Real-world evidence promises to solve many problems inherent in getting a drug to patients at a good price. It could slash development costs and help make the reimbursement case to payers. But there are challenges for companies that want to exploit real-world evidence to get their drug to patients in Europe.

• Real-world evidence has the potential to help companies get drugs to patients more quickly by altering pharma’s R&D paradigm.
• RWE is likely to become a more important means of proving the value of medicines to payers, thus improving the odds of getting reimbursement.
• Adoption has been slow, but increased digitization of real-world data sources should encourage more usage.
• Pharma companies face a number of challenges in successfully exploiting RWE, such as poor data quality and security concerns.

Getting an innovative new drug to patients and convincing payers to pay a good price is no easy feat, as pharma companies know. Real-world evidence has for some time been touted as a remedy for quicker approvals, better discussions with payers and flexible reimbursement agreements. Even though advances in digitization mean that data are potentially much more accessible, realworld evidence has yet to fulfill its promise. A lack of trust in what will happen to patient data, poor approaches to market access and concerns over whether the data are fit for purpose are just some of the challenges in Europe.

Cash-strapped payers are balking at the prices of many pharmaceuticals and thinking hard about whether they want to pay. Real-world evidence originating from, for example, patient registries, electronic health records, claims data or observational cohort studies is likely to become an increasingly important means of proving the value of medicines to payers. Janssen Pharmaceuticals Inc.’s Nigel Hughes, scientific director, RMEDS (real-world evidence, medical affairs, established products, statistics), believes RWE makes good business sense. “Understanding real-world experience and outcomes is critical to ensuring we provide safe, efficacious products to our patients in any given market … and getting excellent outcomes for patients and demonstrating the real-life value of those outcomes to stakeholders is key to the firm’s business success,” he says. “RWE offers the possibility of gaining greater insights into potential opportunities for new products, and/or product extensions, service development and cost efficiencies, including study optimization,” he adds.