBS, it must apply for listing with the Pharmaceutical Benefits Branch of the Department of Health and Family Services. The application must include an economic evaluation. There is no fee for this application. birth control pills
Submissions are first reviewed by a scientific and technical group within the department and then considered by two expert advisory committees: initially by the Economics Subcommittee (ESC) of the PBAC to review the technical aspects of the submission and then by the PBAC to consider broader clinical and policy aspects. The PBAC then makes a recommendation to the Minister for Health about listing. The final price of any product recommended for listing is agreed between the company and the Pharmaceutical Benefits Pricing Authority, which also takes advice from the PBAC. These steps are discussed in the following section and outlined in Figure 1.
Figure 1) Process of assessment and listing of pharmaceuticals in Australia. ESC Economic Subcommitee; PBAC Pharmaceutical Benefits Advisory Committee; PBS Pharmaceutical Benefits Scheme
Guidelines for the pharmaceutical industry on preparation of submissions to the PBAC
Following the 1987 amendment to the National Health Act, the Economics Working Party was established by the Australian government to develop guidelines for the PBAC to use to consider cost and effectiveness in making recommendations. The first draft of the Guidelines for the Pharmaceutical Industry on Preparation of Submissions to the Pharmaceutical Benefits Advisory Committee was released in 1990. Companies had the option of submitting applications according to these guidelines until the end of 1992. In August 1992, the PBAC released the first formal edition of the Guidelines, and companies were required to submit applications prepared according to the Guidelines from the beginning of 1993 .