April 14, 2014 -- Last week, the World Health Organization strongly endorsed two new oral drugs that fight hepatitis C, a liver-damaging virus. The WHO recommended that all 150 million people infected worldwide be assessed for these drug treatments.
With that endorsement, though, came concern from WHO officials about the high price of these new medicines, one of which costs $1,000 per pill. Some doctors and insurers -- and now an editorial in the New England Journal of Medicine -- are voicing the same concern. A large U.S. pharmacy benefits manager is threatening a boycott if costs don't come down.
Meanwhile, new drugs in the pipeline have a success rate that rivals the two main players.
Hepatitis C is spread by an infected person's blood, such as by sharing needles or drug equipment, sexual contact, or, in years past, by transfusions and organ transplants. If infection becomes chronic, it can progress to liver failure, liver cancer, or the need for a transplant. In the U.S., about 3 million people are infected, but many are unaware of it.
WebMD asked experts and the drugmakers to address the most frequently asked questions about these two pricey ''game-changers'' and got some predictions about future treatment costs.
The cost for Sovaldi (sofosbuvir) varies based on the exact use, says Michele Rest, spokeswoman for Gilead, which makes the drug. When used with the hepatitis C drug ribavirin, a common combination, a 12-week course costs about $84,000 wholesale, or $1,000 a day, she says.
A 3-month course of Olysio (simeprevir), also used with other medications, is about $66,000 wholesale, or about $733 a day, says Craig Stoltz, a Janssen spokesman.
Q: Why do the drugs cost so much?
"On average, to research and develop just one medicine takes 10 to 15 years and more than $1 billion," says Jennifer Wall, a spokeswoman for the Pharmaceutical Research and Manufacturers of America.
Rest declined to provide details on research and development costs for Sovaldi or how long it took to develop.
Scientists have been working on these advanced hepatitis C drugs for more than 20 years, and companies take “enormous risks” in developing new drugs, says William Carey, MD, a hepatologist at the Cleveland Clinic. Many trials that looked promising at first had to be stopped. “Those losses must be made up for with the drugs that do make the market,” he says.
Business decisions come into play, too, says Henry Masur, MD, past president of the Infectious Diseases Society of America.
In 2011, Gilead paid $11 billion to acquire Pharmasset, the company that developed Sovaldi, Rest says.
"They have a lot invested in it and have to make their money back," Masur says.