Leveraging real-world data to meet payers’ needs

Payers are becoming savvier in accepting real-world data. Certara’s Lee Stern and Shawn Bates discuss the challenges and how pharma can use real-world data to meet payers’ needs.

For years, clinical trial data was king. But as healthcare costs continue to be squeezed, there is pressure on pharmaceutical companies to actually deliver on clinical trial efficacy in the real world. It’s no small feat in the tightly controlled and “biased” environment of randomised controlled trials. This is where a growing plethora of real-world effectiveness data comes in.

From electronic health records to medical claims information, real-world data (RWD) is increasingly being used to supplement the data generated by clinical trials. Just in September, the US Food and Drug Administration released guidance as part of a framework for evaluating real-world evidence to support the approval of a new indication for an already-approved drug. This comes as more pharma companies include RWD in their regulatory applications.

But it’s not just regulatory applications where RWD can have an impact. As companies are increasingly forced to persuade budget-holders of a drug’s cost-effectiveness to ensure post-approval market access, RWD can play a central role.

Lee Stern, VP and head of global operations of the Evidence and Access Division of Certara, says the industry is noticing the shortcomings of traditional sources of clinical trial data.

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