The European Union’s new Health Technology Assessment (HTA) framework, introduced in January 2025, promises to revolutionize how health technologies are evaluated and adopted across member states. This unified and streamlined approach aims to reduce the burden of multiple submissions, accelerate market access, and promote consistency in clinical evidence requirements.
Key Components of the New HTA Framework
The new framework centers around two crucial elements: Joint Clinical Assessments (JCAs) and PICOs (Population, Intervention, Comparator, and Outcomes). JCAs provide a single assessment of the clinical effectiveness and added value of new health technologies, structured around the PICO framework’s components as defined through Joint Scientific Consultations (JSCs). This process involves collaboration between the European Medicines Agency (EMA), national HTA bodies, and industry stakeholders to ensure comprehensive, evidence-based evaluations tailored to the target population’s needs.
Opportunities and Benefits
The unified EU-wide assessment offers several benefits, including reduced duplication, increased consistency, and more equitable access to innovative health technologies. For developers, this translates to more clarity and predictability regarding clinical evidence requirements. Member states can pool their resources and expertise, lowering administrative burdens on national healthcare systems and making the process more cost-effective.
Accelerated Market Access
The JCA is designed to be completed within a strict six-month timeframe following EMA approval, expediting the adoption of new technologies and allowing patients to benefit from innovative treatments more quickly. This accelerated process should address unmet medical needs and improve patient outcomes.
Improved Decision Making
The PICO framework provides a rigorous, scientifically sound evaluation of new technologies, enhancing the credibility and reliability of assessments. This, in turn, supports more informed decision-making by policymakers and healthcare providers, ultimately leading to better healthcare outcomes.
Challenges for Developers
While the new HTA framework presents opportunities, it also poses significant challenges for developers. The compressed timelines and extensive evidence requirements demand early planning and flexibility in data analysis processes. Developers must be prepared to generate a large volume of evidence, accommodate language-specific requirements, and ensure data privacy, all within a much shorter timeframe.
Technical and Operational Considerations
To navigate these challenges successfully, developers will need to:
- Start planning much earlier in the drug development cycle
- Submit a letter of intent at the point of EMA submission for regulatory approval
- Complete dossier preparation and submission within 100 days of the finalized PICO scope
- Ensure strict quality controls for translated outputs, especially under tight timelines
- Maintain flexibility to accommodate new requirements and evolving requests
Conclusion
The new EU-wide HTA framework represents a significant shift in how health technologies are evaluated and adopted. While it presents challenges for developers, it also offers opportunities for streamlined processes, reduced duplication, and accelerated market access. By understanding the key components of the new HTA and maintaining flexibility in data analysis processes, developers can successfully navigate this regulatory shift and seize opportunities in the evolving HTA landscape.
Stephen Corson is Associate Director of Statistics and Technical Solutions and Head of Statistical Consultancy at Phastar. With extensive experience in providing statistical support to trials across multiple therapeutic areas, Corson is well-positioned to offer insights into the implications of the new HTA framework for developers and the pharmaceutical industry.
