Safety, effectiveness, and cost among Texas Medicaid patients with Diabetic Macular Edema (DME) or Age-Related Macular Degeneration (AMD)

Although bevacizumab is one of the most commonly used treatments for DME and AMD, there are concerns regarding safety and effectiveness due to its off-label use. The study objectives were to determine if: 1) the risk of cardiovascular/ hemorrhagic events (safety) and visual impairment (effectiveness...

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Main Author: Jiang, Shan, 1986-
Format: Others
Published: 2015
Subjects:
Online Access:http://hdl.handle.net/2152/28478
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spelling ndltd-UTEXAS-oai-repositories.lib.utexas.edu-2152-284782015-09-20T17:29:51ZSafety, effectiveness, and cost among Texas Medicaid patients with Diabetic Macular Edema (DME) or Age-Related Macular Degeneration (AMD)Jiang, Shan, 1986-Diabetic macular edemaAge-related macular degenerationSafetyCostMedicaidAlthough bevacizumab is one of the most commonly used treatments for DME and AMD, there are concerns regarding safety and effectiveness due to its off-label use. The study objectives were to determine if: 1) the risk of cardiovascular/ hemorrhagic events (safety) and visual impairment (effectiveness) differed by bevacizumab use (i.e., use vs. non-use and number of treatments) among DME and AMD patients; and 2) direct medical costs differed between DME and DME control patients. A retrospective cohort analysis was conducted with Texas Medicaid medical and prescription data (9/1/07-12/31/12) for patients: 18- 63 years, continuously enrolled 1-year pre- and post-index, and diagnosed with DME or AMD. The index date was the first date of diagnosis. The dependent variables were: 1) cardiovascular/hemorrhagic risk; 2) visual impairment; 3) direct medical costs. The independent variables were bevacizumab use and number of bevacizumab treatments. Covariates were disease state, Charlson Comorbidity Index (CCI) score, total medication use, number of laser treatments, and demographics. Propensity scoring technique was used to match: 1) bevacizumab users and non-users; and 2) DME and DME control cohorts. Descriptive analyses, logistic regression, Cox-regression, and generalized linear models were employed. A final cohort of 3,647 DME, 297 AMD, and 57,897 DME control patients were included. The majority (DME and AMD) was between 45-63 years of age (86.6%), Hispanic (54.0%), and female (65.1%). The mean total number of unique medications and mean CCI were 2.7 ± 3.4 and 6.0 ± 3.3, respectively. Total direct medical costs/person (Mean (±SD)) incurred by DME, DME control, and AMD subjects in the post-index period were $6,704(±9,338), $5,495(±10,153), and $4,935(±12,702), respectively. No differences in cardiovascular/ hemorrhagic risk were found between bevacizumab users and non-users. The claims data lacks the detail to determine the effectiveness of bevacizumab. DME control patients had lower overall direct medical costs than DME patients (p<0.0001). In conclusion, although bevacizumab is a less expensive off-label alternative of ranibizumab, the choice between bevacizumab and ranibizumab should be made through careful consideration. However, as the use of anti-VEGF agent increases, further research should be conducted to determine if any changes in cardiovascular adverse events occur.text2015-02-16T16:45:30Z2014-122014-10-23December 20142015-02-16T16:45:30ZThesisapplication/pdfhttp://hdl.handle.net/2152/28478
collection NDLTD
format Others
sources NDLTD
topic Diabetic macular edema
Age-related macular degeneration
Safety
Cost
Medicaid
spellingShingle Diabetic macular edema
Age-related macular degeneration
Safety
Cost
Medicaid
Jiang, Shan, 1986-
Safety, effectiveness, and cost among Texas Medicaid patients with Diabetic Macular Edema (DME) or Age-Related Macular Degeneration (AMD)
description Although bevacizumab is one of the most commonly used treatments for DME and AMD, there are concerns regarding safety and effectiveness due to its off-label use. The study objectives were to determine if: 1) the risk of cardiovascular/ hemorrhagic events (safety) and visual impairment (effectiveness) differed by bevacizumab use (i.e., use vs. non-use and number of treatments) among DME and AMD patients; and 2) direct medical costs differed between DME and DME control patients. A retrospective cohort analysis was conducted with Texas Medicaid medical and prescription data (9/1/07-12/31/12) for patients: 18- 63 years, continuously enrolled 1-year pre- and post-index, and diagnosed with DME or AMD. The index date was the first date of diagnosis. The dependent variables were: 1) cardiovascular/hemorrhagic risk; 2) visual impairment; 3) direct medical costs. The independent variables were bevacizumab use and number of bevacizumab treatments. Covariates were disease state, Charlson Comorbidity Index (CCI) score, total medication use, number of laser treatments, and demographics. Propensity scoring technique was used to match: 1) bevacizumab users and non-users; and 2) DME and DME control cohorts. Descriptive analyses, logistic regression, Cox-regression, and generalized linear models were employed. A final cohort of 3,647 DME, 297 AMD, and 57,897 DME control patients were included. The majority (DME and AMD) was between 45-63 years of age (86.6%), Hispanic (54.0%), and female (65.1%). The mean total number of unique medications and mean CCI were 2.7 ± 3.4 and 6.0 ± 3.3, respectively. Total direct medical costs/person (Mean (±SD)) incurred by DME, DME control, and AMD subjects in the post-index period were $6,704(±9,338), $5,495(±10,153), and $4,935(±12,702), respectively. No differences in cardiovascular/ hemorrhagic risk were found between bevacizumab users and non-users. The claims data lacks the detail to determine the effectiveness of bevacizumab. DME control patients had lower overall direct medical costs than DME patients (p<0.0001). In conclusion, although bevacizumab is a less expensive off-label alternative of ranibizumab, the choice between bevacizumab and ranibizumab should be made through careful consideration. However, as the use of anti-VEGF agent increases, further research should be conducted to determine if any changes in cardiovascular adverse events occur. === text
author Jiang, Shan, 1986-
author_facet Jiang, Shan, 1986-
author_sort Jiang, Shan, 1986-
title Safety, effectiveness, and cost among Texas Medicaid patients with Diabetic Macular Edema (DME) or Age-Related Macular Degeneration (AMD)
title_short Safety, effectiveness, and cost among Texas Medicaid patients with Diabetic Macular Edema (DME) or Age-Related Macular Degeneration (AMD)
title_full Safety, effectiveness, and cost among Texas Medicaid patients with Diabetic Macular Edema (DME) or Age-Related Macular Degeneration (AMD)
title_fullStr Safety, effectiveness, and cost among Texas Medicaid patients with Diabetic Macular Edema (DME) or Age-Related Macular Degeneration (AMD)
title_full_unstemmed Safety, effectiveness, and cost among Texas Medicaid patients with Diabetic Macular Edema (DME) or Age-Related Macular Degeneration (AMD)
title_sort safety, effectiveness, and cost among texas medicaid patients with diabetic macular edema (dme) or age-related macular degeneration (amd)
publishDate 2015
url http://hdl.handle.net/2152/28478
work_keys_str_mv AT jiangshan1986 safetyeffectivenessandcostamongtexasmedicaidpatientswithdiabeticmacularedemadmeoragerelatedmaculardegenerationamd
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