OBJECTIVES: Since 2013, the CEESP evaluates the efficiency dossier of innovative and high-budget-impact health products and publishes their opinions on the methodological compliance with their guidelines. HAS recommends that the economic evaluation is made under the real life conditions. The objective of this study is to review the published opinions for reinscription drugs and identify the use of real world data (RWD) and the related objections.

METHODS: All publically available HAS/CEESP decisions for reinscription were collected from the HAS website as per June 1^st, 2018 and analysed using the database developed by HEVA HEOR (https://efficience2.heva-heor.com). The use of RWD were classified in categories and quantified. In-depth qualitative analysis was conducted in order to highlight the use of RWD and related objections.

RESULTS: Five published opinions were identified. Only one dossier used RWD to document effectiveness. HAS requested RWD to be considered to evaluate effectiveness for future evaluations in three out of the four remaining dossiers. The absence of RWD leaded only once to an objection (important). RWD were mostly used to evaluate the transposability of the simulated population with respect to real world practice, the target population, to define the comparators, to document the mortality and some of the costs, and to validate the model. RWD were barely used to document the quality of life as well as the safety.

CONCLUSIONS: RWD was requested by the HAS in the majority of the reinscription appraisals in order to evaluate the effectiveness but this did not lead systematically to an objection. A future challenge will deal with evidence synthesis including randomized and real-world data, in absence of HAS methodological guidelines, given the expected increased number of reinscription appraisals.