Model-Based Drug Evaluation in Chronic Disease: Promise, Pitfalls, and Positioning
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0092-8615/2001 Copyright 0 2001 Drug Information Association Inc.
MODEL-BASED DRUG EVALUATION IN CHRONIC DISEASE: PROMISE, PITFALLS, AND POSITIONING* A. DAVIDPALTIEL, PHD Associate Professor, Yale School of Medicine/Yale School of Management, New Haven, Connecticut
Despite the remarkable advances that have been made in the treatment of chronic disease, little is known about whether new drugs deliver adequate value for money. Recognizing that it is not always possible to obtain such information from a clinical trial, economic analysts sometimes turn to models to estimate comparative resource consumption and economic pe~ormunce.Model-based evaluations appear with increased frequency in both the scholarly literature and pharmaceutical industry promotional materials. Yet, skepticism about the rigor and objectivity of such studies often limits their influence among orher imporrant audiences. This paper offers a pracritioner ’s view of the promise of model-driven analysis, inventories the standard objections voiced by critics, and proposes a role for modeling in the drug development and evaluation process. The argument is framed within the context of the inevitability of decision making, wherein evaluation models serve not to supplant decision makers but rather to leverage existing sources of information. Key Words: Cost-effectiveness; Decision analysis; Pharmacoeconomics; Simulation; Mathematical models
INTRODUCTION CHRONIC DISEASE IMPOSES a heavy and growing burden on society, in terms of morbidity, mortality, reduced productivity, and health care costs. In the United States alone, more than 90 million people are currently living with at least one prolonged illness that will not resolve spontaneously and is unlikely to be cured completely. According to the Robert Wood Johnson Foundation,
*This research is supported in part by the Societal Institute for the Mathematical Sciences (SLMS) via Grant DA 09531-OlA2 from the National Institute on Drug Abuse and by the Yale Center for Interdisciplinary Research on AIDS via Grant MH56826-01A1 from the National Institute on Mental Health. Reprint address: AD Paltiel, Yale School of Medicine, 60 College Street, Room 305, New Haven, CT 06520-8034. E-mail: [email protected].
these conditions account for 70% of all United States deaths and for more than 60% of the nation’s medical care costs. More than a third of the total years of potential life lost before age 65 are attributable to chronic illness (1). With 80% of those over age 65 expected to have at least one chronic health problem, chronic disease represents not only a large but also a growing social health problem (2). According to a recent report in Medicine and Health Perspectives, “the cost and prevalence of chronic illness in the United States in the 1990s are emerging as problems that threaten to overwhelm a health care system that was designed primarily to meet the often very different needs of acute-care patients” (3). In the face of this dramatic growth in both the incidence and cost of chronic illness, there
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