NATIONAL IMPLEMENTATION OF THE EU HTA REGULATION: EVOLVING NATIONAL APPROACHES ACROSS MEMBER STATES
Author(s)
Agnieszka Koćwin, MPharm1, Malek Dimassi, MEng2, Cécile Rémuzat, PharmD, MSc3, Clément François, MSc, PhD3.
1Inizio Ignite Putnam, Kraków, Poland, 2Inizio Ignite Putnam, Tunis, Tunisia, 3Inizio Ignite Putnam, Paris, France.
1Inizio Ignite Putnam, Kraków, Poland, 2Inizio Ignite Putnam, Tunis, Tunisia, 3Inizio Ignite Putnam, Paris, France.
OBJECTIVES: The European Union (EU) Health Technology Assessment (HTA) Regulation (Regulation EU 2021/2282) mandates Joint Clinical Assessments (JCAs) across all 27 EU Member States, Norway, Iceland, and Liechtenstein from 2025. With the first JCA report published in June 2026, Member States are beginning to operationalise EU-level assessments within national reimbursement and HTA processes. This research analyses implementation progress and implications for health technology developers (HTDs).
METHODS: Literature review (01/2023-06/2026), covering 30 countries, including HTA websites, PubMed articles, and grey literature.
RESULTS: Countries with established HTA systems are adapting guidelines, dossier templates, and procedures to align with EU HTA requirements. France, Italy, the Netherlands, Denmark, and Sweden revised dossier requirements to reduce duplication of clinical evidence submissions and plan to integrate JCA reports into assessments. Germany maintained AMNOG timelines while incorporating JCA outputs into national appraisals. Finland, Denmark, the Netherlands, and Sweden indicated that national assessments would begin only after JCA publication, whereas France planned no formal delays. Spain approved a new HTA Royal Decree introducing accelerated timelines, including a 15-day clinical assessment post-JCA publication. Divergences remain regarding national PICO scoping and HTD involvement. France excludes HTDs from national PICO development, while Finland, Sweden, Poland, and the Netherlands allow varying levels of HTD input during PICO discussions. Several countries initiated national PICO scoping earlier, in some cases at the beginning of the EMA marketing authorisation process. Countries with developing HTA frameworks initiated legislative reforms, guideline development, and capacity-building activities to support implementation. Overall, early implementation suggests increasing methodological convergence at EU level but continued heterogeneity in national appraisal, pricing, and reimbursement processes.
CONCLUSIONS: Despite increasing methodological convergence under the EU HTA Regulation, national HTA processes remain heterogeneous. The first JCA indicates that a common clinical assessment may not fully eliminate the need for national interpretation, reinforcing the importance of understanding evolving country-specific implementation approaches.
METHODS: Literature review (01/2023-06/2026), covering 30 countries, including HTA websites, PubMed articles, and grey literature.
RESULTS: Countries with established HTA systems are adapting guidelines, dossier templates, and procedures to align with EU HTA requirements. France, Italy, the Netherlands, Denmark, and Sweden revised dossier requirements to reduce duplication of clinical evidence submissions and plan to integrate JCA reports into assessments. Germany maintained AMNOG timelines while incorporating JCA outputs into national appraisals. Finland, Denmark, the Netherlands, and Sweden indicated that national assessments would begin only after JCA publication, whereas France planned no formal delays. Spain approved a new HTA Royal Decree introducing accelerated timelines, including a 15-day clinical assessment post-JCA publication. Divergences remain regarding national PICO scoping and HTD involvement. France excludes HTDs from national PICO development, while Finland, Sweden, Poland, and the Netherlands allow varying levels of HTD input during PICO discussions. Several countries initiated national PICO scoping earlier, in some cases at the beginning of the EMA marketing authorisation process. Countries with developing HTA frameworks initiated legislative reforms, guideline development, and capacity-building activities to support implementation. Overall, early implementation suggests increasing methodological convergence at EU level but continued heterogeneity in national appraisal, pricing, and reimbursement processes.
CONCLUSIONS: Despite increasing methodological convergence under the EU HTA Regulation, national HTA processes remain heterogeneous. The first JCA indicates that a common clinical assessment may not fully eliminate the need for national interpretation, reinforcing the importance of understanding evolving country-specific implementation approaches.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA130
Topic
Health Technology Assessment
Topic Subcategory
Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas