EU HTA and JCA: Europe’s joint approach to clinical assessment
The EU HTA Regulation has established a common European framework for the clinical assessment of new health technologies. For medicinal products, the Joint Clinical Assessment (JCA) is a central component of this framework. Since January 2025, JCA has applied initially to new oncology medicines and ATMPs, with its scope expanding gradually over the coming years.
A JCA assesses the clinical evidence for a medicinal product against a jointly defined European assessment scope. Populations, the intervention and relevant comparators are defined during scoping, before the available evidence is assessed at European level. For Health Technology Developers, this creates new requirements for evidence planning, dossier preparation and coordination with national HTA processes.
JCA provides a common clinical assessment but does not replace national HTA
The JCA report provides Member States with a common clinical evidence base. The conclusions drawn from this evidence for reimbursement, added benefit or pricing remain a national responsibility.
This interface between European assessment and national decision-making is particularly important for Market Access. A European assessment needs to address the assessment needs of different Member States, while Health Technology Developers must anticipate which populations, comparators, outcomes and analyses will subsequently be relevant for individual national HTA processes.
Germany provides a clear example. JCA does not replace the early benefit assessment under AMNOG. European evidence therefore needs to be prepared with a clear understanding of whether and how it can support the requirements of the German benefit assessment.
Understand EU HTA, follow ongoing JCAs and assess the first practical experience
This hub brings together resources for the key questions emerging from the implementation of EU HTA:
EU HTA Guides explain the regulatory and methodological framework. They cover the JCA process from scoping to the final report and the requirements for the structure and evidence of the JCA dossier.
JCA Watch tracks ongoing Joint Clinical Assessments. It provides an overview of assessments that have started, completed or been discontinued and shows where JCA reports are already available.
EU HTA Insights examine how the new framework is developing in practice. They analyse published JCA reports, discontinued assessments, methodological questions and the interface between JCA and national HTA processes such as the German benefit assessment.
With every new assessment and published JCA report, a clearer picture is emerging of how EU HTA works in practice and which requirements Health Technology Developers need to consider early in evidence generation and Market Access planning.
EU HTA Guides
Two guides cover the foundations of Joint Clinical Assessment: the JCA process and the requirements for the JCA dossier.
JCA Dossier
How is a JCA dossier structured and what evidence is required? This guide covers dossier structure, PICO-specific evidence and key submission requirements.
JCA process: timeline, scoping, dossier and assessment under EU HTA
How does a Joint Clinical Assessment work? This guide covers scoping, the assessment scope, PICOs, submission and European assessment.
EU HTA Insights
Current analyses and case studies on Joint Clinical Assessments, evidence requirements and European HTA developments.
JCA Evidence Assessment: PICO, Comparators and Uncertainty
How JCA assessors evaluate PICO questions, comparators, evidence synthesis and uncertainty - and what manufacturers should prepare.
JCA discontinued: implications for Germany and AMNOG
Why are JCAs discontinued? The first cases show why dossier completeness, PICO coverage and AMNOG readiness matter for Germany.
Tovorafenib: JCA and German Benefit Assessment Compared
The first JCA on tovorafenib/OJEMDA shows how PICO, comparator therapy and endpoints translate to German benefit assessment.
EU HTA Insights
Explore all analyses, case studies and expert perspectives on JCA and EU HTA.
JCA Watch
Track ongoing Joint Clinical Assessments and see which procedures have started, been completed or discontinued.