• Luis Hernandez, Tereza Lanitis, Clifford Cele, Hector Toro-Diaz, Andrea Gibson, and Andreas Kuznik.
• 1 Modeling and Simulation, Evidera, Waltham, Massachusetts.
• J Manag Care Spec Pharm. 2018 Jul 1; 24 (7): 608-616.

BackgroundAge-related macular degeneration (AMD) is the leading cause of vision loss in the United States. The most severe vision loss occurs in patients with neovascular AMD, known as wet AMD (wAMD). The most commonly used antivascular endothelial growth factor (VEGF) therapies approved by the FDA to treat patients with wAMD are ranibizumab, 0.5 mg administered by intravitreal injection once a month (approximately every 28 days), and intravitreal aflibercept injection (IAI), 2 mg every 4 weeks (monthly) for the first 12 weeks (3 months), followed by IAI 2 mg once every 8 weeks (2 months). Given the similar efficacy and safety profiles between IAI and ranibizumab, their associated costs and comparative cost-effectiveness are key factors in determining which one represents a more rational investment of scarce health care resources to help address the increasing cost of prescription drugs in the United States, a source of concern for patients, prescribers, payers, and policymakers.ObjectiveTo assess the cost-effectiveness of intravitreal aflibercept injection 2 mg every 8 weeks after 3 initial monthly doses (IAI 2q8) versus ranibizumab 0.5 mg monthly (Rq4) and pro re nata (PRN) in the treatment of patients with wAMD from a U.S. payer perspective.MethodsA Markov cohort model was developed to estimate the lifetime quality-adjusted life-years (QALYs) and costs of treating patients with wAMD with IAI 2q8, Rq4, and ranibizumab PRN. The model considered changes in best-corrected visual acuity in the affected and fellow eyes over time, and the effect of blindness on mortality. Efficacy for IAI 2q8 and Rq4 was from VIEW 1 and VIEW 2 studies and from the Comparison of AMD Treatments Trials for ranibizumab PRN. Utilities and costs (in 2016 U.S. dollars) were from published literature. Health outcomes and costs were discounted at an annual rate of 3%.ResultsOver a lifetime, IAI 2q8 provided equal health benefits with Rq4 (5.44 QALYs) at a lower total cost ($33,745 vs. $48,031) as a result of fewer injections. IAI 2q8 yielded slightly greater QALYs versus ranibizumab PRN (5.44 vs. 5.40) at a slightly higher cost ($33,745 vs. $33,652), with an incremental cost per QALY gained of $2,583. Results were sensitive to variations in drug acquisition costs and number of injections of both drugs and the baseline age of the cohort.ConclusionsIAI 2q8 can be cost saving and cost-effective compared with Rq4 and ranibizumab PRN for the treatment of wAMD in the United States.DisclosuresThis study was funded by Regeneron Pharmaceuticals, the manufacturer of aflibercept. Hernandez, Lanitis, Cele, and Toro-Diaz are employed by Evidera, which received funding from Regeneron Pharmaceuticals to conduct this study. Gibson and Kuznik are employed by and own stock in Regeneron Pharmaceuticals.

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