Jumping Through Hoops and Over Hurdles

Gaining approval from insurance companies for highly effective new hepatitis C virus treatments is fraught with challenges for patients.
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.

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