Are We There Yet? Mapping Member State Readiness for Local Implementation of the EU Health Technology Assessment (HTA) Regulation
Author(s)
Savvas Dimiou, MSc, PhD1, Edel Falla, MSc1, Sian Tanner, BA, PhD2, Ansa Ibok, MSc1, Valentine Berthet, PharmD, MSc3, Doreen Bonduelle, BA4, Daniel Callejo, MSc5, Oliver Curtis, MSc1, Tijl De Celle, PhD6, Brittany du Preez, BSc7, Roel Freriks, DPhil8, Maaike Janssen, MSc9, Maria Kalogeropoulou, PhD10, Agnieszka Koppolu, PhD11, Robert Friedrich Krüger, MSc12, Gloria Lombardi, MSc13, Pauline Pasman, MSc14, Anke van Engen, MSc2, Max van Wijk, MSc2, Jacek Wieczorek, MSc11.
1IQVIA, London, United Kingdom, 2IQVIA, Amsterdam, Netherlands, 3IQVIA Opérations France, Courbevoie, France, 4IQVIA, Munich, Germany, 5IQVIA, MADRID, Spain, 6IQVIA, Zaventem, Belgium, 7IQVIA, Cape Town, South Africa, 8IQVIA, Hollandscheveld, Netherlands, 9IQVIA, Stockholm, Sweden, 10IQVIA, Athens, Greece, 11IQVIA, Warsaw, Poland, 12IQVIA, Bad Homburg, Germany, 13IQVIA, Milan, Italy, 14IQVIA solutions, Amsterdam, Netherlands.
1IQVIA, London, United Kingdom, 2IQVIA, Amsterdam, Netherlands, 3IQVIA Opérations France, Courbevoie, France, 4IQVIA, Munich, Germany, 5IQVIA, MADRID, Spain, 6IQVIA, Zaventem, Belgium, 7IQVIA, Cape Town, South Africa, 8IQVIA, Hollandscheveld, Netherlands, 9IQVIA, Stockholm, Sweden, 10IQVIA, Athens, Greece, 11IQVIA, Warsaw, Poland, 12IQVIA, Bad Homburg, Germany, 13IQVIA, Milan, Italy, 14IQVIA solutions, Amsterdam, Netherlands.
OBJECTIVES: Joint Clinical Assessment (JCA) under the EU Health Technology Assessment Regulation (HTA-R) is now underway for oncology products and ATMPs, marking a significant milestone in harmonising health technology evaluations in Europe. However, key questions remain around Member States’ (MS) readiness to adopt the JCA report into national HTA processes and how this will vary across countries. These uncertainties create challenges for stakeholders navigating the shifting EU access landscape.
METHODS: Local publications, conference presentations, and expert input was gathered to assess MS preparedness for HTA-R implementation, focusing on national HTA procedures, alignment with EU requirements, use of JCA outcomes in local decisions, and broader health system infrastructure readiness.
RESULTS: To date, only five MS (Belgium, Czech Republic, Germany, Italy, and Sweden) have adapted their national legislation in response to HTA-R, whilst two MS (Germany and Netherlands) have amended their established HTA dossier template. Estonia and Poland indicated the JCA report will fully replace the clinical component of national HTA processes, Belgium and the Netherlands stated it will be referenced throughout, whereas five MS (Bulgaria, Denmark, France, Germany, and Sweden) indicated it will be attached to the Appendix of the local HTA report and for the remaining MS it is still unknown. Six MS confirmed no impact to national timelines, five MS expect delays, five MS anticipate reduced timelines, with the impact unknown in the remaining MS. Notably, five MS (Finland, Germany, Poland, Spain, and Sweden) confirmed HTD involvement in the scoping process.
CONCLUSIONS: Preliminary insights reveal varied readiness, with few Member States showing advanced integration and most facing delays. Despite progress since 2024, continued monitoring and proactive engagement are needed to anticipate access challenges.
METHODS: Local publications, conference presentations, and expert input was gathered to assess MS preparedness for HTA-R implementation, focusing on national HTA procedures, alignment with EU requirements, use of JCA outcomes in local decisions, and broader health system infrastructure readiness.
RESULTS: To date, only five MS (Belgium, Czech Republic, Germany, Italy, and Sweden) have adapted their national legislation in response to HTA-R, whilst two MS (Germany and Netherlands) have amended their established HTA dossier template. Estonia and Poland indicated the JCA report will fully replace the clinical component of national HTA processes, Belgium and the Netherlands stated it will be referenced throughout, whereas five MS (Bulgaria, Denmark, France, Germany, and Sweden) indicated it will be attached to the Appendix of the local HTA report and for the remaining MS it is still unknown. Six MS confirmed no impact to national timelines, five MS expect delays, five MS anticipate reduced timelines, with the impact unknown in the remaining MS. Notably, five MS (Finland, Germany, Poland, Spain, and Sweden) confirmed HTD involvement in the scoping process.
CONCLUSIONS: Preliminary insights reveal varied readiness, with few Member States showing advanced integration and most facing delays. Despite progress since 2024, continued monitoring and proactive engagement are needed to anticipate access challenges.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA40
Topic
Health Policy & Regulatory, Health Technology Assessment, Organizational Practices
Topic Subcategory
Systems & Structure, Value Frameworks & Dossier Format
Disease
No Additional Disease & Conditions/Specialized Treatment Areas