Session (CTI)

ISSUE: January 2025 marked the start of the European Regulation on Health Technology Assessment (EU HTAR), initiating Joint Clinical Assessments (JCAs) for the first eligible technologies. Health technology developers (HTDs), HTA bodies, and payers are now seeking early insights on how procedural and methodological requirements are being implemented in practice, and what this means for submission and capacity planning, assessment quality, evidence expectations, national pull-through and use, facilitating patient access to new technologies. This panel will examine early experiences from the first JCAs, focusing on observed process dynamics, facilitators and barriers to effective engagement, and will translate these into practical lessons learned and opportunities for continuous improvement. OVERVIEW: At the time of ISPOR EU 2026, an estimated 6-8 JCA dossiers and reports will have been published, having gone through this new process. These cases provide a unique opportunity to reflect on how requirements, timelines, interactions, and evidence expectations are being implemented, providing valuable insights into optimal preparations for the JCAs to come. The panel will begin with a concise overview of the EU HTAR and the JCA process, including key milestones, roles, and deliverables. Panellists will then discuss hands-on experience from multiple perspectives on key dimensions, such as PICO scoping, evidence requirements, stakeholder engagement, management of uncertainty, timeline adherence, and national procedure integration. A thematic synthesis of cross-case findings will highlight areas of emerging alignment and practical benefits, recurring challenges, and variation in interpretation. The discussion will integrate perspectives from a JCA assessor, an HTA body representative, and a HTD representative. The session will conclude with actionable recommendations for evidence planning, cross-functional alignment, procedural learnings, and effective stakeholder engagement to support high-quality assessments and facilitate patient access.