Real-world Evidence (RWE) for Regulatory and Reimbursement Decisions

We have previously discussed the potential roles of real-world data (RWD) and real-world evidence (RWE) for drug access. However, the precise roles of RWE in facilitating regulatory and reimbursement decisions remain poorly defined. Specifically, the types of studies, quality of data, and level of evidence to consider in the reimbursement decision process remain largely unclear. […]