Session (CTI)

PURPOSE: This workshop will examine how a pan-European solidarity-based reimbursement model (PANSOL) could complement EU HTA processes by translating evidence into joint access decisions for high-cost and orphan medicines. Using PANSOL as the working case, participants will test which elements of a shared reimbursement pathway are scientifically defensible, politically feasible and operationally acceptable across European health systems. DESCRIPTION: Professor Lieven Annemans will chair the session and frame the access problem: persistent launch/reimbursement disparities, fragmented national pricing and reimbursement processes, and the boundary between Joint Clinical Assessment and national appraisal. Tanja Novakovic (Speaker 1; 10 min.) will define the equity and affordability challenge from a payer/HTA perspective, focusing on where current pathways create delays, duplication and unequal negotiating capacity. Krzysztof Landa (Speaker 2; 10 min.) will introduce PANSOL as a conceptual model: voluntary or enhanced-cooperation participation, light-touch EU-level HTA/appraisal, pooled GDP-proportional financing, centralised negotiation, horizon scanning and risk-sharing for high-cost and orphan medicines. Mark Parker (Speaker 3; 15 min.) will assess implementation requirements, including governance, selection criteria, value and affordability thresholds, evidence development, confidentiality, national competence, and safeguards against unintended incentives.