Short Takes On News & Events

A Call For Pricey Treatment For Millions With Hepatitis C

By Richard Knox

April 9th, 2014, 8:43 AM

Authors of the first-ever global hepatitis C guidelines 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 medicines. Gilead Science’s Sovaldi costs $1,000 per pill/$84,000 for a 12-week course of treatment and Olysio, Janssen Pharmaceuticals, $66,360 for its 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.”

Hoping For HIV-Like Success

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 KHN and NPR.

14 Responses to “A Call For Pricey Treatment For Millions With Hepatitis C”

  1. Insurance says:

    Medicines should not be expensive so that everyone can afford it.

  2. evan says:

    “Medicines should not be expensive so that everyone can afford it.”

    Huh?

    Then how could Big Pharma stockholders get wealthy? Then how could Big Pharma afford to pay their senior executives huge salaries and their outrageous bonuses? Then how could Big Pharma afford corporate jets to fly their senior executives around to expensive country clubs worldwide? Medicines should not be expensive so that everyone can afford it? Don’t be so naive! Don’t be so stupid! Medicines will always be expensive because, as Republicans always say, money talks and BS walks! The Republican motto has always been, let the working poor people in this world eat cake! Just ask Budget Committee Chairman Paul Ryan. FACT: A vote for a Republican is a vote to continue allowing Big Pharma to rule the cost of medicines. Get it? If you keep electing Republicans, you’ll continue to pay through the nose for your medicines.

  3. Cassie says:

    While it is terribly expensive to develop a drug (~$800 million), from the lab to the clinical studies, these prices are not viable for patients in even the wealthiest of countries, nevermind the poorer countries where HCV is most prevalent.

  4. evan says:

    Cassie,

    If that’s true, why would any middle class person or working poor person in their right mind vote for a Republican? That’s what Republicans are all about! Protecting Big Pharma profits while the middle class and the working poor die without the medicines they need!

  5. Rick says:

    Evan – pharmaceutical manufacturers employed nearly 800,000 American workers in 2013 according to the Bureau of Labor Statistics. If republicans are all in favor of “big pharma,” and “big pharma” offers fair wages and benefits to these people (mean annual wage is $58,000 dollars for a career in pharmaceutical manufacturing, by the way), then I’d say at the very least these 800,000 people and their families all have a good reason to vote for a republican. :)

  6. Penelope says:

    Rick I just looked it up, and that 800,000 also includes non-pharmaceutical chemical manufacturing. So technically it’s not that big. But still, these major pharmaceutical companies DO employ several hundred thousand Americans. Found this link to be both interesting and relevant:

    http://www.forbes.com/sites/matthewherper/2011/04/13/a-decade-in-drug-industry-layoffs/

  7. evan says:

    Rick,

    So, according to your strange logic, we are to choose to maintain the overly generous wages and overly generous health and welfare benefits of a few hundred thousand “big pharma” workers versus trying to lower the insane and outrageous cost of medicines for possibly billions of working poor and middle-class people worldwide, is that it? Is that your argument? Well, guess what Rick? In my opinion, if you want my vote, the big pharma workers lose hands down! I’d rather see reasonable pricing for medicines for consumers worldwide than to maintain the workers in an industry that has been gouging us all for decades. In my opinion, if big pharma had better control of Jonah Salk back in the 1950′s, those corporate sharks would still be making huge profits from the treatment of polio. By the way, don’t try to tell us that they aren’t keeping the cure for cancer under wraps just to continue the profit gravy train.

  8. Rick says:

    Yes Evan, according to my strange logic, we are to choose to maintain the wages and benefits of a few hundred thousand “big pharma” workers rather than try to over-regulate and control the affairs of a private industry.
    And no, I don’t believe any person would hide the cure for cancer so that pharmaceutical manufacturers can continue to profit off those who have it. Maybe that’s a little naive, but I’ve seen no evidence to suggest otherwise, and I’d rather be an optimist than a cynic or conspiracy theorist.

  9. Dan says:

    “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.” ”

    This is good – nice to see natural market forces at work. Hopefully enough manufacturers will climb on board that prices will decrease significantly. If they don’t, it might be an indication of how expensive this drug is to make. Either way, looks like things will balance out if the market is allowed to do what it’s supposed to do without intervention.

  10. Paul says:

    A little naive? Maybe you should post as “Pollyanna”? Pharma has been screwing consumers for decades, as mentioned above. Any legitimate business deserves a fair profit. However, businesses that hold the keys to life and death should be carefully scrutinized and carefully regulated. We can never trust such businesses. Profit margins need to be monitored and regulated. To allow Pharma to operate without severe regulation would be like allowing the fox to guard the hen house.

  11. Rick says:

    :) I’ll admit I probably put a little too much faith in people. And of course there’s corruption in these large companies (though I hate to admit it). But I just don’t think it should be left up to the government to monitor that. I think market forces can do that work for us. They already are – it’s in the article, and thank you, Dan, for making note of it.
    But you’re right: when it comes to pharmaceuticals, some people don’t have time to wait for the market to correct itself. Their lives could be on the line. Makes this a more complicated situation than it would be in any other major industry.

  12. evan says:

    Most Republicans are in the same boat as you. As staunch capitalists, they initially oppose smart regulations that help consumers and help society and ultimately help the economy until a light bulb comes of and they find themselves saying things like, I’ll admit I probably put a little too much faith in people or a little too much faith in corporations. Face it, given to their own devices, people (and people within corporations) are basically greedy. All people need help with moral direction at times. Even you! That’s why we have regulators and regulations. To keep people from doing the wrong things that they will ultimately do. Alone, people can’t be trusted and neither can corporations that are made up of those same people. They need cameras focused on them constantly in order to help them make honest. Just look at what Wall Street did to us leading up to The Great Bush/Cheney Recession of 2008. The worst recession since The Great Depression. Do we need any more evidence that capitalism, acting alone and without serious regulation, is very dangerous?

  13. If that’s true, why would any middle class person or working poor person in their right mind vote for a Republican? That’s what Republicans are all about! Protecting Big Pharma profits while the middle class and the working poor die without the medicines they need!

  14. evan says:

    “If that’s true, why would any middle class person or working poor person in their right mind vote for a Republican? That’s what Republicans are all about! Protecting Big Pharma profits while the middle class and the working poor die without the medicines they need!”

    Germany in the 1930′s?

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