OBJECTIVES: In France, the price of medical devices is regulated by the CEPS (Healthcare Products Pricing Committee) when products are registered under the LPPR. During negotiations, a contract is signed between the company and the CEPS and may include various terms and conditions of agreements (MEA). The objective of this study is to present the main types of agreements that exist and to determine trends according to the type of product.

METHOD: All medical devices seen by the CEPS between 2018 and 2019 were included in the analysis. Contracts with manufacturers were analyzed individually. Univariate analyses were carried out to determine correlations between the type of MEA and the main characteristics of the products.

RESULTS: 307 products were analyzed in this study. Among these medical devices, 33.6% (103) have at least one MEA present in the agreement between the CEPS and the manufacturer. The most frequent MEA is a discount based on sales volumes (80%), followed by a simple discount (16%) and finally the performance clause (10.6%) and the review clause (6.7%).The univariate analysis shows a correlation between the type of discount and the level of clinical improvement (ASA), the size of the target population, the dispensing area, the therapeutic area and the budgetary impact.

CONCLUSION: The different MEAs represent an important part of the CEPS tariff regulation methods. Not all MEAs are necessarily activated every year (especially if the volume thresholds are not exceeded).