Ben-Hamadi R, Duh M S, Aggarwal J, Henckler A, McKenzie R S, Tak Piech C
Analysis Group, Inc. Boston, MA 02199, USA.
Curr Med Res Opin. 2005 Oct;21(10):1677-82. doi: 10.1185/030079905X65501.
To compare the cost-effectiveness of epoetin alfa (EPO) and darbepoetin alfa (DARB) for the treatment of chemotherapy-induced anemia (CIA), using dosing regimens approved by the FDA (EPO 40,000 U once weekly and DARB 2.25 U once weekly and DARB 2.25 mcg/kg once weekly).
The study compared published results of two double-blind, randomized, phase III trials one utilizing EPO (N = 166) and the other, DARB (N = 367). Patients in both trials similar baseline characteristics. Effectiveness was measured as the proportion of EPO or DARB patients who were successfully treated (i.e., did not require blood transfusion) during weeks 0-16 and 5-16, respectively. Estimated drug costs were presented in 2005 USD based on wholesale acquisition cost (WAC) and average drug utilization over 16 weeks. Cost-effectiveness was calculated as the estimated drug costs divided by transfusion effectiveness. Threshold analysis was used to determine the break-even point at which EPO and DARB had the same drug costs.
Estimated drug costs over 16 weeks were $9,039 for EPO and $13,555 for DARB. During weeks 5-16, 85% of EPO patients and 73% of DARB patients were successfully treated, resulting in average cost-effectiveness ratios of $106 for EPO and $186 for DARB per one per cent of successfully treated patients. A 33% reduction in DARB WAC was required to achieve the same drug costs as for EPO.
Utilizing FDA-approved doses, EPO was found to result in lower drug costs and better treatment success when compared to DARB. Hence, EPO is a dominant alternative compared to DARB for the treatment of CIA. The analyses presented here are not without limitations. Specifically, although the studies were comparable, patients were ultimately drawn from different populations.
使用美国食品药品监督管理局(FDA)批准的给药方案(促红细胞生成素[EPO]每周一次40,000单位,达贝泊汀α[DARB]每周一次2.25单位以及达贝泊汀α每周一次2.25微克/千克),比较EPO和DARB治疗化疗所致贫血(CIA)的成本效益。
该研究比较了两项双盲、随机、III期试验已发表的结果,一项试验使用EPO(N = 166),另一项试验使用DARB(N = 367)。两项试验中的患者基线特征相似。有效性分别通过在第0 - 16周和第5 - 16周期间成功接受治疗(即不需要输血)的EPO或DARB患者比例来衡量。基于批发采购成本(WAC)和16周内的平均药物使用量,以2005年美元呈现估计的药物成本。成本效益计算为估计的药物成本除以输血有效性。采用阈值分析来确定EPO和DARB具有相同药物成本的盈亏平衡点。
16周内EPO的估计药物成本为9,039美元,DARB为13,555美元。在第5 - 16周期间,85%的EPO患者和73%的DARB患者成功接受治疗,导致EPO每成功治疗1%患者的平均成本效益比为106美元,DARB为186美元。DARB的WAC需要降低33%才能达到与EPO相同的药物成本。
使用FDA批准的剂量时,与DARB相比,EPO的药物成本更低且治疗成功率更高。因此,在治疗CIA方面,与DARB相比,EPO是更具优势的选择。此处呈现的分析并非没有局限性。具体而言,尽管这些研究具有可比性,但患者最终来自不同人群。