Wolowacz Sorrel E, Roskell Neil S, Maciver Fiona, Beard Stephen M, Robinson Paul A, Plumb Jonathan M, Dolan Gerry, Brenkel Ivan J
RTI Health Solutions, Manchester, UK.
Clin Ther. 2009 Jan;31(1):194-212. doi: 10.1016/j.clinthera.2009.01.001.
This was an evaluation of the cost-effectiveness of oral dabigatran etexilate compared with subcutaneous low-molecular-weight heparin (enoxaparin) for the prevention of venous thromboembolism (VTE) after total knee replacement (TKR) and total hip replacement (THR) surgery from the perspective of the UK National Health Service.
Dabigatran etexilate (220 mg once daily) was compared with enoxaparin (40 mg once daily) in patients undergoing TKR (duration of prophylaxis, 6-10 days) and THR (duration of prophylaxis, 28-35 days). The 10-week acute postsurgical phase was modeled using a decision tree. A Markov process (1-year cycle length) was used to model long-term events (recurrent VTE, postthrombotic syndrome, and consequences of intracranial hemorrhage) for patients' remaining lifetimes. Relative risks for VTE and bleeding events were derived from 2 Phase III studies that compared dabigatran etexilate with enoxaparin 40 mg once daily. The probabilities of long-term events were estimated using data from published longitudinal studies.
Rates of VTE and bleeding events did not differ significantly between dabigatran etexilate and enoxaparin. Dabigatran etexilate was less costly than enoxaparin in TKR and substantially less costly in THR, primarily due to differences in administration costs. The cost of prophylaxis for THR patients, including drugs and administration costs, was estimated at pound 137 for dabigatran etexilate and pound 237 for enoxaparin ( pound 7 for nursing time during the hospital stay, pound 91 for nurse home visits for administration after hospital discharge, and an additional pound 2 in drug costs). At a willingness-to-pay threshold of pound 20,000 per quality-adjusted life-year, the probability of cost-effectiveness for dabigatran etexilate was 75% in TKR and 97% in THR. These results were robust across a range of sensitivity analyses.
From the perspective of the UK National Health Service, thromboprophylaxis with dabigatran etexilate was cost-saving compared with enoxaparin 40 mg once daily, with comparable efficacy and safety profiles.
从英国国家医疗服务体系的角度，评估口服达比加群酯与皮下注射低分子肝素（依诺肝素）预防全膝关节置换术（TKR）和全髋关节置换术（THR）后静脉血栓栓塞（VTE）的成本效益。
在接受TKR（预防持续时间为6 - 10天）和THR（预防持续时间为28 - 35天）的患者中，将达比加群酯（每日一次，220毫克）与依诺肝素（每日一次，40毫克）进行比较。使用决策树对10周的术后急性期进行建模。采用马尔可夫过程（周期长度为1年）对患者余生的长期事件（复发性VTE、血栓后综合征和颅内出血后果）进行建模。VTE和出血事件的相对风险来自两项将达比加群酯与每日一次40毫克依诺肝素进行比较的III期研究。使用已发表的纵向研究数据估计长期事件的概率。
达比加群酯和依诺肝素之间的VTE和出血事件发生率无显著差异。在TKR中，达比加群酯的成本低于依诺肝素，在THR中成本显著更低，主要是由于给药成本的差异。THR患者的预防成本，包括药物和给药成本，达比加群酯估计为137英镑，依诺肝素为237英镑（住院期间护理时间7英镑，出院后护士家访给药91英镑，药物成本额外2英镑）。在每质量调整生命年20,000英镑的支付意愿阈值下，达比加群酯在TKR中的成本效益概率为75%，在THR中为97%。这些结果在一系列敏感性分析中均很稳健。
从英国国家医疗服务体系的角度来看，与每日一次40毫克依诺肝素相比，使用达比加群酯进行血栓预防具有成本节约效果，且疗效和安全性相当。
