Abstract：
BACKGROUND: This study evaluated the cost-effectiveness of anti-vascular endothelial growth factor (VEGF) therapies for subtypes of neovascular age-related macular degeneration (nAMD) from the societal perspective, and for any nAMD from the patient perspective in Japan.
METHODS: A Markov model was developed to simulate the lifetime transitions of a cohort of patients with nAMD through various health states based on the involvement of nAMD, the treatment status, and decimal best-corrected visual acuity. Ranibizumab biosimilar was compared with aflibercept from the societal perspective regardless of treatment regimen for the analysis of three subtypes (typical nAMD, polypoidal choroidal vasculopathy (PCV), and retinal angiomatous proliferation (RAP)). Two analyses from the patient perspective focusing on the treat-and-extend regimens were performed, one with a cap on patients\' copayments and one without. Ranibizumab biosimilar was compared with branded ranibizumab, aflibercept, aflibercept as the loading dose switching to ranibizumab biosimilar during maintenance (aflibercept switching to ranibizumab biosimilar), and best supportive care (BSC), for patients with any nAMD.
RESULTS: In the subtype analyses, ranibizumab biosimilar when compared with aflibercept resulted in incremental quality-adjusted life years (QALYs) of - 0.015, 0.026, and 0.009, and the incremental costs of Japanese yen (JPY) - 50,447, JPY - 997,243, and JPY - 1,286,570 for typical nAMD, PCV, and RAP, respectively. From the patient perspective, ranibizumab biosimilar had incremental QALYs of 0.015, 0.009, and 0.307, compared with aflibercept, aflibercept switching to ranibizumab biosimilar, and BSC, respectively. The incremental costs for ranibizumab biosimilar over a patient lifetime excluding the cap on copayment were estimated to be JPY - 138,948, JPY - 391,935, JPY - 209,099, and JPY - 6,377,345, compared with branded ranibizumab, aflibercept, aflibercept switching to ranibizumab biosimilar, and BSC, respectively.
CONCLUSIONS: Ranibizumab biosimilar was demonstrated as a cost-saving option compared to aflibercept across all subtypes of nAMD, irrespective of the perspectives considered.
METHODS: A Markov model was developed to simulate the lifetime transitions of a cohort of patients with nAMD through various health states based on the involvement of nAMD, the treatment status, and decimal best-corrected visual acuity. Ranibizumab biosimilar was compared with aflibercept from the societal perspective regardless of treatment regimen for the analysis of three subtypes (typical nAMD, polypoidal choroidal vasculopathy (PCV), and retinal angiomatous proliferation (RAP)). Two analyses from the patient perspective focusing on the treat-and-extend regimens were performed, one with a cap on patients\' copayments and one without. Ranibizumab biosimilar was compared with branded ranibizumab, aflibercept, aflibercept as the loading dose switching to ranibizumab biosimilar during maintenance (aflibercept switching to ranibizumab biosimilar), and best supportive care (BSC), for patients with any nAMD.
RESULTS: In the subtype analyses, ranibizumab biosimilar when compared with aflibercept resulted in incremental quality-adjusted life years (QALYs) of - 0.015, 0.026, and 0.009, and the incremental costs of Japanese yen (JPY) - 50,447, JPY - 997,243, and JPY - 1,286,570 for typical nAMD, PCV, and RAP, respectively. From the patient perspective, ranibizumab biosimilar had incremental QALYs of 0.015, 0.009, and 0.307, compared with aflibercept, aflibercept switching to ranibizumab biosimilar, and BSC, respectively. The incremental costs for ranibizumab biosimilar over a patient lifetime excluding the cap on copayment were estimated to be JPY - 138,948, JPY - 391,935, JPY - 209,099, and JPY - 6,377,345, compared with branded ranibizumab, aflibercept, aflibercept switching to ranibizumab biosimilar, and BSC, respectively.
