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MEDICARE WON'T ALWAYS PAY FOR BOOMERS' PRICEY HEPATITIS C DRUGS

5/13/2014

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Walter Bianco has had hepatitis C for decades. He's known about it for 20 years. And now he's reaching the end of the road.

"The liver is at the stage next to becoming cirrhotic," the 65-year-old Arizona man says.

That means he's approaching the end stage of hep C infection. Cirrhosis is a precursor of liver failure, which requires a transplant. And it can lead to liver cancer.

More and more baby boomers like Walter Bianco are approaching this stage of chronic hep C infection. Researchers estimate that 3 to 5 million Americans have the insidious virus.

 

Alexandra Olgin

Many, like Bianco, got it from injecting illegal drugs in their youth. (He says he's been drug- and alcohol-free for 32 years.) Some got it from transfusions before 1992, a period when blood wasn't screened for the virus. Some got infected from sharing razors or toothbrushes. From contaminated needles used for tattoos or hospital equipment. Some from sexual transmission.

Whatever the source of infection, Bianco's ominous situation is increasingly common.

"There isn't a day that goes by where I don't have a story very similar to Mr. Bianco's," says Dr. Hugo Vargas of Mayo Clinic in Scottsdale, Ariz., Bianco's liver specialist.

Vargas has been trying for two years to stave off the deadly complications of Bianco's infection. So far, nothing has worked.

But there's a very good chance that Bianco can be cured of his hep C. Potent new drugs can clear the virus from his body for good.

"People are ecstatic," Vargas says. "It really is amazing to be seeing what's happening."

These new drugs are curing more than 90 percent of patients – virtually 100 percent in somerecent studies. Just a few years ago, cure rates were 50 percent or less.

But there's a big problem: The cost.



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One of the new drugs, called sofosbuvir (brand name Sovaldi) costs $1,000 per pill.

Vargas says Sovaldi combined with another new drug calledsimeprevir (Olysio) is highly effective in patients like Bianco.

And the new drugs are easy to take. Bianco says the older drugs caused horrible side effects. "Just terrible itching, terrible headaches, nausea," he says.

But Medicare won't pay for the drugs that Vargas says Bianco needs.

Medicare officials wouldn't comment on coverage of new hep C drugs. A spokesman says the federal program turns such decisions over to private insurers that administer its drug plan.

One of those private insurers has twice rejected Vargas's prescription because the Food and Drug Administration hasn't approved use of the two drugs in combination. (Last week Olysio's maker, asked the FDA for approval of the regimen.)

Together the two drugs would cost around $150,000 – far more than Bianco can afford.

"It is a lot of money, and there are a lot of hep C sufferers out there," Bianco says. "I think Medicare's probably thinking. 'If we can hold off for a year or two, some of these following drugs will be cheaper.' "

“If he were my father I would want Mr. Bianco to be treated now — not in a year, not in a year and a half.

- Dr. Hugo Vargas

But Vargas says Bianco, like many others with end-stage liver disease, may not have that long to wait.

"If he were my father," the Mayo specialist says, "I would want Mr. Bianco to be treated now – not in a year, not in a year and a half."

Update 3:05 pm: A spokesman for the Centers for Medicare and Medicaid called NPR to report that the agency is "looking into" Walter Bianco's case. "The policy is trying to catch up with reality," the CMS spokesman said, asking not to be identified by name. "It has been a slow process. We want to try to be helpful as much as we can to get beneficiaries the drugs that they need."

It's not yet clear how insurers and government programs will cope with the problem. The Department of Veterans Affairs and expert panels recently recommended reserving the new drug regimens for patients awaiting liver transplants and others with the most advanced liver disease.

But consumer advocates cringe at the idea that patients may have to wait for a cure until their livers have suffered irreversible damage. For one thing, once a patient has cirrhosis he will have to be monitored for liver cancer every six months for the rest of his life.



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"If I had a chronic infectious disease that could lead to advanced liver disease and complications, I'd want to be treated," says Ryan Clary of the National Viral Hepatitis Roundtable, an advocacy group. "The news is the cure is here. We need to get people into treatment."

But those asked to pay the bill for treatment are expressing alarm at the hundreds of billions of dollars that hep C drugs could cost them. Olysio costs around $66,000 per patient for a 12-week course of treatment. Sovaldi costs $84,000.

"People were very shocked by the price, because it hit a psychological barrier in terms of. 'This is too expensive,'" says Dr. Camilla Graham of Beth Israel Deaconess Hospital in Boston. She recently was turned down in her request to prescribe the two drugs for a Medicare patient.

But Graham says the cost per patient for hep C drugs is not unique.

"We have a lot of drugs where we spend in that $80,000 to $100,000 range –- and the outcome is not cure," Graham says, alluding to specialty drugs for rheumatoid arthritis, multiple sclerosis and cancer.

The cost problem with hep C drugs is that millions of people will need them in the near future, especially as federally recommended screening programs to detect infected people ramp up.

Graham says many of these patients can't wait long for their chance at a cure.

"Hepatitis C is a ticking time bomb," she says. "We have a very limited amount of time to get in here and alter the course of the disease for a good number of people."

If that doesn't happen, a lot of them will suffer liver failure and liver cancer. And that will cost a lot more to treat in the long run.

by RICHARD KNOX May 12, 2014 3:25 AM ET




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