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123. Brand vs. Generic: Addressing Non-Adherence, Secular Trends, and Non-Overlap

Author

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

Subjects
Methodology (stat.ME), FOS: Computer and information sciences, Applications (stat.AP), Statistics - Applications, Statistics - Methodology
Abstract

While 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 (IM) venlafaxine, based on a large insurance claims dataset provided by OptumLabs\textsuperscript{\textregistered}. To properly address this question, 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 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 IM venlafaxine.

Published
2019

124. Supplemental Material, 820050_Appendix_1_and_Appendix_2 - Determinants of Generic Drug Substitution in the United States

Author

Segal, Jodi B., Oluwadamilola Onasanya, Daubresse, Matthew, Chia-Ying Lee, Mischka Moechtar, Pu, Xia, Dutcher, Sarah K., and Romanelli, Robert J.

Subjects
FOS: Clinical medicine, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified
Abstract

Supplemental Material, 820050_Appendix_1_and_Appendix_2 for Determinants of Generic Drug Substitution in the United States by Jodi B. Segal, Oluwadamilola Onasanya, Matthew Daubresse, Chia-Ying Lee, Mischka Moechtar, Xia Pu, Sarah K. Dutcher, and Robert J. Romanelli in Therapeutic Innovation & Regulatory Science

Published
2019
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138. Concentrations of B vitamins and homocysteine in children with sickle cell anemia

Author

Segal, Jodi B., Miller, III, Edgar R., Brereton, Nga Hong, and Resar, Linda M.S.

Subjects
Health
Abstract

Background: Elevated concentration of serum homocysteine contributes to thrombosis, a frequent event in patients with sickle cell anemia. We aimed to test whether children with sickle cell anemia have elevated [...]

Published
2004

145. Setting an agenda for comparative effectiveness systematic reviews in CKD care

Author

Crews Deidra C, Greer Raquel C, Fadrowski Jeffrey J, Choi Michael J, Doggett David, Segal Jodi B, Fawole Kemi A, Crawford Pammie R, and Boulware L

Subjects
Chronic kidney disease, Evidence-based practice, Health services research, Diseases of the genitourinary system. Urology, RC870-923
Abstract

Abstract Systematic reviews comparing the effectiveness of strategies to prevent, detect, and treat chronic kidney disease are needed to inform patient care. We engaged stakeholders in the chronic kidney disease community to prioritize topics for future comparative effectiveness research systematic reviews. We developed a preliminary list of suggested topics and stakeholders refined and ranked topics based on their importance. Among 46 topics identified, stakeholders nominated 18 as ‘high’ priority. Most pertained to strategies to slow disease progression, including: (a) treat proteinuria, (b) improve access to care, (c) treat hypertension, (d) use health information technology, and (e) implement dietary strategies. Most (15 of 18) topics had been previously studied with two or more randomized controlled trials, indicating feasibility of rigorous systematic reviews. Chronic kidney disease topics rated by stakeholders as ‘high priority’ are varied in scope and may lead to quality systematic reviews impacting practice and policy.

Published
2012
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