Managed Entry Agreements: Can CEE Countries Mutualize Lessons Learned?

Issue: Managed Entry Agreements (MEAs) in CEE are often negotiated individually, leading to inconsistent access and varying financial outcomes. This panel will debate whether MEAs can be mutualized across CEE to offer harmonized frameworks and shared learnings, or if national heterogeneity renders mutualization impractical. Overview: CEE countries face common challenges: limited negotiating power with manufacturers, scarce data on real-world outcomes, and budget constraints. While a collective MEA approach could streamline negotiations, increase transparency, and improve patient access, it may falter due to divergent regulatory standards, reimbursement timelines, and economic capacities. This 60-minute session (10 minutes per speaker, 20-minute moderated debate, 10-minute audience Q&A) is structured to provide comprehensive timing: 10 min – Rok Hren, PhD (University of Ljubljana) advocates regionally aligned risk-sharing frameworks to optimize payer collaboration. 10 min – Guenka Petrova, PhD (Medical University of Sofia) highlights benefits of data-sharing for biologics but cautions about achieving consensus on value metrics. 10 min – Anna Kowalczuk, PhD, MSc (Polish HTA Agency) emphasizes legal and procedural disparities that may impede mutualization. 20 min – Moderated debate led by Izabela Pieniazek (Certara), exploring governance models, data infrastructure, and financial implications. 10 min – Audience Q&A and interactive discussion on next steps. Attendees—including HTA bodies, payers, patient advocates, and industry representatives—will explore whether a phased or sub-regional approach could overcome obstacles. By session end, participants should have a clearer view of actionable steps toward or against MEA mutualization in CEE.