OBJECTIVES: The French National Authority for Health increasingly recommends using real-world evidence (RWE) and developing real-world studies for drug assessments in France. However, the use of RWE in the HTA evaluation of medications is not yet systematic. The objectives of this study are to identify the types of RWE used in medicine assessments by the HAS and to evaluate their influence on HAS decisions.

METHODS: Based on an exhaustive review of the HAS database, we identified and analyzed all Transparency (CT) and Economic (CEESP) opinions for breast cancer medicines assessed between January 2022 and February 2024. The documents were analyzed in two steps: first, we quantified the use of the keywords of interest; then, we aimed to qualitatively understand the types of RWE used and their impact on the evaluations.

RESULTS: We identified nine medicines evaluated through 19 HAS assessments in breast cancer, including 13 clinical opinions (CT) and six economic opinions (CEESP). Of the 13 CT opinions, 100% used RWE to support the epidemiology part of the dossiers. The calculation of the target population was done using RWE in 85% of cases, and in 70% of cases (n=9), RWE was included in the safety section. Only one breast cancer assessment included RWE in support of the efficacy part. This was the only reassessment based on a post-registration study identified in the breast cancer analysis. For five out of the eight additional well-known French cases, the use of RWE appears to have influenced the decisions of the HAS.

CONCLUSIONS: Overall, RWE is systematically used to support the epidemiological context of the dossiers submitted to the HAS. In some cases, the use of RWE can allow for reassessment and can have an impact on HAS decisions.