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      Clinical and economic burden of neovascular age-related macular degeneration by disease status: a US claims-based analysis

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          Abstract

          BACKGROUND:

          New treatment alternatives have revolutionized the management of nAMD. However, there is limited evidence on the clinical and economic burden of nAMD in commercially insured US patients.

          OBJECTIVES:

          To examine the clinical and economic burden in patients with nAMD by disease status in the commercially insured US patient population and to identify drivers of nAMD-related costs.

          METHODS:

          Patients with at least 1 International Classification of Diseases, 10 th Revision Clinical Modification (ICD-10-CM) diagnosis for nAMD were identified from the IQVIA PharMetrics Plus database between April 2016 and August 2017 (index period). Patients had continuous enrollment for at least 6 months before and at least 12 months after the index date. Eye-level disease status was reported, along with intravitreal anti-VEGF treatment patterns. Health care resource utilization (HRU) (all-cause and nAMD-related) and direct health care costs were estimated over the 12 month follow-up period. Outcomes associated with falls and fractures were also assessed. Multivariate analysis identified drivers of annual nAMD-related outpatient costs among patients with anti-VEGF therapy. Incident patients (defined as those without an nAMD diagnosis 6 months prior to the index date) with at least 18 months of continuous enrollment after the index date were identified for a subset analysis to evaluate documented changes in disease status.

          RESULTS:

          A total of 6,076 patients with nAMD were identified for the prevalent cohort; 60.1%, 17.2%, and 5.9% had active CNV, inactive CNV, and inactive scar disease stage at index, respectively. The nAMD-related outpatient visit costs were roughly 4 and roughly 7 times higher, respectively, for the active CNV group ($8,658 [SD = $11,612]) compared with the inactive CNV ($2,406 [SD = $5,510]) and inactive scar ($1,198 [SD = $3,035]) groups ( P < 0.0001). About 10% of prevalent patients had a fall/fracture claim over 12 months of follow-up. A total of 3,623 prevalent patients (59.6%) were eligible for the anti-VEGF treatment patterns analysis (mean [SD] duration of therapy = 7.7 [4.5] months; mean [SD] number of injections = 6.0 [3.7]). Qualified incident cases comprised 17.8% (n = 1,081) of the prevalent cohort. Approximately 20% of incident eyes with active CNV at baseline transitioned to inactive CNV. A total of 427 incident patients (39.5%) qualified for anti-VEGF treatment patterns analysis (mean [SD] duration of therapy = 6.2 [4.7] months, mean [SD] number of injections = 5.2 [3.5]). Significant drivers of total nAMD-related costs were the initial anti-VEGF agent and anti-VEGF injection frequency ( P < 0.0001) in both prevalent and incident cohorts.

          CONCLUSIONS:

          The clinical and economic burden of nAMD treatment is substantial to the US healthcare system, where economic burden is higher among those with active CNV. Appropriate treatment may increase the duration of inactive disease periods and preserve visual acuity while lowering costs.

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          Most cited references39

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          Ranibizumab for neovascular age-related macular degeneration.

          Ranibizumab--a recombinant, humanized, monoclonal antibody Fab that neutralizes all active forms of vascular endothelial growth factor A--has been evaluated for the treatment of neovascular age-related macular degeneration. In this multicenter, 2-year, double-blind, sham-controlled study, we randomly assigned patients with age-related macular degeneration with either minimally classic or occult (with no classic lesions) choroidal neovascularization to receive 24 monthly intravitreal injections of ranibizumab (either 0.3 mg or 0.5 mg) or sham injections. The primary end point was the proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months. We enrolled 716 patients in the study. At 12 months, 94.5% of the group given 0.3 mg of ranibizumab and 94.6% of those given 0.5 mg lost fewer than 15 letters, as compared with 62.2% of patients receiving sham injections (P<0.001 for both comparisons). Visual acuity improved by 15 or more letters in 24.8% of the 0.3-mg group and 33.8% of the 0.5-mg group, as compared with 5.0% of the sham-injection group (P<0.001 for both doses). Mean increases in visual acuity were 6.5 letters in the 0.3-mg group and 7.2 letters in the 0.5-mg group, as compared with a decrease of 10.4 letters in the sham-injection group (P<0.001 for both comparisons). The benefit in visual acuity was maintained at 24 months. During 24 months, presumed endophthalmitis was identified in five patients (1.0%) and serious uveitis in six patients (1.3%) given ranibizumab. Intravitreal administration of ranibizumab for 2 years prevented vision loss and improved mean visual acuity, with low rates of serious adverse events, in patients with minimally classic or occult (with no classic lesions) choroidal neovascularization secondary to age-related macular degeneration. (ClinicalTrials.gov number, NCT00056836 [ClinicalTrials.gov].). Copyright 2006 Massachusetts Medical Society.
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            Causes and prevalence of visual impairment among adults in the United States.

