Market Access and Reimbursement: The Increasing Role of Real-World Evidence.

Randomized controlled trials (RCTs) have historically been considered the primary source of evidence to support decision-making in market access and reimbursement. However, thanks to significant progress in capturing data through computerized systems and making these data available, real-world evidence (RWE) has been increasingly considered by manufacturers and payers. Despite initiatives and research worldwide to promote the use of RWE in healthcare decision-making, an overview of its use over a product lifecycle, its strengths and pitfalls, and how it is perceived from a regulatory and payer perspective will provide a better understanding of what RWE is and how it can support decision-making.