Jumping Through Hoops and Over Hurdles | Page 2

BY DEBORAH BELL
Gaining approval from insurance companies for highly effective new hepatitis C virus treatments is fraught with challenges for patients.
PUBLISHED WEDNESDAY, JUNE 10, 2015
“I knew these drugs were coming out, and I was waiting for them,” said Shutts, who believes he was infected with HCV when he was vaccinated in the Army. “They would go down the line, and shoot us with these air guns, both arms at the same time. There wasn’t any sterilization. One guy got the vaccine, then it was your turn.”

Shutts was treated for the infection with interferon and ribavirin, a standard HCV drug cocktail before the advent of the new miracle drugs. Shutts, who worked for Homeland Security, was so tired after the injections that he’d administer the shots on a Friday to have the weekend to recover from his exhaustion. When the new drugs reached the market, Shutts applied and was turned down because his disease was at the F1 and F2 levels and not considered to be dire enough to merit approval.

“I appealed, we got turned down again. I made calls, and got denied. I even went to the [Department of Veterans Affairs]; they turned me down,” he recalled. “If I had had cirrhosis, they’d have given me the OK.”

Shutts came across Support Path, Gilead’s patient assistance program that provided access to Harvoni.

“I filled the paperwork out the same day, faxed it in, and I got Harvoni two days later,” he said.

The miracle drug was his, at no cost. Not everyone has to fight to get access to the HCV miracle drugs. Kathleen Kane-Willis admits that she is “privileged.”‘ She’s the director of the Illinois Consortium on Drug Policy at Roosevelt University in Chicago, and she’s been suffering from HCV for 26 years.

“I contracted it by sharing a needle with my boyfriend back in 1989, before there was such a thing as a needle exchange,” she said.

She’s been on an Olysio and Sovaldi drug combo since January, and she has every expectation she’ll be HCV-free when her treatment ends. A public policy researcher, Kane-Willis first got her medication from her physicians even before the FDA approved the drugs.

“I can’t believe how easy it was for me to get them,” she said, adding that it was cruel and unfair that lower income people—particularly drug users—are denied access.

Part of the problem is that every state administers its own Medicare program, and Kane-Willis feels that Illinois is among the worst due to the hoops patients have to jump through to get needed medicines.

“There shouldn’t be such a difference in the kind of treatment patients receive,” she added.

In Illinois, for example, Kane-Willis said that Medicare patients who get approval may only get two weeks’ worth of pills, and then they have to submit to tests to prove they are still eligible for the drugs.

“If they miss one session, they could be dropped from the program,” she said. “It’s crazy. Someone who starts the protocol and doesn’t finish it can have their disease mutate into a drug-resistant strain. It makes no sense.”

The fact that poorer patients are put through stringent tests to qualify makes Edlin ill.

“Some insurance companies require that you take a test to prove you’re drug-free and alcohol-free. A patient can’t even enjoy a glass of wine with dinner, or he could be rejected,” he said.

The situation is worse for active drug users. Edlin said that it isn’t the actual drug that causes HCV, but the sharing of syringes and transfer of infected blood that transmits the disease. Some of his patients are still engaged in IV drug use. That, Edlin said, should have no bearing on their being approved for a course of the new drugs.

“These restrictions have no medical justification,” he said. “We’re in an era that is a watershed in the treatment of viral infections. It’s like the development of penicillin in the 1940s, which revolutionized the treatment of infection. Denying patients these medications is tantamount to malpractice. It’s certainly suboptimal medical practice.”

Shutts, who just finished his 84-day course of Harvoni in February, said he already is feeling great. He has to wait three months for blood tests to be officially judged as cured, but he’s convinced that his HCV is gone for good.

“I’m feeling better and better every day,” he said, beaming.

What he doesn’t get is why Gilead charged so much for the drug he was taking. At $1,125 a pill, the 84 pills he took amounted to more than $90,000.

“They either charge $90,000, or they give it away for free,” Shutts said. “I can’t make head or tails out of that.”

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