The Health Technology Assessment of Companion Diagnostics: Experience of NICE
The Health Technology Assessment of Companion Diagnostics: Experience of NICE
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DOI：
10.1158/1078-0432.ccr-13-1955
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发表时间：
2014-03-15
影响因子：
11.5
通讯作者：
Newland, Adrian
中科院分区：
文献类型：
--
作者：
Byron, Sarah K.;Crabb, Nick;Newland, Adrian
伴随诊断被用来帮助临床决策，以确定最有可能对治疗有反应的患者。随着越来越多的新药获得许可的适应症，它们变得越来越重要，这些适应症需要使用配套的诊断来确定适当的患者亚组进行治疗。这些药物已被证明在治疗一些癌症和其他疾病方面有好处，并有可能在未来精确地为个人量身定做治疗方法。然而，越来越多地使用伴随诊断可能会给卫生系统资源带来巨大负担，使其无法提供潜在的大量检测。这种情况在一定程度上导致政策制定者和卫生技术评估(HTA)机构审查用于对需要伴随诊断的药品做出补偿决定的政策和方法。与临床试验中使用的伴随诊断一起评估药物可能相对简单，尽管在常规临床实践中可以使用一系列替代伴随诊断的情况下，评估药物存在许多挑战。Ukhta机构，国家健康和护理卓越研究所(NICE)，已经制定了使用其技术评估和诊断评估计划来考虑伴随诊断的政策。其他国家的一些卫生技术评估机构也调整了它们的政策和方法，以适应伴随诊断的评估。在这里，我们将深入了解伴随诊断的HTA，以做出报销决策，以及如何应对相关挑战，特别是NICE。请参阅CCR Focus部分的所有文章，“精准医学难题：伴随诊断共同开发的方法”。(C)2014年AACR。
Companion diagnostics are used to aid clinical decision making to identify patients who are most likely to respond to treatment. They are becoming increasingly important as more new pharmaceuticals receive licensed indications that require the use of a companion diagnostic to identify the appropriate patient subgroup for treatment. These pharmaceuticals have proven benefit in the treatment of some cancers and other diseases, and also have potential to precisely tailor treatments to the individual in the future. However, the increasing use of companion diagnostics could place a substantial burden on health system resources to provide potentially high volumes of testing. This situation, in part, has led policy makers and Health Technology Assessment (HTA) bodies to review the policies and methods used to make reimbursement decisions for pharmaceuticals requiring companion diagnostics. The assessment of a pharmaceutical alongside the companion diagnostic used in the clinical trials may be relatively straightforward, although there are a number of challenges associated with assessing pharmaceuticals where a range of alternative companion diagnostics are available for use in routine clinical practice. The UKHTA body, the National Institute for Health and Care Excellence (NICE), has developed policy for considering companion diagnostics using its Technology Appraisal and Diagnostics Assessment Programs. Some HTA bodies in other countries have also adapted their policies and methods to accommodate the assessment of companion diagnostics. Here, we provide insight into the HTA of companion diagnostics for reimbursement decisions and how the associated challenges are being addressed, in particular by NICE. See all articles in this CCR Focus section, "The Precision Medicine Conundrum: Approaches to Companion Diagnostic Co-development."(C)2014 AACR.