Contextual aspects of Health Technology Assessment in the new EU framework

Abstract Description of the problem The implementation of the 2021 European Regulation on Health Technology Assessment (EUHTAR) is currently making its first steps by producing the first Joint Clinical Assessments (JCAs). JCA evaluate effectiveness and security of innovative technologies. The EUHTAR proposes Member States to conduct additional clinical analyses-such as specific patient subgroups, comparators, or outcome measures-and to undertake non-clinical evaluations. These complementary assessments can incorporate contextual information, including ethical, legal, organizational, social, and increasingly environmental dimensions (ELOSE). In this context, we developed and piloted a methodological approach to support the systematic and, feasible integration of ELOSE dimensions into HTA reports. Results A decision-making algorithm was developed and piloted in selected HTA reports to guide when and how to evaluate ELOSE aspects. This framework built on national and international precedents, including the EUnetHTA Core Model 3.0, GRADE EtD framework, and VALIDATE. The pilot showed that not all technologies warrant the same level of contextual evaluation. Tools such as targeted literature reviews, qualitative studies, or consultation with stakeholders were applied based on the scope of anticipated impact. The process enabled multidisciplinary contributions, including from patients and social scientists. Lessons Contextual evaluation of health technologies requires tested frameworks. It is essential to engage in a deep definition of the scope of the ELOSE impacts of each evaluated technology. Multidisciplinary and the inclusion of social sciences and patient perspectives are essential. The approach developed offers tools for adapting JCAs to national contexts and can support other Member States in the implementation of the EU HTA regulation in a national context while enhancing decision-making relevance. Key messages • Ethical, legal, organizational, social, and increasingly environmental assessments are needed for relevant decision making related to innovative technologies. • Our methodological proposal is feasible and could be adapted in other countries.