Introduction and Objective: Faricimab, the only bispecific antibody targeting both Ang-2 and VEGF-A, is a novel treatment for diabetic macular edema (DME). Real-world evidence is lacking on the impact of baseline diabetes severity on its long-term clinical/economic outcomes.Methods: This retrospective cohort study linked a DME cohort from a large national payer (administrative claims) with the American Academy of Ophthalmology IRIS® Registry (EHR). Adults with ≥2 DME diagnoses, ≥1 faricimab injection (Index period: Feb 2022-Jun 2024), and 12 months continuous coverage pre/post-index were included. Patients without subsequent faricimab injections within 12 months or with unspecified laterality were excluded. Outcomes were stratified by baseline diabetes severity using the claims-based Diabetic Complication Severity Index (DCSI). Baseline demographics, comorbidities, HCRU, and cost data were extracted from claims, while clinical outcomes (Visual Acuity (VA) and injection frequency) were from EHR data pre/post-index.Results: The cohort included 902 patients (1360 eyes) initiating faricimab for DME, including 45 treatment-naïve (85 eyes) and 857 previously-treated patients (1275 eyes). Patients were grouped by baseline DCSI: 0-1 (n=120), 2-3 (n=257), 4-5 (n=265), and ≥6 (n=260). Baseline VA was similar across groups (mean 63.2 [17.8], p=0.3). The lowest severity group had the highest proportion achieving ≥5 ETDRS letter gain (43% vs 30-35% in more severe groups, p=0.4). At follow-up, both total all-cause healthcare costs and diabetes-related costs increased with advancing diabetes severity (p< 0.01). However, DME-related costs (excluding aVEGF), were similar across groups (p=0.7), ranging $1267-$1114.Conclusion: This study highlights trends in the clinical/economic impact of baseline diabetes severity on DME outcomes. These findings emphasize the importance of coordinated diabetes and DME management to optimize visual and overall health outcomes.
B. Cooper: Speaker’s Bureau; Current; Genentech, Inc. Advisory Panel; Current; Regeneron Pharmaceuticals Inc. Consultant; Current; Optomed. S. Ko: Employee; Current; Genentech, Inc. X. Sun: Employee; Current; CVS Health. Stock/Shareholder; Current; CVS Health. J. Clubb: Employee; Current; Genentech, Inc. A. Ahmed: Employee; Current; Genentech, Inc. B. Moore: Employee; Current; Genentech, Inc. L. Lupton: Employee; Current; CVS Health. D. Dai: None. Y. Liu: None. Y. Wu: None. N. Gidaya Bonine: Employee; Current; Genentech, Inc.
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