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'Fourth hurdle reviews', NICE, and database applications.

J E Paul1, P Trueman

  • 1RTI Health Solutions, P.O. Box 12194, Research Triangle Park, NC 27709-2194, USA. jpaul@rti.org

Pharmacoepidemiology and Drug Safety
|January 23, 2002
PubMed
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Gaining market access for new medical products now requires demonstrating cost-effectiveness and clinical effectiveness, not just safety and efficacy. The National Institute for Clinical Effectiveness (NICE) review process is a key example of this

Area of Science:

  • Health economics
  • Pharmaceutical policy
  • Biotechnology regulation

Background:

  • Market access for pharmaceuticals, medical technologies, and biotech products faces a 'fourth hurdle' beyond safety, efficacy, and quality.
  • This hurdle involves demonstrating clinical effectiveness and cost-effectiveness to regulatory and reimbursement agencies.
  • Governmental and non-governmental agencies are increasingly established to conduct these reviews.

Purpose of the Study:

  • To detail the review process of the National Institute for Clinical Effectiveness (NICE) in the UK.
  • To explore the impact of 'fourth hurdle' reviews on drug development and clinical trials.
  • To examine the use of databases and modeling in fourth hurdle assessments.

Main Methods:

  • Detailed description of the NICE review process.

Related Experiment Videos

  • Analysis of the impact of fourth hurdle reviews on pharmaceutical development.
  • Exploration of data and modeling applications in cost-effectiveness evaluations.

    • Main Results:

    • The 'fourth hurdle' necessitates proving a product's superiority over existing alternatives and its value for money.
    • NICE is a highly visible and influential agency conducting these reviews.
    • Fourth hurdle reviews are expected to significantly influence drug development and clinical trial design.

    Conclusions:

    • Regulatory approval requires demonstrating clinical and economic value, impacting market access and reimbursement.
    • The NICE process exemplifies the growing importance of health technology assessment in healthcare.
    • Databases and modeling are crucial tools for navigating the complexities of fourth hurdle reviews.