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OMERACT II: the biologics perspective

V Strand1

  • 1Division of Immunology, Stanford University, San Francisco 94131, USA.

The Journal of Rheumatology
|July 1, 1995
PubMed
Summary

Pharmacoeconomic analyses are crucial for biologic agents in rheumatic diseases. Including cost and quality-of-life data in trials will support regulatory approval and formulary inclusion.

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Area of Science:

  • Rheumatology
  • Pharmacoeconomics
  • Health Services Research

Background:

  • Biologic agents offer targeted immune modulation for rheumatic diseases.
  • These advanced therapies present significant manufacturing, administration, and monitoring costs.
  • Their efficacy, though potentially brief, may serve as effective induction therapy.

Purpose of the Study:

  • To highlight the necessity of pharmacoeconomic analyses in phase III trials for biologic agents.
  • To emphasize the need for comprehensive cost-effectiveness data for regulatory and health services approval.
  • To advocate for the inclusion of patient-reported outcomes in clinical trial evaluations.

Main Methods:

  • Prospective collection of direct and indirect costs associated with biologic treatments and alternatives.
  • Integration of disease-specific functional measures and generic health status/quality-of-life instruments in clinical trials.
  • Utilizing health utilities instruments for comparing diverse therapeutic interventions.

Main Results:

  • Biologic agents demonstrate clinical improvement but require thorough economic evaluation.
  • Data collection should encompass treatment costs, patient-reported outcomes, and toxicity-related expenses.
  • Identifying economic benefits of maintained function and work capacity is essential.

Conclusions:

  • Pharmacoeconomic data and patient-reported outcomes are vital for the approval and formulary placement of biologic agents.
  • Comprehensive cost-benefit analyses, including indirect costs and quality of life, are necessary.
  • Biologics hold promise for early disease intervention, necessitating robust economic justification.

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