Restrictions for Medicaid Reimbursement of Sofosbuvir for the Treatment of Hepatitis C Virus Infection in the United States
Open accessAbstract
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.
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Many patients do not meet the eligibility requirements for insurance approvals of HCV treatment and are left with no other healthcare alternatives to enhance overall health and well-being.
“Many patients do not meet the eligibility requirements for insurance approvals of HCV treatment and are left with no other healthcare alternatives to enhance overall health and well-being [11].”
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“Many patients do not meet the eligibility requirements for insurance approvals of HCV treatment and are left with no other healthcare alternatives to enhance overall health and well-being [11].”
Background
- Authors
- Barua, S., Greenwald, R., Grebely, J., Dore, G. J., Swan, T., & Taylor, L. E.
- Affiliations
- Harvard University (US)
- Venue
- Annals of Internal Medicine
- Publisher
- American College of Physicians
- Published
- 2015-08-04
- Volume
- 163
- Issue
- 3
- Pages
- 215-223
- ISSN
- 0003-4819 (ISSN-L)
- 1539-3704
- OpenAlex
- W1903580466
- Cited by
- 401
- References
- 43
- Citations by year
- 2026: 6 · 2025: 5 · 2024: 11 · 2023: 11 · 2022: 24 · 2021: 25 · 2020: 36 · 2019: 51 · 2018: 69 · 2017: 77 · 2016: 71 · 2015: 13
- FWCI
- 45.36
- Type
- journal article
- Language
- en
- Open access
- green
- handle.unsw.edu.au
- Licence
- cc-by-nc-nd
- Locations
- Annals of Internal Medicine (publishedVersion)
- PubMed (publishedVersion)
- UNSWorks (UNSW Sydney) (submittedVersion, cc-by-nc-nd)
- UNSWorks (University of New South Wales, Sydney, Australia) (submittedVersion, cc-by-nc-nd)
- Funders
- National Institute of Allergy and Infectious Diseases (P30AI042853)
- Topics
- Health Sciences › Medicine › Hepatology › Hepatitis C virus research
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Healthcare Policy and Management
- Keywords
- sofosbuvir, Medicaid reimbursement, hepatitis C virus, state Medicaid policy, liver fibrosis staging, HIV coinfection, substance use, alcohol consumption, urine drug testing
- MeSH terms
- Sofosbuvir, Antiviral Agents, Eligibility Determination, Health Policy, Humans, Insurance, Health, Reimbursement, Medicaid, United States, Uridine Monophosphate, Drug Costs, Hepatitis C, Chronic
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