The ESC comprises members with expertise in clinical pharmacology, internal medicine, epidemiology and economics. It reviews submissions before their consideration by the PBAC. Its role is to provide review of the technical aspects of the submission (quality of trial data, methods used for economic analysis, etc), validate the cost effectiveness ratios provided in the submission and total financial implications of the drug, and provide this advice to the PBAC. The ESC also has a role in developing policy and methods for the ongoing development of the overall process. An industry observer, a nonvoting member (not affiliated with any single pharmaceutical company) bound by the confidentiality requirements, is present at these committee meetings. buy diabetes drugs
The PBAC provides recommendations to the Minister of Health about whether a drug should be listed on the PBS. When making its recommendations, the PBAC is required to consider the effectiveness and clinical need for the product, compared with available treatment. In 1987, an amendment was made to the National Health Act that required the PBAC to consider comparative costs and effectiveness in considering listing of new drugs on the PBS.