New hepatitis treatment cost effective for some patient types

Key clinical point: New treatment for hepatitis C virus (HCV) is cost effective for patients with cirrhosis and for those without cirrhosis who have failed other treatments.

Major finding: Incremental cost-effectiveness ratios for sofosbuvir-based HCV treatment ranged from $238,000 to $266,000 for treatment-naive noncirrhotic patients, exceeding the $100,000 per quality-adjusted life-year cost-effectiveness threshold.

Data source: Application of the Hepatitis C Cost-Effectiveness model to clinical trial and observational cohort data.

Disclosures: The National Institute on Drug Abuse and the National Institute of Allergy and Infectious Disease provided funding. Dr. Weinstein reported receiving personal compensation from OptumInsight; Dr. Kim reported receiving grants and personal compensation from Gilead Sciences, AbbVie Pharmaceuticals, and Bristol-Myers Squibb. The remaining authors reported no relevant disclosures.

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HCV cost-effectiveness analysis raises tough questions for payers

In an editorial accompanying Dr. Linas’ study, Dr. Etzion and Dr. Ghany placed this analysis of the cost-effectiveness of sofosbuvir in the context of payer and clinician priorities. They noted that “from the patient and physician perspective, the benefits of new treatment are evident.” For payers, however, resources are constrained and tough decisions will have to be made.

This cost-effectiveness analysis is needed to inform resource allocation decisions, since the cost of using direct-acting antivirals to treat all those infected in the United States alone would exceed $300 billion. In that context, the editorial noted, quality-of-life assessments become important. HCV infection causes relatively little diminution of quality of life until the stage of cirrhosis is reached; in this analysis, therefore, interferon-based regimens are still a reasonable choice for treatment-naive HCV patients without cirrhosis.

Though Dr. Linas’ study also models incremental cost-effectiveness ratios for various lower price points for sofosbuvir, the editorial authors point out that the price point for the public’s willingness to eradicate HCV has not been established.

Dr. Ohad Etzion and Dr. Marc G. Ghany are at the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Md. Dr. Ghany reported nonfinancial support from Bristol Meyers Squibb.




For individuals infected with hepatitis C virus (HCV), new regimens are highly effective, but also very expensive, at approximately $28,000 for 4 weeks of treatment. However, the treatment is cost effective for HCV patients with cirrhosis and for those without cirrhosis who have failed other treatments, according to a new study.


In an analysis of the cost effectiveness of sofosbuvir-based treatments for patients with HCV genotypes 2 and 3, Dr. Benjamin Linas of Boston Medical Center reported that when compared with pegylated interferon and ribavirin therapy, treatment regimens based on the new direct-acting antiviral are only cost effective for select groups (Ann. Intern Med, [doi:10.7326/M15-0674]).

Cure rates with sofosbuvir are higher than are rates with the previous standard of care, and sustained virologic response (SVR) “is associated with a greatly reduced lifetime risk for liver-related morbidity and mortality,” noted Dr. Linas and his colleagues.

Using sophisticated statistical modeling to compare HCV treatment with pegylated interferon and ribavirin – the previous standard of care – to the newly Food and Drug Administration–approved sofosbuvir-ribavirin regimen, Dr. Linas explored clinical outcomes and costs for several different patient groups, including treatment-naive and treatment-experienced HCV genotype 2 and 3 patients with and without cirrhosis.

Clinical outcomes, modeled from clinical trial and observational cohort data, were expressed as life expectancy in quality-adjusted life-years (QALYs) and lifetime medical costs. Investigators then calculated the incremental cost-effectiveness ratio (ICER) for each treatment strategy, dividing any additional cost for a more expensive treatment by the QALYs gained from this regimen.

Using the commonly accepted ICER threshold of $100,000 per QALY, Dr. Linas and colleagues concluded that sofosbuvir-based HCV therapy for treatment-naive patients without cirrhosis was not cost effective, with ICERs of $238,000-$266,000. Interferon-based treatments, they noted, still achieve an approximately 80% rate of cure in this population.

In the constrained resources of the real world, Dr. Linas and his associates noted that this analysis is important. “Treatment strategies that do not use limited resources where they are likely to have the greatest impact may result in unequal access to interferon-free regimens, thereby limiting the population-level benefits of new HCV treatments,” they said.

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