Introducing evidence-based medicine in reimbursement procedures: Does it affect the outcome?

Objectives: The European Transparency Directive requires that reimbursement decisions of member states are taken in a transparent, objective, and verifiable way within strict timelines. We investigated whether evidence of therapeutic value was a factor affecting the Belgian pharmaceutical reimbursement decision without compromising the respect of strict timelines. Methods: We analyzed 824 reimbursement submissions within the period 2002 to 2004. Results: Only 67 submissions claimed added therapeutic value versus available alternatives: if the applicant failed to prove added value the odds ratio (OR) for a negative decision increased significantly: OR = 9.1 (2.3-35.6). There were 399 "limited evidence" submissions (new medicinal products or new indications) and 425 "extended evidence" submissions (mainly line extensions). The OR for a negative decision decreased significantly for submissions with extended evidence: OR = 0.18 (0.12-0.27). The median time to decision was 175 days. Conclusions: Both factors suggest that evidence plays a role in the decision-making process.