摘要
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 (vascular endothelial growth factor) therapy were randomized 3:2. Two hundred forty received Port Delivery System refills q 24 weeks and 162 received ranibizumab injections. Intervention, or Testing: Ophthalmic patient, time tradeoff utilities, direct medical and societal cost perspectives, 12-year, 1-year, and 5-year timelines, US 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. QALY (quality-adjusted life-year) accruals, costs, and incremental and average cost-utility ratios in $/QALY (dollars expended per QALY gained). Versus no therapy, the one-year PDS QALY gain was .0453 (5.9%) versus .0063 (.82%) for intravitreal injections (p < .001), while 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 two ranibizumab fills, while ranibizumab injection therapy totaled $18,405 with 11.8 injections. The one-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 twelve-year therapy at $761,646/QALY. Average 12-year CURs were $78,773/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 twelve or five years but was at one 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.