Session (CTI)

ISSUE: Health Technology Assessment (HTA) has traditionally been conducted as static, one-off value assessments at launch, which can become outdated as evidence evolves. This panel will explore the emergence of living HTA, where conditional reimbursement is linked to RWE-driven reassessment to enable earlier patient access while managing uncertainty. Topics include (a) whether AI can catalyze living HTA through evidence surveillance and reassessment support, while managing bias, transparency and governance risks, (b) how national health priorities influence HTA flexibility, funding signals and downstream R&D investment, and (c) operational challenges in defining reassessment triggers and decision relevant endpoints. The panel will also examine implications for manufacturers as value assessment shifts from a single upfront decision to a dynamic lifecycle process, as well as challenges for public authorities actively managing conditional decisions, including potential withdrawal of approvals. OVERVIEW: HTA decision making is becoming more complex as technologies reach the market with greater uncertainty and expectations for post-launch evidence generation. In response, decision makers are exploring conditional reimbursement, structured reassessment and expanded RWE use to balance timely patient access with robust evaluation. Alongside advances in AI, these developments have increased interest in living HTA. An introductory overview, 10 minutes, will outline the rationale for living HTA and key drivers of change. Subsequent panellists will offer contrasting perspectives on AI-enabled reassessment, the influence of national priorities on policy choices, and practical challenges in operationalizing lifecycle evidence generation. A manufacturer perspective will address how dynamic value assessment reshapes evidence strategies and lifecycle processes. This panel will debate whether living HTA represents an incremental evolution of current practices or a more fundamental shift in how value is assessed and rewarded, and whether it can improve alignment between public health benefit, patient access, financial sustainability and long-term innovation incentives.