Certolizumab Pegol治疗类风湿性关节炎对tnf抑制剂反应不足:一个证据审查小组的一个单一的技术评估。

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史蒂文森贝尔梅霍我,M,阿切尔R,史蒂文斯JW, Goka E,出彩,斯科特•DL年轻的一个

Certolizumab Pegol治疗类风湿性关节炎对tnf抑制剂反应不足:一个证据审查小组的一个单一的技术评估。

药物经济学。2017年11月,35 (11):1141 - 1151。doi: 10.1007 / s40273 - 017 - 0521 - 5。

PubMed ID
28550592 (在PubMed
]
文摘

作为单一的技术评估的一部分(STA)过程中,国家健康研究所和护理卓越(NICE)邀请制造商(UCB制药)certolizumb pegol (CZP;Cimzia ((R)))提交证据的临床和成本效益的治疗类风湿性关节炎(RA)后对肿瘤坏死因子-α抑制剂反应不足(TNFi)。学校卫生和谢菲尔德大学相关研究技术评估小组委托作为独立证据审查小组(E必威国际appRG)。ERG制作了详细的审查证据的临床和成本效益的技术,基于公司的提交好。公司提交的临床有效性证据CZP主要是基于六个随机对照试验(相关的)比较CZP反对安慰剂的疗效。临床有效性审查确认没有直接证据CZP范围内对比较器的功效;因此,公司进行了网络荟萃分析(NMA)。公司的NMA认为CZP也有类似的功效,它的比较器。公司提交了马尔可夫模型,评估了CZP与比较器的增量成本有效性生物疾病修饰治疗风湿病的药物(bDMARDs)治疗RA的国民健康服务体系的角度对三个决策问题,每一个都跟着一个TNFi应对不足。这些都是(1)比较与利妥昔单抗(RTX)结合甲氨蝶呤(MTX); (2) a comparison against bDMARDs when RTX was contraindicated or withdrawn due to an adverse event; and (3) a comparison against bDMARDs when MTX was contraindicated or withdrawn due to an adverse event. Results from the company's economic evaluation showed that CZP resulted in a similar number of quality-adjusted life years (QALYs) produced at similar or lower costs compared with comparator bDMARDs. The commercial-in-confidence patient access schemes for abatacept and tocilizumab could not be incorporated by the company, but were incorporated by the ERG in a confidential appendix for the NICE Appraisal Committee (AC). The company estimated that the addition of CZP before RTX in a sequence for patients who could receive MTX produced more QALYs at an increased cost, with a cost per QALY of pound33,222. Following a critique of the model, the ERG undertook exploratory analyses that did not change the conclusions reached based on the company's economic evaluation in relation to the comparison with bDMARDs. The ERG estimated that where CZP replaced RTX, CZP was dominated, as it produced fewer QALYs at an increased cost. The AC concluded that there was little difference in effectiveness between CZP and comparator bDMARDs and that equivalence among bDMARDs could be accepted. The AC consequently recommended CZP plus MTX for people for whom RTX is contraindicated or not tolerated and CZP monotherapy for people for whom MTX is contraindicated or not tolerated. The AC concluded that CZP plus MTX could not be considered a cost-effective use of National Health Service resources when RTX plus MTX is a treatment option.

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