Abstract
Real-world evidence (RWE) offers an opportunity to demonstrate effectiveness and safety in populations that are relevant to payers. There has been an ongoing effort by several stakeholders to use a “value”-based metric for making coverage and payment decisions. In a survey of payers, the product safety was mentioned as one of the reasons for leveraging RWE. During the past few years, many different types of value-based agreements have been made between payers and product manufacturers. Different terms have been used for value-based agreements, such as outcomes-based contracts, value-based pricing, performance-based contracts, value-based contracts, risk-sharing agreements, coverage with evidence development, and managed entry schemes. In financial-based agreements the payment is based on financial considerations and is not related to clinical performance. In recent years, some innovative payment models have been proposed that amortize the cost of treatment over multiple years.
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