Session (CTI)

ISSUE: As health systems seek to optimise decisions on technologies already embedded in routine care, real-world evidence (RWE) is becoming crucial. NICE's existing-use HealthTech assessments (formerly late-stage assessments, LSA) apply lifecycle thinking to established products, drawing on registry data, claims data, observational studies, and patient-reported outcomes to address what pre-market evidence was not designed to answer. LSAs are inherently challenging, with key issues including limited direct comparative evidence between similar products, evidence-supported price variation, and uncertainty over whether incremental product innovation translates into meaningful benefit, particularly where evidence base remains limited. These challenges reflect feasibility of generating evidence that is sufficiently timely and decision-relevant. Stakeholders and patients also raised concerns about how LSAs may affect continued access to commonly used technologies in NHS. This panel will explore how a proactive lifecycle evidence strategy, with anticipated future evidence needs for reassessment, can help demonstrate and sustain product value. Using contrasting case studies: drug-eluting stents for coronary artery disease and slide sheets, panellists will discuss which types of RWE are most influential in NICE LSA decisions and how evidence gaps can be planned earlier in a product's commercial cycle. OVERVIEW Prof Lee will introduce the session (5 minutes). Mr Kolovetsios will share views from the industry perspective and challenges in RWE generation in fast-moving med tech industry (12 minutes). Dr Chang-Douglass will present the committee perspective, focusing on decision-making under uncertainty, limitation, and values of RWE (12 minutes). Dr Chalkidou will outline NICE lifecycle approach and the need for closer industry/ stakeholder collaboration for future RWE in HTA. (12 minutes). The session will conclude with moderated audience discussion. This session is relevant to policymakers, clinicians, industry representatives, and patients. Attendees will gain insights into assessing established technologies, the use of RWE, and implications for future HTA processes.