            To estimate the cause-specific prevalence and distribution of blindness and low vision in the United States by age, race/ethnicity, and gender, and to estimate the change in these prevalence figures over the next 20 years. Summary prevalence estimates of blindness (both according to the US definition of < or =6/60 [< or =20/200] best-corrected visual acuity in the better-seeing eye and the World Health Organization standard of < 6/120 [< 20/400]) and low vision (< 6/12 [< 20/40] best-corrected vision in the better-seeing eye) were prepared separately for black, Hispanic, and white persons in 5-year age intervals starting at 40 years. The estimated prevalences were based on recent population-based studies in the United States, Australia, and Europe. These estimates were applied to 2000 US Census data, and to projected US population figures for 2020, to estimate the number of Americans with visual impairment. Cause-specific prevalences of blindness and low vision were also estimated for the different racial/ethnic groups. Based on demographics from the 2000 US Census, an estimated 937 000 (0.78%) Americans older than 40 years were blind (US definition). An additional 2.4 million Americans (1.98%) had low vision. The leading cause of blindness among white persons was age-related macular degeneration (54.4% of the cases), while among black persons, cataract and glaucoma accounted for more than 60% of blindness. Cataract was the leading cause of low vision, responsible for approximately 50% of bilateral vision worse than 6/12 (20/40) among white, black, and Hispanic persons. The number of blind persons in the US is projected to increase by 70% to 1.6 million by 2020, with a similar rise projected for low vision. Blindness or low vision affects approximately 1 in 28 Americans older than 40 years. The specific causes of visual impairment, and especially blindness, vary greatly by race/ethnicity. The prevalence of visual disabilities will increase markedly during the next 20 years, owing largely to the aging of the US population.
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              Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration.

              Two similarly designed, phase-3 studies (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD [VIEW 1, VIEW 2]) of neovascular age-related macular degeneration (AMD) compared monthly and every-2-month dosing of intravitreal aflibercept injection (VEGF Trap-Eye; Regeneron, Tarrytown, NY, and Bayer HealthCare, Berlin, Germany) with monthly ranibizumab. Double-masked, multicenter, parallel-group, active-controlled, randomized trials. Patients (n = 2419) with active, subfoveal, choroidal neovascularization (CNV) lesions (or juxtafoveal lesions with leakage affecting the fovea) secondary to AMD. Patients were randomized to intravitreal aflibercept 0.5 mg monthly (0.5q4), 2 mg monthly (2q4), 2 mg every 2 months after 3 initial monthly doses (2q8), or ranibizumab 0.5 mg monthly (Rq4). The primary end point was noninferiority (margin of 10%) of the aflibercept regimens to ranibizumab in the proportion of patients maintaining vision at week 52 (losing <15 letters on Early Treatment Diabetic Retinopathy Study [ETDRS] chart). Other key end points included change in best-corrected visual acuity (BCVA) and anatomic measures. All aflibercept groups were noninferior and clinically equivalent to monthly ranibizumab for the primary end point (the 2q4, 0.5q4, and 2q8 regimens were 95.1%, 95.9%, and 95.1%, respectively, for VIEW 1, and 95.6%, 96.3%, and 95.6%, respectively, for VIEW 2, whereas monthly ranibizumab was 94.4% in both studies). In a prespecified integrated analysis of the 2 studies, all aflibercept regimens were within 0.5 letters of the reference ranibizumab for mean change in BCVA; all aflibercept regimens also produced similar improvements in anatomic measures. Ocular and systemic adverse events were similar across treatment groups. Intravitreal aflibercept dosed monthly or every 2 months after 3 initial monthly doses produced similar efficacy and safety outcomes as monthly ranibizumab. These studies demonstrate that aflibercept is an effective treatment for AMD, with the every-2-month regimen offering the potential to reduce the risk from monthly intravitreal injections and the burden of monthly monitoring. Proprietary or commercial disclosure may be found after the references. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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                Author and article information

                Journal
                J Manag Care Spec Pharm
                J Manag Care Spec Pharm
                jmcsp
                Journal of Managed Care & Specialty Pharmacy
                Academy of Managed Care Pharmacy
                2376-0540
                2376-1032
                September 2021
                : 27
                : 9
                : 10.18553/jmcp.2021.27.9.1260
                Affiliations
                [1 ]Carolina Eye Associates, Southern Pines, NC.
                [2 ]Global Health Economics and Outcomes Research, Allergen, an AbbVie Company, Irvine, CA.
                [3 ]Global Health Economics and Outcomes Research, Noesis Healthcare Technologies, Inc, Redwood City, CA.
                [4 ]Health Economics and Outcomes Research, Real-World Evidence, IQVIA Inc, Falls Church, VA.
                [5 ]Health Economics and Outcomes Research, Real-World Evidence, IQVIA Inc, Plymouth Meeting, PA.
                [6 ]Global Health Economics and Outcomes Research, Allergan, an AbbVie Company, Irvine, CA.
                Author notes
                [* ]AUTHOR CORRESPONDENCE: Katelyn Keyloun, 714.246.5324; katelyn.keyloun@ 123456abbvie.com

                This study was funded by Allergan, an AbbVie Company. Allergan employees were involved in the study design, interpretation of data, writing of the manuscript, and the decision to submit for publication. Keyloun and Campbell are employees of Allergan. Multani, McGuiness, and Chen are employees of IQVIA, which received funding from Allergan for conducting the analysis. Almony and Shah-Manek have nothing to disclose.

                Article
                10.18553/jmcp.2021.27.9.1260
                10391196
                34464210
                88a09fa0-58b0-47ad-9386-05f659bd3f28
                Copyright © 2021, Academy of Managed Care Pharmacy. All rights reserved.

                This article is licensed under a Creative Commons Attribution 4.0 International License, which permits unrestricted use and redistribution provided that the original author and source are credited.

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