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The choice of pharmacoeconomic study design during drug development—part 2

✍ Scribed by Wendy Ungar

Publisher
John Wiley and Sons
Year
1997
Tongue
English
Weight
159 KB
Volume
6
Category
Article
ISSN
1053-8569

No coin nor oath required. For personal study only.

✦ Synopsis

Pharmaceutical manufacturers are faced with the challenge of when and how to conduct pharmacoeconomic (PE) evaluations to satisfy formulary decision-makers. 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) add-on to a phase III safety and ecacy randomized controlled clinical trial (RCT), (2) stand-alone phase IIIb trial and (3) a phase IV observational study. Hypothetical data on the cost of performing each type of study, the probability of a conclusive PE evaluation and the 5-year sales potential of a cost-eective product were incorporated into the model. At a discount rate of 7%, the incremental net bene®t of a phase IIIb PE study was $4.2 million compared to a phase III RCT and $10.5 million compared to a phase IV study. The incremental net bene®t of a stand-alone phase IIIb trial compared to an add-on phase III design was negligible when the formulary percentage of total sales was 25% and the discount rate 10%. Although the data used to demonstrate the model were hypothetical, decision analysis can be a useful tool for preparing a sensible development strategy or uncovering de®ciencies in an existing plant.

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