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达肝素与维生素K拮抗剂用于预防癌症合并肾功能损害患者复发性静脉血栓栓塞:一项加拿大药物经济学分析。

Dalteparin versus vitamin K antagonists for the prevention of recurrent venous thromboembolism in patients with cancer and renal impairment: a Canadian pharmacoeconomic analysis.

作者信息

Dranitsaris George, Shane Lesley G, Crowther Mark, Feugere Guillaume, Woodruff Seth

机构信息

Health Economic and Outcomes Research, Augmentium Pharma Consulting Inc, Toronto, ON, Canada.

Pfizer Inc, New York, NY, USA.

出版信息

Clinicoecon Outcomes Res. 2017 Jan 10;9:65-73. doi: 10.2147/CEOR.S126379. eCollection 2017.

Abstract

BACKGROUND

Patients with cancer are at increased risk of venous thromboembolism (VTE) and the risk is further elevated after a primary VTE. To reduce the risk of recurrent events, extended prophylaxis with vitamin K antagonists (VKA) is available for use. However, in a large randomized trial (Comparison of Low-Molecular-Weight Heparin versus Oral Anticoagulant Therapy for the Prevention of Recurrent Venous Thromboembolism in Patients with Cancer [CLOT]; Lee et al), extended duration dalteparin reduced the relative risk of recurrent VTE by 52% compared to VKA (=0.002). A recent subgroup analysis of patients with moderate-to-severe renal impairment also revealed lower absolute VTE rates with dalteparin (3% vs. 17%; =0.011). To measure the economic value of dalteparin as an alternative to VKA, a patient-level cost utility analysis was conducted from a Canadian perspective.

METHODS

Resource use data captured during the CLOT trial were extracted and linked to 2015 Canadian unit cost estimates. Health state utilities were then measured using the Time-Trade-Off technique in 24 randomly selected members of the general Canadian public to estimate the gains in quality-adjusted life years (QALYs).

RESULTS

For the entire CLOT trial population (n=676), the dalteparin group had significantly higher mean costs compared to the VKA group ($Can5,771 vs. $Can2,569; <0.001). However, the utility assessment revealed that 21 of 24 respondents (88%) selected dalteparin over VKA, with an associated gain of 0.14 (95% confidence interval [CI]: 0.10-0.18) QALYs. When the incremental cost of dalteparin was combined with the QALY gain, dalteparin had a cost of $Can23,100 (95% CI: $Can19,200-$Can25,800) per QALY gained. The analysis in patients with renal impairment suggested even better economic value with the cost per QALY gained being <$14,000.

CONCLUSION

Extended duration dalteparin is a cost-effective alternative to VKA for the prevention of recurrent VTE in patients with cancer, especially in those with renal impairment.

摘要

背景

癌症患者发生静脉血栓栓塞(VTE)的风险增加,初次发生VTE后风险进一步升高。为降低复发事件的风险,可使用维生素K拮抗剂(VKA)进行延长预防。然而,在一项大型随机试验(低分子肝素与口服抗凝治疗预防癌症患者复发性静脉血栓栓塞的比较[CLOT];Lee等人)中,与VKA相比,延长疗程的达肝素使复发性VTE的相对风险降低了52%(=0.002)。最近一项对中重度肾功能损害患者的亚组分析也显示,达肝素的绝对VTE发生率较低(3%对17%;=0.011)。为衡量达肝素作为VKA替代药物的经济价值,从加拿大角度进行了患者层面的成本效用分析。

方法

提取CLOT试验期间收集的资源使用数据,并与2015年加拿大单位成本估计值相关联。然后使用时间权衡技术对24名随机选择的加拿大普通公众成员进行健康状态效用测量,以估计质量调整生命年(QALY)的增益。

结果

对于整个CLOT试验人群(n = 676),与VKA组相比,达肝素组的平均成本显著更高(5771加元对2569加元;<0.001)。然而,效用评估显示,24名受访者中有21名(88%)选择达肝素而非VKA,相关的QALY增益为0.14(95%置信区间[CI]:0.10 - 0.18)。当将达肝素的增量成本与QALY增益相结合时,达肝素每获得一个QALY的成本为23100加元(95%CI:19200加元 - 25800加元)。对肾功能损害患者的分析表明经济价值甚至更好,每获得一个QALY的成本低于14000加元。

结论

延长疗程的达肝素是预防癌症患者复发性VTE的一种具有成本效益的VKA替代药物,尤其是在肾功能损害患者中。

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