Presentation (CTI)

OBJECTIVES: A managed entry agreement (MEA) is an arrangement between a manufacturer and a payer that enables reimbursement of a health technology subject to specified conditions. This research characterises MEA implementation patterns across EU5 markets, including prevalence, sub-type composition, effectiveness, and evolution over time.
METHODS: A survey was conducted with N=15 ex-payer experts across EU5 markets (N=3 per market). Respondents quantified MEA prevalence as a % of recommended drugs, allocated utilization shares across six MEA subtypes (confidential discounts/rebates, fixed per-patient pricing, price-volume agreements, budget caps, free-stock/continuation, instalments/annuities), and rated effectiveness on a 1-5 Likert scale. Open-ended responses captured rationale and trends.
RESULTS: MEA prevalence varied across markets: UK, France and Spain respondents reported the highest MEA use, covering ≥60% of recommended drugs, while Italian and German respondents reported lower rates of 40-60% and 0-20%, respectively. In most markets (except Germany), confidential discounts/rebates were the dominant MEA type with use estimated between 60-100%. Volume-based agreements (price-volume, budget caps) were the next most common, while performance-based arrangements were largely confined to high-cost, ultra-rare, and/or gene therapies. Mean effectiveness was rated 3.6/5, with the highest ratings from UK, Spain, and France. Furthermore, 64% of respondents observed MEAs becoming more common; however, Italian respondents diverged, citing an AIFA-led decline in MEA use due to feasibility/ bureaucracy.
CONCLUSIONS: Although MEAs remain a cornerstone tool, use across EU5 is heterogeneous, with France, Spain, Italy, and the UK, primarily leveraging confidential discounting and volume-based contracts to control net pricing; whereas Germany relies on mandatory GKV-SV price-volume agreements to provide financial certainty. There is generally low appetite for more innovative agreements (including performance-based contracts) and, where used, these are confined to ATMPs where there is substantial clinical and financial uncertainty.