POST-LAUNCH STUDIES - WHAT IS DESIRABLE, WHAT IS FEASIBLE?

Author(s)

Mason A1, Drummond MF1, Towse A2, 1University of York, York, United Kingdom; 2Office of Health Economics, London, United Kingdom

OBJECTIVE: Given the increased interest in conducting pharmacoeconomics and outcomes studies post-launch, the objective of this study was to explore the desirability and feasibility of different types of studies. METHODS: The published literature on post-launch studies was reviewed and the recommendations for further research made by the National Institute for Clinical Excellence (NICE) in the UK were analysed. In addition, global heads of pharmacoeconomics and outcomes research (PE/OR) in major pharmaceutical companies were surveyed to ascertain their experience in conducting studies post-launch and the problems encountered. RESULTS: In the first 46 technology appraisal of drugs conducted by NICE, recommendations for further research included head-to-head studies of the new drug with relevant alternatives (39% of appraisals); better information on impacts on quality of life (43%); longer term evidence on compliance, adverse events or maintenance of clinical effect (41%); study of the drug in relevant patient sub-groups (33%); and understanding the most cost-effective use of the drug in routine practice (43%). The survey of heads of PE/OR departments revealed a wide variety of experience with conducting post-launch studies. The problems identified included the need for large sample sizes, difficulties in financing studies and the unfavourable risk-benefit of some studies from a commercial perspective. CONCLUSIONS: Whilst it is desirable to conduct pharmacoeconomics and outcomes research post-launch, those bodies recommending such studies should pay more attention to the practical and methodological challenges raised by certain study designs.

Conference/Value in Health Info

2004-05, ISPOR 2004, Arlington, VA, USA

Value in Health, Vol. 7, No. 3 (May/June 2004)

Code

PHP40

Topic

Health Policy & Regulatory

Topic Subcategory

Pricing Policy & Schemes

Disease

Multiple Diseases

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