2025/01/01 by Mario Cesare Nurchis, Gian Marco Raspolini, Pietro Derrico +4
Economics, Econometrics and Finance · Medicine · #Biomedical Ethics and Regulation #Health Systems, Economic Evaluations, Quality of Life #Pharmaceutical Economics and Policy
paper · doi:10.1017/s0266462325100251
openalex publication_date 2025/01/01 · openalex created_date 2025/10/10 · openalex updated_date 2026/07/28
OBJECTIVES: Health technology assessment of medical devices (HTA-MDs) presents unique challenges compared to pharmaceuticals. Total MD expenditure continues to grow in Europe, and countries typically conduct their own HTA-MDs evaluations, with varying institutionalization arrangements. European Union's (EU's) HTA Regulation aims to establish collaborative clinical assessments across Member States, potentially expediting the path from EU safety certification of MDs to pricing and reimbursement decisions. This study aims to identify emergent configurations among institutionalizations of HTA-MDs in the EU, European Economic Area (EEA), and European Free Trade Association (EFTA) countries. METHODS: Publicly available data were cross-sectionally collected for EU, EEA, and EFTA countries until August 2024 to allow a cross-country analysis of HTA-MDs institutionalizations. Countries were included if they had at least one publicly mandated body for HTA-MDs. Data sources were scientific databases, institutional websites, and HTA bodies' documentation. A framework of 16 elements, qualitatively describing the institutionalization of HTA-MDs, was developed based on a document review and used as a dataset for agglomerative hierarchical cluster analysis to identify patterns of HTA-MDs institutionalization. RESULTS: The 21 included countries formed three clusters: Cluster 1 featured regulatory-focused, legally bound HTA-MDs systems with mandatory assessments determining reimbursement decisions; Cluster 2 was characterized by regulatory functions, external expert collaboration, formal prioritization processes, and organized Horizon Scanning; Cluster 3 showed recommendatory functions, nonmandatory assessments, and limited impact on reimbursement decisions. CONCLUSIONS: HTA-MDs institutionalizations could benefit from implementing prioritization processes of evaluations, establishing networks of collaborative assessment centers, and ensuring links between evaluations and reimbursement decisions.