PDG57 DRUG PRICING PREDICTABILITY IN FRANCE: WHICH MANAGED ENTRY AGREEMENT SUITS THE BEST?

Abstract

In France, the price of drugs is negotiated between the French Healthcare Products Pricing Committee (the so-called CEPS) and manufacturers. In some cases, the list price is associated with managed entry agreement. This study aims to identify if a correlation can be made between the type of rebates, drug characteristics and its evaluation by the French National Authority for Health (HAS). A retrospective analysis of all drugs with a rebate agreement in 2017 was conducted. It exhaustively considers all drugs reimbursed in France since 2010. The characteristics analysed were drug status (Orphan / Non orphan ; Oncologic / Non oncologic drug), Added-medical value (ASMR) score (I; II; III; IV; V), target population (0-1000; 1000-10 000; 10 000-100 000; >100 000 patients/year) and type of rebate (capping; simple discount; price-volume; posology; daily treatment cost; and pay for performance). 129 drugs were identified and 3 different analyses were performed. The first one is based on drug status. Most orphan drugs have a capping agreement (84%) and to a lesser extent a price volume rebate (46%). Simple discounting is observed for 67% of oncologic drugs. The second analysis is based on the HAS evaluation, and more particularly the level of ASMR. Capping is applied to 67% of the drugs with an ASMR score of I to III pooled. Simple discount is observed for 67% of drugs with ASMR rating of III. The third analysis is based on target populations. Daily treatment cost rebate is observed for 27% of ASMR V and 35% for ASMR I and II. The type of rebate may be predictable based on evaluation criteria and drug characteristics. The different trends can be explained by mechanisms of payment such as the envelopes for orphan drugs leading to capping rebates for 84% of them.