Risk-Sharing Agreements

Risk-sharing agreements are a type of innovative payment model that brings together two key stakeholders—health care payers and biopharmaceutical manufacturers—to deliver medicines to patients. Under risk-sharing agreements, biopharmaceutical manufacturers and payers agree to link coverage and reimbursement levels to a drug’s effectiveness and/or how frequently it is utilized.

The benefits of risk-sharing agreements include:

  • Reducing payers’ risk of a sub-optimal purchase;
  • Providing earlier access to biopharmaceuticals for patients and consumers;
  • Offering more efficient pricing mechanisms; and
  • Serving as a catalyst for generating enhanced real-world medical evidence.

However, there are existing barriers, described below, that make it difficult to design and implement risk-sharing agreements in the current environment.

Risk-Sharing Agreements in the United States

In the United States to date, risk-sharing agreement activity has been limited. But interest in the agreements among both payers and biopharmaceutical manufacturers is strong, and a changing health care environment may generate more activity in this arena in the future.

There are compelling arguments for both manufacturers and payers to consider risk-sharing agreements:

  • Manufacturers said they can use risk-sharing agreements to differentiate and demonstrate the effectiveness of their product versus their competitors, which can assist payers in making formulary decisions.
  • Payers can utilize risk-sharing agreements to gain experience with a product, reducing uncertainty regarding clinical value, performance and financial impact.

There are many difficulties inherent in implementing risk-sharing agreements, particularly outcomes-based agreements:

  • Significant payer and provider infrastructure is necessary to monitor an outcomes-based agreement. For example, payers may not have the capability to monitor and track the pharmaceutical usage of individual patients.
  • Manufacturers are reluctant to accept financial consequences when they can’t control how a drug is prescribed or used.
  • Agreeing upon outcomes that are meaningful and measurable within a reasonable timeframe is challenging.

Potential for the Future

There is a belief among stakeholders that more RSA activity could be seen in the future. This expansion could be fueled by (1) improved data systems, which can help create the mechanisms to monitor patient usage of biopharmaceuticals and their effect on health outcomes; and (2) the changing of incentives within the health care system toward value-based orientations. The increased use of accountable care organizations, for example, may lead to enhanced health system alignment with risk-sharing agreements.