Limited Access to New Hepatitis C Virus Treatment Under State Medicaid Programs

Ideas and Opinions4 August 2015Limited Access to New Hepatitis C Virus Treatment Under State Medicaid ProgramsLauren A. Canary, MPH, R. Monina Klevens, DDS, MPH, and Scott D. Holmberg, MD, MPHLauren A. Canary, MPHFrom Centers for Disease Control and Prevention, Atlanta, Georgia., R. Monina Klevens, DDS, MPHFrom Centers for Disease Control and Prevention, Atlanta, Georgia., and Scott D. Holmberg, MD, MPHFrom Centers for Disease Control and Prevention, Atlanta, Georgia.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M15-0320 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail The burden of fatal liver disease is increasing in the estimated 3.2 million adults chronically infected with hepatitis C virus (HCV) in the United States (1–3). Sofosbuvir (Sovaldi, Gilead Sciences), which was approved by the U.S. Food and Drug Administration in December 2013, is a new oral HCV treatment that, when combined with other therapies, has a therapeutic efficacy (cure) greater than 90% across the 4 major HCV genotypes, limited adverse effects, and a shorter treatment window (usually 12 weeks) than its interferon-based predecessors (4). However, this drug currently retails at $84 000 per patient, forcing many payers to ration this ...References1. Denniston MM, Jiles RB, Drobeniuc J, Klevens RM, Ward JW, McQuillan GM, et al. Chronic hepatitis C virus infection in the United States, National Health and Nutrition Examination Survey 2003 to 2010. Ann Intern Med. 2014;160:293-300. [PMID: 24737271] doi:10.7326/M13-1133 LinkGoogle Scholar2. Ly KN, Xing J, Klevens RM, Jiles RB, Ward JW, Holmberg SD. The increasing burden of mortality from viral hepatitis in the United States between 1999 and 2007. Ann Intern Med. 2012;156:271-8. [PMID: 22351712] doi:10.7326/0003-4819-156-4-201202210-00004 LinkGoogle Scholar3. Holmberg SD, Spradling PR, Moorman AC, Denniston MM. Hepatitis C in the United States. N Engl J Med. 2013;368:1859-61. [PMID: 23675657] doi:10.1056/NEJMp1302973 CrossrefMedlineGoogle Scholar4. Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013;368:1878-87. [PMID: 23607594] doi:10.1056/NEJMoa1214853 CrossrefMedlineGoogle Scholar5. Kim WR, Gross JB, Poterucha JJ, Locke GR, Dickson ER. Outcome of hospital care of liver disease associated with hepatitis C in the United States. Hepatology. 2001;33:201-6. [PMID: 11124837] CrossrefMedlineGoogle Scholar6. Grebely J, Dore GJ. Can hepatitis C virus infection be eradicated in people who inject drugs? Antiviral Res. 2014;104:62-72. [PMID: 24468275] doi:10.1016/j.antiviral.2014.01.002 CrossrefMedlineGoogle Scholar7. Leidner AJ, Chesson HW, Xu F, Ward JW, Spradling PR, Holmberg SD. Cost-effectiveness of hepatitis C treatment for patients in early stages of liver disease. Hepatology. 2015;61:1860-9. [PMID: 25677072] doi:10.1002/hep.27736 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAuthors: Lauren A. Canary, MPH; R. Monina Klevens, DDS, MPH; Scott D. Holmberg, MD, MPHAffiliations: From Centers for Disease Control and Prevention, Atlanta, Georgia.Disclaimer: The findings and conclusions in this article are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.Acknowledgment: The authors thank Cecily Campbell, JD, LLM (ORISE Fellow, Division of Viral Hepatitis, Centers for Disease Control and Prevention), and the Center for Health Law and Policy Innovation at Harvard Law School for providing their expert knowledge of Medicaid law and structure.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-0320.Corresponding Author: Lauren A. Canary, MPH, Division of Viral Hepatitis, National Foundation for the Centers for Disease Control and Prevention, Mailstop G-37, Atlanta, GA 30329; e-mail, lcanary@cdc.gov.Current Author Addresses: Ms. Canary: Division of Viral Hepatitis, National Foundation for the Centers for Disease Control and Prevention, Mailstop G-37, Atlanta, GA 30329.Dr. Klevens: Centers for Disease Control and Prevention, 12 Corporate Square Boulevard, Atlanta, GA 30329.Dr. Holmberg: Division of Viral Hepatitis, Mailstop G-37, Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA 30333.Author Contributions:Conception and design: L.A. Canary.Analysis and interpretation of the data: L.A. Canary, M. Klevens, S.D. Holmberg.Drafting of the article: L.A. Canary, S.D. Holmberg.Critical revision of the article for important intellectual content: M. Klevens, S.D. Holmberg.Final approval of the article: M. Klevens, S.D. Holmberg.Obtaining of funding: M. Klevens, S.D. Holmberg.Administrative, technical, or logistic support: S.D. Holmberg.Collection and assembly of data: L.A. Canary.This article was published online first at www.annals.org on 30 June 2015. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoRestrictions for Medicaid Reimbursement of Sofosbuvir for the Treatment of Hepatitis C Virus Infection in the United States Soumitri Barua , Robert Greenwald , Jason Grebely , Gregory J. Dore , Tracy Swan , and Lynn E. Taylor Hepatitis C Virus Treatment and Injection Drug Users: It Is Time to Separate Fact From Fiction Elinore F. McCance-Katz and Ronald O. 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