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Introducing evidence-based medicine in reimbursement procedures: does it affect the outcome?
Philippe Van Wilder1, Alain Dupont
1RIZIV National Insurance Agency against Sickness and Disability, Brussels, Belgium. philippe.vanwilder@riziv.fgov.be
Summary
Evidence of therapeutic value significantly impacts Belgian pharmaceutical reimbursement decisions. Failing to prove added value increases the odds of a negative decision, while extended evidence decreases them, all within strict timelines.
Area of Science:
- Health Economics
- Pharmaceutical Policy
- Regulatory Science
Background:
- The European Transparency Directive mandates transparent, objective, and timely pharmaceutical reimbursement decisions.
- Member states must adhere to strict timelines for evaluating reimbursement submissions.
Purpose of the Study:
- To assess the influence of therapeutic value evidence on Belgian pharmaceutical reimbursement decisions.
- To determine if therapeutic value evidence impacts decisions without violating strict timelines.
Main Methods:
- Analysis of 824 pharmaceutical reimbursement submissions in Belgium between 2002 and 2004.
- Statistical evaluation of the impact of claimed therapeutic value and evidence type on reimbursement outcomes.
Main Results:
- Only 67 submissions claimed added therapeutic value.
- Failure to prove added value significantly increased the odds of a negative decision (OR = 9.1).
- Submissions with extended evidence (line extensions) had significantly decreased odds of a negative decision (OR = 0.18).
- Median decision time was 175 days, adhering to timelines.
Conclusions:
- Evidence of therapeutic value is a significant factor in Belgian pharmaceutical reimbursement decisions.
- The decision-making process appears to balance evidence assessment with adherence to strict timelines.
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