CONCLUSIONS: Ranibizumab biosimilar was demonstrated as a cost-saving option compared to aflibercept across all subtypes of nAMD, irrespective of the perspectives considered.
摘要：
背景：这项研究从社会角度评估了抗血管内皮生长因子（VEGF）治疗新生血管性年龄相关性黄斑变性（nAMD）亚型的成本效益，以及从日本患者角度来看的任何nAMD。
方法：开发了一个马尔可夫模型，以模拟一组nAMD患者通过各种健康状况的生命周期过渡，治疗状态,和十进制最佳矫正视力。Ranibizumab生物仿制药从社会角度与阿柏西普进行了比较，无论治疗方案如何，用于分析三种亚型（典型的nAMD，息肉状脉络膜血管病变（PCV），和视网膜血管瘤样增生（RAP））。从患者的角度进行了两项分析，重点是治疗和延长方案。一个对病人的共付额有上限，一个没有。雷珠单抗生物仿制药与品牌雷珠单抗进行了比较，aflibercept,阿柏西普作为负荷剂量在维持期间转换为雷珠单抗生物仿制药（阿柏西普转换为雷珠单抗生物仿制药），和最佳支持治疗(BSC)，对于任何nAMD患者。
结果：在亚型分析中，与阿柏西普相比，雷珠单抗生物仿制药的质量调整寿命年(QALYs)增量为-0.015、0.026和0.009，日元(JPY)增量成本为-50,447，JPY-997,243和JPY-1,286,570，PCV,和RAP,分别。从病人的角度来看,雷珠单抗生物仿制药的QALY增量为0.015、0.009和0.307，与阿柏西普相比，阿柏西普改用雷珠单抗生物仿制药，BSC,分别。与品牌雷珠单抗相比，雷珠单抗生物仿制药在患者一生中的增量成本估计为JPY-138,948，JPY-391,935，JPY-209,099和JPY-6,377,345，aflibercept,阿柏西普改用雷珠单抗生物仿制药，BSC,分别。
结论：与所有nAMD亚型的阿柏西普相比，雷珠单抗生物仿制药被证明是一种节省成本的选择，不管所考虑的观点如何。
方法：开发了一个马尔可夫模型，以模拟一组nAMD患者通过各种健康状况的生命周期过渡，治疗状态,和十进制最佳矫正视力。Ranibizumab生物仿制药从社会角度与阿柏西普进行了比较，无论治疗方案如何，用于分析三种亚型（典型的nAMD，息肉状脉络膜血管病变（PCV），和视网膜血管瘤样增生（RAP））。从患者的角度进行了两项分析，重点是治疗和延长方案。一个对病人的共付额有上限，一个没有。雷珠单抗生物仿制药与品牌雷珠单抗进行了比较，aflibercept,阿柏西普作为负荷剂量在维持期间转换为雷珠单抗生物仿制药（阿柏西普转换为雷珠单抗生物仿制药），和最佳支持治疗(BSC)，对于任何nAMD患者。
结果：在亚型分析中，与阿柏西普相比，雷珠单抗生物仿制药的质量调整寿命年(QALYs)增量为-0.015、0.026和0.009，日元(JPY)增量成本为-50,447，JPY-997,243和JPY-1,286,570，PCV,和RAP,分别。从病人的角度来看,雷珠单抗生物仿制药的QALY增量为0.015、0.009和0.307，与阿柏西普相比，阿柏西普改用雷珠单抗生物仿制药，BSC,分别。与品牌雷珠单抗相比，雷珠单抗生物仿制药在患者一生中的增量成本估计为JPY-138,948，JPY-391,935，JPY-209,099和JPY-6,377,345，aflibercept,阿柏西普改用雷珠单抗生物仿制药，BSC,分别。
结论：与所有nAMD亚型的阿柏西普相比，雷珠单抗生物仿制药被证明是一种节省成本的选择，不管所考虑的观点如何。
