Gap between the US and Japan in coverage of pharmacogenomic biomarkers by health insurance programs: More coverage is needed in Japan
Gap between the US and Japan in coverage of pharmacogenomic biomarkers by health insurance programs: More coverage is needed in Japan
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DOI：
10.1016/j.dmpk.2018.08.006
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发表时间：
2018-12-01
影响因子：
2.1
通讯作者：
Mushiroda, Taisei
中科院分区：
文献类型：
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作者：
Hikino, Keiko;Fukunaga, Koya;Mushiroda, Taisei
在本研究中，我们旨在了解日本和美国之间药物基因组学（PGx）生物标志物覆盖率的差距。测定PGx生物标志物（1）临床药物遗传学实施联盟（CPIC）指南中的;（2）CPIC A或B级;或（3）具有美国食品和药物管理局（FDA）批准的药物标签。随后，对美国健康保险公司和日本国民健康保险（NHI）的覆盖范围进行了调查。我们确定了在美国市场份额最大的前六家健康保险公司，并调查了这些健康保险公司，医疗保险，医疗补助和日本NHI对PGx生物标志物的覆盖范围。我们发现，这些生物标志物中有19.9%被六家公司覆盖（10.0%，CPIC指南; 25.1%，FDA批准的药物标签）。在美国，体细胞和生殖细胞生物标志物的覆盖率分别为86.8%和8.5%，在日本为56.3%和0.6%。日本和美国均涵盖了一些生殖系PGx生物标志物，但日本的体细胞和生殖系生物标志物的覆盖率较低。因此，应考虑扩大覆盖范围，以改善日本处方药后的患者结局。(c)2018年日本异生物学研究学会。由爱思唯尔有限公司出版。保留所有权利。
In this study, we aimed to understand the gap in coverage of pharmacogenomic (PGx) biomarkers between Japan and the US. PGx biomarkers (1) in the Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines; (2) that are CPIC level A or B; or (3) have US Food and Drug Administration (FDA)-approved drug labels, were determined. Subsequently, their coverage by US health insurance companies and the National Health Insurance (NHI) in Japan was investigated. We identified the top six health insurance companies with the largest market shares in the US and investigated the coverage for the PGx biomarkers by these health insurers, Medicare, Medicaid, and the NHI in Japan. We found that 19.9% of these biomarkers are covered by the six companies (10.0%, the CPIC guidelines; 25.1%, the FDA-approved drug labels). The coverage of somatic and germline biomarkers was respectively 86.8% and 8.5% in the US and 56.3% and 0.6% in Japan. A few germline PGx biomarkers are covered both in Japan and the US, but the coverage of both somatic and germline biomarkers was lower in Japan. Therefore, more coverage should be considered to improve patient outcomes after prescribing medications in Japan. (c) 2018 The Japanese Society for the Study of Xenobiotics. Published by Elsevier Ltd. All rights reserved.