PURPOSE: With RWE playing a more central role in the drug evaluation process, we would like to discuss the applications, advantages and challenges of using RWE for advanced HEOR analytics.

DESCRIPTION: RWE has been consistently used in drug reimbursement decisions to demonstrate treatment patterns, unmet need and burden of illness. However RWE also has tremendous analytical potential beyond descriptive statistics. Although it includes the inherent messiness of real world practice and data collection, it can also provide the advantage of larger samples sizes and longer follow-up time compared to data available from clinical trials. Dr. Basu will introduce the session with an overview of potential analytic areas where RWE might be able to contribute. Dr. Adamson will then discuss the fit-for-purpose of EHR-derived RWD with strengths and weaknesses in various advanced analytics ( specific examples will include hybrid RWE-enhanced extrapolation, synthetic control arms, etc.). She will also discuss potential analytical biases and how they can be mitigated. Dr. Manson will share the manufacturer’s perspective of how these analyses can support reimbursement submissions, including a demonstration of correlating progression and survival across multiple types of RWE databases. She will also discuss how other analytical frameworks such as estimands and indirect comparisons can be considered. Dr. Campbell will then share the health technology assessment (HTA) perspective by summarizing past case studies and lessons learned. He will share ideas on how RWE analytics can reduce uncertainty and what types of RWE are most helpful through the lifecycle of HTA. The discussants will poll the audience on their perceptions of the future direction of RWE analytics, and barriers for use.