The choice of pharmacoeconomic study design during drug development—part 1

✍ Scribed by Wendy Ungar

• Publisher: John Wiley and Sons
• Year: 1997
• Tongue: English
• Weight: 135 KB
• Volume: 6
• Category: Article
• ISSN: 1053-8569
• DOI: 10.1002/(sici)1099-1557(199711/12)6:6<391::aid-pds276>3.0.co;2-4

✦ Synopsis

Given the rising cost of health care, it is no longer sucient to demonstrate the safety and ecacy of a medical intervention. A medication must have exhibited economic bene®t as well. Pharmaceutical manufacturers are faced with the challenge of when and how to conduct pharmacoeconomic (PE) evaluations to satisfy third-party drug formulary decision-makers. A wide variety of study designs and methodologies are available to assess economic bene®t during drug development. Choosing the best strategy is a complex process. To illustrate the usefulness of decision analysis for strategic planning in drug development, a model was created to compare the cost±bene®t of three PE design options: (1) addon to a phase III safety and ecacy randomized controlled clinical trial (RCT), (2) stand-alone phase IIIb trial and (3) a post-marketing phase IV observational study. Although this model does not represent all the factors involved in a complicated drug development decision, the exercise may facilitate the decision process by rendering the inputs and probable consequences of various options more transparent to the decision-maker. Thus decision analysis can be a useful tool for preparing a sensible development strategy or uncovering de®ciencies in an existing plan.