OBJECTIVES : Patient-reported outcomes (PROs) are reports on health condition directly by the patient, without interpretation from anyone else. Their role in reimbursement decisions in the United States (US) is unclear. We aimed to assess the use of PRO measures (PROMs) in decision-making, and identify the opportunities and challenges associated with their use in formulary management in the US.

METHODS : A literature review was conducted using PubMed and EMBASE. Studies of interest included primary research through payer interviews, or review articles on policy and payer research in the US. Data extracted were: type of PROMs preferred, evaluation criteria used by payers in their decisions, and opportunities and challenges for payers in decision-making.

RESULTS : Out of 606 studies, 15 were deemed appropriate. Most were reviews (n=10) and five studies reported primary payer research. Seven studies focused solely on oncology. Most studies showed that payers prefer PROs aligning with objective measures (i.e. laboratory values and clinician ratings). Opportunities for payers included value-based contracting, local level coverage, identification of targets for quality improvement, and identification of technologies impacting healthcare utilization. Challenges associated with the use of PROs included the need for content and psychometric validation, lack of reliability due to poor survey response rates, and the lack of standardization. Solutions identified were sharing information with payers about the methods used to develop and implement PROs, increasing awareness of guidance on data collection, and publishing results of PRO instruments in peer-reviewed journals.

CONCLUSIONS : Our findings suggest that PROs present several advantages for reimbursement decision-making. While there is a shift from fee-for-service to value-based healthcare in the US, most payers are unfamiliar with PROMs. With PRO usage expected to increase in the next 5 years, further research is needed to address challenges faced by payers when using PROs in their decision-making.