OBJECTIVES: Lowering the uncertainty is becoming more important in CEESP’s economic evaluation of therapies in France so RWDs may prove increasingly useful. This work aims to describe the use of RWD in the economic evaluation of anticancer drugs.

METHODS: All efficiency opinions in oncology and onco-hematology published on HAS website from 2018 to 2020 were reviewed. In each opinion, every mention of RWD was identified in the cost effectiveness model and the budget impact model. RWD were described according to their source and sorted by CEESP’s section titles (12 in the CEM, 6 in the BIM). RWD utilization was compared between opinions with no major reservation and opinions with major reservation.

RESULTS: In total, 37 opinions were included in which 17 (46%) were invalidated (major reservation). At least one source of RWD was retrieved in 34 opinions (92%), for an average of 7 sources per opinion (min:1; max:15). RWD were from primary data collection (registry/cohort: 56%), secondary data (SNDS/other: 17%), market research (16%) and preference elicitation studies (11%). In the CEM, RWD were most frequently used in the following sections: simulated population (62% of opinions), utilities (54%), costs (51%) and model validation (49%). The proportions of opinions using RWD in these categories were lower in opinions with a major reservation regarding efficiency analysis than in opinions with none : simulated population (56% vs 76%), utilities (50% vs 57%), costs (31% vs 76%) and model validation (44% vs 57%). In the BIM, RWD were most frequently used to estimate target populations (64% of opinions) and market shares (43%). CEESP requested additional RWD in 24 opinions (65%), mainly for effectiveness (51%).

CONCLUSIONS: Most economic evaluations for anticancer drugs used RWDs, found in all sections of CEESP’s opinions, and new RWDs were requested in two third of opinions for future evaluations.