Cost Analysis of Sofosbuvir/Ribavirin Versus Sofosbuvir/Simeprevir for Genotype 1 Hepatitis C Virus in Interferon-Ineligible/Intolerant Individuals

• Type of Material: Article
• Authors: Liesl M. Hagan, Veterans Affairs Medical Center, Atlanta; Mark S. Sulkowski, Johns Hopkins University; Raymond Schinazi, Emory University
• Language: English
• Date: 2014-07-01
• Publisher: Wiley: 12 months
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2014 by the American Association for the Study of Liver Diseases.
• Final Published Version (URL): http://dx.doi.org/10.1002/hep.27151
• Title of Journal or Parent Work: Hepatology
• ISSN: 0270-9139
• Volume: 60
• Issue: 1
• Start Page: 37
• End Page: 45
• Grant/Funding Information: This work was supported in part by NIH grants P30-AI-050409 (to RFS) and K24-DA-034621 (to MSS) and the Department of Veterans Affairs (to RFS).
• Keywords: SUSTAINED VIROLOGICAL RESPONSE; UNITED-STATES; QUALITY-OF-LIFE; RIBAVIRIN; LIVER-TRANSPLANTATION; MORTALITY; Science & Technology; TREATMENT-NAIVE PATIENTS; Life Sciences & Biomedicine; CIRRHOSIS; INFECTION; ANTIVIRAL THERAPY; Gastroenterology & Hepatology
• Research Categories: Health Sciences, Pharmacy; Health Sciences, Public Health; Biology, Genetics

Abstract

Treatment guidance for chronic hepatitis C (CHC) released by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) offers two options for interferon (IFN)-ineligible/intolerant individuals with genotype 1 infection: sofosbuvir/ribavirin (SOF/RBV) for 24 weeks or sofosbuvir/simeprevir (SOF/SMV) for 12 weeks. A 24-week course of SOF/RBV costs approximately US$169,000, with sustained virologic response (SVR) rates ranging from 52% to 84%; 12 weeks of SOF/SMV costs approximately $150,000, with SVR between 89% and 100%. Because SOF/SMV is currently used off-label, debate exists among physicians and payers about whether it should be prescribed and covered. This article presents a cost-effectiveness analysis of these two treatment regimens accounting for costs of drugs, treatment-related medical care, retreatment for individuals who do not achieve SVR, and natural history of continued HCV infection after failed retreatment. Analysis uses a Markov model with a lifetime horizon and a societal perspective. In the base-case scenario, SOF/SMV dominated SOF/RBV in a modeled 50-year-old cohort of treatment-naïve and -experienced subjects, excluding those who failed earlier therapy with telaprevir or boceprevir. SOF/SMV yielded lower costs and more quality-adjusted life years (QALYs) for the average subject, compared to SOF/RBV ($165,336 and 14.69 QALYs vs. $243,586 and 14.45 QALYs, respectively). In base-case cost analysis, the SOF/SMV treatment strategy saved $91,590 per SVR, compared to SOF/RBV. Under all one-way sensitivity scenarios, SOF/SMV remained dominant and resulted in cost savings. Conclusions: These results suggest that a 12-week course of SOF/SMV is a more cost-effective treatment for genotype 1 CHC than 24 weeks of SOF/RBV among IFN-ineligible/intolerant individuals, supporting the AASLD/IDSA guidance and offering implications for both clinical and regulatory decision making as well as pharmaceutical pricing.