Presentation (CTI)

OBJECTIVES: The increasing use of high-cost,multi-indication therapies has accelerated the shift from traditional pricing toward Indication-Based Pricing(IBP) and Value-Based Reimbursement(VBR) in Europe. Western European countries increasingly use outcome-based Managed Entry Agreements(MEAs) to support patient access while maintaining financial sustainability. In contrast, Central and Eastern European(CEE) countries, including Türkiye,mainly rely on financial-based MEAs, such as mandatory discounts and price-volume agreements. This policy review examines the structural causes of this difference and explores whether the absence of systematic Health-Related Quality of Life data collection, particularly EQ-5D, limits the implementation of VBR and IBP in the CEE region.
METHODS: A comparative policy analysis was conducted by reviewing HTA guidelines, reimbursement frameworks, and MEA models in selected Western European systems, including the UK and Italy,and CEE systems,including Türkiye,Poland, and Hungary. The analysis focused on the infrastructural requirements for IBP, including national patient registries,Real-World Evidence generation, and routine collection of Patient-Reported Outcome Measures such as EQ-5D.
RESULTS: The review identified a major infrastructural divide between regions.In Western Europe, EQ-5D and related outcome data are increasingly used within registries and HTA processes to monitor clinical and quality-of-life outcomes. This enables more dynamic, indication-specific pricing and performance-linked reimbursement.In contrast, CEE systems face administrative, technical, and data infrastructure barriers that limit routine real-world tracking of patient-level utility changes.Without reliable EQ-5D-based evidence, payers are often unable to assess real-world value and therefore negotiate primarily on price. As a result, multi-indication therapies frequently receive uniform blended prices, often linked to substantial discounts, which may delay access and affect regional launch sequencing.
CONCLUSIONS: Advancing VBR and IBP in the CEE region requires more than pricing reform.Systematic integration of EQ-5D into national registries and reimbursement data systems could enable real-world utility measurement, support outcome-based MEAs,and facilitate indication-specific value assessment. Building this PROM infrastructure is essential for aligning CEE market access practices with European value-based healthcare standards.