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Emerging lessons from the drug effectiveness review project.

Peter J Neumann1

  • 1Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts-New England Medical Center, Boston,Massachusetts, USA. pneumann@tufts-nemc.org

Health Affairs (Project Hope)
|June 8, 2006
PubMed
Summary

The Drug Effectiveness Review Project (DERP) synthesizes clinical evidence for drug reviews. Implementing evidence-based medicine for drug formulary decisions involves organizational, process, and leadership challenges beyond review methods.

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Area of Science:

  • Health Services Research
  • Evidence-Based Medicine
  • Pharmaceutical Policy

Background:

  • The Drug Effectiveness Review Project (DERP) is a multi-state collaboration.
  • DERP synthesizes clinical evidence for drug-class reviews to inform formulary decisions.
  • Evidence-based medicine implementation faces practical challenges.

Purpose of the Study:

  • To highlight challenges in implementing evidence-based medicine for drug formulary decisions.
  • To examine organizational, process, and leadership issues in evidence review.
  • To discuss the role of public sector in judging clinical evidence.

Main Methods:

  • Alliance of fifteen states and two private organizations.
  • Synthesis and judgment of clinical evidence for drug-class reviews.

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  • Exploration of practical implementation questions.

    • Main Results:

    • Evidence review for drug formulary decisions involves complex challenges.
    • Key issues include the use of surrogate markers, review transparency, cost-effectiveness considerations, and the public sector's role.
    • Organizational, process, and leadership factors are critical for successful evidence-based reviews.

    Conclusions:

    • Implementing evidence-based medicine for drug formulary decisions extends beyond methodological refinement.
    • Effective drug reviews require careful consideration of organizational structure, procedural transparency, and leadership.
    • The DERP experience provides insights into the practicalities of evidence-based pharmaceutical policy.