Krejczy Martin, Harenberg Job, Marx Svetlana, Obermann Konrad, Frölich Lutz, Wehling Martin
Department of Clinical Pharmacology, Medical Faculty Mannheim, Ruprecht-Karls-University Heidelberg, Maybachstrasse 14, 68169, Mannheim, Germany.
J Thromb Thrombolysis. 2014 May;37(4):507-23. doi: 10.1007/s11239-013-0989-6.
We did a cost-utility analysis for the new oral anticoagulants (NOACs) in the German population based on the quality-adjusted life years (QALY), total costs, and incremental cost-effectiveness ratios (ICER). The aim of our investigation was to examine cost-utility for current German drug market costs and compared to other countries. Outcome data were taken from dabigatran's RE-LY, rivaroxaban's ROCKET AF, and apixaban's ARISTOTLE trials. A Markov decision model, the Monte Carlo simulation (MCS), and further sensitivity analyses were used to simulate comparisons between NOACs over a follow up period of 20 years. The main perspective used for the analyses is from a German public health care insurance perspective. The base-case analyses of a 65 years old person with a CHADS2 score >1 resulted in 7.56-7.64 QALYs gained for warfarin. NOACs added 0.04-0.19 QALYs. Total costs for warfarin ranged from 7622 to 9069
我们基于质量调整生命年(QALY)、总成本和增量成本效益比(ICER),对德国人群中的新型口服抗凝药(NOACs)进行了成本效用分析。我们调查的目的是研究当前德国药品市场成本下的成本效用,并与其他国家进行比较。结果数据取自达比加群的RE-LY试验、利伐沙班的ROCKET AF试验以及阿哌沙班的ARISTOTLE试验。采用马尔可夫决策模型、蒙特卡洛模拟(MCS)以及进一步的敏感性分析,来模拟20年随访期内NOACs之间的比较。分析所采用的主要视角是德国公共医疗保险视角。对一名CHADS2评分>1的65岁老人进行的基础病例分析显示,华法林可获得7.56 - 7.64个QALY。NOACs增加了0.04 - 0.19个QALY。华法林的总成本在7622至9069欧元之间,NOACs的总成本在19537至20048欧元之间。敏感性分析表明,在所有治疗方案中,当前德国市场上NOACs的成本超过了(假设的)每QALY 50000欧元的支付意愿阈值。MCS显示,支付意愿阈值从阿哌沙班的每QALY 60500欧元到每日两次服用110毫克达比加群的每QALY 278000欧元不等,每日两次服用150毫克达比加群和利伐沙班的数值介于两者之间。总之,从德国公共医疗保险视角来看,相对于所获得的生活质量,当前市场成本较高。这些临床研究(疗效)的结果仍有待在现实生活条件下(有效性)得到证实。