New York University School of Medicine, New York.
Miller School of Medicine, University of Miami, Miami, Florida.
JAMA Ophthalmol. 2022 Jul 1;140(7):716-723. doi: 10.1001/jamaophthalmol.2022.1819.
The study team investigated costs associated with the ranibizumab port delivery system (PDS) for neovascular age-related macular (nAMD), an alternative to conventional intravitreal anti-vascular endothelial growth factor (VEGF) injections.
To investigate costs of intravitreal anti-VEGF injections vs ranibizumab PDS for patients with neovascular AMD (nAMD).
DESIGN, SETTING, AND PARTICIPANTS: This cost analysis used trial data and Medicare reimbursement rates and included patients with nAMD who were receiving ranibizumab, aflibercept, bevacizumab injections, or ranibizumab PDS.
The number of intravitreal ranibizumab, aflibercept, and bevacizumab injections to break even with costs of ranibizumab PDS. Total direct medical costs over 1 year and 5 years for the ranibizumab PDS arm with refills at fixed 6-month intervals compared with monthly or bimonthly injections were calculated using Medicare rates. Scenario and sensitivity analyses accounted for uncertainty and variation.
The mean (SD) number of ranibizumab, aflibercept, and bevacizumab injections to break even with the cost of ranibizumab PDS with 1 refill was 10.8 (1.3), 9.3 (1.1), and 34.5 (4.2), respectively. Ranibizumab PDS with fixed 6-month refills over 1 year cost $21 016 ($2102). Comparatively, monthly intravitreal ranibizumab cost $1943 (95% CI, -$3047 to $6932; P = .34) more, aflibercept cost $5702 (95% CI, $253-$11 151; P = .04) more, and bevacizumab cost $16 732 (95% CI, -$20 170 to -$13 294, P < .001) less. For bimonthly injections, aflibercept cost $7658 (95% CI, -$11 649.52 to -$3665.61; P = .006) less. Over 5 years, monthly intravitreal ranibizumab projected to cost $25 581 (95% CI, $2275-$48 887; P = .04) more, aflibercept cost $44 374 (95% CI, $18 623-$70 125; P = .008) more, and bevacizumab cost $67 793 (95% CI, -$82 501 to -$53 085; P < .001) less than PDS with fixed refills (mean [SD] cost, $89 218 [$8921]). For bimonthly injections, aflibercept cost $22 422 (95% CI, -$40 287 to -$45,56; P = .03) less. In scenario analyses, ranibizumab PDS with refills as needed offered cost savings compared with real-world intravitreal ranibizumab or aflibercept use at 5 years but not at 1 year.
In this cost analysis, ranibizumab PDS with 1 refill cost more than intravitreal ranibizumab or aflibercept injections if less than or equal to approximately 11 or 10 injections, respectively, are required within the first year. Long term, if less than 4.4 and 3.8 injections are needed per refill, intravitreal ranibizumab and aflibercept is lower cost. Ranibizumab PDS costs more than intravitreal bevacizumab injections throughout scenarios.
重要性：研究团队调查了与雷珠单抗港交付系统（PDS）相关的成本，该系统是新生血管性年龄相关性黄斑变性（nAMD）的替代方法，属于常规玻璃体内抗血管内皮生长因子（VEGF）注射。
目的：研究新生血管性 AMD（nAMD）患者使用玻璃体内抗 VEGF 注射与雷珠单抗 PDS 的成本。
设计、设置和参与者：本成本分析使用了试验数据和医疗保险报销率，包括接受雷珠单抗、阿柏西普、贝伐单抗注射或雷珠单抗 PDS 的 nAMD 患者。
主要结果和措施：雷珠单抗 PDS 臂的固定 6 个月间隔补充与每月或每两个月注射相比，在 1 年内和 5 年内达到收支平衡所需的玻璃体内雷珠单抗、阿柏西普和贝伐单抗注射的数量。使用医疗保险费率计算雷珠单抗 PDS 臂的直接医疗总费用，以及在有补充的情况下的 6 个月固定间隔。情景和敏感性分析考虑了不确定性和变化。
结果：在 1 年内达到收支平衡所需的雷珠单抗、阿柏西普和贝伐单抗注射的平均（SD）数量分别为 10.8（1.3）、9.3（1.1）和 34.5（4.2）。雷珠单抗 PDS 与固定的 6 个月补充相比，在 1 年内的成本为 2102 美元。相比之下，每月玻璃体内雷珠单抗的成本高出 1943 美元（95%CI，-3047 美元至 6932 美元；P=.34），阿柏西普高出 5702 美元（95%CI，253 美元至 11511 美元；P=.04），贝伐单抗低 16732 美元（95%CI，-20170 美元至-13294 美元，P 小于.001）。对于每两个月的注射，阿柏西普的成本低 7658 美元（95%CI，-11649.52 美元至-3665.61 美元；P=.006）。在 5 年内，每月玻璃体内雷珠单抗预计成本高出 25581 美元（95%CI，2275 美元至 48887 美元；P=.04），阿柏西普高出 44374 美元（95%CI，18623 美元至 70125 美元；P=.008），贝伐单抗低 67793 美元（95%CI，-82501 美元至-53085 美元；P 小于.001）。与固定补充的 PDS 相比（平均[SD]成本为 89218 美元[8921]）。对于每两个月的注射，阿柏西普的成本低 22422 美元（95%CI，-40287 美元至-4556 美元；P=.03）。在情景分析中，与现实世界中玻璃体内雷珠单抗或阿柏西普的使用相比，有需要时使用雷珠单抗 PDS 可在 5 年内节省成本，但在 1 年内并非如此。
结论和相关性：在本成本分析中，在第一年需要注射 11 次或 10 次以下时，雷珠单抗 PDS 单次注射的成本高于玻璃体内雷珠单抗或阿柏西普注射。长期来看，如果每次补充注射需要少于 4.4 次或 3.8 次，玻璃体内雷珠单抗和阿柏西普的成本较低。在所有情况下，雷珠单抗 PDS 的成本均高于玻璃体内贝伐单抗注射。
