Brand versus generic: addressing non‐adherence, secular trends and non‐overlap

Lamar Hunt, Irene B. Murimi, Jodi B. Segal, Marissa J. Seamans, Daniel O. Scharfstein and and Ravi Varadhan

Journal of the Royal Statistical Society Series A, 2020, vol. 183, issue 4, 1461-1478

Abstract: Whereas generic drugs offer a cost‐effective alternative to brand name drugs, regulators need a method to assess therapeutic equivalence in a post‐market setting. We develop such a method in the context of assessing the therapeutic equivalence of immediate release venlafaxine, based on a large insurance claims data set provided by OptumLabs\circledR. To address this question properly, our methodology must deal with issues of non‐adherence, secular trends in health outcomes and lack of treatment overlap due to sharp uptake of the generic drug once it becomes available. We define, identify (under assumptions) and estimate (using G‐computation) a causal effect for a time‐to‐event outcome by extending regression discontinuity to survival curves. We do not find evidence for a lack of therapeutic equivalence of brand and generic immediate release venlafaxine.

Date: 2020
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