University of Michigan School of Public Health, Ann Arbor.
Jaeb Center for Health Research, Tampa, Florida.
JAMA Ophthalmol. 2023 Mar 1;141(3):268-274. doi: 10.1001/jamaophthalmol.2022.6142.
The DRCR Retina Network Protocol AC showed no significant difference in visual acuity outcomes over 2 years between treatment with aflibercept monotherapy and bevacizumab first with switching to aflibercept for suboptimal response in treating diabetic macular edema (DME). Understanding the estimated cost and cost-effectiveness of these approaches is important.
To evaluate the cost and cost-effectiveness of aflibercept monotherapy vs bevacizumab-first strategies for DME treatment.
DESIGN, SETTING, AND PARTICIPANTS: This economic evaluation was a preplanned secondary analysis of a US randomized clinical trial of participants aged 18 years or older with center-involved DME and best-corrected visual acuity of 20/50 to 20/320 enrolled from December 15, 2017, through November 25, 2019.
Aflibercept monotherapy or bevacizumab first, switching to aflibercept in eyes with protocol-defined suboptimal response.
Between February and July 2022, the incremental cost-effectiveness ratio (ICER) in cost per quality-adjusted life-year (QALY) over 2 years was assessed. Efficacy and resource utilization data from the randomized clinical trial were used with health utility mapping from the literature and Medicare unit costs.
This study included 228 participants (median age, 62 [range, 34-91 years; 116 [51%] female and 112 [49%] male; 44 [19%] Black or African American, 60 [26%] Hispanic or Latino, and 117 [51%] White) with 1 study eye. The aflibercept monotherapy group included 116 participants, and the bevacizumab-first group included 112, of whom 62.5% were eventually switched to aflibercept. Over 2 years, the cost of aflibercept monotherapy was $26 504 (95% CI, $24 796-$28 212) vs $13 929 (95% CI, $11 984-$15 874) for the bevacizumab-first group, a difference of $12 575 (95% CI, $9987-$15 163). The aflibercept monotherapy group gained 0.015 (95% CI, -0.011 to 0.041) QALYs using the better-seeing eye and had an ICER of $837 077 per QALY gained compared with the bevacizumab-first group. Aflibercept could be cost-effective with an ICER of $100 000 per QALY if the price per dose were $305 or less or the price of bevacizumab was $1307 per dose or more.
Variability in individual needs will influence clinician and patient decisions about how to treat specific eyes with DME. While the bevacizumab-first group costs still averaged approximately $14 000 over 2 years, this approach, as used in this study, may confer substantial cost savings on a societal level without sacrificing visual acuity gains over 2 years compared with aflibercept monotherapy.
DRCR 视网膜网络协议 AC 显示，在治疗糖尿病黄斑水肿 (DME) 方面，与贝伐单抗联合治疗相比，阿柏西普单药治疗在 2 年内的视力结果没有显著差异，对于治疗反应不佳的患者，先使用贝伐单抗治疗，然后转换为阿柏西普。了解这些方法的估计成本和成本效益非常重要。
评估阿柏西普单药治疗与贝伐单抗优先策略治疗 DME 的成本和成本效益。
设计、设置和参与者：这是一项在美国进行的随机临床试验的预先计划的二次分析，该试验纳入了 2017 年 12 月 15 日至 2019 年 11 月 25 日期间年龄在 18 岁或以上、有中心性 DME 和最佳矫正视力在 20/50 至 20/320 之间的参与者，这些参与者来自美国各地。
阿柏西普单药治疗或贝伐单抗优先治疗，在符合方案定义的治疗反应不佳的情况下转换为阿柏西普。
在 2022 年 2 月至 7 月期间，评估了 2 年内每增加一个质量调整生命年 (QALY) 的增量成本效益比 (ICER)。使用随机临床试验的疗效和资源利用数据，并结合文献中的健康效用映射和医疗保险单位成本。
这项研究纳入了 228 名参与者（中位年龄 62 岁[范围 34-91 岁]；116 名[51%]女性和 112 名[49%]男性；44 名[19%]黑人或非裔美国人，60 名[26%]西班牙裔或拉丁裔，117 名[51%]白人），其中 1 只眼患有研究性疾病。阿柏西普单药治疗组包括 116 名参与者，贝伐单抗优先组包括 112 名参与者，其中 62.5%最终转换为阿柏西普。在 2 年内，阿柏西普单药治疗组的成本为 26504 美元（95%CI，24796 美元至 28212 美元），而贝伐单抗优先组的成本为 13929 美元（95%CI，11984 美元至 15874 美元），差异为 12575 美元（95%CI，9987 美元至 15163 美元）。使用视力较好的眼睛，阿柏西普单药治疗组获得了 0.015（95%CI，-0.011 至 0.041）个 QALY，与贝伐单抗优先组相比，ICER 为 837077 美元/QALY。如果阿柏西普的每剂价格为 305 美元或更低，或者贝伐单抗的每剂价格为 1307 美元或更高，那么阿柏西普可能具有成本效益，ICER 为 100000 美元/QALY。
个体需求的变化将影响临床医生和患者关于如何治疗特定 DME 眼睛的决策。虽然贝伐单抗优先组的平均成本仍在 2 年内约为 14000 美元，但与阿柏西普单药治疗相比，在这项研究中使用的这种方法可能会在不牺牲 2 年内视力增益的情况下，在社会层面上带来大量的成本节约。
