Restrictions for Medicaid Reimbursement of Sofosbuvir for the Treatment of Hepatitis C Virus Infection in the United States

被引:344
作者
Barua, Soumitri
Greenwald, Robert
Grebely, Jason
Dore, Gregory J.
Swan, Tracy
Taylor, Lynn E.
机构
[1] Brown Univ, Providence, RI 02912 USA
[2] Miriam Hosp, Providence, RI 02906 USA
[3] Harvard Univ, Sch Law, Cambridge, MA 02138 USA
[4] Univ New S Wales, Sydney, NSW, Australia
[5] Treatment Act Grp, New York, NY USA
基金
英国医学研究理事会;
关键词
SUSTAINED VIROLOGICAL RESPONSE; INJECTION-DRUG USERS; PLUS SOFOSBUVIR; GENOTYPE; ALCOHOL; INTERFERON; RIBAVIRIN; THERAPY; PEOPLE; HCV;
D O I
10.7326/M15-0406
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页码:215 / +
页数:10
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