TY - JOUR
T1 - Health Preference Research in Europe
T2 - A Review of Its Use in Marketing Authorization, Reimbursement, and Pricing Decisions - Report of the ISPOR Stated Preference Research Special Interest Group
AU - Marsh, Kevin
AU - van Til, Janine A.
AU - Molsen-David, Elizabeth
AU - Juhnke, Christine
AU - Hawken, Natalia
AU - Oehrlein, Elisabeth M.
AU - Choi, Y. Christy
AU - Duenas, Alejandra
AU - Greiner, Wolfgang
AU - Haas, Kara
AU - Hiligsmann, Mickael
AU - Hockley, Kimberley S.
AU - Ivlev, Ilja
AU - Liu, Frank
AU - Ostermann, Jan
AU - Poder, Thomas
AU - Poon, Jiat L.
AU - Muehlbacher, Axel
PY - 2020/7
Y1 - 2020/7
N2 - 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.
AB - 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.
KW - Benefit-risk assessment
KW - European regulatory
KW - Health preferences
KW - Health technology assessment
KW - Marketing authorization
KW - Preference research
KW - Pricing
KW - Quantitative preference data
KW - Reimbursement
KW - Stakeholder preferences
KW - 22/2 OA procedure
UR - http://www.scopus.com/inward/record.url?scp=85087391192&partnerID=8YFLogxK
U2 - 10.1016/j.jval.2019.11.009
DO - 10.1016/j.jval.2019.11.009
M3 - Article
AN - SCOPUS:85087391192
VL - 23
SP - 831
EP - 841
JO - Value in health
JF - Value in health
SN - 1098-3015
IS - 7
ER -