Payers across the globe are becoming increasingly assertive regarding products whose costs aren’t in line with perceived performance—a trend that shows no signs of slowing down. In fact, Express Scripts, one on the largest pharmacy benefit managers (PBMs) in the United States, recently announced a plan that would link the price of some cancer drugs to their real-world performance.¹ Express Scripts’ action is significant, considering that the US has been slower than many European markets to implement new pharmaceutical reimbursement schemes.

Managed entry or risk-sharing agreements (RSAs) represent another mechanism that payers use to mitigate the cost of new drugs based on real-world performance. Financial and performance-based RSAs (PBRSAs) have been widely employed throughout Europe to reduce drug expenditures. While these agreements may not be universally applicable or without challenge, they are gaining momentum in certain markets where they will likely play a role in enhancing economic efficiency.

This article explores some of the driving forces behind RSA implementation, provides an update on the status of RSAs in the European Union, and discusses some of the inherent challenges manufacturers will need to overcome to achieve success under these types of arrangements.