Accelerating Patient Access to Innovations in Europe: Is It Possible to Integrate the JCA Into Diverse HTA systems?

ISSUE: The Joint Clinical Assessment (JCA) offers a pivotal opportunity to streamline evidence generation across European markets, but integrating its clinically focused outcomes into diverse health technology assessment (HTA) systems presents both challenges and opportunities. Despite implementation in early 2025, there remain key outstanding questions, such as: How can JCA outputs be better aligned with the diverse evidence expectations of national HTA bodies? To what extent can Member State-specific PICOs be harmonised to avoid duplication of work while respecting local decision-making processes? How can the JCA report align to cost-effectiveness frameworks in economic-driven markets? How can we balance the patient-centric focus of patient-reported outcomes (PROs) with the technical requirements of economic modeling?

OVERVIEW: Overview provided by Ruairi O’Donnell (moderator), introducing the panel and challenges associated with the JCA procedure (10min).Anja Schiel will present a national HTA body perspective, highlighting how Norwegian authorities have begun adapting to the introduction of JCA (12min). James Ryan will share findings of the health technology developer (HTD) experience (12min), exploring how preparation for JCA can inform preparation for a range of market requirements, with implications for timing of key activities and cross-functional collaboration.Professor Taylor will share an academic insight on the implications of JCA for HTA science, exploring how state-of-art methods may evolve with respect to comparative evidence analysis and patient-relevant outcomes (12min). Time is allowed for audience questions and panel discussion. This session will benefit those with involvement in national HTA procedures, either from the HTD or assessor perspective.