FAQ: The High Cost of Hepatitis C Drugs
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.
Q: Are these treatments that much better than older ones?
The newer treatments have success rates of 90% or more -- meaning there is no sign of the hepatitis C virus in the body-- compared to success rates of up to 70% for older treatments, Masur says. Some of the new drug treatments wipe out the need to use interferon, which is taken by injection and has unpleasant side effects.
Q: Do any patients pay those total costs out of pocket, or does insurance cover it?
Insurance plans may cover the costs, but also may require copays from patients. "We have had [insurance] approvals for both, with some copays from patients," Carey says. Both drugmakers say they have programs to provide assistance either to reduce the out-of-pocket costs or to provide the drugs at no charge.
Even so, the assistance programs for the new hepatitis C drugs are not, so far, ''as mature, friendly or helpful'' as similar programs for other drugs, Carey says.
Q: Why has the cost of Sovaldi gotten more attention than Olysio?
The focus on Sovaldi is not just because it costs more. Some experts see Sovaldi as the front-runner of the two drugs.
In one analysis, experts favored Sovaldi as the drug with the most potential to increase the number of patients who are virus-free.