New HCV Drugs Cost-effective for Some With Genotypes 2 and 3

Marcia Frellick

March 31, 2015

Researchers assessing the cost-effectiveness of expensive new interferon-free hepatitis C drugs looked beyond the most common group, genotype 1, and found the drugs are cost-effective for some patients with genotypes 2 and 3, budgets permitting.

The sofosbuvir-based drugs have cure rates above 90% and have previously been shown to be cost-effective for at least genotype 1, as reported in Medscape Medical News.

However, the drugs cost nearly $1000 a pill, or $28,000 for 4 weeks of therapy, which may be too expensive for patients in publicly funded insurance programs, which do not guarantee access to them. So society is left with the question of who should get the medications.

In an article published online March 30 in the Annals of Internal Medicine, Benjamin Linas, MD, MPH, from Boston Medical Center, HIV Epidemiology and Outcomes Research Unit, Massachusetts, and colleagues, using evidence-based simulation modeling, report that at its current cost, sofosbuvir-based hepatitis C virus (HCV) therapy improves outcomes and provides good economic value if patients have cirrhosis, if they have genotype 2 or 3 infection, and if they were previously treated with interferon.

However, in patients without cirrhosis who have never been treated and for whom the less expensive pegylated interferon-ribavirin remains an option, sofosbuvir-based therapy is not cost-effective. In those cases, the sofosbuvir-based therapy for genotype 2 or 3 infection is well over the US willingness-to-pay threshold of $100,000 per quality-adjusted life-year that insurers use.

There are two reasons for that, the authors write. First, the potential benefits of interferon-free treatments are lower if the interferon-based treatment is an option and works with 80% efficacy in treatment-naive patients.

Second, patients are at low risk for death from HCV until they develop cirrhosis, and not all of them will. As a result, the sustained virologic response benefits of interferon-free therapy do not translate directly into large boosts in life expectancy or quality-adjusted life expectancy in noncirrhotic patients.

"This finding was consistent even when we increased mortality in cirrhotic patients, assumed lower [quality of life] with early-stage HCV infection, and assumed higher costs attributable to HCV infection," the authors write.

Should Anyone Get Interferon?

The research raises questions of when, if ever, providers should administer interferon to save costs. Recent HCV guidelines identified pegylated interferon-ribavirin as a regimen "to avoid."

Patients who have insurance are unlikely to want the older therapies that have longer treatment and higher toxicity. So, from a societal perspective, is it acceptable to limit the total number of people treated to avoid interferon therapies at all costs?

The authors write that the best option is for insurers to negotiate discounts for the new drug prices, but if that does not happen, the authors support offering the interferon treatments to treatment-naive noncirrhotic patients and saving sofosbuvir for patients with cirrhosis and those who cannot tolerate or have previously not benefited from interferon therapy.

Such a strategy would treat the sickest first while offering a less costly alternative to those with early disease.

Cost Stands in Way of Eradication

In an accompanying editorial, Ohad Etzion, MD, and Marc Ghany, MD, MHSc, from the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health in Bethesda, Maryland, agree that the simplest solution would be lowering the dug prices, but they acknowledge that if that happened, it would be too late for many patients, and still the prices would be too high in some settings.

They find, as authors of other studies have found, that cost may be the only thing standing in the way of eradicating HCV.

"Medicine does not often have the potential to eradicate a disease with significant public health burden," they write. "Results from the studies discussed here offer a price that would make these treatments cost-effective, but is society willing to pay even the reduced price?"

This study was funded by the National Institute on Drug Abuse and the National Institute of Allergy and Infectious Disease. Dr Linas and a coauthor received grants from the National Institute on Drug Abuse. Another coauthor reports receiving grants and personal fees from Gilead Sciences, Bristol-Myers Squibb, and Abbvie Pharmaceuticals outside the work. The other authors have disclosed no relevant financial relationships. Dr Ghany reports receiving nonfinancial support from Bristol Meyers Squibb outside the work. Dr Etzion has disclosed no relevant financial relationships.

Ann Intern Med. Published online March 30, 2015. Article abstract/a>, Editorial extract

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