Wickstrøm & Langkilde ApS, Vejle, Denmark.
J Med Econ. 2012;15(4):695-703. doi: 10.3111/13696998.2012.673525. Epub 2012 Mar 22.
To estimate the economic implications of introducing dabigatran etexilate ('dabigatran') for anti-coagulation therapy in Danish patients with non-valvular atrial fibrillation based on results of the RE-LY trial.
The lifetime cost and outcomes of dabigatran and warfarin were estimated using a previously published cost-effectiveness model. The model utilizes the data from the RE-LY study to estimate the costs and outcomes of stroke prevention in atrial fibrillation. Cost estimates were based on official Danish tariffs and prices, and published literature on the cost of stroke. In the base-case analysis a conservative approach was adopted applying tariffs from the lowest range for the cost of International Normalized Ratio (INR) monitoring associated with warfarin. The effectiveness measure of the analysis was quality-adjusted life-years (QALY).
The model estimated that the mean cost per patient for the remaining life-time is euro 16,886 treated with warfarin and euro 18,752 treated with dabigatran. This was associated with mean QALYs per patient of 8.32 with warfarin and 8.59 with dabigatran. The resulting incremental cost-effectiveness ratio (ICER) of ∼ euro 7000 per QALY gained is regarded as cost-effective by Danish standards. This conclusion was seen to be robust to realistic variations in input parameters, including adjustment for the RE-LY centres achieving the best INR monitoring quality. Threshold analysis revealed that dabigatran would be cost-saving in settings where the cost of warfarin monitoring exceeds euro 744 per year.
The analysis does not include all aspects of Danish clinical practice anti-coagulation that will influence cost-effectiveness of dabigatran, e.g., this study did not attempt to model quality of anticoagulation monitoring and under-utilization in clinical practice.
Based on the outcomes observed in the RE-LY trial, dabigatran represents a cost-effective alternative to warfarin in Denmark for all patients with atrial fibrillation within the licensed indication of dabigatran.
根据 RE-LY 试验结果，估算在丹麦非瓣膜性心房颤动患者中引入达比加群酯（达比加群）进行抗凝治疗的经济意义。
使用先前发表的成本效益模型估算达比加群和华法林的终身成本和结果。该模型利用 RE-LY 研究的数据来估计心房颤动中预防中风的成本和结果。成本估算基于丹麦官方关税和价格，以及关于中风成本的已发表文献。在基本案例分析中，采用了一种保守的方法，即对华法林相关国际标准化比值（INR）监测成本应用关税范围中的最低值。该分析的有效性衡量标准为质量调整生命年（QALY）。
模型估计，使用华法林治疗的患者在剩余寿命内的平均每位患者成本为 16886 欧元，使用达比加群治疗的患者为 18752 欧元。这与每位患者的平均 QALY 分别为 8.32 和 8.59 相关。由此产生的增量成本效益比（ICER）为每获得一个 QALY 约 7000 欧元，被丹麦标准认为是具有成本效益的。这一结论被认为在输入参数的实际变化情况下是稳健的，包括调整在 INR 监测质量方面表现最佳的 RE-LY 中心。阈值分析表明，在华法林监测成本超过每年 744 欧元的情况下，达比加群将具有成本效益。
该分析未包括影响达比加群成本效益的丹麦临床实践抗凝的所有方面，例如，本研究并未尝试模拟抗凝监测质量和临床实践中的利用不足。
根据 RE-LY 试验的结果，在丹麦，对于达比加群许可适应症范围内的所有心房颤动患者，达比加群是华法林的一种具有成本效益的替代选择。
