EU HTA Publication Digest: RWE Submission for European Regulators and Payers: Challenges, Uncertainties, and Opportunities

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, Taylor et al. explored challenges and opportunities associated with incorporating real-world evidence (RWE) into submissions under the EU’s new Joint Clinical Assessment process. The authors highlighted key uncertainties around PICO specification (Population, Intervention, Comparator, Outcomes) and the alignment of regulatory and HTA evidence requirements. The study identified that, despite a constrained 100-day submission window and methodological ambiguity, early cross-functional planning and strategic use of RWE can enable more robust, fit-for-purpose evidence generation for both regulators and payers.

Access the full-text article here.