OBJECTIVES: To describe the cost-effectiveness evaluation of the medical device by the French Health Authority (HAS) issued between 2014 and 2022 and discuss the issues.

METHODS: Based on cost-effectiveness analysis, HAS opinions concerning medical devices have been extracted from the Vyoo Agency’s database. The reservations issued by the HAS have been analyzed.

RESULTS: Out of the 195 opinions, only 16 were for a medical device, covering 19 indications, mainly in the cardiology area (15/19) and 10 medical devices. The remaining cost-effectiveness opinions concerned drugs (173) and vaccines (6).

Evaluations were invalidated due to a major reservation in 38.2% (68/178) of drugs’ indications and 47.4% (9/19) of medical devices’ indications. The uncertainty was targeted as a hurdle for interpreting the RDCR in 12.9% (23/178) of drugs’ indications and 10.5% (2/19) of medical devices’ indications.in 12.9% (23/178) of drugs’ indications and 10.5% (2/19) of medical devices’ indications. All in all, at least one RDCR was interpretable in 52.8% (94/178) of drugs’ indications and 47.4% (9/19) of medical devices’ indications.

For medical devices, more than one out of four dossiers got a major reservation concerning the utility assessment (5/16 dossiers concerned). This is the first source of total reservations (20 reservations, 13/16 dossiers), followed by the efficacy and costs assessments (17 reservations each, 10/16 dossiers) and the simulated population (17 reservations, 10/16 dossiers) targeting primarily the analysis of the transposability to the French population. As a comparison, the efficacy assessment was the first source of reservations in the drugs’ opinions (312 reservations, 146/173 dossiers).

CONCLUSIONS: No methodological specificities were identified for the economic evaluation of medical devices compared to drugs, except for the evaluation of incremental versions. The principal hurdle to tackle was the utility score assessment.