A Literature Review of Risk-sharing Agreements

Objective: To summarize and analyze the available literature around risk-sharing agreements and related concepts. Summary: As both payers and manufactures continue to try and maximize the value of new pharmaceutical technologies, it has become increasingly clear that the previous methods of in-market evidence generation and review have been insufficient, proving to be too costly, time consuming, and removed from real-world aspects of treatment. To counter these limitations, risk-sharing agreements have been proposed as a way to develop evidence for the market (once safety is proven) while still offering incentives to manufactures to continually develop new technology. Manufacturers can use the agreements to first get covered within a market, and then to build trust and good faith in their products with payers by proving their therapeutic value via real-world evidence collection. This literature review summarizes the available literature on the topic of risk-sharing agreements and provides key examples of agreements that were previously signed.