Introduction 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) 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. The aim is to identify emergent configurations among institutionalizations of HTA-MDs in EU, European Economic Area (EEA), and European Free Trade Association (EFTA) countries. Methods Publicly available data was 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 HTA-MDs institutionalization 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, legally56 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, non-mandatory assessments, and limited impact on reimbursement decisions. Conclusions HTA-MDs institutionalizations could benefit from implementing prioritization 61 processes of evaluations, establishing networks of collaborative assessment centers, and ensuring links between evaluations and reimbursement decisions.
Institutionalization of Health Technology Assessment of medical devices: a cluster analysis of EU, EEA, and EFTA countries
Mario Cesare Nurchis;
2025-01-01
Abstract
Introduction 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) 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. The aim is to identify emergent configurations among institutionalizations of HTA-MDs in EU, European Economic Area (EEA), and European Free Trade Association (EFTA) countries. Methods Publicly available data was 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 HTA-MDs institutionalization 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, legally56 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, non-mandatory assessments, and limited impact on reimbursement decisions. Conclusions HTA-MDs institutionalizations could benefit from implementing prioritization 61 processes of evaluations, establishing networks of collaborative assessment centers, and ensuring links between evaluations and reimbursement decisions.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
