BACKGROUND: Much of the discussion of the use of health technology assessment (HTA) in pricing and reimbursement decisions for pharmaceuticals and other health technologies is in the context of healthcare systems with one major payer or HTA agency. We read about the analyses conducted for or by, and decisions made by, IQWiG/G-BA in Germany or NICE in England.1,2 We also read about the similarities and differences of decisions made by the payers/agencies in different countries.3,4 In these (largely) “single-payer” healthcare systems, the conduct and use of HTA is relatively straightforward. The manufacturer submits clinical data (plus an economic model in jurisdictions that require them) to the HTA agency or payer according to the required guidelines, and merely waits for the outcome. However, if one takes a broad, worldwide view, healthcare systems with one major payer or HTA agency are in the minority. Most healthcare systems are “pluralistic,” with many payers. The most well-known example is the United States, which has a multipayer private healthcare system operating alongside a public system, plus systems serving particular categories of individuals, such as military veterans. The conduct and use of HTA/HEOR in pluralistic healthcare systems is likely to be more complex, since the different payers may have different needs, data requirements and objectives. They may also have budgets of different sizes, with implied differences in willingness to pay for new health technologies. In addition, in pluralistic systems, the resources for conducting HTAs/HEOR are more thinly spread, raising doubts about whether a rigorous assessment can be performed in all cases. This topic was selected for further study by the ISPOR HTA Council, which established a Working Group to consider these issues and to make recommendations for how the conduct and use of HTA could be improved in pluralistic healthcare systems. The group has recently produced its report and the main findings are summarized here. For more details and an extensive list of references, please consult the full paper.
