Identifying and Rewarding Pharmaceutical Innovation: Application in an EU Member State

Abstract

The European Pharmaceutical Forum (EPF) issued "good practice" recommendations on the need to identify and reward valuable innovation. We investigated the compliance of the Belgian reimbursement procedure with the specific EPF recommendations by analyzing all 110 submissions for added therapeutic value (ATV) in the period 2002-2007. Prior to the reimbursement decision, a relative assessment of the therapeutic value was done with a binary outcome (ATV granted or refused). Overall, ATV was granted for 61 submissions (55%) or 10 compounds per year Because this number is similar to the number of new products with CDER priority review or with "important to major" therapeutic benefit granted by the French reimbursement authority, we expect that valuable innovation has been identified. A positive reimbursement decision was obtained in 76 cases (69%). Granting of ATV (P < .001) was the most significant factor affecting the reimbursement decision (OR and its 95% CI: 179 [5.5-58.3]), suggesting the Belgian reimbursement procedure also rewards value for innovative products as EPF recommends. Because more than 50% of the variance still remains unexplained, one cannot confirm or reject the impact of other factors (financial, economic, etc) possibly affecting the reimbursement decision.