Soumitri Barua; Robert Greenwald, JD; Jason Grebely, PhD; Gregory J. Dore, MBBS, PhD; Tracy Swan; Lynn E. Taylor, MD
Note: Dr. Taylor and Mr. Greenwald had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Dr. Taylor affirms that she has listed everyone who contributed significantly to the work. There was no involvement of any pharmaceutical company or commercial entity in the preparation of this work.
Disclaimer: The views expressed in this publication do not necessarily represent the position of the Australian government. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Allergy and Infectious Diseases or the National Institutes of Health.
Acknowledgment: The authors thank Evan Cunningham (The Kirby Institute, University of New South Wales, Sydney, Australia) for his assistance with preparing the figures for this manuscript; Amy Rosenberg (Center for Health Law and Policy Innovation, Harvard Law School, Cambridge, Massachusetts) for her suggested edits; and Kellen Wittkop and Sam Hammond (Center for Health Law and Policy Innovation, Harvard Law School, Cambridge, Massachusetts) for assistance with data collection.
Financial Support: The Kirby Institute is funded by the Australian Government Department of Health and Ageing. Dr. Grebely is supported by a National Health and Medical Research Council Career Development Fellowship. Mr. Greenwald is supported by Harvard Law School. Dr. Taylor is supported by a Rhode Island Innovation Fellowship from the Rhode Island Foundation for her “Rhode Island Defeats Hep C” project and the Lifespan/Tufts/Brown Center for AIDS Research (grant P30AI042853 from the National Institute of Allergy and Infectious Diseases). Ms. Barua was supported by the Lifespan/Tufts/Brown Center for AIDS Research Summer Student Internship program (grant P30AI042853).
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-0406.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer.
Requests for Single Reprints: Lynn E. Taylor, MD, Department of Medicine, Division of Infection Diseases, The Warren Alpert Medical School of Brown University, The Miriam Hospital, 164 Summit Avenue, Center for AIDS Research Building, Room 156, Providence, RI; e-mail, LTaylor@Lifespan.org.
Current Author Addresses: Ms. Barua: Brown University, 69 Brown Street, Box 2222, Providence, RI 02912.
Mr. Greenwald: Center for Health Law and Policy Innovation, Harvard Law School, 122 Boylston Street, Jamaica Plain, MA 02130.
Drs. Grebely and Dore: The Kirby Institute, University of New South Wales, Wallace Wurth Building, Sydney New South Wales 2052, Australia.
Ms. Swan: Treatment Action Group, 611 Broadway, Suite 308, New York, NY 10012.
Dr. Taylor: Department of Medicine, Division of Infectious Diseases, The Warren Alpert Medical School of Brown University, The Miriam Hospital, 164 Summit Avenue, Center for AIDS Research Building, Room 156, Providence, RI 02906.
Author Contributions: Conception and design: J. Grebely, L.E. Taylor.
Analysis and interpretation of the data: S. Barua, R. Greenwald, J. Grebely, G.J. Dore, T. Swan, L.E. Taylor.
Drafting of the article: S. Barua, R. Greenwald, J. Grebely, T. Swan, L.E. Taylor.
Critical revision of the article for important intellectual content: J. Grebely, G.J. Dore, Swan T, L.E. Taylor.
Final approval of the article: S. Barua, R. Greenwald, J. Grebely, G.J. Dore, T. Swan, L.E. Taylor.
Statistical expertise: S. Barua, J. Grebely.
Obtaining of funding: S. Barua, L.E. Taylor.
Administrative, technical, or logistic support: S. Barua, J. Grebely, L.E. Taylor.
Collection and assembly of data: S. Barua, R. Greenwald, J. Grebely, L.E. Taylor.
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.
Barua S, Greenwald R, Grebely J, Dore GJ, Swan T, Taylor LE. Restrictions for Medicaid Reimbursement of Sofosbuvir for the Treatment of Hepatitis C Virus Infection in the United States. Ann Intern Med. 2015;163:215–223. doi: 10.7326/M15-0406
Download citation file:
Published: Ann Intern Med. 2015;163(3):215-223.
Gastroenterology/Hepatology, Healthcare Delivery and Policy, Infectious Disease, Liver Disease, Viral Hepatitis.
Results provided by:
Copyright © 2019 American College of Physicians. All Rights Reserved.
Print ISSN: 0003-4819 | Online ISSN: 1539-3704
Conditions of Use