Brand versus Generic: Addressing Non-Adherence, Secular Trends and Non-Overlap

Autor:	Irene B. Murimi, Daniel O. Scharfstein, Jodi B Segal, Lamar Hunt Iii, Marissa J. Seamans, Ravi Varadhan
Rok vydání:	2020
Předmět:	Statistics and Probability Time varying confounding Economics and Econometrics Regression discontinuity design Econometrics G computation Statistics Probability and Uncertainty Psychology Social Sciences (miscellaneous) Non adherence Therapeutic equivalence Secular variation
Zdroj:	Journal of the Royal Statistical Society Series A: Statistics in Society. 183:1461-1478
ISSN:	1467-985X 0964-1998
DOI:	10.1111/rssa.12573
Popis:	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.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::8921873fcf870f19c4a42074edbf2de7 https://doi.org/10.1111/rssa.12573 Zobrazit plný text záznamu Plný text ve formátu PDF