PMD160 - PRICING OF REIMBURSED MEDICAL DEVICES IN FRANCE: WHAT FACTORS IMPACT DECISION-MAKING?

Abstract

Regarding medical devices, the French Healthcare Products pricing Committee (CEPS) uses different criteria (R.165-14 of the Social Security Code) for the price setting which are: the ASA (additional medical benefit) rating, prices of comparable products or services, estimated sales volume and estimated conditions of use. The objective of this analysis is to assess the impact of these criteria and other parameters (such as the price claimed by the company, the European prices of the device, and its therapeutic area) on price setting and on following price discounts. All the devices that had their reimbursement inscription published in the Official Journal or those with a tariff agreement signed between the CEPS and the company between January 2017 and May 2018 were retrieved. For each device, we calculated the difference between the net price one year after their inscription and its comparator price, in percentage. The impact of the different criteria on the price was assessed using linear regression. 173 medical devices met our inclusion criteria. 83% of the devices obtained an ASA V (no improvement relative to the comparator), 10% an ASA IV (minor improvement), and 7% an ASA III or II (moderate or important improvement). In the univariate analysis, price setting was correlated with ASA (p<0.05), whereas other criteria were not significant. ASA II and III obtained a higher price than their comparator (+60% as median value), while ASA IV had the same price than their comparator (0% as median value), and ASA V resulted in a price discount (-3,2% as median value). ASA is the major factor impacting price negotiation, premium price and discounts. These results must be interpreted carefully as we focused only on medical device prices. A broader perspective including other aspects such as organizational impact is expected.