RESULTS: 14 studies and 127 reports (56 therapeutic positioning reports, 56 European Medicine Assessment Reports, and 15 regional evaluations) were reviewed. After discussion with payers, four main findings were gathered: 1) Currently, RWE has a minor impact on the P&R decision-making for RDs in Spain, limited to a supporting tool for outcome-based agreements. 2) RWE can play a key role in establishing innovative dynamic and value-based pricing strategies (currently under evaluation in Spain) and in re-evaluation processes and price reviews. 3) Key points to consider RWE in P&R decisions include an early dialogue with payers to co-create the most suitable study design that addresses payers’ uncertainties and to include RWE studies within the evidence generation plan. 4) Main challenges to overcome include a commitment from the public administration to set a framework for the use and applicability of RWE, commitment from pharmaceutical companies to publish generated evidence; transparency of the decision-making process; application of technologies to extract the RWD from primary sources; and data governance.