PNS136 MEDICAL DEVICES PRICE SETTING IN FRANCE: A RETROSPECTIVE ANALYSIS (2018-2019)

Abstract

In France, the price of medical devices included in the positive reimbursement list (LPPR) is negotiated between manufacturers and the Healthcare Products Pricing Committee (CEPS). French law provides criteria for setting and reviewing medical device prices. This study aims to establish the effective impact of legislative pricing criteria in the latest negotiations between CEPS and manufacturers. Medical devices which price was negotiated by CEPS from January 2018 to May 2019 were included. For each, the relative difference between the rebated price and the comparator's list price one year after reimbursement inclusion or the price requested was calculated. Several characteristics were tested (e.g. therapeutic area, HTA score, target population, European prices, sales forecast.). Managed entry agreements (e.g. price-volume, risk sharing) are excluded from this analysis. Afterward univariate analysis using non-parametric tests was performed. 126 medical devices were included in the analysis. After 1 year, devices that did not provide medical improvement (ASA V) compared to existing devices had experienced faced a tariff decrease of 5.64% [2% - 5%]. For innovative devices (ASA I-II-III), only 18% have another medical device as a comparator. For these innovative devices, the percentage decrease of rebated price compared to requested price by manufacturer is statistically (p<0.0001) higher than for no added value medical devices (25,3% versus 5,83%). For all devices, a significant difference is observed depending on the therapeutic area (p=0.004). Legislative pricing criteria indicate that a new medical device without clinical advantage may be reimbursed only if it generates savings. This analysis confirmed a decrease of around 5% for these devices. A majority of innovative devices generally have surgical procedures (or no alternative) as comparators, which makes this type of analysis more complex. For these devices, the price requested by the manufacturer is significantly more negotiated than for the ASA V.