Global Impact of JCA: Evaluating the Implications of the New EU HTA Regulation

PURPOSE:This workshop discusses the ripple effects of the EU health technology assessment (HTA) Regulation, with a key focus on the recently implemented Joint Clinical Assessment (JCA) on HTA in non-EU countries. It will feature perspectives from industry, HTA community, and international public health agency. DESCRIPTION:The initiation of EU JCA is a major topic within the HTA and payer communities in 2025. It was designed to enhance efficiency and harmonize the evaluation of new treatments across EU member states. While it garners significant attention in the EU, its influence is expected to extend globally, impacting HTA and payer decision-making in both established and emerging non-EU HTA markets.This workshop will evaluate the broader implications of JCA, including the harmonization of standards, development of HTA methodologies, and fostering of cross-border collaboration. The panel will provide an international perspective on the complexities, opportunities, and shifts arising from JCA implementation.Dr. Yeh (moderator) will set the stage with an overview of the JCA, emphasizing the challenges and opportunities associated with leveraging HTA evidence across borders. Dr. Vidal will discuss the impact of JCA on global pharmaceutical strategies, sharing findings from a recent survey examining its anticipated effects on the U.S. and 13 other non-EU countries. Dr. O'Rourke will bring insight from a global HTA community perspective on the EU HTA Regulation, including Joint Scientific Consultations, horizon scanning, and voluntary cooperation. He will also share lessons learned from JCA discussions with payers and policymakers worldwide. Professor Augustovski will bring his longstanding academic and HTA experience focused on the Americas and LMIC settings. He will discuss how recent EU policies have influenced regulatory and reimbursement processes and decisions in Latin America and the projected impact of JCA in the region.