Session (CTI)

ISSUE: The inclusion of adverse events (AEs) in economic evaluations (EE) is a critical yet often overlooked component of health technology assessment (HTA). While AEs can significantly impact both costs and quality of life, their integration into cost-effectiveness models is inconsistent, methodologically variable, and frequently absent. This omission risks underestimating the true burden of interventions—particularly those with substantial safety concerns-and may distort value assessments used to inform pricing, reimbursement, and access decisions. Currently, there is no standardised approach for incorporating AEs into economic evaluations. Some models include only severe or treatment-related AEs, while others rely on limited trial data or exclude AEs entirely due to data gaps or methodological uncertainty. This inconsistency reflects broader challenges: the lack of harmonised guidance, limited access to real-world safety data (RWSD), and insufficient use of patient registries that could provide richer, more representative safety profiles. The issue, then, is whether the absence of standardised AE inclusion undermines the credibility, transparency, and patient-centeredness of EE. Addressing this gap could improve alignment between regulatory and HTA perspectives, enhance the use of RWSD, and ultimately lead to more informed and equitable healthcare decisions. OVERVIEW: This panel will explore the scientific, methodological, and policy implications of standardising AE inclusion in EE. Moderator Tanja Fens will open with a brief reflection (5 min) and guide discussion through key questions (15 min): Should HTA bodies adopt standardised methods for AE inclusion to improve consistency and transparency?; What standards are needed to align regulatory and HTA use of safety data?; How can patient registries and RWSD be leveraged to better capture safety outcomes?; What are the practical implications for industry, policymakers, and patients regarding evidence and decision-making? Panellists Peter Mol, Dalia Dawoud and Mondher Toumi will each present their perspectives (10 min each), followed by audience engagement through live polls and open Q&A (10 min).