Once seen as a “nice to have,” real-world evidence (RWE) is becoming “mission-critical” for biopharma companies. Not only is it being used in outcomes-based pricing, but the regulatory authorities are sitting up and taking notice, too. Under the 21st Century Cures Act and the Prescription Drug User Fee Act (PDUFA IV), the FDA will publish guidance on the use of RWE by September 2021, with revised guidance by March 2023. And over in Europe, the EMA is using RWE as part of its PRIME (PRIority MEdicines) initiative to speed up drugs through development.
Deloitte’s 2018 survey on the life sciences industry’s RWE capabilities is based on 20 responses from RWE, IT, scientific, medical, and business executives from global life sciences companies. According to the report, there already have been some major steps forward. There is more patient-generated and medical-record data available, technology and analytics is better and more easily accessible, and regulatory bodies are seeing the value. Perhaps top of mind in both payers and biopharma companies, RWE is playing an even bigger role in drug prices, particularly where pay-for-performance contracts are in place.