BMC ophthalmology · 2026
Cost-effectiveness of the Port Delivery Platform compared with intravitreal injection of anti-vascular endothelial growth factor for patients with neovascular age-related macular degeneration.
СтатьяСравнительное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Siekerman Michelle Mies Elisabeth, Kristiansen Ivar Sønbø, Jørstad Øystein Kalsnes, Bragadóttir Ragnheiður, Burger Emily A
Аннотация
BACKGROUND: Standard ranibizumab anti-vascular endothelial growth factor (anti-VEGF) intravitreal injection (IVI) therapy for neovascular age-related macular degeneration (nAMD) may be alternatively delivered using the Port Delivery Platform (PDP), a drug delivery system surgically inserted into the eye that was re-approved by the U.S. Food and Drug Administration in July 2024. Quantifying the added health benefits and cost consequences of new health interventions is required in various health systems. This study aims to evaluate the cost-effectiveness of universal and targeted use of the PDP with ranibizumab compared to treat-and-extend (T&E) aflibercept injections for patients with nAMD in Norway.
METHODS: We compared the PDP with ranibizumab 100 mg/ml with fixed 24-week refill-exchanges (Q24W) to T&E IVI with vial split aflibercept 2 mg. We developed a probabilistic visual acuity-based simulation model using data derived from published clinical trials and studies. Resources were valued using Norwegian healthcare tariffs and included time and travel costs, in line with Norwegian guidelines. We simulated individuals with nAMD (mean age of 75 years) at treatment initiation and with a best-corrected visual acuity (BCVA) of 71-85 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters. Subgroup analysis simulated individuals undergoing monthly aflibercept treatment, who face long-distance travel times, or who feel extremely anxious about IVI. Main outcomes include total discounted lifetime costs and quality-adjusted life years (QALY) disaggregated by health state, treatment modality, and adverse events. Cost-effectiveness was measured using the incremental cost-effectiveness ratio (ICER) and compared against benchmark thresholds of cost-effectiveness in Norway.
RESULTS: Universal use of the PDP (Q24W) provided greater health benefits (6.5606 QALYs) than aflibercept T&E (6.5516 QALYs) but increased costs by $11,431, yielding an ICER >$1 million per QALY gained, which far exceeds cost-effectiveness thresholds in Norway. In contrast, for patients requiring monthly IVI treatments or facing travel distances of ≥ 4 h, the PDP was considered cost-saving.
CONCLUSIONS: Compared to aflibercept IVIs under a T&E regimen for bilateral nAMD, universal use of the PDP with 24-week refills is unlikely to be considered cost-effective in Norway. However, the PDP may be considered high-value for patients needing frequent IVI or facing long travel distances.
TRIAL REGISTRATION: NA.
METHODS: We compared the PDP with ranibizumab 100 mg/ml with fixed 24-week refill-exchanges (Q24W) to T&E IVI with vial split aflibercept 2 mg. We developed a probabilistic visual acuity-based simulation model using data derived from published clinical trials and studies. Resources were valued using Norwegian healthcare tariffs and included time and travel costs, in line with Norwegian guidelines. We simulated individuals with nAMD (mean age of 75 years) at treatment initiation and with a best-corrected visual acuity (BCVA) of 71-85 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters. Subgroup analysis simulated individuals undergoing monthly aflibercept treatment, who face long-distance travel times, or who feel extremely anxious about IVI. Main outcomes include total discounted lifetime costs and quality-adjusted life years (QALY) disaggregated by health state, treatment modality, and adverse events. Cost-effectiveness was measured using the incremental cost-effectiveness ratio (ICER) and compared against benchmark thresholds of cost-effectiveness in Norway.
RESULTS: Universal use of the PDP (Q24W) provided greater health benefits (6.5606 QALYs) than aflibercept T&E (6.5516 QALYs) but increased costs by $11,431, yielding an ICER >$1 million per QALY gained, which far exceeds cost-effectiveness thresholds in Norway. In contrast, for patients requiring monthly IVI treatments or facing travel distances of ≥ 4 h, the PDP was considered cost-saving.
CONCLUSIONS: Compared to aflibercept IVIs under a T&E regimen for bilateral nAMD, universal use of the PDP with 24-week refills is unlikely to be considered cost-effective in Norway. However, the PDP may be considered high-value for patients needing frequent IVI or facing long travel distances.
TRIAL REGISTRATION: NA.
Предметные рубрики MeSH
HumansIntravitreal InjectionsCost-Benefit AnalysisAngiogenesis InhibitorsRecombinant Fusion ProteinsReceptors, Vascular Endothelial Growth FactorCost-Effectiveness AnalysisRanibizumabVascular Endothelial Growth Factor ADrug Delivery SystemsFemaleWet Macular DegenerationMaleVisual AcuityAgedQuality-Adjusted Life YearsAged, 80 and over