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.

Keywords: benefit-risk assessment, European regulatory, health preferences, health technology assessment, marketing authorization, preference research, pricing, quantitative preference data, reimbursement, stakeholder preferences

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