OBJECTIVES: In France, the price of medical devices is negotiated when they are listed in the LPPR. The negotiation is between the CEPS (Healthcare Products Pricing Committee) and the manufacturer. The criteria for setting the price are set out in the law. This study aims to determine correlations between different variables and the percentage decrease in the price of a new product relative to the comparators.

METHODS: The new medical devices whose price was negotiated with CEPS in 2018 and 2019 were selected. For each of these devices, the percentage decrease between the net price of the product and the price of the comparator was calculated. Discount mechanisms (price-volume, risk sharing, etc.) have not been accounted for. An univariate analysis and a multivariate analysis using non-parametric tests were then performed.

RESULTS: 201 medical devices were included in the analysis. The average price discount for products without clinical improvement (ASA V) was 5.1%. Univariate analysis shows that a correlation would exist for clinical improvement (ASA), number of committee meetings, type of comparator, European prices, type of discounts and therapeutic area. Multivariate analysis shows no correlation.

CONCLUSION: Negotiations are based on tangible criteria, but it is very complex to be able to determine predictive models. Comparators of innovative products are difficult to value economically (surgery, lack of alternative...) limiting the available data and biasing this type of analysis. The simplest analysis focuses on clinical improvement where CEPS is asked to achieve savings for unimproved products (ASA V) and this study confirms that this is achieved. In addition, rebate mechanisms are provided for a large number of products and further modify net prices and thus the results of this type of analysis.