High Price of Gilead's Sovaldi Could Deter Early Hep C Treatment

Gilead Silences has cleaned up on their new $1,000 Hepatitis C pill Sovaldi (84,000 per treatment), hauling in a record-breaking $2.3 billion in its first full quarter on the market. The previous record (also a Hepatitis C drug Incivek from Vertex) came in with $1.56 billion, according to EP Vantage.

And Sovaldi may well go on to trump the record for first-year sales, at least in the United States, the company stated in an analyst conference call on Tuesday.

It couldn’t come at a better time for Gilead, whose first-quarter revenue of $5 billion was double that of a year ago. Net income for the quarter was $2.23 billion, well above the $722.2 million of the same period last year, according to the New York Times.

Sovaldi is definitely supplying a need. Three million to four million Americans, mostly baby boomers, may have hepatitis C, a liver disease that causes cirrhosis, or scarring of the liver, and liver cancer, though usually not for decades after the infection occurs. Contagious, it is caused by a virus, and estimated to infect up to four million Americans, with more than 350,000 dying annually from hepatitis C-related liver disease.

Currently hepatitis C can be cured ( less than than 50 percent success rate) in some patients with an antiviral therapy, but the treatment is both difficult to administer (daily injectable) and results in debilitating flu-like side effects that can prevent a patient from fully functioning, even from working.

Sovaldi, on the other hand, is a pill and has been shown to have vastly fewer side effects than the interferon therapies. And yet, the extremely high cost is putting tremendous pressure on a variety of stakeholders including patients, insurers, state Medicaid programs, and the Department of Veterans Affairs and prison systems.

United Health Group, one of the largest insurers, said last week that its first-quarter earnings had declined in part because it had spent more than $100 million on hepatitis C treatments, including Sovaldi, far more than it expected, according to the Wall Street Journal.

Gilead defends the price, saying Sovaldi can save the health system money overall.

“First and foremost, the value of a cure, I tend to think, is underestimated in terms of the overall advantage that the health care system receives from it,” John F. Milligan, chief operating officer of Gilead, said on a conference call with analysts Tuesday.

So, what’s the solution? Hold off treatment suggests some organization until your condition becomes dire. But how can you tell what’s dire, especially given it’s a liver disease and difficult to track.

Determining how far liver disease has progressed is not an exact science, and hepatitis C may worsen more quickly than expected. There is evidence patients have a better chance of curing the disease the less time they’ve been infected. And there isn’t any guarantee that the new generation of medications, (other than Sovaldi) not yet been approved by federal regulators, won’t suffer setbacks. Last year, for instance, Bristol-Myers Squibb Co. BMY -0.18% scrapped development of a once-promising hepatitis C treatment after serious safety issues emerged in testing.

The advantage of treating early stages of the virus is to prevent scaring of the liver. “If cost were not a factor, we would want to treat the entire population,” said Dr. Rena Fox, a professor of medicine at the University of California, San Francisco. She said it was frustrating that “we finally get this great treatment and then we withhold it.”

On the other hand, “With certain types of patients who have mild disease, I think it’s reasonable to defer treatment,” says Ira M. Jacobson, a physician specializing in hepatitis C research and chief of the division of gastroenterology and hepatology at Weill Cornell Medical College in New York. He estimates at least half of his hepatitis C patients are currently being “warehoused,” a term that refers to patients deferring treatment in hopes a better therapy comes along soon.

Doctors told the Wall Street Journal that they faced an ethical dilemma in advising people whether to wait to seek treatment for hepatitis C, especially if they are dealing with patients with mid-stage liver damage, “We’re constantly weighing whether to treat now to avoid problems downstream versus waiting for newer, easier and potentially better therapies a couple years from now,” says Donald M. Jensen, director of the Center for Liver Diseases at the University of Chicago Medical Center.

Dr. Sharon Levine, an executive at Kaiser Permanente criticized Gilead’s pricing, saying that if all of Kaiser’s members with hepatitis C were to be treated in a single year, “it would double our total drug budget for all of our nine million members nationally.”

That won’t happen because many people infected with the virus do not know they have it. And there is a limit to the capacity of doctors to treat patients. Gilead executives said on Tuesday that 30,000 people have tried the drug so far, leaving many more who haven’t. So the number of patients to be treated - and big sales for Sovaldi - may last years.