Various forms of outcomes-based or risk-sharing agreements have been implemented since early 2000s as a way of access to innovative medicinal products. This study aims to summarize the international experience of performance-based risk-sharing arrangements (PBRSAs) and identify the preconditions for a successful implementation of such schemes. Their implications for the Chinese healthcare market are discussed.

A systematic literature review (in PubMed) was conducted to review the evidence on the nature and performance of PBRSAs in the past 10 years. Grey literature was searched for reports in government websites of the countries in scope.

The search identifies 463 records from PubMed and 3 additional records from other sources. Thirty-one publications are included in the final review. The following preconditions were identified to support a successful implementation of PBRSAs: (1) Identify meaningful and feasible outcome measurements; (2) Establish an effective and efficient data collection infrastructure; (3) Control of the implementation costs; (4) Develop governance and administrative infrastructure to allow delisting and rebate/refund; (5) Clarify personal data protection issues.

The implementation of PBRSAs has proven to be challenging. Although the Chinese healthcare system is not yet well equipped to implement such schemes, some recent changes may pave the way to successful PBRSAs for particular innovative products.