Understanding the EU Joint Clinical Assessment (JCA) Implementation
Gain stakeholder insights on EU JCA challenges, industry implications and practical strategies for adapting health technology evaluation (HTA) processes in 2025 and beyond.
The EU JCA, now mandatory for oncology and advanced therapies, is reshaping how evidence is generated, reviewed and applied across Europe. For market access leaders and HTA administrators, the framework introduces both opportunities and challenges — from dossier preparation to patient engagement.
This document highlights key considerations for pharmaceutical teams working to stay ahead of evolving EU HTA requirements in 2025 and beyond, including:
- Scope and Role of the EU JCA in HTA: How the JCA complements, rather than replaces, national HTA processes
- JCA Goals vs. Real-World Impact on EU Market Access: Examining where harmonization delivers value and where local variations persist
- Early Engagement with HTA and The Role of Joint Scientific Consultations (JSCs): Guidance on aligning evidence planning early in development
- Organizational and Operational Implications for Pharmaceutical Market Access Teams: Strategies for cross-functional coordination and timely compliance
- Assessing Pharmaceutical Industry Readiness: What manufacturers need to do now to adapt to the new JCA framework
- Dossier Preparation, PICOs, Timelines and Evidence Standards: Practical insights into dossier integration and evolving evidence expectations
- Strategic Considerations for Withdrawing or Opting Out of the EU JCA Process: Why withdrawal is rarely viable and what to weigh before making decisions
- Integrating Patient Perspectives into the JCA Framework: The growing role of patient voices in shaping HTA outcomes
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