Abstract

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.