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中国直接口服抗凝剂与低分子量肝素及不进行血栓预防用于癌症相关静脉血栓栓塞一级预防的成本效益分析

Cost-effectiveness analysis of direct oral anticoagulants versus low-molecular-weight heparin and no thromboprophylaxis in primary prevention of cancer-associated venous thromboembolism in China.

作者信息

Wu Yue, Yin TianChen, Jian GuiLin, Wan Tao, Zhou Benhong

机构信息

Department of Pharmacy, Renmin Hospital, Wuhan University, Wuhan, China.

School of Pharmaceutical Sciences, Wuhan University, Wuhan, China.

出版信息

Front Pharmacol. 2024 Sep 23;15:1373333. doi: 10.3389/fphar.2024.1373333. eCollection 2024.

Abstract

BACKGROUND AND OBJECTIVE

Cancer-associated venous thromboembolism (CAVTE) is a preventable, life-threatening complication with a considerable morbidity and mortality. Primary venous thromboembolism (VTE) prophylaxis is currently recommended; however, the health and economic benefits have not been evaluated and compared in China. This study aimed to assess and compare the cost-effectiveness of anticoagulants in primary CAVTE prevention among cancer patients in China.

METHODS

A Markov model with a 5-year horizon was established to evaluate the costs and effectiveness of direct oral anticoagulants (DOACs) compared to low-molecular-weight heparins (LMWHs) and no prevention in primary prophylaxis of CAVTE in China. Key clinical outcomes were obtained from the available clinical trials, comparing DOACs (rivaroxaban and apixaban) with LMWHs or with no thromboprophylaxis. Utility and the cost inputs were all obtained from the published literature or local data with public sources. The total costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were estimated as the main endpoints of the modal for each strategy. The assessment of uncertainty was performed involving deterministic sensitivity analysis and probabilistic sensitivity analysis (PSA). Impact of time horizon, generic drug price, and individual DOACs were assessed in scenario and subgroup analyses.

RESULTS

Primary prophylaxis using DOACs were projected to yield 1.866 QALYs at a cost of $3,287.893, resulting in the ICERs of $12,895.851 (DOACs vs. no-thromboprophylaxis) and $43,613.184/QALYs (LMWHs vs. DOACs). Sensitivity analysis revealed that ICER was sensitive to the VTE and bleeding risk, drug cost of anticoagulants, self-payment ratio, and overall death rate of cancer. Probabilistic sensitivity analysis showed that DOACs and LMWHs had a 48% and 45% probability of being cost-effective at a 5-year time horizon, respectively. When the time horizon extended to 10 years, DOACs achieved a cost-effective probability of 43%. Among individual DOACs, apixaban was found to be the preferred strategy in VTE prevention due to its incremental health gain with an acceptable cost increase.

CONCLUSION

Primary thromboprophylaxis with DOACs was cost-effective in cancer patients at a willing-to-pay (WTP) threshold of $37,125.24/QALY in China. Cancer death rate, risk of VTE and major bleeding, and the drug cost assumed greater relevance and importance in the decision-making process for primary thromboprophylaxis in cancer.

摘要

背景与目的

癌症相关静脉血栓栓塞症(CAVTE)是一种可预防的、危及生命的并发症,具有相当高的发病率和死亡率。目前推荐进行原发性静脉血栓栓塞症(VTE)预防;然而,在中国尚未对其健康和经济效益进行评估与比较。本研究旨在评估和比较抗凝剂在中国癌症患者原发性CAVTE预防中的成本效益。

方法

建立了一个为期5年的马尔可夫模型,以评估在中国原发性CAVTE预防中,直接口服抗凝剂(DOACs)与低分子肝素(LMWHs)及不进行预防相比的成本和效果。关键临床结局取自现有临床试验,比较DOACs(利伐沙班和阿哌沙班)与LMWHs或不进行血栓预防的情况。效用和成本投入均取自已发表的文献或公开来源的本地数据。估计总成本、质量调整生命年(QALYs)和增量成本效益比(ICERs)作为每种策略模型的主要终点。通过确定性敏感性分析和概率敏感性分析(PSA)进行不确定性评估。在情景分析和亚组分析中评估时间范围、仿制药价格和个别DOACs的影响。

结果

预计使用DOACs进行原发性预防可产生1.866个QALYs,成本为3287.893美元,导致ICERs为12895.851美元(DOACs与不进行血栓预防相比)和43613.184美元/QALY(LMWHs与DOACs相比)。敏感性分析表明,ICERs对VTE和出血风险、抗凝剂药物成本、自付比例以及癌症总体死亡率敏感。概率敏感性分析显示,在5年时间范围内,DOACs和LMWHs具有成本效益的概率分别为48%和45%。当时间范围延长至10年时,DOACs实现成本效益的概率为43%。在个别DOACs中,由于阿哌沙班在成本增加可接受的情况下能带来健康收益的增加,因此被发现是VTE预防的首选策略。

结论

在中国,以意愿支付(WTP)阈值为37125.24美元/QALY时,使用DOACs进行原发性血栓预防对癌症患者具有成本效益。癌症死亡率、VTE和大出血风险以及药物成本在癌症原发性血栓预防的决策过程中具有更大的相关性和重要性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2da3/11456474/08da7a416031/fphar-15-1373333-g001.jpg

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