Grant: Doctoral Research Award - PA: Drug Safety and Effectiveness

The current evidence used to inform drug regulatory approvals for biologic response modifiers for the treatment of rheumatoid arthritis (RA) has focused on efficiency, quantified as incremental cost-effectiveness. However, there are many discrepancies in this evidence base, and there has been substantial debate over the decisions made on this evidence in Canada and elsewhere. No advanced analyses have been undertaken to determine the strength and completeness of the existing evidence base, nor have any robust models been developed to improve the decision-making processes. With many new biologics for RA currently being tested in late stage clinical trials, and the significant costs associated with the use of these drugs, it is pertinent that we further develop the methods and tools used in the evidence synthesis of biologics for RA so that appropriate decisions can be made about their use. I propose to strengthen coverage decision-making in relation to biologics for RA. In order to achieve this goal, I propose the following linked tasks: 1) To develop valid and reliable clinical research evidence; 2) To develop robust economic evaluation and decision models; 3) To review the strength and completeness of existing evidence for informing economic models; and 4) To develop a robust coverage decision making process.