Journal
VALUE IN HEALTH
Volume 23, Issue 7, Pages 831-841Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jval.2019.11.009
Keywords
benefit-risk assessment; European regulatory; health preferences; health technology assessment; marketing authorization; preference research; pricing; quantitative preference data; reimbursement; stakeholder preferences
Funding
- AHRQ HHS [K12 HS026370] Funding Source: Medline
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Objective: This study examines European decision makers' consideration and use of quantitative preference data. Methods: The study reviewed quantitative preference data usage in 31 European countries to support marketing authorization, reimbursement, or pricing decisions. Use was defined as: agency guidance on preference data use, sponsor submission of preference data, or decision-maker collection of preference data. The data could be collected from any stakeholder using any method that generated quantitative estimates of preferences. Data were collected through: (1) documentary evidence identified through a literature and regulatory websites review, and via key opinion leader outreach; and (2) a survey of staff working for agencies that support or make healthcare technology decisions. Results: Preference data utilization was identified in 22 countries and at a European level. The most prevalent use (19 countries) was citizen preferences, collected using time-trade off or standard gamble methods to inform health state utility estimation. Preference data was also used to: (1) value other impact on patients, (2) incorporate non-health factors into reimbursement decisions, and (3) estimate opportunity cost. Pilot projects were identified (6 countries and at a European level), with a focus on multi-criteria decision analysis methods and choice-based methods to elicit patient preferences. Conclusion: While quantitative preference data support reimbursement and pricing decisions in most European countries, there was no utilization evidence in European-level marketing authorization decisions. While there are commonalities, a diversity of usage was identified between jurisdictions. Pilots suggest the potential for greater use of preference data, and for alignment between decision makers.
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