Sofosbuvir-Based Regimen Cost-Effective for Some Hepatitis C Virus Infections

By Will Boggs MD

NEW YORK (Reuters Health) - Sofosbuvir-based regimens are cost-effective for treating patients chronically infected with hepatitis C virus (HCV) genotype 2 or 3 and for those who also have cirrhosis, according to a Monte Carlo simulation.

"Ideally, we should be treating all patients with HCV infection using oral, interferon-free regimens - without restriction by disease stage," Dr. Benjamin P. Linas, from Boston Medical Center, Massachusetts, told Reuters Health by email. "For most patients, this approach is cost-effective and would provide the best outcomes. Unfortunately, at their current cost - even with discounts - these meds place a great financial stress on payers."

Sofosbuvir in combination with ribavirin yields cure rates higher than those with the previous standard of care, its sustained virologic responses greatly reduce the lifetime risk for liver-related morbidity and mortality, and it improves short-term survival for patients with advanced liver disease.

But it is expensive. Priced at $1000 per tablet, sofosbuvir currently costs $84,000 for 12 weeks of treatment, and the projected cost of treating all patients in the United States exceeds $300 billion. Many payers balk at these costs, and several state Medicaid programs cover sofosbuvir only for patients with advanced liver disease.

Dr. Linas's team used the Hepatitis C Cost-Effectiveness simulation of screening and treatment for HCV to estimate the effectiveness and cost-effectiveness of strategies for treating chronic HCV genotype 2 or 3 infection.

Sofosbuvir (compared with interferon-ribavirin) was not cost-effective at currently accepted levels for treatment-naïve noncirrhotic patients with HCV genotype 2 (incremental cost-effectiveness ratio (ICER), $238,000 per quality-adjusted life-year (QALY) gained) or genotype 3 (ICER, $266,000 per QALY).

Twelve weeks of sofosbuvir treatment (compared with no treatment) was, however, cost-effective for treatment-experienced patients without cirrhosis infected with genotype 2 (ICER, $63,700 per QALY) or genotype 3 (ICER, $82,000 per QALY), according to the March 30 Annals of Internal Medicine online report.

Sofosbuvir treatment was cost-effective for treatment-naïve and treatment-experienced patients with cirrhosis for both genotype 2 and genotype 3 infections.

Among treatment-experienced patients and patients with cirrhosis, sofosbuvir-based therapy was cost-effective in more than 90% of simulations when the societal willingness-to-pay threshold was less than $100,000 per QALY.

"New medications are very effective and well tolerated, but unfortunately very costly," Dr. Linas said. "At this time, one of the main things preventing us from trying to eliminate HCV infection in the U.S. is drug cost."

"When an insurer refuses to cover HCV therapy, there is a human nature response to blame the insurance company," Dr. Linas said. "In many cases, however, the payer who is denying coverage is a Medicaid managed care plan that is simply trying to remain solvent. In such a case, I find it hard to really blame the payer for trying to maintain pharmacy coverage for all patients enrolled in the plan. The root cause of the problem is the price of these agents, which is essentially dictated by the pharmaceutical companies who manufacture them."

"At its current cost," the researchers conclude, "access to sofosbuvir will likely be unequal and restricted and will limit the number of people ultimately cured of HCV infection in the United States."

Dr. Ohad Etzion and Dr. Marc G. Ghany, from the National Institutes of Health, Bethesda, Maryland, wrote an editorial related to this report. Dr. Ghany told Reuters Health by email, "If the cost comes down, then we could potentially treat everyone but so long as the cost remains high, the approach that is most widely taken is to treat paints at greatest risk of complications or death first. This is not a palatable solution to all, since there may be patients with mild disease who are quite symptomatic and wish to be treated for that reason or women with mild disease who wish to become pregnant and want to be treated to reduce the risk of maternal-fetal transmission."

"Costs have been decreasing as some insurance providers have negotiated discounts with manufactures, but I am not privy to the details of the negotiated contracts," Dr. Ghany said. "We hope as other regimens gain approval, costs will decrease further."

Dr. Ghany added, "Healthcare providers need to be strong advocates for their patients to get them access to the new regimens."

Dr. Jagpreet Chhatwal, from the University of Texas MD Anderson Cancer Center, Houston, told Reuters Health by email, "New therapies are highly effective and provide a good value for money. Therefore, timely diagnosis and treatment of HCV with new therapies should be of high priority. The cost of treatment should not become a barrier."

"Like in most of the developed countries, we need regulations on costs of drugs," Dr. Chhatwal said. "HCV therapies provide a good example of how high costs are unsustainable for our healthcare system."

Dr. David B. Rein, from independent research organization NORC at the University of Chicago, Atlanta, Georgia recently demonstrated the cost-effectiveness of new antiviral treatments for HCV in a similar study. He told Reuters Health by email, "The very most important point to make is the genotype 2 and 3 patients represent only a small proportion of all patients with chronic hepatitis C infection (about 30% of infected whites, and 10% of infected blacks). The majority of HCV patients have genotype 1 disease, for which the conclusions of this paper do not apply. The authors are clear about this point, but I am nervous that the distinction will get lost in translation."

"Many patients cannot tolerate interferon-based therapy (which the paper addresses) or will simply refuse to be treated with interferon because of interferon's side effects," Dr. Rein said. "The cost-savings associated with using older therapies need to be balanced with a recognition that interferon-based therapy comes with significant side effects. It's easy to recommend these treatments to 'society' at large, but it's also important to consider what you would choose for yourself or a loved one if you were in a similar situation."

The National Institute on Drug Abuse (NIDA) and the National Institute of Allergy and Infectious Diseases supported this research. Two authors reported receiving research support from NIDA; two authors reported receiving research support from the National Institutes of Health and Optuminsight, Gilead, Bristol-Myers Squibb, and Abbvie.

SOURCE: https://bit.ly/1IdlxcN

Ann Intern Med 2015.

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