Oregon poised to restrict hep C drug under Medicaid

Sovaldi has worked for many, but too expensive for state budget

By Tara Bannow / The Bulletin / @tarabannow

Jacki Gethner contracted hepatitis C while treating a patient at a hospital in Denver, Colorado, in 1986 before universal precautions protected health care workers from infections.

The 64-year-old Portland resident didn’t find out until several years later, when she tried to donate blood and was rejected. She’s uninsured, and for a long time relied on Chinese medicine and acupuncture, that is, until this year, when she first qualified for the Oregon Health Plan, the state’s Medicaid program. After a six-month wait, Gethner finally saw Dr. Atif Zaman, a hepatologist and hepatitis C specialist at Oregon Health & Science University. By then, she had already developed cirrhosis, irreversible scarring of the liver that impairs its function.

As Oregon moves closer to becoming the first state to restrict access to a new hepatitis C drug for most OHP patients, Gethner wonders whether the drug could have prevented her cirrhosis, and whether it could prevent it from developing in other hepatitis C patients, too.

“I really hate the thought of having to get cirrhosis of the liver in order to be able to be treated with these new drugs,” Gethner said last week before a committee that discussed the issue.

The proposal being considered would restrict coverage of Sovaldi, a new hepatitis C drug that’s prohibitively expensive but hailed as a game-changer by patients and advocates, to only the sickest OHP patients. State leaders say the restrictions are necessary, as the cost of the drug — $84,000 for a 12-week round of treatment — would take a substantial bite out of OHP’s drug budget.

The idea is that the state will revisit and loosen the restrictions in less than a year, just long enough for new, more affordable drugs currently under development to be released.

“What we need to do now is just sort of stop the bleeding,” said Tom Burns, OHA’s director of pharmacy programs. “We just need to stop the accidental dispensing of the product so that we can get a plan in place that will adequately address this drug for the taxpayers of Oregon.”

Giving the drug to all of the state’s hepatitis C patients would have cost $480 million, about half of OHP’s drug budget, Burns said. He estimates that narrowing its availability to only the sickest patients who meet certain exceptions would drop that to $40 million, which he said the program still doesn’t have in its budget.

“We are either going to have to make a choice to not cover some other benefit, or go to the Legislature for more money,” he said.

The OHA convened a panel of hepatitis C experts, led by OHSU’s Zaman, to create a list of exceptions that hepatitis C patients would need to meet in order to receive Sovaldi, such as certain patients with cirrhosis. The OHA’s Pharmacy and Therapeutics Committee, which sets drug policies for OHP, approved the exceptions at a meeting last week.

A temporary fix

About 5,600 current OHP patients have hepatitis C, and more than 13,000 are believed to be infected but don’t know it yet.

Hepatitis C is a contagious liver disease that affects an estimated 3.2 million people in the U.S., according to the Centers for Disease Control and Prevention. Because the disease is slow-progressing, baby boomers who contracted it decades ago are just finding out by developing serious liver problems such as cirrhosis or cancer. People contract the disease through sharing needles with infected people, being born to infected mothers or from needlestick injuries in health care settings. More rarely, it can be transmitted through sexual contact.

Speaking before the Pharmacy and Therapeutics Committee last week, Zaman said he expects cheaper versions of Sovaldi to come on the market within the next six to 12 months, and he hopes the restrictions can be revisited at that time. He said the list of exceptions his group compiled is meant to cover everyone who wouldn’t be able to wait for the drug without suffering serious consequences.

Zaman said hepatologists from across the country have contacted him to express concern about his panel’s work.

“They are quite confused and quite dismayed on why we’re being so restrictive,” he said.

Members of the panel have experienced “angst” over their role in restricting access to the drug, Zaman said.

But Lorren Sandt, the executive director of the Caring Ambassadors Program, an Oregon City-based group that advocates for hepatitis C patients, said she believes if anything, the new drugs will be even more expensive.

“Let’s not assume that they’re going to get cheaper,” she said.

Rationing care

Oregon’s Medicaid program, like all others in the country, operates under a finite budget, so leaders are constantly struggling to delegate care to those who need it the most. The program is unlike other state Medicaid programs, however, in that the federal government allows it to ration its funds by restricting coverage to certain conditions and treatments. Other Medicaid programs ration funds by limiting who can be in the program.

A group called the Health Evidence Review Commission is constantly reviewing evidence and making tough decisions about which treatments will and will not be covered and for whom. A HERC subcommittee will make a recommendation regarding coverage for Sovaldi on Friday, and the full HERC will take up the issue Aug. 14.

Before Sovaldi, which received Food and Drug Administration approval in December 2013, the drugs prescribed to treat hepatitis C caused flulike symptoms throughout the treatment. The side effects were so severe they prevented most people from following through with the treatment.

Burns said once new versions of Sovaldi are released, he hopes to offer exclusive access to Oregon’s OHP population to one of the companies in hopes they’ll cut the state a deal. State Medicaid programs already receive more than 20 percent discounts on new varieties of drugs, but he hopes to get an even deeper discount.

Sandt — whose organization receives unrestricted grants from a number of pharmaceutical companies, including Gilead Sciences, Inc., the maker of Sovaldi — said allowing exclusive access to one company wouldn’t work, as one drug won’t work for all OHP patients.

“We need to work with all of them,” she said.

Gilead has come under widespread scrutiny in recent months for what critics say is exorbitant pricing on Sovaldi, which the company reported last month had brought in $3.48 billion. Two Congressmen, including Sen. Ron Wyden of Oregon, called a joint investigation into the company’s pricing. In a letter to Gilead’s CEO, the Congressmen pointed out that U.S. Food and Drug Administration documents show the company that developed the drug, which was later purchased by Gilead, originally planned to sell it for $36,000 per treatment.

“The large patient population combined with the high price of each individual treatment creates a question as to whether payors of health care, including Medicare and Medicaid, can carry such a load,” the Congressmen wrote.

Implications unclear

Steve Nemirow, a hepatitis C patient who lives in a rural area outside of Hillsboro, said before he started taking Sovaldi in January, his energy and mind were deteriorating and he suffered from major bleeding as a result of his cirrhosis. (Bleeding is a common side effect of liver failure, as the scarring prevents blood from accessing the liver, creating large, swollen veins that are prone to rupturing.)

By March, he said his hepatitis C was cured. Nemirow, who had tried other treatments unsuccessfully in the past, said he hopes the state can find a way to get the new drug to more people.

“How do you explain to somebody, ‘Your dad didn’t qualify for the new hep C treatment,’” Nemirow said. “‘He wasn’t sick enough, so we had to let him develop really terrible diseases.’ It could be cirrhosis, it could be cancer.”

Burns said it’s difficult to put his foot down and say there simply is not enough money in the OHP budget for this drug.

“If I thought for one minute that somebody was going to die because of this, I would be making a different recommendation,” he said. “I’ve been assured by everybody that there are safety valves built in, that we will catch the most seriously ill patients and move them around the stop sign so they can get treated for this drug so they don’t in fact fall into liver failure.”

But Sandt insists that if the HERC approves the restrictions, people will die. If the state only treats the sickest patients — those who have already developed cirrhosis — then it will allow others to develop cirrhosis that could otherwise have been prevented.

Although only 1 percent to 5 percent of people die from cirrhosis, it’s an irreversible condition that increases a person’s risk of liver cancer and is the most common reason people need liver transplants.

“When you have cirrhosis, you will die prematurely,” Sandt said.

— Reporter: 541-383-0304,

tbannow@bendbulletin.com

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