Hikino Keiko, Fukunaga Koya, Mushiroda Taisei
Laboratory for Pharmacogenomics, RIKEN Center for Integrative Medical Sciences, Yokohama, Japan.
Drug Metab Pharmacokinet. 2018 Dec;33(6):243-249. doi: 10.1016/j.dmpk.2018.08.006. Epub 2018 Sep 1.
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.
在本研究中，我们旨在了解日本和美国在药物基因组学（PGx）生物标志物覆盖范围上的差距。确定了以下PGx生物标志物：（1）临床药物基因组学实施联盟（CPIC）指南中的；（2）CPIC A级或B级的；或（3）有美国食品药品监督管理局（FDA）批准的药物标签的。随后，调查了美国健康保险公司和日本国民健康保险（NHI）对它们的覆盖情况。我们确定了美国市场份额最大的六家健康保险公司，并调查了这些健康保险公司、医疗保险、医疗补助和日本国民健康保险对PGx生物标志物的覆盖情况。我们发现，这些生物标志物中有19.9%被这六家公司覆盖（10.0%符合CPIC指南；25.1%有FDA批准的药物标签）。在美国，体细胞和生殖系生物标志物的覆盖比例分别为86.8%和8.5%，在日本分别为56.3%和0.6%。日本和美国都覆盖了少数生殖系PGx生物标志物，但日本体细胞和生殖系生物标志物的覆盖比例都较低。因此，在日本，为改善用药后的患者预后，应考虑扩大覆盖范围。
