EU HTA Publication Digest: Mapping the Use of Real-World Evidence Across the EU Health Technology Assessment Regulation: Methodological Considerations, Challenges, and Opportunities for Harmonization

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its EU HTA Publications Digest. 

In a recent publication, Sarri et al. mapped the role of real-world evidence (RWE) within the EU Health Technology Assessment Regulation, examining its methodological applications in EU joint clinical assessments. 

The authors found that RWE can support PICO simulations, disease landscape assessment, identification of prognostic factors and effect modifiers, and comparative clinical evaluation, but current EU-level guidance remains limited. They conclude that broader, better-planned, and methodologically robust integration of RWE could strengthen both EU joint assessments and subsequent national HTA submissions.

Access the full-text article here.