Bridging National and EU HTA Regulation: Policy Responses to the JCA Rollout

Author(s)

Kurt Neeser, MPH, PhD1, Katarzyna Lasota, PhD2, Andrea Bernardini, PhD3, Sanja Stanisic, MSc4, Elvira Mueller, MPH, PhD1.
1Evidence and Access, Certara, Lörrach, Germany, 2Certara, Kraków, Poland, 3Certara, London, United Kingdom, 4Certara, Inc, Milan, Italy.
OBJECTIVES: From 12 January 2025, the EU Joint Clinical Assessment (JCA) has become effective for new oncology and advanced therapy medicinal products. Its rollout will expand to new orphan medicines by 2028 and all new medicines by 2030. This research aims to identify national policy initiatives designed to align national health technology assessment (HTA) frameworks with the EU HTA Regulation (HTAR).
METHODS: We conducted a comprehensive desk-research of policy documents, official announcements from national HTA agencies and health ministries, academic literature, and EU reports. The analysis covered 10 EU countries with the highest nominal Gross Domestic Product - Germany, France, Italy, Spain, Sweden, Norway, the Netherlands, Belgium, the Czech Republic and Poland - across EU4 and key HTA collaborations such as the Joint Nordic HTA-Bodies, The BeNeLuxa initiative and the Central Eastern Europe.
RESULTS: As of June 2025, national policies to align JCA and national HTA submissions have been established in Germany, France, Norway, the Netherlands, are being actively refined in Spain, Sweden, Belgium, Czech Republic, Poland, and are at an exploratory stage in Italy. Germany, Sweden, the Netherlands, and Norway adapted HTA guidelines to link/embed JCA information. France established incorporation processes. Belgium is rescheduling assessment timelines and stakeholder consultation processes, while Spain, Poland and Czech Republic are developing new procedures to embed JCA findings. Italy is increasing internal capacities, but no formal policy changes have been issued. Anticipated implementation challenges include tight timelines, assessor capacity constraints, and stakeholder consultation uncertainties.
CONCLUSIONS: European countries are progressing to align national HTA processes with EU JCA to streamline submissions, reduce duplication, and enhance transparency. 90% of the investigated countries have issued or are drafting guidance to synchronize contents and timelines. With intensive work ongoing, it is assumed that remaining gaps could be closed shortly, ensuring that Member States can integrate JCA results in national appraisals effectively.

Conference/Value in Health Info

2025-11, ISPOR Europe 2025, Glasgow, Scotland

Value in Health, Volume 28, Issue S2

Code

HTA57

Topic

Health Policy & Regulatory, Health Technology Assessment, Methodological & Statistical Research

Disease

No Additional Disease & Conditions/Specialized Treatment Areas

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