Presentation (CTI)

OBJECTIVES: Broader value evidence beyond an intervention’s cost-effectiveness is increasingly discussed in health technology assessment (HTA). However, it is unclear whether European HTA bodies require this evidence routinely, permit its inclusion selectively, or do not address it in their submission guidance. This study assessed how selected European HTA bodies treat broader value evidence in methods guidance.
METHODS: We conducted a targeted review of HTA methods guidance from 8 major European agencies: NICE, SMC, HAS, ZIN, TLV, IQWiG, NoMA, and DMC. Guidance was screened for 5 broader value elements: productivity, caregiver burden, health equity, environmental sustainability, and health system capacity. Evidence was extracted and classified using a predefined framework: required in standard analysis, permitted in scenario analysis, discussed qualitatively, explicitly excluded, or not mentioned.
RESULTS: Broader value evidence was more often permitted than required and varied by value element. Health equity was the most required element, addressed via disease severity modifiers for 5/8 agencies and permitted in distributional cost-effectiveness scenarios by 1/8 agencies. Productivity was required by 2/8 agencies adopting a societal or limited societal perspective, permitted in scenario analyses by 3/8, and explicitly excluded by 2/8. Caregiver burden was required by 2/8 agencies and permitted in scenarios by 5/8. Environmental sustainability was absent from all submission guidance. Health system capacity is captured qualitatively by one agency and considered in post-reimbursement supplementary analyses by one agency, falling outside of the classification framework. All agencies permitted at least one element qualitatively or as a scenario, and half required consideration of a broader value element.
CONCLUSIONS: Broader value evidence remains largely optional rather than routinely expected in European HTA methods guidance. Most agencies permit selected elements qualitatively or in scenario analyses, but few require formal modelling in reimbursement submissions. Clearer expectations are needed to support consistent use of broader value evidence in pricing and access decisions.