Overview
Beginning in 2025, the European Union (EU) introduced a new Joint Clinical Assessment (JCA) process designed to centralize EU health technology assessment (HTA) clinical evaluation of new medications across EU member states. Under this new process, HTA timelines are embedded into EMA regulatory timelines, and pharmaceutical companies must submit evidence for EU HTA under an ambitious timeline—just 100 days after the company is notified of the evidence parameters. This new framework creates challenges for evidence generation, particularly when the necessary study populations, interventions, comparators, and outcomes (known as PICOs) are not fully defined until after EMA regulatory submission.
In this commentary, Flatiron Health researchers examine the practical challenges and uncertainties companies may face when preparing evidence under this new process, particularly when using real-world evidence (RWE). The authors highlight several key obstacles, including uncertainty around the final PICO requirements, differences between regulatory and HTA evidence standards, and the limited time available to generate new evidence. They also discuss the potential role of real-world data in filling evidence gaps, such as contextualizing clinical trial results, performing transportability analyses, or informing indirect treatment comparisons.
Why this matters
Despite these challenges, the new JCA process also creates opportunities to improve how evidence is generated for both regulatory and payer decision-making. The authors emphasize that early coordination across clinical development, regulatory, and health economics teams—combined with proactive planning for RWE generation—can help ensure evidence is “fit-for-purpose” for both regulatory HTA objectives. By integrating real-world data into evidence strategies earlier in the drug development process, companies may be better positioned to meet JCA requirements and ultimately help bring innovative treatments to patients across Europe more efficiently.