Health Economic Data Requirements and Availability in the European Union: Results of a Survey Among 10 European Countries

Objectives: To compare data requirements and their availability for health economic (HE) evaluations in five countries in Central/Eastern Europe (CEE) (Poland, the Czech Republic, Slovakia, Hungary, and Romania) and five countries in Western Europe (WE) (the United Kingdom, France, Germany, The Netherlands, and Sweden). Methods: A questionnaire was developed and distributed to market access personnel from Pfizer who were asked to complete the questionnaire either from their own knowledge or with support of external experts. The questionnaire focused on the obligation to conduct HE assessment for reimbursement submissions, local HE guidelines, applied discount rates for future costs and effects, willingness-to-pay thresholds, and available data sources. Results: HE is mandatory in all CEE and three WE participating countries for reimbursement applications of innovative drugs. Usually, cost-effectiveness analysis and budgetimpact analyses are required. The preferred outcome of costeffectiveness analysis is quality-adjusted-life years. In Romania, France, and the Czech Republic, guidelines could not be identified at the time of the survey. The applicant usually prepares HE evaluations; in Sweden, the United Kingdom, The Netherlands, and Poland, unlocked models have to be presented for scrutiny. Discount rates vary from 1.5% to 5%, and, usually, is the same for costs and outcomes (except in The Netherlands and Poland). Only the United Kingdom, Poland, and Slovakia have an explicit willingness-to-pay threshold. In Poland, it is based on the gross domestic product per capita, and in Slovakia, it is based on multiples of average monthly salary. Differences were found on data availability. In WE, data can be acquired easier than in CEE. Health insurance funds do not provide their data unless they were published. Patient registries are either not available in CEE or difficult to access, so applicants mostly rely on retrospective medical chart data, hospital information systems, or expert panels. Conclusions: We found similar requirements for HE analyses in CEE and WE but differences in data availability. This results in less accurate inputs across the CEE, influencing analyses’ outcomes.