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

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

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.

Suggested Citation

  • Lamar Hunt & Irene B. Murimi & Jodi B. Segal & Marissa J. Seamans & Daniel O. Scharfstein & and Ravi Varadhan, 2020. "Brand versus generic: addressing non‐adherence, secular trends and non‐overlap," Journal of the Royal Statistical Society Series A, Royal Statistical Society, vol. 183(4), pages 1461-1478, October.
    • Handle: RePEc:bla:jorssa:v:183:y:2020:i:4:p:1461-1478
    DOI: 10.1111/rssa.12573
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    References listed on IDEAS

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    1. Ernst Berndt & Murray Aitken, 2011. "Brand Loyalty, Generic Entry and Price Competition in Pharmaceuticals in the Quarter Century after the 1984 Waxman-Hatch Legislation," International Journal of the Economics of Business, Taylor & Francis Journals, vol. 18(2), pages 177-201.
    2. Weiwei Wang & Daniel Scharfstein & Chenguang Wang & Michael Daniels & Dale Needham & Roy Brower, 2011. "Estimating the causal effect of low tidal volume ventilation on survival in patients with acute lung injury," Journal of the Royal Statistical Society Series C, Royal Statistical Society, vol. 60(4), pages 475-496, August.
    3. Imbens, Guido W. & Lemieux, Thomas, 2008. "Regression discontinuity designs: A guide to practice," Journal of Econometrics, Elsevier, vol. 142(2), pages 615-635, February.
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