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首页> 外文期刊>PharmacoEconomics >Ramucirumab for Treating Advanced Gastric Cancer or Gastro-Oesophageal Junction Adenocarcinoma Previously Treated with Chemotherapy: An Evidence Review Group Perspective of a NICE Single Technology Appraisal
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Ramucirumab for Treating Advanced Gastric Cancer or Gastro-Oesophageal Junction Adenocarcinoma Previously Treated with Chemotherapy: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

机译：用于治疗先前用化疗治疗的晚期胃癌或胃食高结腺癌腺癌的Ramucirumab：证据审查集团的一个漂亮的单一技术评估视角

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Abstract The National Institute for Health and Care Excellence (NICE) invited the company that manufactures ramucirumab (Cyramza ? , Eli Lilly and Company) to submit evidence of the clinical and cost effectiveness of the drug administered alone (monotherapy) or with paclitaxel (combination therapy) for treating adults with advanced gastric cancer or gastro-oesophageal junction (GC/GOJ) adenocarcinoma that were previously treated with chemotherapy, as part of the Institute’s single technology appraisal (STA) process. Kleijnen Systematic Reviews Ltd (KSR), in collaboration with Erasmus University Rotterdam, was commissioned to act as the Evidence Review Group (ERG). This paper describes the company’s submission, the ERG review, and NICE’s subsequent decisions. Clinical effectiveness evidence for ramucirumab monotherapy (RAM), compared with best supportive care (BSC), was based on data from the REGARD trial. Clinical effectiveness evidence for ramucirumab combination therapy (RAM?+?PAC), compared with paclitaxel monotherapy (PAC), was based on data from the RAINBOW trial. In addition, the company undertook a network meta-analysis (NMA) to compare RAM?+?PAC with BSC and docetaxel. Cost-effectiveness evidence of monotherapy and combination therapy relied on partitioned survival, cost-utility models. The base-case incremental cost-effectiveness ratio (ICER) of the company was ￡188,640 (vs BSC) per quality-adjusted life-year (QALY) gained for monotherapy and ￡118,209 (vs BSC) per QALY gained for combination therapy. The ERG assessment indicated that the modelling structure represented the course of the disease; however, a few errors were identified and some of the input parameters were challenged. The ERG provided a new base case, with ICERs (vs BSC) of ￡188,100 (monotherapy) per QALY gained and ￡129,400 (combination therapy) per QALY gained and conducted additional exploratory analyses. The NICE Appraisal Committee (AC), considered the company’s decision problem was in line with the NICE scope, with the exception of the choice of comparators for the combination therapy model. The most plausible ICER for ramucirumab monotherapy compared with BSC was ￡188,100 per QALY gained. The Committee considered that the ERG’s exploratory analysis in which RAM?+?PAC was compared with PAC by using the direct head-to-head data (including utilities) from the RAINBOW trial, provided the most plausible ICER (i.e. ￡408,200 per QALY gained) for ramucirumab combination therapy. The Committee concluded that end-of-life considerations cannot be applied for either case, since neither failed to offer an extension to life of at least 3?months. The company did not submit a patient access scheme (PAS). After consideration of the evidence, the Committee concluded that ramucirumab alone or with paclitaxel could not be considered a cost-effective use of National Health Service resources for treating advanced GC/GOJ patients that were previously treated with chemotherapy, and therefore its use could not be recommended. We might wonder if a complete STA process is necessary for treatments without a PAS, which are, according to the company’s submission, already associated with ICERs far above the currently accepted threshold in all (base-case, sensitivity and scenario) analyses.
机译：摘要国家健康和护理研究所（尼斯）邀请了制造Ramucirumab（Cyramza？，Eli Lilly和Company）的公司提交单独给药（单一疗法）或与紫杉醇给药的临床和成本效果的证据（联合治疗）用于治疗具有先进的胃癌或胃食性癌症的成人（GC / GOJ）腺癌，以前用化疗治疗，作为研究所的单一技术评估（STA）过程的一部分。 Kleijnen Systematic评论有限公司（KSR）与Erasmus大学鹿特丹合作，被委托作为证据审查小组（ERG）。本文介绍了该公司的提交，ERG审查和尼斯的后续决策。与最佳支持护理（BSC）相比，Ramucirumab单药（RAM）的临床有效性证据是基于试验的数据。与紫杉醇单药治疗（PAC）相比，Ramucirumab联合治疗（RAM？+α - PAC）的临床有效性证据基于彩虹试验的数据。此外，该公司进行了网络元分析（NMA）以比较RAM？+？PAC与BSC和Docetaxel。单疗法和联合治疗的成本效益证据依赖于分区存活，成本实用机型。本公司的基本情况增量成本效益率（ICER）为每年质量调整的生命年份（QALY）的188,640英镑（VS BSC），每次脑药疗法获得118,209英镑（VS BSC），获得联合治疗。 ERG评估表明，建模结构代表了疾病的过程;但是，确定了一些错误，并且某些输入参数受到挑战。 ERG提供了一种新的基础案例，其每种QALY每种QALY获得188,100英镑（单一疗法），每QALY获得129,400英镑（联合治疗），并进行了额外的探索性分析。众议院评估委员会（AC），被认为是公司的决策问题符合良好的范围，除了用于组合治疗模型的比较器的选择。与BSC相比，RAMUCIRUMAB单疗法最合理的患者是每QALY获得188,100英镑。委员会认为，ERG的探索性分析，其中RAM？+？PAC通过彩虹试验中的直接头数据（包括公用事业）与PAC进行了比较，提供了最具合理的通道（即每个Qaly获得408,200英镑）对于Ramucirumab组合疗法。委员会的结论是，无论任何一种情况都不能申请人生终止考虑因素，因为既未向延期提供至少3个月的延期。该公司未提交患者访问计划（PAS）。在审议证据后，委员会得出结论，单独或与紫杉醇的Ramucirumab不得被视为对治疗先前用化疗治疗的先进GC / GOJ患者进行成本效益的国家卫生服务资源，因此它不能受到推崇的。我们可能想知道如果没有PA的处理，那么根据公司提交的处理是必要的，这是根据本公司的提交的，这已经与Repers相关的ICES（基本情况，敏感性和场景）分析。

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  • 来源
    《PharmacoEconomics》 |2017年第12期|共11页
  • 作者

    Nasuh C. Büyükkaramikli; Hedwig M. Blommestein; Rob Riemsma; Nigel Armstrong; Fiona. J. Clay; Janine Ross; Gill Worthy; Johan Severens; Jos Kleijnen; Maiwenn J. Al;

  • 作者单位

    Institute for Medical Technology Assessment (iMTA) Institute of Health Policy and Management (iBMG;

    Institute for Medical Technology Assessment (iMTA) Institute of Health Policy and Management (iBMG;

    Kleijnen Systematic Reviews Ltd;

    Kleijnen Systematic Reviews Ltd;

    Department of Psychiatry University of Melbourne;

    Kleijnen Systematic Reviews Ltd;

    Kleijnen Systematic Reviews Ltd;

    Institute for Medical Technology Assessment (iMTA) Institute of Health Policy and Management (iBMG;

    Kleijnen Systematic Reviews Ltd;

    Institute for Medical Technology Assessment (iMTA) Institute of Health Policy and Management (iBMG;

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  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 药学;
  • 关键词

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