1Department of Clinical Pharmacy, UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), San Francisco.
2Department of Population Science, and.
J Natl Compr Canc Netw. 2020 Jul;18(7):866-872. doi: 10.6004/jnccn.2020.7542.
Clinical adoption of the sequencing of circulating tumor DNA (ctDNA) for cancer has rapidly increased in recent years. This sequencing is used to select targeted therapy and monitor nonresponding or progressive tumors to identify mechanisms of therapeutic resistance. Our study objective was to review available coverage policies for cancer ctDNA-based testing panels to examine trends from 2015 to 2019.
We analyzed publicly available private payer policies and Medicare national coverage determinations and local coverage determinations (LCDs) for ctDNA-based panel tests for cancer. We coded variables for each year representing policy existence, covered clinical scenario, and specific ctDNA test covered. Descriptive analyses were performed.
We found that 38% of private payer coverage policies provided coverage of ctDNA-based panel testing as of July 2019. Most private payer policy coverage was highly specific: 87% for non-small cell lung cancer, 47% for EGFR gene testing, and 79% for specific brand-name tests. There were 8 final, 2 draft, and 2 future effective final LCDs (February 3 and March 15, 2020) that covered non-FDA-approved ctDNA-based tests. The draft and future effective LCDs were the first policies to cover pan-cancer use.
Coverage of ctDNA-based panel testing for cancer indications increased from 2015 to 2019. The trend in private payer and Medicare coverage is an increasing number of coverage policies, number of positive policies, and scope of coverage. We found that Medicare coverage policies are evolving to pan-cancer uses, signifying a significant shift in coverage frameworks. Given that genomic medicine is rapidly changing, payers and policymakers (eg, guideline developers) will need to continue to evolve policies to keep pace with emerging science and standards in clinical care.
近年来，临床对循环肿瘤 DNA（ctDNA）测序在癌症中的应用迅速增加。这种测序用于选择靶向治疗，并监测无反应或进展的肿瘤，以确定治疗耐药的机制。我们的研究目的是回顾现有的癌症 ctDNA 检测面板的覆盖政策，以检查 2015 年至 2019 年的趋势。
我们分析了公共可用的私人支付者政策和医疗保险国家覆盖范围决定以及针对癌症的 ctDNA 面板测试的本地覆盖范围决定。我们为每年的政策存在、涵盖的临床情况和特定的 ctDNA 测试编码变量。进行了描述性分析。
截至 2019 年 7 月，我们发现 38%的私人支付者覆盖政策提供了基于 ctDNA 的面板测试的覆盖范围。大多数私人支付者政策覆盖范围非常具体：87%用于非小细胞肺癌，47%用于 EGFR 基因检测，79%用于特定品牌测试。有 8 项最终、2 项草案和 2 项未来有效的最终 LCD（2020 年 2 月 3 日和 3 月 15 日）涵盖了未经 FDA 批准的基于 ctDNA 的测试。草案和未来有效的 LCD 是第一个涵盖泛癌应用的政策。
癌症适应症的 ctDNA 面板测试的覆盖范围从 2015 年到 2019 年有所增加。私人支付者和医疗保险覆盖范围的趋势是覆盖政策数量、积极政策数量和覆盖范围的增加。我们发现，医疗保险覆盖政策正在向泛癌应用演变，这标志着覆盖框架的重大转变。鉴于基因组医学正在迅速变化，支付者和政策制定者（例如指南制定者）将需要继续制定政策，以跟上临床护理中不断出现的科学和标准。
