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生物疗法在类风湿关节炎临床实践中的经济负担:意大利患者皮下注射抗 TNFα 治疗的成本效益分析。

The economic burden of biological therapy in rheumatoid arthritis in clinical practice: cost-effectiveness analysis of sub-cutaneous anti-TNFalpha treatment in Italian patients.

出版信息

Int J Immunopathol Pharmacol. 2009 Oct-Dec;22(4):1147-52. doi: 10.1177/039463200902200434.

DOI:10.1177/039463200902200434
PMID:20074482
Abstract

Rheumatoid arthritis (RA), with a prevalence of 0.46%, is found in about 272,004 patients in Italy. The socioeconomic cost of rheumatoid arthritis in Italy in 2002 has been estimated at Euro 1,600 million. Cost-effectiveness evaluations have been based on the concept that, with treatment, patients will not progress to the next level(s) of disease severity or will take a longer time to progress, thus avoiding or delaying the high costs and low utility associated with more severe disease. Many cost-effective studies have been based on the variation of Health Assessment Questionnaire (HAQ) in clinical trials. The objective of this study is to perform a cost-effective analysis of 86 patients with rheumatoid arthritis in therapy with adalimumab 40 mg every other week and etanercept 50 mg/week for two years in a population of patients observed in clinical practice. The group of patients in therapy with adalimumab had also taken methotrexate, mean dose 12.4+/-2.5 mg/week (22 patients) or leflunomide 20 mg/day (16 patients). The group of patients in therapy with etanercept had also taken methotrexate, mean dose 11.7+/-2.6 mg/week (24 patients) or leflunomide 20 mg/day (24 patients). Incremental costs and QALYs (quality adjusted life years) gains are calculated compared with baseline, assuming that without biologic treatment patients would remain at the baseline level through the year. Conversion HAQ scores to utility were based on the Bansback algorithm. The results after two years showed: in the group methotrexate+adalimumab the QALY gained was 0.62+/-0.15 with a treatment cost of Euro 26,517.62 and a QALY/cost of Euro 42,521.13. In the group methotrexate + etanercept the QALY gained was 0.64+/-0.26 with a treatment cost of Euro 25,020.96 and a QALY/cost of Euro 39,171.76. The result of using etanercept in association with methotrexate is cost-effectiveness with a QALY gained under the acceptable threshold of Euro 50,000. These are important data for discussion from an economic point of view when we choose a biologic therapy for rheumatoid arthritis in clinical practice.

摘要

类风湿关节炎(RA),患病率为 0.46%,在意大利约有 272,004 名患者。2002 年,意大利类风湿关节炎的社会经济学成本估计为 16 亿欧元。成本效益评估基于这样的概念,即通过治疗,患者不会进展到疾病严重程度的下一个级别,或者进展所需的时间更长,从而避免或延迟与更严重疾病相关的高成本和低效用。许多具有成本效益的研究都是基于临床试验中健康评估问卷(HAQ)的变化。本研究的目的是对在临床实践中观察到的患者人群中接受阿达木单抗 40mg 每两周一次和依那西普 50mg/周治疗的 86 例类风湿关节炎患者进行成本效益分析,为期两年。接受阿达木单抗治疗的患者组还接受了甲氨蝶呤,平均剂量为 12.4+/-2.5mg/周(22 例)或来氟米特 20mg/天(16 例)。接受依那西普治疗的患者组还接受了甲氨蝶呤,平均剂量为 11.7+/-2.6mg/周(24 例)或来氟米特 20mg/天(24 例)。与基线相比,计算了增量成本和 QALYs(质量调整生命年)的收益,假设如果没有生物治疗,患者在这一年中仍将保持在基线水平。将 HAQ 评分转换为效用基于 Bansback 算法。两年后的结果显示:在甲氨蝶呤+阿达木单抗组,获得的 QALY 为 0.62+/-0.15,治疗费用为 26,517.62 欧元,QALY/成本为 42,521.13 欧元。在甲氨蝶呤+依那西普组,获得的 QALY 为 0.64+/-0.26,治疗费用为 25,020.96 欧元,QALY/成本为 39,171.76 欧元。在联合使用甲氨蝶呤的情况下,使用依那西普具有成本效益,获得的 QALY 低于 50,000 欧元的可接受阈值。这些是从经济角度讨论我们在临床实践中为类风湿关节炎选择生物治疗时的重要数据。

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