New Study Examines Risk-Sharing Agreements Between Pharmaceutical Manufacturers and Payers

For Immediate Release
Contact: Andrea Hofelich,, 202-827-2078

(Washington, DC, September 16, 2015)—A newly released study has found that risk-sharing agreements (RSAs) between pharmaceutical companies and health insurers—which could significantly transform the cost and accessibility of medications—are not widely utilized in the U.S. today, but could increase as the health care system becomes more value-focused and data-driven.

The peer-reviewed study, “Private Sector Risk-Sharing Agreements in the U.S.: Trends, Barriers and Prospects,” published today in The American Journal of Managed Care, was conducted jointly by experts from the National Pharmaceutical Council (NPC), the University of Washington, Tufts University and the United Kingdom’s Office of Health Economics. The researchers utilized database reviews, interviews with key stakeholders and an online survey to assess current barriers to pharma-insurer risk-sharing agreements in the U.S. and future prospects for such arrangements.

Under risk-sharing arrangements, health care payers and pharmaceutical manufacturers agree to link coverage and reimbursement levels to a drug’s effectiveness and/or how frequently it is utilized. According to the study, there are some benefits to these arrangements. Manufacturers said they can use RSAs to differentiate and demonstrate the effectiveness of their product versus their competitors, which can assist payers in making formulary decisions. Payers can utilize RSAs to gain experience with a product, reducing uncertainty regarding clinical value, performance and financial impact.

The new study shows, however, that RSAs are not frequently utilized in the U.S. today, in part because significant data collection and monitoring infrastructure is necessary to monitor patients’ drug usage and health outcomes. Manufacturers are reluctant to expose themselves to financial consequences when they can’t control how drugs are prescribed or how well patients adhere to their physicians’ instructions. It also can be challenging to agree upon meaningful and measurable health outcomes within a reasonable timeframe, the study notes.

“Existing barriers, such as the effort and expense involved in patient monitoring, make it difficult to design and implement risk-sharing agreements in the current environment,” said NPC Chief Science Officer Robert W. Dubois, MD, PhD, one of the study’s authors. “As our health and data systems evolve, more opportunities for creative interactions between insurers and drug manufacturers may present themselves.”

Stakeholders, according to the study, believe that more RSA activity could be on the horizon. They cite improved data systems, which could strengthen the capability to monitor patient adherence and health outcomes. They also said that new health care payment and delivery systems could enable the alignment of risk-sharing agreements with value-focused systems like accountable care organizations.

Looking to follow-on research, the study’s director, Lou Garrison, PhD, Professor in Pharmaceutical Outcomes Research & Policy Program at the University of Washington, remarked, “In principle, RSAs can generate valuable information about the real-world performance of medicines. We should consider exploring whether there are policy tools or incentives that could be used to support the adoption of RSAs in the US private sector.”   

About the National Pharmaceutical Council
The National Pharmaceutical Council is a health policy research organization dedicated to the advancement of good evidence and science, and to fostering an environment in the United States that supports medical innovation. Founded in 1953 and supported by the nation’s major research-based pharmaceutical companies, NPC focuses on research development, information dissemination, and education on the critical issues of evidence, innovation and the value of medicines for patients. For more information, visit and follow NPC on Twitter @npcnow