Health Preference Research in Europe: A Review of Its Use in Marketing Authorization, Reimbursement, and Pricing Decisions—Report of the ISPOR Stated Preference Research Special Interest Group

• Published in: Value in health Vol. 23; no. 7; pp. 831 - 841
• Main Authors: Marsh, Kevin, van Til, Janine A., Molsen-David, Elizabeth, Juhnke, Christine, Hawken, Natalia, Oehrlein, Elisabeth M., Choi, Y. Christy, Duenas, Alejandra, Greiner, Wolfgang, Haas, Kara, Hiligsmann, Mickael, Hockley, Kimberley S., Ivlev, Ilya, Liu, Frank, Ostermann, Jan, Poder, Thomas, Poon, Jiat L., Muehlbacher, Axel
• Format: Journal Article
• Language: English
• Published: Lawrenceville Elsevier Inc 01.07.2020; Elsevier Science Ltd; Elsevier
• Subjects: Authorization; benefit-risk assessment; Business administration; Decision analysis; Decision makers; Decision making; Documentary evidence; European regulatory; Health care; Health care delivery; health preferences; health technology assessment; Humanities and Social Sciences; Literature reviews; Marketing; marketing authorization; preference research; Preferences; pricing; Quantitative analysis; quantitative preference data; Reimbursement; stakeholder preferences; Technology; Treatment preferences; Websites; Europe; health technology assessment; European regulatory; health preferences; benefit-risk assessment; reimbursement; stakeholder preferences; marketing authorization; quantitative preference data; preference research; pricing
• ISSN: 1098-3015; 1524-4733
• DOI: 10.1016/j.jval.2019.11.009

This study examines European decision makers' consideration and use of quantitative preference data. 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. 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. 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. •Health decisions involve value judgments, and decision makers are interested in the use of health preference data to support these judgments. Recent reviews have identified an increasing amount of health preference research to inform regulatory decisions. There is, however, no summary of European decision makers’ use of this health preference data—either the guidance they offer on which preference methods to use and when or the findings that have been used in decisions.•Preference data utilization was identified in 22 countries 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. Quantitative preference data support reimbursement and pricing decisions in most European countries. Pilots have explored the use of preference data for European-level marketing authorization decisions.•Health preference data currently have a wide range of applications: (1) valuing health impacts, (2) valuing other impacts on patients, (3) incorporating nonhealth factors into reimbursement decisions, and (4) estimating opportunity cost. Pilot projects point to ongoing interest in multicriteria decision analysis methods and choice-based methods to elicit patient preferences.