OBJECTIVES:

Medical devices are increasing by almost 4% per year in France and represent one of the most dynamic growth areas. When applying for reimbursement, manufacturers submit a file and must forecast sales volumes. The aim of this study is to find out whether or not the forecasts are close to what has actually been reimbursed.

METHODS:

Medical devices with a file for renewal of registration on the LPPR examined by the CEPS between 2018 and 2022 and with a 4-year history were analysed. Sales forecasts from 2014 to 2021 are based on the companies' declarations in the previous file submitted. Reimbursement data from 2014 to 2021 were taken from Health Insurance submitted to the Comité économique des produits de santé (CEPS). The devices general characteristics were taken from the French Health Technology Agency (HAS) assessment. For each device and for each year (n), an index (kn) corresponding to the ratio of the reimbursement data to the sales forecast data and the absolute difference (dn) between these data are calculated. A final index (kf) corresponding to the average of the kn weighted by the dn values is measured. Files with missing or irrelevant data were excluded.

RESULTS:

Of all the files received, 160 could be included in the analysis. It was found that the files forecast higher growth than that actually observed in the reimbursement bases. There was no particular correlation according to the type of product or the presence of a discount mechanism to control expenditure.

CONCLUSIONS:

In our sample, sales forecasts tended to be higher than reimbursed data. Contextual factors such as the COVID period, the arrival of competitors or a new version of the product are factors that can impact on the forecasts but which have not been specifically considered in this study.