Chasing a Cure for Hepatitis C

By Dorri Olds 03/09/16

Three months of Harvoni costs upwards of $95,000 and my insurance refused to pay for it. I was told I wasn’t sick enough.

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Chasing a Cure for Hepatitis C
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When I quit drugs and drinking, I found out I had chronic persistent hepatitis C. I’d contracted it in 1978 when I was 17. As the years went by, my chances increased for developing cirrhosis, liver cancer, or liver failure. I might even need a liver transplant. I’d heard about interferon and its brutal side effects, including suicidal depression. I had HCV (hepatitis C virus) because I’d been so depressed as a teen, I shot drugs and shared needles in hopes I’d croak.

But, in addition to stirring up thoughts of killing myself, interferon would’ve meant six months of using needles to administer the drug. It had been nearly impossible to kick drugs and harder still to stay off them, so I was terrified that injecting drugs might steer me toward relapse. Interferon also had a puny 45% success rate, so I opted out.

A few years ago, I found a primary care physician who specializes in infectious diseases and stays up-to-date on HCV treatments. He was waiting and watching for Harvoni (ledipasvir/sofosbuvir) to go on the market. “Now we’ll be able to cure you within 90 days,” he’d said. “And with only one daily pill.”

HCV is divided into six genotypes. I have genotype 1, the most common type in the U.S. and the most difficult to treat. In October 2014, when the FDA approved Gilead’s miracle drug Harvoni, my insurance company refused to pay for it—three months of Harvoni costs upwards of $95,000. I was told I wasn’t sick enough. They were willing to gamble with my health, but my doctor wasn’t. He and his staff submitted appeal after appeal. I switched insurance companies three times hoping to get Harvoni coverage, but to no avail.

Finally, I received an okay for AbbVie’s Viekira Pak with ribavirin. It costs $12,000 less than Harvoni and has a similar cure rate (97%), but Viekira Pak comes with a frightening warning: “It may cause severe liver problems.” My doctor reassured me that the treatment was worth it. He also said there’d be no side effects. He knew how scared I was. If I’d known how difficult taking the medication would be, I would’ve chickened out. That would’ve been stupid, so I’m glad he lied.

My three months on this cocktail have included severe gastrointestinal issues including nausea, constipation and diarrhea. I’ve had skin rashes and chills, confusion, forgetfulness, high anxiety and depression. The worst has been the exhaustion, which often made it impossible for me to work. As a freelancer, no work equals no pay.

The ribavirin caused anemia, and I’ve had to stay in bed most days not knowing if it was day or night. Instead of one Harvoni pill, I’ve had to take three Viekira Pak pills (two different kinds) with three ribavirin pills with breakfast, and one Viekira Pak pill plus two ribavirin with dinner. If my husband hadn’t kept me on schedule, I would’ve slept through most of the doses. Even when I set my alarm, most times I couldn’t move. Thank goodness I have a mate who kept track of the pills and woke me up at correct intervals to bring food and drug cocktails. He also shopped, cooked, did laundry, vacuumed, massaged my aching legs, and took over full-time care of our dog. Without a support system, I don’t know how anyone could manage.

On the upside, my blood tests showed that my viral load went from 1,000,000 from the time I began treatment, to 20 at the end of the first month. Now, after a total of three months, it is at zero. My liver inflammation has gone way down as well, and my doctor assures me that my side effects will cease now that I’ve finished the meds. Still, I wish I could’ve been treated with Harvoni and had known about the multiple class action lawsuits against insurance companies for not covering it.

Eleanor Hamburger is a lawyer at Sirianni Youtz Spoonemore Hamburger, the Seattle firm litigating two class action lawsuits against Washington state health insurers Group Health Cooperative and BridgeSpan, a subsidiary of Regence BlueShield. Hamburger told me, “We had people approach us who had been denied Harvoni. In most states, there’s just a handful of lawyers who do cases involving denials of treatment that people need by their insurance companies.”

She explained, “Here’s the problem. The insurance companies and payers, like Medicaid, are putting patients in the middle of this tug of war with pharmaceutical companies. Payers, whether it’s Medicaid or private insurance, have a responsibility to pay when all the requirements for coverage are met. The whole point of health insurance, and the safety net provided by Medicaid, is to be there with medically-necessary treatment when those terms and conditions are met. The fact that it’s expensive requires the payers to take action against the pharmaceutical companies to get the right price. What clearly should not happen and what has been occurring is, instead of really pushing on that process to get to a fair price between pharmaceutical companies and insurance companies and payers, the payers have been saying, ‘No, we’re just not going to give coverage.’ The ones that get harmed are the patients. It’s wrong.”

