Presentation (CTI)

OBJECTIVES: Obesity is a global public health challenge, driving increased rates of chronic disease and healthcare costs. New pharmacologic interventions are entering the market with limited long-term data leading to evidence gaps. Real-world evidence (RWE) has the potential to address these gaps, especially in a disease like obesity where lifestyle and behavioural components are integral to treatment success. This study examines the role of RWE in obesity-related HTAs across the EU5 and Canada and aims to explore the presence and clarity of national RWE guidance frameworks.
METHODS: A retrospective review of HTAs published between 2015 and 2025 was conducted across: NICE (UK), HAS (France), IQWiG (Germany), AIFA (Italy), TLV (Sweden), and CADTH (Canada). HTA documents for obesity-related pharmacological interventions were assessed for inclusion and use of RWE in clinical effectiveness, economic modelling, or post-launch data collection.
RESULTS: Three NICE obesity-related TAs referenced RWE. TA664 (semaglutide) and TA600 (liraglutide) mentioned RWE but did not incorporate it into decision-making. TA664 cited observational adherence data and highlighted lack of long-term RWE as a limitation; TA600 referenced real-world discontinuation and weight regain data but did not incorporate RWE into modelling. TA1026 (tirzepatide) included a formal RWE plan using national databases (CPRD, HES, OpenSAFELY) to inform post-launch uptake and cost-effectiveness. Outside the UK, no RWE was found in obesity HTAs.
CONCLUSIONS: The integration of RWE into obesity HTAs remains limited. Only one NICE appraisal formally utilised RWE. While RWE frameworks are in place at HAS, CADTH, IQWiG, and others, their actual use in obesity-specific HTAs remains absent highlighting a disconnect between policy and practice, however understanding obesity needs real-world context. The relative novelty of some obesity medicines might contribute to limited RWE availability.