Session (CTI)

The Joint Clinical Assessment (JCA), introduced under the EU HTA Regulation, focuses on patient level efficacy and safety of new health technologies. This debate will explore whether this narrow focus is at odds with the concept of Whole Health, particularly with the backdrop of EU Antimicrobial Resistance (AMR) priorities. The current JCA assessment necessarily has a strictly defined focus, but does this mean patient and broader population level benefits will be inadequately captured, particularly for antimicrobials? Does the tight framework risk a focus on inappropriate comparators and outcomes for some types of technologies? Does the existing approach to JCA run counter to other EU priorities, such as AMR and the General Pharmaceutical Legislation. As the first JCAs are finalised, the panel will explore the uncertainties in both the willingness and capacity for methodological evolution. The debate becomes more consequential as the scope of JCA expands to all health technologies by 2030. This panel will examine whether JCA could hinder rather than support the achievement of Whole Health in Europe, particularly in the context of AMR. The session brings together perspectives from EU HTA bodies, industry and the HEOR community to explore limitations and opportunities for JCA evolution. The moderator will introduce the topic and policy context (6 minutes). Panellist 1 will outline how JCA is expected to evolve and if this can address concerns expressed regarding the existing framework (8 minutes). Panellist 2 will highlight emerging challenges for industry and contextualises it with wider AMR policies at EU level (8 minutes). Panellist 3 will assess JCA limitations from an HEOR perspective and propose recommendations for methodological reform (8 minutes). Interactive audience engagement (incl. polling) will be done throughout the session (5 min). The session will conclude with audience Q&A (25 min). This session will be highly relevant for policymakers, HTA bodies, regulators, industry leaders, HEOR researchers and patient representatives seeking to understand whether JCA can fully support whole health ambitions and how it may need to evolve to do so. .