OBJECTIVES : Increasing competition, pressure from payers and greater regulatory constraints require pharmaceutical manufacturers to seek methods for product differentiation. One way of differentiating pharmaceuticals is the generation of patient-centric value messages utilizing patient-reported outcomes (PROs).  PROs may be primary or nonprimary endpoints in clinical trials, and commercial use is typically dependent on PROs that support key endpoints and appear in labeling (US) or in the summary of product characteristics (EU) to support reimbursement. However, despite this obvious utility, the cost and logistical complexity of including PROs may deter clinical teams. The purpose of this research is to better understand the value of PROs and the ability of PROs to provide data critical to decision making for patients, clinicians, and payers. METHODS : A detailed case study was conducted of three marketed products: ivacaftor, mirabegron, and botulinum type A. Selection of these products represent a range of therapeutic areas and may provide insight into the differing roles of PROs. For each product available US and European submission and review documents were analyzed RESULTS : PROs were included in all three submissions. A PRO labeling claim was granted for a primary endpoint for mirabegron, and while claims for nonprimary PROs were denied, the review documents indicate that the decision for drug approval was supported by results of the nonprimary endpoints. Ivacaftor was granted a claim based on a nonprimary PRO endpoint, though the tool did not meet the specifications of the FDA's PRO guidance. Finally, health authorities recognized the impact on health-related quality of life for botulinum type A for migraine in support of a positive appraisal. CONCLUSIONS : The results of this review indicate that PROs included in clinical trials may have a strong influence on the drug approval process, regardless of whether a PRO labeling claim is ultimately granted. Further research is warranted.