Table 1.

RWE limitations.

Payer concerns about RWE studies

Uncertainty regarding internal validity Lack of familiarity with study methods (eg, regression, propensity score matching, etc) Lack of institutionalized methods of obtaining RWD Inaccurate recording of health events Missing data Lack of interoperable data, including genomic data Lack of transparency regarding use of methods and reporting of results Lack of study timeliness for coverage decision making Lack of resources to locate and review observational studies Privacy of patient data/HIPAA compliance Recurring breaches of privacy may discourage individuals from allowing their data to be used for research purposes

HIPAA indicates Health Insurance Portability and Accountability Act; RWD, real-world data; RWE, real-world evidence.