ArticleInternational journal of technology assessment in health care2026
Use of RWD in the assessment of economic evaluations of innovative health products: lessons learned from the French National Authority for health (HAS).
Article in International journal of technology assessment in health care, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed.
- R WE ready for reimbursement? A round-up of developments in real-world evidence relating to health technology assessment: part 25.Journal of comparative effectiveness research · 2026Article
- Lowering the Barriers to the Appropriate Use of Individual-Level Simulation for Health Economic Evaluation.PharmacoEconomics · 2026Article
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Authors and funding
2 authors.
Funding
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Abstract
objectivesOur objective was to identify key patterns and discuss the lessons learned from the use of real-world data (RWD) in the cost-effectiveness analyses (CEAs) of innovative health products (IHPs) as assessed by the French National Authority for Health from January 2016 to May 2023.
methodsA retrospective analysis was conducted on the use of RWD in the CEAs of IHPs. Our material included HAS assessments of CEAs and manufacturers' technical reports. The RWD studies were classified into eight categories, and a specific template was constructed to report and discuss their use in terms of predefined methodological aspects.
resultsIn all, 88 percent (129/147) of the CEAs integrated RWD studies. Retrospective cohorts were the most frequently used kind of study in the CEAs, while prospective cohorts were mainly used to identify the analyzed population and to externally validate models. We identified opposing temporal trends in the use of cohort studies versus registries. Approximately 8 percent (10/129) of the CEAs could be adjudged as invalidated due to major limitations regarding RWD use (e.g., lack of relative effectiveness).
conclusionsWe learned several lessons from the use of RWD in the HAS assessments of the CEAs of IHPs. Retrospective cohort studies were the most commonly used RWD source to populate CEA parameters of the CEAs regardless of the type of IHP, and their use has increased over time. The implementation of good practices for the use of RWD studies should improve the role of RWD in economic modeling and address uncertainties surrounding CEAs.
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