Article

Importance of real world evidence in post market surveillance and launch success

Sept. 6, 2019

In an increasingly competitive disease, drug and technology landscape, winning payer and provider choice can be difficult. The following marketplace conditions can make gaining this choice even more challenging:

• The ever-evolving regulations for medical device manufacturers make staying current with regulations a full-time endeavor.
• Gaining access to a health system or obtaining coverage can be the key to actualizing a new technology’s benefit before the window of competitive advantage closes.  
• Healthcare’s shifting focus to a more patient-centered approach acknowledges the variety of factors that can influence how a drug or medical device interacts with a patient’s life.
• By shining the spotlight on the patient story using real world evidence (RWE) and real world data (RWD), manufacturers have an opportunity to gain an edge in the market.

The importance of RWE and RWD

As healthcare evolves, manufacturers should consider placing greater emphasis on the growing importance of RWE and RWD in crafting a value story. RWE and RWD, as defined by the U.S. Food and Drug Administration (FDA), is “Healthcare information derived from multiple sources outside of typical clinical research settings, including electronic medical records (EMRs), claims and billing data, product and disease registries and data gathered by personal devices and health applications.”1 The FDA can then use this data to monitor the safety and efficacy of products and make regulatory decisions.

The limitations of traditional clinical trials are becoming more apparent and supplementing trial data with RWE can allow manufacturers to collect data that are more representative from a larger, more inclusive patient population. Planning for how this data will be collected and what role it will play in the pre/post approval process can accelerate adoption of the technology by payers or as part of a health system’s preferred offering.

It’s not only the FDA that is interested in using RWE to understand the value of a new device or technology. Payers also look to RWE to support the efficacy claims of a new therapy or device. Having demonstrative evidence of the cost saving or therapeutic benefit of a product can significantly affect its commercialization and coverage success.

Payers are increasingly stressing the importance of outcomes and value in their review and assessment for coverage of pharmaceuticals, medical devices and diagnostics. Medical devices have always been subject to RWE documentation from the FDA, and more than ever, payers and provider organizations are requiring RWE through the use of product experience programs or patient registries that supplement evidence obtained through clinical trial.