国产依那西普类似物治疗早期活动性类风湿关节炎的药物经济学评价

目的：从社会角度对国产依那西普类似物（益赛普）治疗早期活动性类风湿关节炎（RA）及进入疾病低活动度后的减药方案进行药物经济学评价。方法：根据RA疾病进展的规律，构建含多个健康状态的Markov模型；利用国外相关临床试验估算转移概率；根据某综合医院的收费标准确定治疗方案单周期成本；利用实际临床调查结果确定各状态的健康效用值；对早期活动性RA的甲氨蝶呤（MTX）单药治疗、MTX联合益赛普及达疾病低活动度后的减药方案进行时间跨度为10年的成本效果分析，并对结果进行一元敏感性和概率敏感性分析。结果：Markov模型成本效果分析结果显示MTX联合益赛普达疾病低活动度后继续减半量维持半年为可接受的药物治疗方案。回乘分析结果显示MTX单药治疗的累计成本和健康结果分别为31 598元和6.71QALYs；联合益赛普的累计成本和健康结果分别为79 872元和6.93QALYs，增量成本-效果比为219 427元/QALY；联合益赛普达疾病低活动度后继续减半量维持半年的累计成本和健康结果分别为86 879元和7.18QALYs，增量成本-效果比为117 619元/QALY。一元敏感性分析和概率敏感性分析显示，模型参数的不确定性不影响模型分析结论。结论：从社会角度，在中国对早期活动性RA的治疗方案中，相比单用MTX，联合使用益赛普达疾病低活动度后继续减半量维持半年更具有经济学优势。

Pharmacoeconomic evaluation of domestic etanercept analogue against early active rheumatoid arthritis

OBJECTIVE To explore the cost-effectiveness of domestic etanercept analogue treatment during early phase of active rheumatoid arthritis (RA) and during the period of low disease activity.METHODS A multi-health state Markov model was developed based on the disease progression, the transition probabilities were estimated from published clinical trials, the cost of per treatment cycle was calculated according to the charge standard of some general hospitals, utility of each state was determined by the real clinical investigation. The model was analyzed to explore the cost-effectiveness for metrotrexate (MTX) alone and MTX combined with domestic etanercept analogue during early phase of active RA and during the period of low disease activity for 10 years. One-way sensitivity analysis and probabilistic sensitivity analysis were performed.RESULTS The cost-effectiveness analysis of the model showed that continuation of half-dose etanercept analogue in case of low disease activity after etanercept analogue combined with MTX was the most cost-effective treatment method. Roll analysis showed that the total cost and total QALYs were 31 598 yuan and 6.71 QALYs for MTX alone, 79 872 yuan and 6.93 QALYs for the combined therapy, 86 879 yuan and 7.18 QALYs for half-dose etanercept analogue in case of low disease activity. The incremental cost-effectiveness ratios (ICER) were 219 427 yuan/QALY and 117 619 yuan/QALY for the combined therapy and half-dose etanercept analogue, respectively. The results of sensitivity analysis showed that the uncertainty of the parameters did not influence the conclusion of the model.CONCLUSION To treat early RA, the etanercept analogue treatment followed by half-dose etanercept analogue in case of low disease activity is the most cost-effective treatment from social aspect compared with MTX alone.