ABSTRACT
INTRODUCTION Economic analysis of new vaccines has become increasingly important, contributing to decisions ranging from vaccine development to vaccine recommendation and program implementation. Over the past decades, the cost of developing and licensing pharmaceutical products has increased markedly. An estimate based on the cost of new drug development suggests costs ranging from $400 to $800 million in 2000 dollars. This estimate is nearly four times higher than costs estimated previously using a similar methodology in 1987 dollars (1). Costs associated with development of vaccines that use new technologies or contain novel adjuvants may be even higher. As vaccine development costs have risen, so too have vaccine prices. Driven by the high prices of new vaccines, the cost of fully vaccinating a child in the United States in 2008 was more than $1200 in the private sector and $850 in the public sector (2). This cost exceeds by more than twofold the cost to fully vaccinate a U.S. child in 2001 (3). Adolescent vaccination adds about $500 to these costs, driven by the three-dose human papillomavirus (HPV) vaccine, which costs $120 per dose. This increase has outstripped expansion of appropriations to support state-based vaccination programs, forcing some states to decide which vaccinations can and which cannot be provided for children who need assistance but do not qualify for coverage under the Vaccines for Children program. Recognizing the challenges to the U.S. vaccine-financing system and the value of stimulating continued development of new products, in 2004 the U.S. National Academy of Science’s Institute of Medicine (IOM) recommended major changes to increase incentives for new product development, increase stability of vaccine supply, and enhance coverage. One recommendation calls for insurance mandates and subsidies for current and future vaccines based on the values of the products to society using a methodology that considers ‘‘such factors as reduced health expenditures, enhanced quality of life, and increased labor productivity’’ (4). Although the IOM recommendations have not been implemented, the suggestion that vaccine prices, in part, should reflect their societal value raises some essential questions: can an economic analysis of a new vaccine appropriately determine its societal value? Are the analytic strategies sufficient? Can the necessary data be obtained? And would the results be viewed by manufacturers and payers as valid?
