Presentation (CTI)

OBJECTIVES: Pharmaceutical payback mechanisms are increasingly used to contain public pharmaceutical expenditure, yet their design, intensity and relationship with Health Technology Assessment (HTA) maturity vary across the EU. This study aimed to map EU mechanisms, classify payback burden, and explore whether HTA maturity is associated with payback intensity.
METHODS: A scoping review was conducted according to PRISMA-ScR guidance. PubMed, Google Scholar, Scopus, Web of Science, OECD iLibrary, EC publications, national agency and policy reports were reviewed for 2008-2025. Eligible sources described clawbacks, statutory rebates, Managed Entry Agreements (MEAs) and HTA maturity indicators, including formal legislation, dedicated bodies, process transparency and EU HTA Regulation readiness. Due to payback confidentiality, burden was classified using an ordinal evidence-based matrix. HTA maturity was categorized as mature/leading, established, developing or emerging/minimal. Exploratory Spearman correlation used ordinal scores for HTA maturity and payback burden categories.
RESULTS: Across 27 EU Member States, payback burden varied substantially. Very high/high burden was observed in 3/27 countries (Greece, Romania and Hungary), all within emerging/developing HTA systems. Greece was the most extreme case, with companies financing approximately 54% of public pharmaceutical expenditure through clawbacks/rebates. Medium-high burden occurred in 4/27 countries (Bulgaria, Croatia, Poland and Italy), showing comparable intensity across different HTA maturity levels. Italy was the outlier, as medium-high burden persisted despite mature/leading HTA, monitoring registries and MEA use. Medium burden was most frequent to 12/27 countries, spanning mature/established and developing systems. Lower burden accounted for the remaining 8/27 countries, where ex-ante tools were more prominent. Exploratory analysis showed no meaningful monotonic association between HTA maturity and payback burden (Spearman’s rho=-0.10; p=0.63; n=27).
CONCLUSIONS: HTA maturity was not consistently associated with lower payback intensity but appeared to influence how paybacks are operationalised. Rather than primarily reducing expenditure, HTA supports evidence-based prioritisation and resource allocation, potentially improving sustainability, transparency and predictability of pharmaceutical cost-containment policies.