Role of centralized review processes for making reimbursement decisions on new health technologies in Europe

BACKGROUND The purpose of this study was to compare centralized reimbursement/coverage decision-making processes for health technologies in 23 European countries, according to: mandate, authority, structure, and policy options; mechanisms for identifying, selecting, and evaluating technologies; clinical and economic evidence expectations; committee composition, procedures, and factors considered; available conditional reimbursement options for promising new technologies; and the manufacturers' roles in the process. METHODS A comprehensive review of publicly available information from peer-reviewed literature (using a variety of bibliographic databases) and gray literature (eg, working papers, committee reports, presentations, and government documents) was conducted. Policy experts in each of the 23 countries were also contacted. All information collected was reviewed by two independent researchers. RESULTS Most European countries have established centralized reimbursement systems for making decisions on health technologies. However, the scope of technologies considered, as well as processes for identifying, selecting, and reviewing them varies. All systems include an assessment of clinical evidence, compiled in accordance with their own guidelines or internationally recognized published ones. In addition, most systems require an economic evaluation. The quality of such information is typically assessed by content and methodological experts. Committees responsible for formulating recommendations or decisions are multidisciplinary. While criteria used by committees appear transparent, how they are operationalized during deliberations remains unclear. Increasingly, reimbursement systems are expressing interest in and/or implementing reimbursement policy options that extend beyond the traditional "yes," "no," or "yes with restrictions" options. Such options typically require greater involvement of manufacturers which, to date, has been limited. CONCLUSION Centralized reimbursement systems have become an important policy tool in many European countries. Nevertheless, there remains a lack of transparency around critical elements, such as how multiple factors or criteria are weighed during committee deliberations.