A Retrospective of the Sales Forecast and Target Population Impact on Medical Devices Effective Clawback Mechanism in France (2020-2021)

OBJECTIVES: Access to the French medical devices (MD) reimbursement list requires manufacturers to submit a dossier to the Healthcare Products Pricing Committee (CEPS), responsible for negotiating a face value price and possible financial regulation contractual clauses. This review analyses whether the agreed clawback tiers are correlated to the sales forecast submitted by manufacturers in their dossier or to the target population defined by the Health Technology Agency (HAS) assessment and whether these echelons are reached.

METHODS: A database from all dossiers for which the latest price mandate has been issued in 2020 or 2021 was created. It gathers administrative data, sales forecast as submitted by the manufacturers, target population as defined by the HAS, face value prices and clawback conditions as agreed in the corresponding signed convention, and reimbursement data from the National Health Insurance Fund. This retrospective study focuses on dossiers that have resulted in effective first-time inclusion on the MD reimbursement list expecting a sufficient benefit. A dossier is submitted for every MD which can be split into multiple references, thus this study presents data for each identified reference.

RESULTS: Of the 549 dossiers submitted to the CEPS for which the latest decision has been issued in 2020 or 2021, 163 met the inclusion and exclusion criterions of the study leading to the analysis of 407 individual references. 121 (30%) references were concerned by at least one type of clawback payment (price/volume clause, mutualized or not, first unit clause — delta between the listed and the net price — and treatment cost or performance related clauses), the most frequent one being indexed on the volume (62%).

CONCLUSIONS: The CEPS considers the sales forecast as well as the target population defined by the HAS when deciding on a price-volume clawback mechanism.