Authors of the first-ever global guidelines for treating hepatitis C went big Tuesday, advocating for worldwide use of two of the most expensive specialty drugs in the world.
The new guidelines from the World Health Organization give strong endorsement to the two newest drugs. Gilead Sciences' Sovaldi costs $1,000 per pill, or $84,000 for a 12-week course of treatment. Olysio, sold by Johnson & Johnson's Janssen Pharmaceuticals unit, costs $66,360 for a three-month course.
The high prices have ignited a firestorm of objection. In the United States, doctors and insurers argue that the cost of the drugs will make their widespread use impossible. And critics say even if the prices are heavily discounted in other countries, the drugs will still be unaffordable in most of the world.
The WHO endorsement of treatment with Sovaldi and Olysio was made without taking the cost of the two drugs into consideration. That's because the price of the drugs outside the U.S. was unknown in December, when the WHO panel wrapped up its work.
But the price of the drugs isn't the only issue. The WHO recommends that all 150 million or so people around the globe with chronic hepatitis C infection be assessed for treatment — a gargantuan task in itself. Authors of the report are quick to acknowledge that neither the assessment of people's health status nor actual treatment will happen anytime soon.
"A lot has to happen for this to really take off in a big way," says the guidelines' chief architect, Dr, Stefan Wiktor. "Even if prices came down dramatically tomorrow, that doesn't mean there would be an immediate rush to treatment."
Screening programs for hepatitis C need to be ramped up. Labs to determine the genetic type of the virus (crucial in choosing treatment regimens) have to be built and staffed. Medical personnel need to be able to assess when viral liver damage has progressed to the point when treatment is urgent. And drugs have to be chosen wisely and administered carefully.
Fewer than a quarter of Americans with chronic hepatitis C currently have had or are getting any treatment. In Europe, treatment has reached only 3.5 percent. And in most countries, Wiktor says, "hardly anyone is getting treatment."
The WHO guidelines are setting a deliberately high standard in the hope, Wiktor says, of replicating the remarkable dissemination of antiviral therapy for HIV.
Starting from a similar point of little distribution 15 years ago, antiviral treatment for HIV now reaches around 10 million people, most of them in the poorest countries of sub-Saharan Africa. HIV infects more than 35 million people globally (and almost a third of those also have hepatitis C). That makes chronic hepatitis C infection at least four times more prevalent.
But HIV requires lifelong antiviral treatment. The big difference with hepatitis C is that suddenly there are drugs that can actually cure more than 90 percent of patients with a three-month regimen. "Treatments are getting better, shorter and safer," Wiktor says.
The controversy over the cost is apparently beginning to have an effect on pricing. Egypt, which has the world's highest infection rates – somewhere around 20 percent of the population – has negotiated a 99 percent discount on Sovaldi, to $900 for a 12-week course.
Gilead, Sovaldi's maker, is tiering prices for the drug in other countries too — $55,000 in Canada, $66,000 in Germany, and reportedly around $2,000 for a generic version that may be licensed to several Indian companies.
But those discounts don't impress some critics, such as Rohit Malpani of Doctors Without Borders. "When you're starting from such an exorbitant price in the U.S., the price Gilead will offer middle-income countries like Thailand and Indonesia may seem like a good discount," Malpani says. "But it will still be too expensive for many of these countries to scale up treatment."
Other forces may drive prices lower. "A number of other medicines are coming down the pike — at least 20," WHO's Wiktor says. "That in itself will provide competition as companies try to assure market share."
A flood of new data on the effectiveness of new medicines is expected this week at an International Liver Congress in London, where the new WHO guidelines were unveiled.
"The dynamism around hep C is really remarkable," Wiktor says. "Once you know you can cure somebody, that really changes the tone of the conversation."
But until the prices fall, and until (or unless) pressure develops to shake loose massive new amounts of funding to pay for access to the new drugs, hard choices loom.
For instance, the WHO guidelines say that treatments will have to be rationed, starting with patients whose livers are heavily scarred or cirrhotic – putting them at high risk for liver cancer or the need for liver transplants.
"We don't have reliable figures, but about 20 percent of people with chronic hep C are in that stage," he says. "That would be 26 to 30 million people globally."
Or around three times the number receiving HIV treatment.
This report is produced as part of a partnership with NPR and Kaiser Health News.