Cost-Utility Analysis of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration

Abstract

To quantify the cost-utility ratio of the ranibizumab Port Delivery System (PDS; SUSVIMO) versus intravitreal ranibizumab injections for treating neovascular age-related macular degeneration (nAMD) based upon Archway Phase 3 Trial data. Cost-utility analysis. Archway Phase 3 Clinical Trial nAMD participants previously responsive to anti-VEGF therapy were randomized 3:2. Two hundred forty received PDS refills q 24 weeks and 162 received ranibizumab injections. Ophthalmic patient, time tradeoff utilities, direct medical and societal cost perspectives, 12-year, 1-year, and 5-year timelines, United States 2022 real dollars, and a 3% annual discount rate were employed. Utilities were adjusted for nAMD conversion in fellow eyes during the 12-year, mean participant life expectancy. Premature death associated with severe vision loss was integrated as per the population-based Salisbury Eye Evaluation Study. Quality-adjusted life-year (QALY) accruals, costs, and incremental and average cost-utility ratios in $/QALY (dollars expended per QALY gained). Versus no therapy, the 1-year PDS QALY gain was 0.0156 (6.8%) versus 0.0063 (0.82%) for intravitreal injections (P < 0.001), whereas the respective 12-year QALY gains were 1.714 (28%) and 1.639 (26.8%) (P= 0.99). One-year direct PDS ophthalmic costs totaled $21 825 with 2 ranibizumab fills, whereas ranibizumab injection therapy totaled $18 405 with 11.8 injections. The 1-year incremental PDS $/QALY versus injections was cost effective at $75 497/QALY. Five-year PDS therapy was not incrementally cost effective at $304 108/QALY, nor was the 12-year therapy at $761 646/QALY. Average 12-year cost-utility ratios were $78773/QALY for the PDS and $47 917/QALY for injection therapy. Adding-$476 442 12-year offsetting societal costs netted $314 521 to society per PDS participant versus $370 958 per participant for injection therapy. Ranibizumab PDS therapy was not incrementally cost effective versus ranibizumab injection therapy at 12 or 5 years but was at 1 year. Injection therapy had a more favorable 12-year average cost-utility ratio. Vision gain was the major determinant of participant value gain and was the same for both interventions. Both interventions were highly cost effective utilizing average cost-utility analysis with the societal cost perspective. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.