Work

BrandversusGeneric: Addressing Non-Adherence, Secular Trends and Non-Overlap

Year: 2020

Type: article

Abstract: Summary 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.

Source: Journal of the Royal Statistical Society Series A (Statistics in Society)

DOI: 10.1111/rssa.12573

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

Institutions: Johns Hopkins University, Massachusetts College of Pharmacy and Health Sciences, Johns Hopkins Medicine

Language: English

Topic: Pharmaceutical Economics and Policy

Subfield: Economics and Econometrics

Field: Economics, Econometrics and Finance

Domain: Social Sciences

SDG: Good health and well-being

Open Access status: green

Funders: U.S. Food and Drug Administration, National Heart, Lung, and Blood Institute, National Institute on Drug Abuse