Building an Understanding of the Economics of a New Vaccine Through the Use of Clinical Trial and Non-Clinical Trial Data: The Case of the Zoster Vaccine
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Glenn Davies, Merck Research Laboratories  Robbin F. Itzler, Merck Research Laboratories  *James M. Pellissier, Merck Research Laboratories 

Keywords: cost analysis, resource use, healthcare claims, herpes zoster

The demonstration of compelling economic value represents an important hurdle to the success of a drug or vaccine in the marketplace. A continuing challenge in outcomes research and clinical development is to decide the magnitude and level of detail of trial-based economic assessments. The Shingles Prevention Study (SPS), a large randomized, double-blinded, placebo-controlled clinical trial, showed a live-attenuated varicella-zoster virus vaccine prevented herpes zoster, post-herpetic neuralgia and reduced the morbidity associated with incident zoster and its sequelae. Within SPS, health economic data were gathered. We describe the nature of the data necessary for the development of an economic case for the zoster vaccine, the approach and constraints in collection of economic data in SPS, and present interpretation of the trial-based results in the context of the economic analysis.

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For more information send email: ichps@amstat.orgHPSS 2005