The role and value of real-world evidence in health technology decision-making in France, Germany, Italy, Spain, and the UK: insights on external control arms.

Real-world evidence (RWE) is increasingly used and accepted by health technology assessment (HTA) bodies as supportive evidence to inform the approval of new technologies. However, the criteria driving RWE acceptance are often unclear.This study aims to improve understanding of the role and value of RWE in HTA decision-making and outline the best practices in building real-world external control arms (ECAs).A mixed approach of a targeted literature review and HTA expert interviews was applied. The HTA reports of ten selected technologies and the expert interviews from France, Germany, Italy, Spain, and the UK informed the criteria driving the acceptance of RWE. Overall, the UK and Spanish HTA bodies are more receptive to accepting RWE, whereas the French and German are the least accepting. When RWE is used to substantiate efficacy claims, the level of scrutiny from regulators and HTA bodies is considerably higher than when RWE has different intended uses. Representativeness of the data source, overall transparency in the study and robust methodologies are the key criteria driving RWE acceptance across markets.