Subject(s)
Biomedical Technology , Biotechnology , Research Support as Topic/trends , Biotechnology/economics , Financing, Government , Humans , Interinstitutional Relations , National Institutes of Health (U.S.) , Private Sector , Research Support as Topic/organization & administration , Research Support as Topic/statistics & numerical data , United StatesABSTRACT
OBJECTIVES: The objectives of this study were to examine variations in the methods used by researchers to estimate QALYs in published cost-effectiveness analyses, and to investigate whether the methods have improved over time. DATA AND METHODS: Using a MEDLINE search, the authors identified 86 original cost-effectiveness analyses, published between 1975 and 1995, that used QALYs as the measure of effectiveness. For each study, they recorded the health-state classification system, the source of the preference weights, the measurement technique, and the discount rate. The methods used were compared with the recommendations of the U.S. Panel on Cost-Effectiveness in Health and Medicine. RESULTS: Only 20% of the studies used "generic" health-state classification systems (e.g., health utilities index); 21% relied on community-based weights; 40% used formal measurement techniques (e.g., time-tradeoff method); and 88% discounted both future costs and QALYs. There was little evidence that methods had improved over time. CONCLUSIONS: The results illustrate extensive variation in the construction of QALYs in cost-effectiveness analyses and reveal that most studies have not adhered to practices now recommended by leaders in the field. There is a need for more methodologic rigor and consistency if the results of such studies are to be compared and used for purposes of allocating resources.
Subject(s)
Decision Support Techniques , Health Care Costs , Quality-Adjusted Life Years , Classification , Cost-Benefit Analysis , Humans , Research DesignABSTRACT
The Food and Drug Administration (FDA) has issued draft guidelines that would require more rigorous standards for making pharmacoeconomic claims. This paper critiques the guidelines and explores the objectives of market regulation for health-related cost and effectiveness information on pharmaceutical products. It argues that the FDA should proceed with caution and flexibility. In particular, regulations should recognize the potential usefulness of pharmacoeconomic information in helping health care decisionmakers make better-informed choices. They also should acknowledge the enhanced ability of those using the information to evaluate pharmacoeconomic studies and the degree to which the various players in the market can impose their own regulatory discipline.
