Lawsuits claim insurers unfairly refuse pricey hepatitis C drugs

http://www.pharmacychoice.com/News/article.cfm?Article_ID=1507549

Feb. 03David Morton figures he contracted hepatitis C back in the late 1980s, when the Ph.D. chemist was doing a dirty job: analyzing raw-sewage samples for toxins in Texas.

“We were looking for priority pollutants on the Environmental Protection Agency watch list,” the 61-year-old Redmond man said. “I thought I was benefiting society. I sort of clenched my teeth and did it.”

Back then, no one knew what hep C was, let alone that it could be transmitted by dirty needles or other exposure. It took nearly a decade before Morton was diagnosed.

Today, however, doctors not only know what causes the liver-damaging virus that affects 3.5 million Americans, they know how to cure it.

But when Morton got a prescription last fall for Harvoni, one of the new, highly effective drugs to halt the hep C virus (HCV), he couldn’t fill it. Group Health Cooperative, his insurance provider, wouldn’t pay for it.

Treatment with Harvoni, which costs about $95,000 for a 12-week course, was limited to people with more severe infection, the denial letters explained.

“They said I wasn’t sick enough,” Morton said.

So Morton has sued, agreeing to be the face of a class-action lawsuit. His is one of two class-action cases recently filed in King County Superior Court, and among a handful nationwide aimed at forcing insurers to provide drugs to patients, regardless of high prices set by pharmaceutical firms.

“I believe that all those infected with hep C should qualify for treatment,” Morton said.

The complaints allege that two Washington state insurers Group Health and BridgeSpan insurance, a subsidiary of Regence BlueShield are unfairly limiting use of hep C drugs based on cost, not medical necessity. Some insurers in the state cover patients at all stages of the disease.

Group Health Cooperative “has put in place internal coverage restrictions that impermissibly deny all its insureds access to curative treatment for HCV solely because it is perceived to be expensive by GHC,” the complaint states. “Specifically, GHC rations treatment, excluding all coverage except to the most severely ill insureds.”

“It’s not Mr. Morton’s responsibility to think about how to pay for this,” said Ele Hamburger, one of the lawyers at Sirianni Youtz Spoonemore Hamburger, the Seattle firm handling both lawsuits. “What they’re trying to do is put patients in the middle.”

At issue are what Michael Ninburg, executive director of Seattle’s Hepatitis Education Project, calls “wonder drugs” and a “medical revolution.”

In the past few years, drugmakers have begun marketing new direct-acting antivirals, or DAAs, medications that can cure hep C with more than 90 percent success, eliminating the virus from the body.

Such drugs can halt and perhaps reverse the ravages of chronic hep C, which can destroy the liver and lead to liver cancer.

But drugs such as Gilead’s Sovaldi and Harvoni came with those high price tags more than $1,000 a pill, prompting Medicaid programs in dozens of states, including Washington, to restrict use to people with the most severe fibrosis, or liver scarring. Private insurers followed suit.

The state Health Care Authority said it is considering broadening access through Medicaid.

Last fall the American Association for the Study of Liver Diseases (AASLD) updated its guidelines, saying drugs such as Harvoni “would benefit nearly all of those chronically infected with HCV.”

That changed the game, said Hamburger. If the new hep C drugs are now the standard for medical care, they should be provided to all patients and not rationed to a few.

Officials with Group Health and BridgeSpan declined to comment on the lawsuits, citing pending litigation. But BridgeSpan officials said policies surrounding Harvoni are “still evolving and changing.”

Group Health officials, responding to a survey about hep C policies from Washington Insurance Commissioner Mike Kreidler, also said they are “continuously re-evaluating treatment guidelines in light of the new guidelines, medications and new literature.”

For his part, Kreidler said he is encouraging insurers to follow the medical standard of care, though he said he can’t mandate which drugs should be covered or which patients should receive them.

“They really need to, from my perspective, follow the medical guidelines, and if they don’t, we have a process to challenge them on that,” he said.

Dr. Scott Ramsey, a health economist at Seattle’s Fred Hutchinson Cancer Research Center, said the volatile hep C drug market underscores larger issues that won’t be solved with lawsuits.

“The larger issue is whether we will accept the pharmaceutical industry’s argument that these high prices are justified or whether we feel like the pricing model for these drugs needs some change,” he said.

In the meantime, however, David Morton said he’s happy to be the face of change. And he’d like to get his prescription filled, too.

“I’d like to eradicate the virus,” he said.

JoNel Aleccia: 206-464-2906 or jaleccia@seattletimes.com. On Twitter @JoNel-Aleccia

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