Using Real-world Evidence to Advance Market Access for New Therapeutics
Building a successful drug development program and securing regulatory approval do not guarantee that a sponsor will achieve its desired price and market access for its new product. To achieve those goals, the sponsor must quantify the drug’s value and develop the right strategies and insights to convey that value effectively to external stakeholders. Sponsors need to demonstrate product value not just in a past clinical trial, which is an artificial construct, but objectively with high-quality, real-world evidence. Furthermore, that real-world evidence needs to be gathered with forethought about what core messages it will support. Payers need to know how a new product or technology will help them solve a public health management problem in their country, organization, or health insurance plan.
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