The new Sovaldi hepatitis C drug, which has a wholesale cost of $1,000 a pill, will pose a challenge to Medicare, Medicaid and prison systems during a time of austere budgets.
Sovaldi’s price already has sparked controversy among activist groups and could, in time, accelerate serious debate about how federal and state agencies buy medicines. Advocates for people with hepatitis C have welcomed Sovaldi as a true medical breakthrough while decrying the high price that its owner, Gilead Sciences Inc., intends to charge.
Gilead has said that a 28-pill bottle of Sovaldi will have a wholesale cost of $28,000, or $1,000 a pill. Many patients will take the drug for 12 weeks, or 84 days; such a course of Sovaldi would cost $84,000.
Sovaldi is seen as a leader in an expected new wave of drugs with the potential to replicate some of the rarest victories in medical science, the near total containment of a disease.
“We’ve got the first of many tools that will allow us to seriously have the discussion about eradicating hepatitis C,” said Michael Ninburg, executive director of the Hepatitis Education Project in Seattle. “In the next few years, there will be very few people living with hepatitis C who won’t be able to be cured by taking a pill, or a couple of pills, a day for 12 weeks, or in some cases maybe a little bit longer.”
The Food and Drug Administration called Sovaldi a “significant shift” in how hepatitis C will be treated. It can be used for some patients without requiring a combination of interferon injections, which are known to frequently cause side effects.
Sovaldi was the third medicine to win the FDA’s relatively new designation as a breakthrough therapy, meaning that it’s considered a substantial improvement over available treatments for a serious and potentially fatal condition.
The FDA noted in a news release that Sovaldi worked for some people who couldn’t tolerate interferon, although the new pill will be combined with injections of the older drug for some patients in other regimens. It’s intended to be taken with the generic pill ribavirin.
“It’s absolutely to be applauded,” Ninburg said. “The price, on the other hand, is an issue.”
It’s certainly a problem for government health programs. Officials at the Federal Bureau of Prisons warned Congress last year about an expected spike in the cost of treating inmates infected with hepatitis C, also called HCV, due to the introduction of new, more expensive medicines.
“More patients will be candidates for treatment and drug regimens will become more and more expensive,” the bureau said in its fiscal 2014 budget request to Congress. “As treatment indications broaden in the future and multi-drug regimens become the standard of care, the drug costs for managing HCV will grow significantly.”
Prisons host a disproportionate share of people infected with hepatitis C, according to the Centers for Disease Control and Prevention. About 3.2 million people in the United States have chronic hepatitis C, meaning that their bodies didn’t clear the liver-damaging virus on their own without treatment. The infection is primarily linked to a history of injections of illegal drugs, such as heroin, although it can be transmitted in other ways.