Wednesday, December 17, 2014

In Hepatitis C, Treatment Rationing Has Already Begun

To curb an estimated 6% to 11% increase in Medicare Part D spending, 3 states have already placed limitations on which patients with chronic hepatitis C are candidates for treatment with novel antiviral agents. 

The debate about which patients with hepatitis C are appropriate treatment candidates is a contentious issue, according to Marc G. Ghany, MD, MHSc, in an editorial published in JAMA Internal Medicine.  

 With nearly 30% of cirrhosis cases and 1 in 4 cases of hepatocellular carcinoma caused by hepatitis C, a clear opportunity for prevention of expensive public health issues exists. However, the cost of treatments is also expensive.   

According to a recent study by the Division of Viral Hepatitis at the Centers for Disease Control and Prevention analyzing more than 18,000 patients, a minority of patients with chronic hepatitis C virus infection are receiving treatment—just 7% to 11% of eligible patients.   This low treatment rate may initially have been be due to delays in treatment, or “siloing” patients with the hope that effective treatments would become available, and possibly at a lower cost. With the approval of ledipasvir/sofosbuvir, and the COSMOS trial indicating efficacy of a simeprevir/sofosbuvir combination, the time for treatment may be at hand.   

These new regimens have response rates in excess of 90%, defined by sustained viral response 12 weeks after the end of treatment. With these highly efficacious, all-oral treatments, Ghany argues for universal treatment of all patients with chronic hepatitis C infection, but notes that the high cost of treatment is an impediment to universal use. For instance, a 12-week course of sofosbuvir, as has often been quoted, costs approximately $84,000 to insurers. Similarly, a 12-week course of simeprevir costs $66,000.   

The high cost of these 2 medications alone are expected to increase Part D spending by 6% to 11% over 2015. To curb this trend, 3 states, Colorado, Illinois, and Pennsylvania, have already limited treatment to patients with chronic hepatitis C who are experiencing advanced-stage liver disease.   With limitations on treatment likely to be put in place in other states, it is important for patients with hepatitis C to receive treatment as soon as possible. Limitations on treatment for patients who are not candidates mean that close monitoring is crucial to ensure that limitations on access to treatment do not ultimately result in the spread of hepatitis C, and progression of infection to preventable cases of hepatocellular cancer or cirrhosis due to a lack of monitoring.   

Reference: Ghany MG. The Ongoing Debate of Who to Treat for Chronic Hepatitis C Virus. JAMA Intern Med. 2014. - 

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