Insurance coverage policies for personalized medicine.
Insurance coverage policies for personalized medicine.
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DOI：
10.3390/jpm2040201
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发表时间：
2012-10-30
影响因子：
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通讯作者：
Haga SB
中科院分区：
文献类型：
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作者：
Hresko A;Haga SB
个性化医疗在实践中的采用一直很缓慢，部分原因是缺乏这些技术提供临床益处的证据。保险公司的覆盖范围是实现广泛采用个性化医疗的关键一步。保险公司在制定个性化医疗保险政策时考虑多种因素，包括测试证据的总体强度、临床指南的可用性和独立组织的卫生技术评估。在本研究中，我们回顾了美国最大的保险公司对基因组（疾病相关）和药物遗传学（PGx）测试的保险政策，以确定这些测试的覆盖范围和覆盖决策的证据基础。我们确定了49项独特检测的41项覆盖政策：22项疾病诊断、预后和风险检测，27项PGx检测。50%（或更少）的检查是由保险公司承保的。缺乏临床效用的证据似乎是决定不覆盖的主要因素。在药品包装说明书中列入PGx信息似乎是所涵盖的PGx检测的共同主题。该分析强调了覆盖范围的确定和考虑的因素的可变性，表明个人用药的采用将受到许多因素的影响，但由于缺乏临床效益，将继续放缓。
Adoption of personalized medicine in practice has been slow, in part due to the lack of evidence of clinical benefit provided by these technologies. Coverage by insurers is a critical step in achieving widespread adoption of personalized medicine. Insurers consider a variety of factors when formulating medical coverage policies for personalized medicine, including the overall strength of evidence for a test, availability of clinical guidelines and health technology assessments by independent organizations. In this study, we reviewed coverage policies of the largest U.S. insurers for genomic (disease-related) and pharmacogenetic (PGx) tests to determine the extent that these tests were covered and the evidence basis for the coverage decisions. We identified 41 coverage policies for 49 unique testing: 22 tests for disease diagnosis, prognosis and risk and 27 PGx tests. Fifty percent (or less) of the tests reviewed were covered by insurers. Lack of evidence of clinical utility appears to be a major factor in decisions of non-coverage. The inclusion of PGx information in drug package inserts appears to be a common theme of PGx tests that are covered. This analysis highlights the variability of coverage determinations and factors considered, suggesting that the adoption of personal medicine will affected by numerous factors, but will continue to be slowed due to lack of demonstrated clinical benefit.