EU Introduces New Framework for Health Tech Assessments

View profile for Dr. Sara Al Dallal

President of Emirates Health Economics Society at Emirates Medical Association

🔍 Harmonizing Health Technology Assessments Across Europe The new EU Joint Clinical Assessment (JCA) framework marks a pivotal shift toward a unified approach in evaluating the clinical effectiveness and safety of new health technologies. Introduced under Regulation (EU) 2021/2282, it aims to streamline national health technology assessments (HTAs), reduce duplication, and improve patient access to innovative therapies across member states. While JCA focuses on clinical evidence and safety, national systems still handle economic evaluations such as cost-effectiveness analyses. The article underscores the need for early alignment between Health Technology Developers (HTDs) and national HTA bodies—particularly around PICO parameters (Population, Intervention, Comparator, Outcome)—to ensure efficient integration of clinical and economic evidence. Key recommendations include: Sharing national PICOs early to align evidence generation. Selecting populations and comparators based on clinical—not economic—criteria. Leveraging patient-reported outcomes to inform quality-of-life assumptions in economic models. Using pragmatic approaches to safety and surrogate data. Embracing innovation in modelling, including AI and large language models, for faster, more adaptable evaluations. Ultimately, the JCA offers an opportunity to enhance transparency, efficiency, and equity in access to healthcare innovation across Europe—if paired with strong collaboration and methodological innovation among regulators, HTAs, and industry stakeholders. Adam Johns André Andrade, MBA Sukhvinder (Sukhi) Johal

Sherif Kamal

RPh;MSc;PhD candidate;HCMD

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💬 Excellent milestone for European HTA collaboration! The Joint Clinical Assessment (JCA) under Regulation (EU) 2021/2282 is a crucial step toward a more coherent, transparent, and efficient evaluation system. Early alignment on PICO parameters and pragmatic use of real-world and surrogate data can truly bridge the gap between clinical and economic assessments. The next frontier lies in leveraging AI-driven modelling and adaptive evidence synthesis—not only to accelerate evaluations but also to enable dynamic reassessments as new data emerge. This harmonization can reshape market access pathways, improve equity in patient access, and strengthen Europe’s collective voice in global health technology governance. #HTA #JCA #HealthPolicy #Regulation20212282 #ValueBasedHealthcare #AIinHTA

Jussara Rötzsch

Presidente do HL7 Brasil | Psiquiatra | Arquiteta da Informação em Saúde | Terminologista SNOMED CT | Líder em FHIR e Interoperabilidade

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