A comparative analysis of managed entry agreements in Europe: trends, reporting practices, and financial outcomes.

Abstract

Background: Payers use Managed Entry Agreements (MEAs) across Europe to manage the financial risks associated with high-cost medicines. While these agreements aim to improve affordability and address uncertainty, their confidential nature raises concerns about transparency, international price referencing, and the validity of economic evaluations. This study examines MEA practices across 13 European countries, analyzing adoption trends, reporting practices, and financial outcomes, and their implications for payer decision-making.

Methods: Data from 2016 to 2022 were collected through (1) mapping national MEA frameworks, stakeholders, and implementation processes; (2) desk research on publicly available activity and financial reports; and (3) validation interviews with public-sector negotiators in each country.

Results: Across 13 countries, 24 MEA frameworks were identified. MEA usage increased substantially, with the highest numbers in 2022 in Germany (356) and France (349), and the largest growth in Belgium (+ 250%) and Norway (+ 227%). Reported expenditure reductions ranged from €0.04 billion (Slovakia) to €5.56 billion (France), with estimated discounts between 14% (Germany) and 54% (Belgium). Reporting remained heterogeneous, with activity data available for fourteen frameworks and financial data for ten. More granular reporting, such as by discount mechanism (Netherlands), therapeutic class (France), or gender (Sweden), was uncommon.

Conclusion: The growing use of MEAs across Europe has widened the gap between list and actual prices. Incomplete and non-standardized reporting reduces the ability to assess financial performance and limits cross-country comparability. Harmonized reporting of aggregated data, without compromising confidentiality, could improve transparency, accountability, and support value-based pricing strategies.