Precision Oncology and the Universal Health Coverage System in Japan.
Precision Oncology and the Universal Health Coverage System in Japan.
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DOI：
10.1200/po.19.00291
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发表时间：
2019-01-01
影响因子：
4.6
通讯作者：
Bando, Hideaki
中科院分区：
文献类型：
--
作者：
Ebi, Hiromichi;Bando, Hideaki
尽管精准肿瘤学正在改变癌症患者的临床管理，但许多医院在有效实施精准肿瘤学方面面临挑战。此外，基因组分析所花费的成本和时间需要与每位患者的获益预期相平衡。本文总结了日本在实施精准肿瘤学方面所做的努力。最有希望的进展是，国家健康保险系统现已完全覆盖对特定癌症基因组进行分析的测试。 2019年5月，两个基因panel获得了报销批准：FoundationOne CDx癌症基因组图谱和OncoGuide NCC Oncopanel系统，后者是在日本开发的。为了更好地利用稀缺资源，报销仅限于接受标准化疗后进展的实体瘤、罕见肿瘤或原发灶不明的肿瘤患者。为了集中日本的精准肿瘤学，政府指定了大约 170 家医院，并根据其职责将它们分为三层。此外，日本国家癌症中心还成立了癌症基因组学和先进治疗中心（C-CAT），收集接受基因组分析测试的患者的基因组信息和临床特征。 C-CAT 预计将成为中央数据存储库，将患者与临床试验相匹配，并协助转化研究。国民健康保险制度下的集中制度可能是一把双刃剑。尽管严格的监管可能使其难以跟上精准肿瘤学的快速发展，但用于共享临床和基因组数据的联合生态系统将是宝贵的资产，并允许共享数据访问。获得未经批准的药物和 C-CAT 的行政支持将是日本精准肿瘤学充分发挥潜力的关键。
Although precision oncology is transforming clinical management of patients with cancer, many hospitals face challenges to effectively implement precision oncology. In addition, the cost and time exerted for genomic profiling needs to be balanced with expectations of benefit for each patient. This article summarizes the effort to implement precision oncology in Japan. The most promising development is that tests to profile the genomes of select cancers are now fully covered by the national health insurance system. In May 2019, two gene panels were approved with reimbursement: FoundationOne CDx Cancer Genomic Profile and OncoGuide NCC Oncopanel System, the latter of which was developed in Japan. To make better use of scarce resources, the reimbursement is restricted to patients with solid tumors that have progressed on standard chemotherapy, rare tumors, or tumors of unknown primary. To centralize Japanese precision oncology, the government designated approximately 170 hospitals and stratified them to three layers on the basis of their roles. In addition, Japan's National Cancer Center launched a Center for Cancer Genomics and Advanced Therapeutics (C-CAT) that collects genomic information and clinical characteristics of patients who received genomic profiling tests. C-CAT is expected to be the central data repository, to match patients with clinical trials, and to assist translational research. The centralized system under the national health insurance system could be a double-edged sword. Although tight regulation may make it hard to keep up with the rapid development of precision oncology, a federated ecosystem for sharing clinical and genomic data will be a precious asset and allow for shared access to data. Access to unapproved drugs and administrative support from C-CAT will be keys for Japanese precision oncology to meet its full potential.