The role of health economic analyses in vaccine decision making.

Beginning in the 20th century with the consideration of the seven-valent pneumococcal conjugate vaccine in the US, the cost effectiveness became a topic of discussion when this vaccine was being considered for universal use by the US Advisory Committee on Immunization practices (ACIP). In 2008, the ACIP began using formal criteria for the presentation of such data and their inclusion in ACIP discussions. More recently, the US Institute of Medicine has recommended that health economic considerations play a primary role in the prioritization of future vaccine for development. However, such analyses can be biased towards vaccines that provide economic benefit rather than those that reduce severe morbidity and mortality. This is because the economic impact of minor common events that result in medical utilization or time lost from work for parents can outweigh the economic impact of severe morbidity and mortality. Thus diseases with a low mortality and morbidity but with a common clinical manifestation such as the common cold could be prioritized over vaccines against diseases such as meningococcal sepsis where the morbidity and mortality associated with each case is very high, but there is no associated common clinical syndrome. Thus the use of cost effectiveness analyses as a 'gating criteria' to decide which vaccines should be developed or routinely used runs the risk of transforming vaccines into primarily a tool for achieving cost savings within the health care system rather than a public health intervention targeting human suffering, death and disability. It is the purpose of this article to review the framework under which health economic evaluations can be undertaken, to review the experience with and reliability of such analyses, and to discuss the potential negative implications of the use of health economic analyses as a primary decision making tool.