The US Centers for Medicare and Medicaid Services (CMS) noted in a recent guidance that it will consider real-world data (RWD) and real-world evidence (RWE) as part of its upcoming Medicare drug pricing negotiations. However, the pharma industry is still awaiting clear guidance on the process, which would be the first time a wealthy nation based such decisions not entirely on traditional clinical trial data.
According to Jeannie Baumann, “Drawing on evidence about the risks and benefits of medical products based on data that comes from outside a clinical trial has long been a priority for the FDA. The drug regulator issued a real-world evidence framework in 2018 and approved a new indication for a drug using real-world evidence two years ago. If the CMS process can overcome challenges like missing data and ensuring the data sources fit their purpose, it will build on the FDA’s longstanding work to advance real-world evidence.”
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(Source: Bloomberg Law, May 25th, 2023)