Luckham Kirsty, Tebbs Hannah, Dadswell Clare, Yosef Ahmed, Claxton Lindsay, Kelley Kate, Taske Nichole, Burgess Philip I, Dinah Christiana, Lois Noemi, Mohiuddin Syed
Science, Evidence and Analytics Directorate, National Institute for Health and Care Excellence, London, UK.
Clinical Evidence, BMJ Technology Assessment Group, London, UK.
Eye (Lond). 2025 Sep 19. doi: 10.1038/s41433-025-04015-6.
Diabetic macular oedema (DMO) is a common cause of vision loss and blindness. To inform the 2024 UK NICE guideline for treating people with centre-involving DMO (CI-DMO) and central retinal thickness (CRT) of ≥400 µm, the cost-effectiveness of various anti-vascular endothelial growth factor (anti-VEGF) and macular laser treatments was evaluated.
A de novo Markov model evaluated the lifetime costs and quality-adjusted life-years (QALYs) of various anti-VEGFs (aflibercept, bevacizumab, brolucizumab, faricimab, ranibizumab and ranibizumab biosimilar), macular lasers (standard threshold laser and subthreshold micropulse laser), and some treatment combinations from the perspective of the UK NHS. The model included eight health states defined by best-corrected visual acuity ranging between >85 and ≤25 letters. The model's inputs were derived from published literature, while an original network meta-analysis of several clinical trials informed visual outcomes.
All anti-VEGFs demonstrated greater clinical effectiveness and produced more QALYs (ranging from 9.211 to 9.271) than both types of macular lasers (8.928 and 8.944), but lasers were the most cost-effective due to their substantially lower costs. Using confidential price discounts, ranibizumab biosimilar (Ongavia) and brolucizumab had ICERs below £20,000 per QALY, while aflibercept, ranibizumab (Lucentis) and faricimab had ICERs below £25,000 per QALY, compared to no treatment. Bevacizumab was the most cost-effective anti-VEGF treatment due to its significantly lower cost.
Given their clinical and cost-effectiveness at confidential prices, NICE recommends offering a licensed cost-effective anti-VEGF as first-line treatment for people with CI-DMO and CRT ≥ 400 µm. The use of bevacizumab for this population is not licensed in the UK and would be considered off-label.
糖尿病性黄斑水肿（DMO）是视力丧失和失明的常见原因。为了为2024年英国国家卫生与临床优化研究所（NICE）关于治疗中心累及性DMO（CI-DMO）且中心视网膜厚度（CRT）≥400µm患者的指南提供信息，评估了各种抗血管内皮生长因子（抗VEGF）和黄斑激光治疗的成本效益。
一个全新的马尔可夫模型从英国国民健康服务体系（NHS）的角度评估了各种抗VEGF药物（阿柏西普、贝伐单抗、布罗利尤单抗、法西单抗、雷珠单抗和雷珠单抗生物类似药）、黄斑激光（标准阈值激光和阈下微脉冲激光）以及一些治疗组合的终生成本和质量调整生命年（QALY）。该模型包括由最佳矫正视力定义的八个健康状态，视力范围在>85至≤25个字母之间。模型的输入数据来自已发表的文献，同时一项对多项临床试验的原始网络荟萃分析为视觉结果提供了依据。
所有抗VEGF药物都显示出更高的临床疗效，并且产生的QALY比两种黄斑激光更多（范围从9.211到9.271，而黄斑激光为8.928和8.944），但激光因其成本大幅降低而最具成本效益。使用保密价格折扣后，与不治疗相比，雷珠单抗生物类似药（Ongavia）和布罗利尤单抗的增量成本效果比（ICER）低于每QALY 20,000英镑，而阿柏西普、雷珠单抗（Lucentis）和法西单抗的ICER低于每QALY 25,000英镑。由于成本显著更低，贝伐单抗是最具成本效益的抗VEGF治疗药物。
鉴于其在保密价格下的临床和成本效益，NICE建议为CI-DMO且CRT≥400µm的患者提供一种有许可的成本效益高的抗VEGF药物作为一线治疗。在英国，该人群使用贝伐单抗未获许可，将被视为超说明书用药。
