Real-World Evidence: Bridging Gaps in Evidence to Guide Payer Decisions

Melissa H. Roberts () and Gary T. Ferguson
Additional contact information
Melissa H. Roberts: The University of New Mexico College of Pharmacy, University of New Mexico
Gary T. Ferguson: Pulmonary Research Institute of Southeast Michigan

PharmacoEconomics - Open, 2021, vol. 5, issue 1, No 2, 3-11

Abstract: Abstract Randomized controlled trials (RCTs) are preferred by payers for health technology assessments and coverage decisions. However, the inclusion of a highly selective patient population and the rigorously controlled conditions in RCTs may not be reflective of real-world clinical practice. Real-world evidence (RWE) obtained from an analysis of real-world data (RWD) from observational studies can bridge gaps in evidence not addressed by RCTs and is thus valuable to public and private payers for decision-making. Through a broad literature search to obtain insights into payers’ experience, we found that payers have concerns about real-world studies with respect to data quality, poor internal validity, potential bias, and lack of meaningful endpoints. However, they valued RWE to fill evidence gaps not addressed by RCTs, such as high-quality, real-world, long-term effectiveness and safety data; head-to-head drug comparisons; cost analyses for tiering formulary placement; medication use and adherence patterns; identification of relevant responder and non-responder patient subpopulations; and patient-reported outcomes (PROs). RWE can be used to assess clinically meaningful endpoints and gauge the impact of interventions on the quality of healthcare. Here, we review how payers use or can use RWD on the comparative effectiveness and safety of treatments, PROs, medication adherence and persistence, prescribing patterns, healthcare resource utilization, and patient characteristics and/or biomarkers associated with treatment response when making health technology assessments and payer coverage decisions across therapeutic areas.

Date: 2021
References: View complete reference list from CitEc
Citations: View citations in EconPapers (1)

Downloads: (external link)
http://link.springer.com/10.1007/s41669-020-00221-y Abstract (text/html)

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:spr:pharmo:v:5:y:2021:i:1:d:10.1007_s41669-020-00221-y

Ordering information: This journal article can be ordered from
http://www.springer.com/adis/journal/41669

DOI: 10.1007/s41669-020-00221-y

Access Statistics for this article

PharmacoEconomics - Open is currently edited by Timothy Wrightson and Christopher Carswell

More articles in PharmacoEconomics - Open from Springer
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().