Presentation (CTI)

OBJECTIVES: Evidence-informed frameworks guide reimbursement and access decisions for costly innovations. The 2019 European Commission Expert Panel defined value-based healthcare (VBHC) through four pillars: personal, technical, allocative and societal value. Separately, the World Health Organization (WHO) regional office for Europe published a Managed Entry Agreement (MEA) policy framework. To our knowledge, no structured framework connects VBHC pillars to MEA operational principles for achieving access. This study aimed to develop a conceptual framework mapping MEA archetypes to VBHC pillars.
METHODS: An evidence-informed document analysis used the 2019 VBHC framework and the WHO-Europe MEA policy framework, supplemented by literature on international financing and access models. Eight MEA archetypes were identified: (1) financial MEAs, (2) outcome-based MEAs, (3) carve-out funds, (4) installment payments, (5) risk pooling, (6) subscription models, (7) portfolio/basket agreements, and (8) reinsurance/stop-loss mechanisms. A qualitative coding framework assessed each model against value dimensions most directly supported by its core mechanism.
RESULTS: The framework suggests different MEA models embody distinct value priorities with inherent trade-offs across VBHC pillars. While all MEA models aligned with multiple VBHC pillars, the degree of alignment varied. Outcome-based MEAs primarily aligned with personal and technical value through their focus on patient outcomes, evidence generation, and performance accountability. Financial MEAs, carve-out funds, and reinsurance mechanisms primarily aligned with allocative value through budget protection, affordability and risk distribution. Subscription models, portfolio agreements, and installment-payments primarily aligned with societal value by supporting long-term sustainability, access to innovation, and management of high-cost therapies. No single model aligned equally across all pillars, suggesting that combinations of MEAs may be required to balance value objectives.
CONCLUSIONS: MEAs are not merely pricing tools, but also operational mechanisms for translating VBHC principles into access decisions. This framework provides a structured approach for aligning MEA selection with explicit values and supports portfolio approaches to balance competing health system objectives.