重组人促卵泡激素应用于辅助生殖技术的成本-效果分析

Cost-effectiveness analysis of recombinant human follicle-stimulating hormone in assisted reproductive technology

摘要

目的: 比较注射用重组人促卵泡激素α(果纳芬^®,follitropin alfa,GONAL-f)与其他注射用重组人促卵泡激素(金赛恒^®、芳乐舒^®和安欣保^®)应用于接受辅助生殖技术(assisted reproductive technology,ART)行控制性卵巢刺激(controlled ovulation stimulation,COS)不孕女性的经济性。方法: 建立决策树模型,该模型包含接受1次COS后1个鲜胚移植周期和3个冻胚移植周期,模拟患者行ART周期的治疗路径。模型中的临床参数来自3个独立临床随机试验和专家访谈意见;成本参数中的药品用量来自3个临床试验,药品价格来自于药智网;其他医疗服务成本来自各省市医疗价格目录和专家意见访谈。基础分析中以累积活产率(cumulative live birth rates,CLBR)作为效果指标,计算增量成本效果比(incremental cost effectiveness ratio,ICER)。通过单因素敏感性分析和概率敏感性分析测试结果的稳健性。结果: 虽然果纳芬与金赛恒组、安欣保组和芳乐舒组中果纳芬方案总成本更高(增量成本依次为1 219.44、643.19和250.61元),但同时有更高的CLBR(增量CLBR依次为3.91%、3.13%和3.84%),平均每活产成本依次为44 238.72和44 844.00元·活产^－1、52 701.11和54 096.63元·活产^－1以及44 028.08和45 775.20元·活产^－1,ICER依次为31 174.32、13 795.07 和6 530.83元·增量活产^－1。敏感性分析结论与基础分析一致,概率敏感性分析中随着患者的支付意愿(willingness to pay,WTP)的提高至100 000元以上,果纳芬相对于金赛恒、安欣保和芳乐舒具有经济性的概率稳定在92.9%、69.9%和81.9%左右;在WTP为35 000元时,果纳芬具有经济性的概率分别为58.0%、71.9%及77.8%。结论: 本研究显示,在ART治疗中COS用药果纳芬与金赛恒、安欣保和芳乐舒相比成本更高,CLBR也更高;WTP高于31 174.32元时,果纳芬更具经济性。

Abstract

Objective: To compare the cost-effectiveness of recombinant human follicle-stimulating hormone alfa (follitropin alfa, GONAL-f^®) versus other recombinant human follicle-stimulating hormone injections (Jinsaheng^®, Fangleshu^®, and Anxinbao^®) for controlled ovarian stimulation (COS) in infertile women undergoing assisted reproductive technology (ART). Methods: A decision tree model was developed, simulating the treatment pathway of patients undergoing one ART cycle including one fresh embryo transfer cycle and three frozen embryo transfer cycles following a single COS treatment. Clinical parameters were derived from three independent randomized controlled trials and expert interviews. Drug utilization data for cost parameters came from the same trials, while drug prices were sourced from Yaozh.com. Costs of other medical services were obtained from provincial/city medical price lists and expert opinions. The base-case analysis used cumulative live birth rate (CLBR) as the effectiveness measure to calculate the incremental cost-effectiveness ratio (ICER). The robustness of the results was tested through one-way sensitivity analysis and probabilistic sensitivity analysis (PSA). Results: Although the total cost of the GONAL-f strategy was higher than that of Jinsaheng, Anxinbao, and Fangleshu (incremental cost: ￥1 219.44, ￥643.19, and ￥250.61, respectively), it also yielded higher CLBRs (incremental CLBRs: 3.91%, 3.13%, and 3.84%, respectively). The average cost per live birth was ￥44 238.72 vs ￥44 844.00 (GONAL-f vs Jinsaheng), ￥52 701.11 vs ￥54 096.63 (GONAL-f vs Anxinbao), and ￥44 028.08 vs ￥45 775.20 (GONAL-f vs Fangleshu). The corresponding ICERs were ￥31 174.32, ￥13 795.07, and ￥6 530.83 per additional live birth, respectively. Sensitivity analyses supported the base-case findings. In the PSA, as the willingness-to-pay (WTP) threshold increased to over ￥100 000, the probability of GONAL-f being cost-effective stabilized at approximately 92.9%, 69.9%, and 81.9% compared to Jinsaheng, Anxinbao, and Fangleshu, respectively. At a WTP of ￥35 000, these probabilities were 58.0%, 71.9%, and 77.8%, respectively. Conclusion: This study indicates that for COS in ART, GONAL-f incurs higher costs but also achieves higher CLBRs compared to Jinsaheng, Anxinbao, and Fangleshu. GONAL-f is the more cost-effective option when the WTP exceeds ￥31 174.32 per additional live birth.    

关键词

重组人促卵泡激素 / 果纳芬^® / / 金赛恒^® / / 安欣保^® / / 芳乐舒^® / / 辅助生殖技术 / 累积活产率 / 决策树模型

Key words

recombinant human follicle-stimulating hormone / GONAL-f^® / Jinsaheng^® / Anxinbao^® / Fangleshu^® / assisted reproductive technology / cumulative live birth rate / decision tree model

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