Authors' Affiliations: Diagnostics Assessment Programme; and Diagnostics Advisory Committee, National Institute for Health and Care Excellence, Manchester; and Technology Appraisal Programme, National Institute for Health and Care Excellence, London, United Kingdom.
Clin Cancer Res. 2014 Mar 15;20(6):1469-76. doi: 10.1158/1078-0432.CCR-13-1955.
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 UK HTA 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."
伴随诊断用于辅助临床决策，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物获得需要伴随诊断来识别治疗合适患者亚组的许可适应症，它们变得越来越重要。这些药物已被证明在治疗某些癌症和其他疾病方面具有益处，并且将来也有可能将治疗精确地针对个体。然而，伴随诊断的日益使用可能会给卫生系统资源带来巨大负担，需要进行大量的检测。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）机构审查了用于为需要伴随诊断的药物做出报销决策的政策和方法。在临床试验中使用的伴随诊断评估药物可能相对简单，尽管在评估可用于常规临床实践的一系列替代伴随诊断的药物时存在许多挑战。英国 HTA 机构国家卫生与保健卓越研究所（NICE）已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 HTA 机构也调整了其政策和方法，以适应伴随诊断的评估。在这里，我们深入了解伴随诊断的 HTA 以做出报销决策，以及 NICE 如何解决相关挑战。
请注意，以上翻译内容仅供参考，具体翻译结果可能因语境、上下文等因素而有所不同。
