OBJECTIVES:

In France, the price of medical devices included in the positive reimbursement list (LPPR) is negotiated between the manufacturer and the French Healthcare Products Pricing Committee (CEPS).

The agreement leads to the list price publication. However, it can also include other elements which are not public as the managed entry agreement (MEA). MEA are confidential.

This study aims to exhaustively review the MEA use for reimbursed medical devices in France.

METHODS:

All the agreements signed between 2018 to May 2019 were reviewed to identify those including a MEA.

Analyses considered the MEA type depending on the medical device characteristics (e.g. therapeutic area, HTA score, target population, budgetary impact).

Statistical analysis was conducted.

RESULTS:

Among the 259 agreements analysed, 30% of them include a MEA.

Confidential agreements are mostly associated to innovative devices (81% of them). While they are less frequent for medical devices with no added medical value (22%).

Price-volume agreements are the most commonly used (71%), followed by simple discount (16%) and performance-based agreement (7%).

When considering the distribution channel, inpatient medical devices are more entitled to be associated to a MEA than outpatient devices.

In terms of therapeutic area, devices in cardiology and neurology ranks first in MEA use.

CONCLUSIONS:

CEPS increasingly uses MEA as a regulation tool to contain reimbursed medical devices expenditures.