Presentation (CTI)

OBJECTIVES: Regulation 2021/2282 on Health Technology Assessment (HTAR) became applicable on 12 January 2025, introducing Joint Clinical Assessments (JCAs) across European Union (EU) and European Economic Area (EEA) countries. The Regulation establishes a framework for joint assessment of relative clinical effectiveness and safety, supporting national HTA processes. JCA outcomes do not affect Member States’ discretion to assess clinical added value in their national contexts or to make pricing and reimbursement decisions. This study explored the extent to which the HTAR has been implemented at the national level.
METHODS: A structured review of publicly available national legislation, procedural updates, methodological HTA guidelines, and submission templates was conducted across 30 EU and EEA countries. Data were extracted into a predefined framework and synthesised descriptively.
RESULTS: Evidence from 30 European jurisdictions indicated implementation activities since the HTAR came into force, with 22 countries (73%) introducing HTAR-related updates to their national processes. Among these, five countries (17%) have formally designated a competent authority responsible for HTAR implementation and defined its roles and responsibilities at the legislative level (Bulgaria, Croatia, Czech Republic, Iceland, Slovenia). A further six countries (20%) incorporated JCA-related adaptations into their HTA methodological guidelines (Belgium, Estonia, Hungary, Ireland, Italy, Spain), while five countries (17%) updated their submission templates (Denmark, Finland, France, the Netherlands, Norway). For national dossier submissions, applicants were not required to resubmit clinical evidence already covered by the JCA. Instead, they were expected to demonstrate the relevance of the JCA to local clinical practice, including justification that its PICO framework was applicable as the basis for national clinical assessment.
CONCLUSIONS: National implementation of the HTAR is progressing across Europe. Countries with well-established HTA systems have integrated the JCA process through updates to procedures, methodological guidelines, or submission templates, while newer or less established HTA systems have primarily addressed HTAR implementation through high-level legislative measures.