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2 HCV lawsuits in Washington State
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http://www.statnews.com/pharmalot/2016/02/04/lawsuits-hepatitis-c/
Given the American Association for the Study of Liver Diseases' endorsement of these drugs as the standard for medical care for Hep C, the insurers' practice is illegal, attorneys for complainants argue.
A consumer in Washington state has sued Group Health Cooperative for denying the combination drug, asserting that it is limited to people with more severe infections. The class-action lawsuit is one of two class-action suits recently filed in King County Superior Court that seek to have insurers provide drugs to patients, regardless of the high prices that drug makers set. Washington State Insurance Commissioner Mike Kreidler says he is encouraging insurers to follow the medical standard of care, although he cannot 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," says Kreidler. 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.
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."[and recently changed their Guidelines to recommend treatment for all. that is, not to impose restrictions to access]
The ongoing outrage over the cost of hepatitis C treatments is, once again, prompting consumers to fight back against insurers that deny them access to the medicines. In the latest instance, a pair of lawsuits was filed that accuse two large insurers in the state of Washington of rationing.
The lawsuits, which were filed late last month in state court and seek class action status, charge that Group Health Cooperative and BridgeSpan restricted access to the medicines except to the "most severely ill" people, but not for a "clinical purpose." Instead, the consumers charge the insurers do so due to "financial concerns." And they want the insurers to provide coverage.
BridgeSpan requires "infected individuals wait for treatment - potentially for years - until they demonstrate serious scarring or cirrhosis of the liver from hepatitis C infection," one lawsuit charges. Meanwhile, patients are "forced to live with … an increased risk of cancer or death." The lawsuit pointed to criteria for the coverage decision made by Regence.
A spokesman for Group Health Cooperative declined to comment and we will pass along any reply that BridgeSpan sends us. [UPDATE: A spokeswoman for BridgeSpan similarly declined to comment, citing pending litigation.]
The newest crop of hepatitis C medicines - Gilead Sciences sells Harvoni and Sovaldi, while AbbVie markets Viekira Pak - boast cure rates exceeding 90 percent. Their arrival over the past two years marked a turning point because older treatments were less effective and caused difficult side effects.
However, the treatments cost between $83,300 and $94,500, depending upon the drug and the regimen, before any rebates offered to payers. And the price tags helped trigger a national outcry over the cost of pharmaceuticals.
For its part, Gilead, which is not named as a defendant in the lawsuits, has consistently maintained that its medicines offer good value because they lower the potential for long-term costs of treating liver disease, liver cancer, and transplantations.
Nonetheless, payers continue to complain the drugs have been budget busters, and many have taken steps to restrict coverage. For instance, shortly after Sovaldi became available in early 2014, Illinois officials instituted two dozen stringent criteria for usage.
This is the not the first time that consumers have fought back like this, though. Last year, consumers in California filed similar lawsuits against Anthem Blue Cross, claiming they suffered physical injuries, emotional stress, and economic damages, among other things, because access was restricted.
Health care experts had predicted still more lawsuits would be filed while prices remain high. What remains to be seen is whether the arrival of a new Merck hepatitis C drug, which is priced at $54,600, will generate sufficient discounting so that insurers loosen restrictions.
Read more: Merck ushers in price war for hepatitis C medicines with new drug
A spokesman for Express Scripts, which is the nation's largest benefits manager and used the new AbbVie drug to extract rebates from Gilead, wrote us that "having multiple, clinically effective options allows us to again leverage competition and make medicine more affordable for our clients while ensuring appropriate patient access."
One health care expert thinks this is unlikely, though. "The fundamental issue is that it costs $54,000-plus. So it's still a problem," said Randy Vogenberg, a partner at Access Market Intelligence, a consulting firm that specializes in managed care.
Meanwhile, some state officials are trying their own strategies to lower the cost of hepatitis C drugs. Last week, the Massachusetts Attorney General threatened to sue Gilead for violating consumer protection laws if the drug refuses to lower its prices.
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Lawsuits claim insurers unfairly refuse pricey hepatitis C drugs
Originally published February 2, 2016
http://www.seattletimes.com/seattle-news/health/lawsuits-claim-insurers-unfairly-ration-pricey-hepatitis-c-drugs/
Two Washington state insurers - Group Health Cooperative and BridgeSpan - are targeted in class-action lawsuits that claim the companies are unfairly rationing new drugs that can cure hepatitis C based on high cost, not medical need.
David 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.
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