When I told her, “Insurance companies told me I wasn’t sick enough,” she raised her voice in anger. “No one should be forced to walk around with a viral time bomb in their body, gambling on the chance that they’re not going to get sicker while they’re waiting. The whole point of insurance, when you pay your premium, is you transfer the risk of having that catastrophic cost to the insurance company. At the end of the year, if you haven’t needed anything expensive for your health insurance, you don’t get your money back! The same is true if you have a year when you’ve got high healthcare costs. Insurance companies can’t suddenly say, ‘Well, even though you’re entitled to coverage under the terms and conditions of our policy, we’re not going to cover it for everyone because it’s too expensive.’ The policies do not allow insurance companies to wait around saying, ‘Oh, but, it’s so expensive we have to ration it.’”

Hamburger led me to Michael Ninburg, the executive director at Hepatitis Education Project (HEP), a nonprofit whose mission is to provide support, advocacy and services for those affected by HCV. He was eager to talk about updates regarding the Washington state class action lawsuits. The lawsuits allege that denying treatment to HCV patients, unless they demonstrated significant liver damage, was illegal and improper.

“We applaud the Regence group,” said Ninburg. “They’re one of the largest insurers in the Pacific Northwest and as of February 16, Regence will conform to recommendations of the HCV guidelines issued by IDSA and AASLD.”

He said, “This change is important to HCV patients because Regence, and its affiliated pharmacy benefit manager Omega Rx, removed all previous restrictions on coverage.”

Ninburg then put me in touch with Sean Hemmerle, a 43-year-old ex-heroin addict and ex-con who is now a full-time college student in Olympia. Hemmerle served time in prison “for a robbery related to my heroin use,” he said. He was diagnosed with HCV in 2010 at Harborview Medical Center in Seattle while undergoing surgeries “to repair wounds from injecting black tar heroin.”

Hemmerle said he was sure he’d gotten HCV from “sharing cookers because I’ve never shared a needle in my life.” When he was on his way to prison, he said, "I looked forward to receiving interferon while I was locked up. I figured it would be an opportune time to go through all the BS associated with it. Unfortunately, the prison medical staff, once they finally got my genotype and viral count, told me that I had too little in my sentence left to begin."

“When I got out [of prison],” Hemmerle said, “Obamacare happened, and I got a primary care provider in winter of 2013, who referred me to the liver clinic at Harborview in summer of 2014. Once I was seen by the liver clinic, they sent a script for 12 weeks of Harvoni to DSHS [Washington State Department of Social and Health Services]. DSHS denied it but the clinic appealed. DSHS denied it again. The clinic then sent my script to the patient assistance program at Harborview, which contacted Gilead. Once the patient assistance program got involved, it was only a week before I received my first month of Harvoni. I completed my 12 weeks in July 2015 with absolutely no side effects, and my viral load was undetectable by week 5.”

He added, “I have loads of survivor’s guilt because I lucked out—literally days after approving me, Gilead began approving only levels 3 and 4 for patient assistance for Harvoni. Some HMOs, like Group Health, have just recently begun approving 1s and 2s for treatment.”

While the drug companies battle it out in a price war, Merck’s rock-'n'-roll-sounding pill, Zepatier (elbasvir/grazoprevir) became available Jan. 29 for $54,600 per three-month treatment. Like the other meds, Zepatier has a cure rate of 97%. Due to its lower price tag, insurance companies are more likely to cover it. Unfortunately, Zepatier’s side effects are similar to those I’ve experienced on Viekira Pak with ribavirin.

Gilead has raked in approximately $20 billion dollars for HCV treatment. AbbVie has earned billions from their Viekira Pak. It’s too soon to know how much money Merck will pull in from Zepatier.

Regulus Therapeutics is the newest threat to Gilead’s profits. On February 17, Regulus announced test results showing that RG 101 administered two times in one month, along with a month’s worth of Harvoni, can reduce an HCV cure to a total of four weeks. Regulus is working on testing RG 101 with GlaxoSmithKline’s NS5B inhibitor, which would eliminate Harvoni. If that pans out, Gilead will suffer, but insurance companies will benefit. Hopefully that means that more people with HCV will receive coverage.

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Dorri Olds is an award-winning writer whose work has appeared in many publications including The New York Times, Marie Claire, Woman’s Day and several book anthologies. Find Dorri on Twitter, Facebook, and LinkedIn.