Restrictions for Medicaid Reimbursement of Sofosbuvir for the Treatment of Hepatitis C Virus Infection in the United States
Restrictions for Medicaid Reimbursement of Sofosbuvir for the Treatment of Hepatitis C Virus Infection in the United States
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DOI：
10.7326/m15-0406
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发表时间：
2015-08-04
影响因子：
39.2
通讯作者：
Taylor, Lynn E.
中科院分区：
文献类型：
--
作者：
Barua, Soumitri;Greenwald, Robert;Taylor, Lynn E.
本研究的目的是系统地评估美国使用索非布韦治疗丙型肝炎病毒（HCV）感染的州医疗补助政策。索非布韦的医疗补助报销标准在所有50个州和哥伦比亚特区进行了评估。作者在2014年6月23日至12月7日期间搜索了州医疗补助网站，并提取了两份数据。任何分歧都通过协商一致解决。数据提取是否sofosbuvir覆盖和覆盖标准基于以下类别：肝病阶段，艾滋病毒合并感染，处方类型，药物或酒精使用。在已知索非布韦医疗补助报销标准的42个州中，74%限制索非布韦用于晚期纤维化（病毒性肝炎[METAVIR]纤维化F3期组织学数据的荟萃分析）或肝硬化（F4）患者。四分之一的州要求同时感染HCV和HIV的人接受抗逆转录病毒治疗或抑制HIV RNA水平。三分之二的州有基于处方者类型的限制，88%的州在其索非布韦资格标准中包括药物或酒精使用，50%的州需要禁欲期，64%的州需要尿液药物筛查。在美国，索非布韦的医疗补助报销标准中存在关于肝病分期、HIV合并感染、处方者类型以及药物或酒精使用的异质性。限制似乎不符合专业组织的建议，如美国传染病协会和美国肝病研究协会。目前的限制似乎违反了联邦医疗补助法，该法要求各州覆盖与美国食品和药物管理局标签一致的药物。
The aim of this study was to systematically evaluate state Medicaid policies for the treatment of hepatitis C virus (HCV) infection with sofosbuvir in the United States. Medicaid reimbursement criteria for sofosbuvir were evaluated in all 50 states and the District of Columbia. The authors searched state Medicaid Web sites between 23 June and 7 December 2014 and extracted data in duplicate. Any differences were resolved by consensus. Data were extracted on whether sofosbuvir was covered and the criteria for coverage based on the following categories: liver disease stage, HIV co-infection, prescriber type, and drug or alcohol use. Of the 42 states with known Medicaid reimbursement criteria for sofosbuvir, 74% limit sofosbuvir access to persons with advanced fibrosis (Meta-Analysis of Histologic Data in Viral Hepatitis [METAVIR] fibrosis stage F3) or cirrhosis (F4). One quarter of states require persons co-infected with HCV and HIV to be receiving antiretroviral therapy or to have suppressed HIV RNA levels. Two thirds of states have restrictions based on prescriber type, and 88% include drug or alcohol use in their sofosbuvir eligibility criteria, with 50% requiring a period of abstinence and 64% requiring urine drug screening. Heterogeneity is present in Medicaid reimbursement criteria for sofosbuvir with respect to liver disease staging, HIV co-infection, prescriber type, and drug or alcohol use across the United States. Restrictions do not seem to conform with recommendations from professional organizations, such as the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases. Current restrictions seem to violate federal Medicaid law, which requires states to cover drugs consistent with their U.S. Food and Drug Administration labels.