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Steve Duff, Nancy Holekamp, Yamina Rajput; Cost-effectiveness of FDA-approved anti-VEGF treatments for diabetic macular edema. Invest. Ophthalmol. Vis. Sci. 2016;57(12):5583.
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© ARVO (1962-2015); The Authors (2016-present)
Diabetic macular edema (DME) is a complication of diabetic retinopathy that can lead to vision loss if untreated. Visual impairment and blindness due to DME have become escalating clinical and economic issues as the number of diabetic patients increases worldwide. This study evaluates the relative differences in the costs and quality-adjusted life years (QALYs) of the two approved anti–vascular endothelial growth factor (VEGF) therapies, aflibercept and ranibizumab, in patients with DME.
A model was developed using one-year patient-level visual acuity (VA) data from the DRCR.net Protocol T study—a head-to-head randomized controlled trial of anti-VEGF treatments for DME. In addition to the costs of treatment with aflibercept (2.0 mg) or ranibizumab (0.3 mg) (given at baseline and up to every 4 weeks using defined retreatment criteria), VA-related medical costs and QOL were simulated based on 8 VA health states. Costs (2015 USD) for treatments, adverse events (AEs) and VA-related resources were based on Medicare reimbursement and literature. VA-related utilities were determined by a published algorithm. Costs and QALYs were quantified for two patient groups based on baseline VA: 20/40 or better and 20/50 or worse.
One-year total costs (for treatment, AE management, and visual impairment) and QALYs for ranibizumab vs. aflibercept were: $16,624 vs. $24,460 and 0.767 vs. 0.767 in the better VA group and $20,141 vs. $30,416 and 0.710 vs. 0.720 in the worse VA group. Comparing aflibercept to ranibizumab, the incremental cost-effectiveness ratio (ICER) was $964,607/QALY in the worse VA group which far exceeds conventional ICER thresholds for recommended product adoption. An ICER was not calculated in the better VA group because ranibizumab is less costly and equally effective. While ICERs were sensitive to assumptions about the relative weighting of the better- and worse-seeing eye on patient outcomes, conclusions remained unchanged.
Although anti-VEGF treatments for DME are associated with high costs, the increase comes with improved visual acuity and QOL benefits. Treatment with aflibercept is more costly than with ranibizumab and yields only similar or nominal increases in QALYs. Therefore, based solely on this health economic analysis of FDA-approved anti-VEGF treatments, aflibercept is not cost-effective when compared to ranibizumab for DME patients based on one-year results.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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