It Takes 2 to Tango. Setting Out the Conditions in Which Performance-Based Risk-Sharing Arrangements Work for Both Parties.

Faster regulatory approval processes often fail to achieve faster patient access. We seek an approach, using performance-based risk-sharing arrangements, to address uncertainty for payers regarding the relative effectiveness and value for money of products launched through accelerated approval schemes. One important reason for risk sharing is to resolve differences of opinion between innovators and payers about a technology's underlying value. To date, there has been no formal attempt to set out the circumstances in which risk sharing can address these differences. We use a value of information framework to understand what a performance-based risk-sharing arrangements can, in principle, add to a reimbursement scheme, separating payer perspectives on cost-effectiveness and the value of research from those of the innovator. We find 16 scenarios, developing 5 rules to analyze these 16 scenarios, identifying cases in which risk sharing adds value for both parties. We find that risk sharing provides an improved solution in 9 out of 16 combinations of payer and innovator expectations about treatment outcome and the value of further research. Among our assumptions, who pays for research and scheme administration costs are key. Steps should be undertaken to make risk sharing more practical, ensuring that payers consider it an option. This requires additional costs to the health system falling on the innovator in an efficient way that aligns incentives for product development for global markets. Health systems benefits are earlier patient access to cost-effective treatments and payers with higher confidence of not wasting money. Innovators get greater returns while conducting research. • Accelerated regulatory approvals often fail to provide early access because of uncertainty about value. Performance-based risk-sharing arrangements (PBRSAs) have been used in some circumstances to achieve access, but many payers and innovators are resistant to using them. Value of Information approaches allow analysis of when risk sharing may help provide early access but, to date, have not addressed PBRSA use to resolve differences of opinion between innovators and payers about a technology's value. • We use a Value of Information framework to understand what a PBRSA can add to a reimbursement scheme, separating payer perspectives on cost-effectiveness and on the value of research from those of the innovator. We find 16 scenarios, developing 5 rules to analyze these 16 scenarios, identifying situations in which risk sharing adds value for both parties. We show that PBRSAs can address differences of opinion between payers and innovators about underlying value in 9 out of 16 scenarios. • Incentives should be aligned to make PBRSA choices efficient. Key requirements are that (1) innovators pay for both evidence generation costs and for the administration of PBRSAs, (2) prices could go up or down after evidence collection, and (3) innovators face penalties if they do not undertake and complete agreed research. Health systems benefits are earlier patient access to cost-effective treatments and payers having higher confidence of not wasting money. Innovators get greater returns while conducting research. [ABSTRACT FROM AUTHOR]