FDA approval of new hepatitis C drug may temper drug prices

Patients with hepatitis C have gained a new treatment option, which may help curb the rising cost of drugs treating the virus. The FDA has approved Zepatier® with or without ribavirin for the treatment of chronic hepatitis C virus infections in adult patients. Previously, the FDA gave Zepatier a breakthrough therapy designation, which is a program designed to expedite the development and review of drugs intended to treat a serious condition after preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over currently available therapy.

Growing competition among hepatitis C drugs may help to stabilize the increasingly high prices for these products. Merck stated that including Zepatier in treatment options for patients with chronic hepatitis C virus (HCV) provides the U.S. “with an unprecedented opportunity to significantly reduce the burden of [the virus.]” Merck has set a list price for Zepatier of $54,600 for a 12-week regimen, which it believes to be in the range of net prices for other 12-week antiviral regimens used to treat HCV. Merck anticipates that its competitive pricing and its comprehensive access strategy to seek broad coverage “will help broaden and accelerate patient access to treatment and move us closer to our shared goal of reducing the burden of chronic HCV in the U.S.”

Compared with the prices of treatments from Gilead Sciences Inc., an early competitor in the market for oral hepatitis C drugs, like Sovaldi® being sold at $1,000 per pill ($84,000 for a single course of treatment) and single-tablet regimen Harvoni® with a list price of $94,500, Zepatier is expected to be a welcome addition to the market. In December 2015, the Senate Committee on Finance found, through its own investigation, a revenue-driven pricing strategy behind Sovaldi, which caused Medicare and Medicare to spend more than $5 billion on Sovaldi and Harvoni in 2014. Financial statements showed U.S. sales of the drugs through public programs and private payers totaling $20.6 billion after rebates in the first 21 months following Sovaldi’s introduction to the market.