Center for Business Models in Healthcare, Glencoe, IL, USA; Department of Clinical Pharmacy, UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), University of California San Francisco, San Francisco, CA, USA; Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Center for Business Models in Healthcare, Glencoe, IL, USA; Department of Clinical Pharmacy, UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), University of California San Francisco, San Francisco, CA, USA; Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Value Health. 2018 Sep;21(9):1062-1068. doi: 10.1016/j.jval.2018.06.011. Epub 2018 Aug 3.
Next-generation sequencing promises major advancements in precision medicine but faces considerable challenges with insurance coverage. These challenges are especially important to address in oncology in which next-generation tumor sequencing (NGTS) holds a particular promise, guiding the use of life-saving or life-prolonging therapies. Payers' coverage decision making on NGTS is challenging because this revolutionary technology pushes the very boundaries of the underlying framework used in coverage decisions. Some experts have called for the adaptation of the coverage framework to make it better equipped for assessing NGTS. Medicare's recent decision to cover NGTS makes this topic particularly urgent to examine. In this article, we discussed the previously proposed approaches for adaptation of the NGTS coverage framework, highlighted their innovations, and outlined remaining gaps in their ability to assess the features of NGTS. We then compared the three approaches with Medicare's national coverage determination for NGTS and discussed its implications for US private payers as well as for other technologies and clinical areas. We focused on US payers because analyses of coverage approaches and policies in the large and complex US health care system may inform similar efforts in other countries. We concluded that further adaptation of the coverage framework will facilitate a better suited assessment of NGTS and future genomics innovations.
下一代测序有望在精准医学方面取得重大进展，但在医疗保险覆盖方面面临着相当大的挑战。这些挑战在肿瘤学中尤为重要，因为下一代肿瘤测序（NGTS）具有特殊的应用前景，可以指导使用救命或延长生命的疗法。由于这项革命性技术突破了覆盖决策中使用的基本框架的极限，因此支付方在 NGTS 方面的覆盖决策具有挑战性。一些专家呼吁调整覆盖框架，使其更能评估 NGTS。医疗保险最近决定覆盖 NGTS，这使得这个话题尤其需要研究。在本文中，我们讨论了之前提出的用于调整 NGTS 覆盖框架的方法，强调了它们的创新之处，并概述了它们在评估 NGTS 特征方面的能力存在的差距。然后，我们将这三种方法与医疗保险对 NGTS 的国家覆盖范围的确定进行了比较，并讨论了其对美国私人支付方以及其他技术和临床领域的影响。我们关注美国支付方，是因为对美国庞大而复杂的医疗保健系统中覆盖范围分析和政策的分析，可能会为其他国家的类似工作提供信息。我们的结论是，进一步调整覆盖框架将有助于更好地评估 NGTS 和未来的基因组学创新。
