Jumping Through Hoops and Over Hurdles

Arlen Nilsen can tell you the meaning of bone-tired. She’s felt that way for decades.

The 48-year-old freelance artist has been suffering from the hepatitis C virus (HCV) since a minor fling with an intravenous (IV) drug user in her late 20s inadvertently brought the disease to her doorstep. Exhaustion is her constant companion.

“It’s the kind of tired that a nap doesn’t cure. It’s profound exhaustion,” she said.

A single woman who has spent years caring for ill family members, Nilsen now finds herself alone to deal with a disease that’s dragged her down to the point where she can barely function, much less earn a living. She’s been on Medicare for her health needs since dire, HCV-caused poverty had her bunking on couches in friends’ apartments for two years when she lost her own home. It is embarrassing and debilitating, and accompanied by a depression for which she has to take drugs.

Arlen Nilsen is her “HCV name” when she warily ventures into discussing the disease; she doesn’t tell clients that she suffers from the affliction because of stereotypes and prejudice that could negatively affect her ability to support herself. That was why the bright new era of HCV drugs—such as Harvoni, Sovaldi, Olysio, and Viekira Pak, that provide actual cures, shortened treatment times, and relatively few side effects—has been just short of miraculous for the HCV patient population, and a godsend for Nilsen.

Nilsen made it into a drug trial, where the meds—which can cost $1,000 per pill and more, depending on the drug—were provided to her for free. But Nilsen’s bad luck held out: the treatment didn’t work. HCV emerged again in her system just two months after the course of treatment ended. Now Nilsen finds herself at a crossroads: enroll in another drug trial or find the strength to battle Medicare to pay for the high-priced drugs that could cure HCV and give her back her life.

It’s a situation Dr. Brian R. Edlin finds all too common. Edlin, a physician and senior principal investigator for the Institute for Infectious Disease Research at the National Development and Research Institute in New York City, has been treating HCV patients for over a decade. Many of them are impoverished and on Medicare.

“The people I see are very anxious to get treated. Most doctors who treat hepatitis C patients have that experience, that it’s heartbreaking and frustrating,” he said.

It isn’t just a matter of the enormous cost of the drugs, Edlin added. It’s the strange practice, engaged in by Medicare, Medicaid, and private health insurance companies, of only approving the new class of medications for patients whose HCV has advanced to the worst stage: cirrhosis of the liver. HCV, Edlin said, is a slowly progressing disease, so it takes time for a patient’s infection to move from less lethal F1 and F2 classifications of fibrosis to the worst, F4, which represents cirrhosis. Patients who are at stages F1 and F2 routinely get turned down by government and private insurance companies, he said. It’s a situation Edlin finds unconscionable.

“We could eradicate hepatitis C in the United States and in many countries around the world if we could use these drugs freely. The companies that manufacture these drugs have decided that their responsibility to their shareholders outweighs their responsibility to the public and society,” Edlin said. “It’s the same situation with insurance companies.”

Dr. Diana Sylvestre deals almost exclusively with low-income patients. She serves as executive director of the OASIS Clinic in Oakland, California, which is devoted to treating uninsured and underinsured HCV patients. Many of the patients she treats are homeless or drug users, or both, she said. Sylvestre echoed many of the same concerns as Edlin, but with a twist. The Affordable Care Act (ACA) has given many of her patients insurance, but with “crazy high co-pays” and high deductibles. For some patients, it may be the first time they’ve actually had insurance, but they are shocked to find out that walking into Dr. Sylvestre’s clinic with their ACA card doesn’t ensure that they’ll be treated cheaply or for free.

“They discover we aren’t in their network. They have no idea they have to pay a co-payment or that they have to hit a deductible before the insurance kicks in. It always comes as a shock,” she said. “It’s more expensive for them than it was before. Some are paying more for their care than if they were uninsured.”

For Edlin, and for Sylvestre’s patient population in particular, poverty may mean that patients qualify for drug assistance programs run by the pharmaceutical firms who own the miracle HCV drugs.

“You have to be pretty wealthy not to qualify [for a patient assistance program],” Edlin said.

First, however, patients have to be rejected for the miracle drugs by Medicare or a private insurance company first, and then appeal that finding. If they are still denied and meet income qualifications, the assistance programs may offer free or low-cost drugs.

That was how John Shutts, a 56-year-old disabled veteran, obtained Harvoni, one of the new HCV drugs manufactured by Gilead.

“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.”