OBJECTIVES : This study aims to examine how Real World Evidence (RWE) is currently incorporated in US Value Assessment Frameworks (VAFs).

METHODS : A literature review was conducted in PubMed and Embase using the keywords: value assessment frameworks, real world evidence and the United States of America. Grey literature was also searched and English articles were included.

RESULTS : Over the past few years, many value assessment frameworks (VAFs) have been proposed in the United States. VAFs like Institute for Clinical and Economic Review (ICER), National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO), Memorial Sloan Kettering Cancer Center (MSK DrugAbacus), American College of Cardiology and American Heart Association (ACC-AHA) assess the value of drugs based on clinical and economic evidence. The evolving regulatory, payer and market access landscape in the US has seen increased interest in RWE by all relevant stakeholders.

The current use of RWE in US VAFs was found to be limited. ICER VAF includes data from observational studies, registries and patient-reported outcome (PRO), which provide evidence of long-term net health benefits for patients. NCCN mainly focuses on clinical expert panel views based on their knowledge of existing evidence and their clinical experience with treatment in real-world patient population. ASCO has recently agreed to incorporate cross-trial comparisons and also expressed interest in including PROs into their VAF. MSK VAF considers epidemiological data and disease burden while evaluating cancer drugs. ACC-AHA emphasizes on heath economic studies while acknowledging that quality care, quality of life and PROs should be integrated in their VAF.

CONCLUSIONS : Real world data with respect to epidemiology, burden of disease, patient pathways has made its way into VAFs. RWE in terms of efficacy to effectiveness translation, comparative effectiveness research and other aspects can potentially inform VAFs moving forward. However, the incorporation of RWE in VAFs needs further research.