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Cost-effectiveness of ranibizumab for the treatment of neovascular age-related macular degeneration in germany: Model analysis from the perspective of germany's statutory health insurance system.

机译:雷尼单抗治疗德国新血管性年龄相关性黄斑变性的成本效益:从德国法定健康保险制度的角度进行模型分析。

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BACKGROUND: In clinical trials, ranibizumab has been associated with stabilization and even improvement of visual acuity among patients with neovascular age related macular degeneration (AMD), but its use is also associated with considerable costs. OBJECTIVE: The aim of this work was to compare ranibizumab with best supportive care or photodynamic therapy (PDT) for AMD by means of economic cost-utility and cost-effectiveness analysis from the perspective of Germany's Statutory Health Insurance System. METHODS: Visual acuity data from the Anti-VEGF (vascular endothelial growth factor) Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in AMD (ANCHOR) and Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular AMD (MARINA) studies were applied, based on a ranibizumab dose of 0.5 mg. A Markov model simulated visual acuity and costs over 10 years (discounted at 3%). The base-case analysis assumed 5 injections per year over 2 years. Treatment costs were based on year-2008 euros (using German prices) and recommendations for procedure reimbursement from a public health insurance perspective. To assess cost-effectiveness, costs per year of legal blindness avoided (ie, vision-year gained [VYG]) and per quality-adjusted life-year (QALY) were calculated. The model assumed each patient's affected eye had better sight than the other eye, and the 2 comparators against which ranibizumab treatment was assessed were best supportive care and PDT. The robustness of the results was investigated in a univariate sensitivity analysis of all relevant parameters and a multivariate probabilistic sensitivity analysis. The multivariate 95% CIs for incremental cost-effectiveness ratios were obtained by conducting 1000 Monte Carlo simulations. RESULTS: Compared with best supportive care, costs per VYG for ranibizumab were euro6767 in occult choroidal neovascularization (CNV) and euro6020 in minimally classic CNV. In classic CNV, costs were euro5734/VYG for ranibizumab compared with supportive care and euro778/VYG for ranibizumab compared with PDT. Costs per QALY for ranibizumab treatment for occult, minimally classic CNV, and classic CNV were euro22,320, euro22,538, and euro25,036, respectively, and euro3294 for classic CNV compared with PDT. Results were sensitive to the cost of blindness, injection frequency, and duration. The multivariate 95% CIs for the incremental cost effectiveness ratios were euro14,438 to euro41,110/QALY for occult CNV, euro13,463 to euro43,614/QALY for minimally classic CNV, and euro15,634 to euro51,106/QALY for classic CNV. CONCLUSION: In this model analysis using costs and clinical trial data from Germany, ranibizumab appeared to be a cost-effective treatment option for all angiographic subtypes of neovascular AMD, from the perspective of Germany's Statutory Health Insurance System.
机译:背景:在临床试验中,兰尼单抗与新血管性年龄相关性黄斑变性(AMD)患者的稳定甚至视力提高有关,但使用它也需要大量费用。目的:本研究的目的是通过经济成本效用和成本效益分析,从德国法定健康保险系统的角度比较雷珠单抗与AMD的最佳支持治疗或光动力疗法(PDT)。方法:从抗VEGF(血管内皮生长因子)抗体治疗主要用于经典脉络膜新血管形成(ANCHOR)的视力数据,以及抗VEGF抗体雷珠单抗治疗新血管性AMD的最小经典/隐性试验(基于0.5 mg雷珠单抗剂量进行了MARINA研究。马尔可夫模型可模拟10年以上的视敏度和成本(折价3%)。基本案例分析假设两年内每年注射5次。治疗费用基于2008年欧元(使用德国价格)和从公共健康保险角度提出的程序报销建议。为了评估成本效益,计算了避免每年因法律失明而产生的成本(即获得视力年[VYG])和每个经过质量调整的生命年(QALY)的成本。该模型假设每位患者的患眼都比另一只眼具有更好的视力,并且评估兰尼单抗治疗的两个比较者是最佳支持治疗和PDT。在所有相关参数的单变量敏感性分析和多元概率敏感性分析中研究了结果的稳健性。通过进行1000次蒙特卡洛模拟获得了95%CI的增量成本效益比。结果:与最佳支持治疗相比,兰尼单抗的每VYG费用在隐匿性脉络膜新生血管(CNV)中为euro6767,在最低标准的CNV中为euro6020。在经典CNV中,兰尼单抗与支持治疗相比的费用为euro5734 / VYG,兰尼单抗与PDT相比的费用为778 / VYG。兰尼单抗治疗隐性,最小经典CNV和经典CNV的每QALY成本与PDT相比分别为22,320欧元,22,538欧元和25,036欧元,经典CNV为3294欧元。结果对失明,注射频率和持续时间的成本敏感。隐性CNV的成本效益比率的多元95%CI为14,438欧元至41,110 / QALY,最小经典CNV的欧元13,463至43,614 / QALY,以及15,634欧元至51,106 / QALY。经典CNV。结论:在此使用德国成本和临床试验数据进行的模型分析中,从德国法定健康保险系统的角度来看,兰尼单抗似乎是所有新生血管AMD血管造影亚型的经济有效的治疗选择。

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