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October 10, 2014 12:00 AM

Gilead Sciences gets go-ahead for Harvoni, its second high-priced hepatitis C drug

Paul Demko
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    A second potential blockbuster drug manufactured by Gilead Sciences to treat hepatitis C has been approved by the FDA. But at a cost of nearly $100,000 for a full course of treatment, the drug is certain to spark further debate over the pricing of specialty drugs.

    The agency approved Harvoni following three clinical trials and an expedited review process because of the drug's potential for curing the liver disease. The trials showed that 94% of patients had no evidence of the virus in their bloodstream after 12 weeks of treatment with Harvoni and 99% of patients were cured after 24 weeks of treatment.

    “Unlike other serious chronic diseases, hepatitis C can be cured and Harvoni offers patients the potential for a cure in as little as eight weeks,” John Martin, CEO of Gilead Sciences, said in a statement. “Gilead is proud to have played a role in developing a once-daily therapy that is safe, simple and well tolerated. We are now working to ensure rapid and broad access to Harvoni.”

    In December 2013, the FDA approved Sovaldi for treatment of hepatitis C. In the first half of this year, Gilead Sciences racked up $6 billion in sales, making it the most successful drug launch in U.S. pharmaceutical industry history. But at a cost of $1,000 per pill, it's also sparked an outcry over out-of-control pricing on specialty drugs. Sovaldi typically is taken in combination with other drugs, which can push the cost of a full 12-week course of treatment well above $100,000.

    The cost for a 12-week course of treatment with Harvoni is $94,500. Some patients will only require an eight-week course of treatment, which would cost $63,000. An analysis by Bank of America Merrill Lynch predicted that there will be $1.6 billion in Harvoni sales during the fourth quarter of this year. The price of Harvoni elicited immediate blowback from consumer advocates and the insurance industry.

    "By charging $94,500 for Harvoni, Gilead has made clear that it values Wall Street above the interests of patients, taxpayers, employers, and working families who must shoulder the burden of high healthcare costs,” wrote John Rother, president of the National Coalition on Health Care, a nonpartisan advocacy group, in a blog post. “The company's refusal to take a more reasonable and moderate approach to pricing cements its status as the poster child for everything that is wrong with pharmaceutical industry pricing.”

    America's Health Insurance Plans, which has been in a pitched battle with pharmaceutical interests over drug pricing in recent months, was similarly critical. "Gilead had an opportunity to demonstrate that it wants to be part of the affordability solution, but the company still seems to believe it has a blank check,” AHIP spokesman Brendan Buck said in a statement. “Our healthcare system has long relied upon a careful balance between affordability and rewarding innovation, and this pricing topples it.”

    But Dr. Bruce Bacon, a liver specialist at the St. Louis University School of Medicine, indicated that the drug will be an improvement over Sovaldi in two important ways: The cure rate is slightly higher and patients won't have to take additional drugs.

    There are approximately 3.2 million individuals in the country with hepatitis C, according to the CDC. But many of them are unaware that they are infected because the disease can remain dormant for years.

    Follow Paul Demko on Twitter: @MHpdemko

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