—Alan Franciscus, Editor-in-Chief
The recently approved hepatitis C inhibitors—sofosbuvir (Solvadi) and simeprevir (Olysio)—have greatly improved cure rates. The American Association for the
Study of Liver Diseases (AASLD) and the Infectious Disease Society of
America (IDSA) recently released guidelines for hepatitis C including
the use of the newly approved hepatitis C inhibitors.
One recommendation that raised
eyebrows was the use of the combination of sofosbuvir plus simeprevir
for those patients who are interferon-intolerant. The controversy is due to the
expense of the two drugs. This study should help to provide a
scientific and cost-effective rationale for the use of the combination
of these two drugs to treat a select patient population. -AF
Cost analysis of
sofosbuvir/ribavirin versus sofosbuvir/simeprevir for genotype 1 HCV in
interferon ineligible/intolerant individuals.
Hagan LM, Sulkowski MS, Schinazi RF.
2014 Mar 28. doi: 10.1002/hep.27151. [Epub ahead of print]
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) offer two options for
interferon-ineligible/intolerant individuals with genotype 1 infection:
sofosbuvir (Solvadi) plus /ribavirin for 24 weeks, or sofosbuvir plus simeprevir (Olysio) for 12 weeks.
A 24-week course of
sofsobuvir plus ribavirin costs approximately US$169,000, with
sustained virologic response (SVR) rates ranging from 52-84%;
12 weeks of sofosbuvir plus simeprevir costs approximately $150,000, with SVR between 89% and 100%.
Because sofosbuvir plus
simeprevir is currently used off-label, debate exists among physicians
and payers about whether it should be prescribed and covered. This
paper presents a cost-effectiveness analysis of these two treatment
regimens accounting for costs of drugs, treatment-related medical care,
re-treatment for individuals who do not achieve SVR, and natural
history of continued HCV infection after failed re-treatment.
The model uses a lifetime horizon and a societal perspective.
Results: In the
base case scenario, sofosvuvir plus simeprevir dominated sofosbuvir
plus ribavirin in a modeled 50-year-old cohort of treatment-naïve and
treatment-experienced subjects, excluding those who failed prior
therapy with telaprevir or boceprevir. Sofosbuvir plus simeprevir
yielded lower costs and more quality-adjusted life years (QALYs) for
the average subject compared to sofosbuvir plus ribavirin ($165,336 and
14.69 QALYs vs. $243,586 and 14.45 QALYs, respectively). In base case
cost-analysis, the sofosbuvir plus simeprevir treatment strategy saved
$91,590 per SVR compared to sofosbuvir plus ribavirin. Under all
one-way sensitivity scenarios, sofosbuvir plus simeprevir remained
dominant and resulted in cost savings.
These results suggest that a 12-week course of sofosbuvir plus
simeprevir is a more cost-effective treatment for genotype 1 chronic
hepatitis C than 24 weeks of sofosbuvir plus ribavirin among
interferon-ineligible/intolerant individuals, supporting the AASLD/IDSA
guidance and offering implications for both clinical and regulatory
decision-making as well as pharmaceutical pricing. (Hepatology 2014;).
Copyright © 2014 American Association for the Study of Liver Diseases.