Potential Risk-Sharing Agreements for Vaccines

After each negotiation between a health care provider and a payer, financial risks exists that may jeopardize the payer’s budget. Risk-sharing agreements (RSAs) in medical care can be used to reassure payers on budget trajectory. This has grown during the recent years resulting from increased budget restrictions. Typically, RSAs have been used for costly products for diseases with a high unmet need such as in oncology. To date, experience with RSAs in vaccines is limited. In this conceptual research we intend to identify RSAs that would be relevant and operable for vaccination programs. We described the different types of uncertainties and associated financial risks a vaccine payer faces in the real-world setting. We conducted a literature review to list the various RSAs proposed in the field of therapeutics. We then assessed how existing RSAs can mitigate those vaccines payers’ risks and evaluated those contracts for a hypothetical vaccine. Vaccine specificities (few doses, potentially a large target population, herd effect and delayed benefit) need to be accounted for when designing RSAs. Financial risks in vaccination budget may arise from uncertainty on effectiveness/safety, uptake, supply, and real-world implementation. RSAs, categorized in either cost-sharing or performance-based risk-sharing, could enable vaccine payers to diminish those risks. As for drugs, cost-based deals would be easier to implement for vaccines than performance-based RSAs. The second should only be used when vaccine effects are observed on the short-term. Insurance mechanisms such as real-option pricing can be used to quantify the risk and price the associated RSA. RSA can be used to mitigate financial risk associated with the access to vaccines. Based on the risks they entail, RSAs for vaccines can be viewed as real-option offered by the manufacturer to the payer. However their practical implementation is likely to differ from therapeutics.