Presentation (CTI)

OBJECTIVES: Traditional health technology assessment (HTA) frameworks have primarily focused on clinical effectiveness and cost-effectiveness. However, increasing attention is being given to broader societal value elements, such as disease severity, unmet need, equity, caregiver burden, and productivity impacts. This study evaluated how major European HTA agencies incorporate these considerations into value assessment frameworks and reimbursement decision-making.
METHODS: A targeted literature review was conducted across seven European HTA agencies: NICE (England), SMC (Scotland), HAS (France), IQWiG/G-BA (Germany), TLV (Sweden), ZIN (Netherlands), and the Norwegian HTA system. HTA methodological guidelines, policy documents, agency reports, and peer-reviewed literature published between 2016 and 2026 were reviewed. Evidence was extracted and synthesized to identify societal value elements considered within HTA processes, including disease severity, unmet need, health equity, caregiver burden, productivity impacts, and wider societal benefits.
RESULTS: Four distinct approaches to incorporating societal value were identified across European HTA systems. Sweden and Norway employed ethical prioritization frameworks incorporating severity, need, and solidarity principles. NICE utilized modifier-based approaches, including severity modifiers and consideration of health inequalities. France and Germany primarily relied on deliberative appraisal processes, where societal value informed committee discussions without formal methodological frameworks. Scotland and the Netherlands demonstrated hybrid approaches combining prioritization criteria with deliberative assessment. Across all systems, disease severity and unmet need were the most consistently applied societal value elements, while caregiver burden, productivity impacts, and wider societal benefits were considered less systematically. Quantitative assessment of societal value remained uncommon, with most agencies relying on qualitative deliberation.
CONCLUSIONS: European HTA agencies increasingly recognize societal value beyond traditional measures of clinical and economic benefit; however, implementation follows distinct methodological pathways. Four approaches to societal value integration were identified: ethical prioritization frameworks, modifier-based approaches, deliberative appraisal processes, and hybrid models. Greater methodological transparency may support more consistent incorporation of societal value considerations into HTA and reimbursement decision-making.