Setting the Stage for Risk-Sharing Agreements: International Experiences and Outcomes-based Reimbursement

Abstract

Background: Biological medicines are clinically effective but very expensive in South Africa. The business decisions of biological manufacturers and payers (medical schemes) impact the access patient’s have to biological medicines. This paper presents risk-sharing agreements as a means of managing the risk of introducing biological medicines into the healthcare market. Methods: The paper critically reviews literature of some prominent international experiences with risk-sharing agreements and the nuances associated with such agreements. The paper also critiques the outcomes-based reimbursement of biological medicine and the structural necessities for its successful implementation. Results: A risk-sharing agreement is a useful tool to manage the risk of introducing clinically effective and very expensive medicines into the healthcare market. It is also a tool that bridges the conflicting priorities of the manufacturer of biological medicine and the payer. Conclusion: The application of risk-sharing agreements within an international context informs the local discussion. This paper is the first in a two-part series that serves to review the international experience with risk-sharing agreements and critique the outcomes-based reimbursement of biological medicines. The backdrop is set for a discussion of the application of risk-sharing agreements in South Africa, which is the purpose of the second paper in this series.