Muto Manabu
Dept. of Therapeutic Oncology, Graduate School of Medicine, Kyoto University.
Gan To Kagaku Ryoho. 2020 Feb;47(2):197-202.
From June, 2019, 2 different cancer genomic profiling(CGP)test panels(OncoguideNCCOncopanel, FoundationOneCDx) were decided to be covered by National Insurance System in Japan. To run the precision medicine based on CGP(genomic medicine), Ministry of Health, Labour and Welfare of Japan assigned the 11 certified core hospitals on genomic medicine, 34 sub-core hospitals and affiliated hospitals. In addition, Center for Cancer Genomics and Advanced Therapeutics(C-CAT) was established to collect genomic data and clinical data from these hospitals in June, 2018. To reimburse the genomic medicine, so called "expert-panel" with sufficient required specialists(eg medical oncologist, pathologist, genomic counselor, bioinformatician, et al)must be held to discuss on the treatment strategy and secondary findings. The expert panel was held by certified core hospital for genomic medicine and their affiliated hospital should join it. One of the important problems is the availability for drug based on genomic panel. In real world, only 10-15%of the patients can access the drug as a clinical trial. Secondary findings are also important issue to manage. To improve the operation and management of genomic medicine in clinical practice, we have to solve these issues as soon as possible.
从2019年6月起,日本国民保险体系决定覆盖2种不同的癌症基因组图谱(CGP)检测平台(Oncoguide NCCOncopanel、FoundationOne CDx)。为开展基于CGP的精准医学(基因组医学),日本厚生劳动省指定了11家基因组医学认证核心医院、34家次核心医院及附属医院。此外,癌症基因组学与先进治疗中心(C-CAT)于2018年6月成立,负责收集这些医院的基因组数据和临床数据。为报销基因组医学费用,必须召开有所需足够专家(如医学肿瘤学家、病理学家、基因组咨询师、生物信息学家等)参与的所谓“专家小组”会议,以讨论治疗策略和次要发现。专家小组会议由基因组医学认证核心医院召开,其附属医院应参加。重要问题之一是基于基因组检测平台的药物可及性。在现实世界中,只有10%至15%的患者能够作为临床试验参与者使用该药物。次要发现也是需要处理的重要问题。为改善临床实践中基因组医学的运营和管理,我们必须尽快解决这些问题。