Woman sues Anthem Blue Cross for denying hepatitis C drug Harvoni
The virus could win.
It wants to do to Shima Andre what it already has done to so many thousands of people worldwide: Drain her of energy. Change the color of her skin. Make her panic when she feels a pain on her right side.
But the 42-year-old West Hollywood woman with hepatitis C said there’s a sure-fire weapon on the market that could help her fight and kill the virus.
A drug called Harvoni is one of precious few prescription medications that can actually cure a virus. It’s been touted as a miracle drug. But her health insurer says she’s not sick enough and therefore the drug is not medically necessary. That’s why they won’t cover it.
Andre, who was diagnosed four years ago, is at an early stage of hepatitis C. She gets her viral load checked every six months. She endures ultrasounds on her liver. So far, the tumor that was discovered is benign, but the whites of her eyes are starting to change color. She wonders how much time she has.
She has filed a lawsuit against Anthem Blue Cross for denying Harvoni and for saying in a letter dated October of last year that until she has reached Stage 3 of severity, she can’t have the pills. That means that by the time Blue Cross approves the lifesaving drug for her, she will be too exhausted to work as a book editor, her liver will develop scar tissue and cirrhosis, and she may have to consider an organ transplant.
“I was shocked, devastated and outraged,” Andre said. “I thought it was a mistake.”
Denial letters for specialty drugs such as for those with diabetes, multiple sclerosis and HIV are becoming more common. The reason, say Andre’s attorneys and others: the cost. Harvoni’s price tag exceeds $90,000 for a 12-week prescription.
Andre’s attorneys say in the lawsuit that Blue Cross is obligated to help her obtain the drug and is violating state standards by ignoring her physician’s recommendations.
For Andre and many insured Americans with hepatitis C, Harvoni is the only way for her to fight the virus, not only for its high cure rate, but also because it has very few side effects. Harvoni, made by San Dimas-based Gilead Sciences, was approved by the U.S. Food and Drug Administration in 2014 and cures up to 99 percent of patients within 12 weeks.
Another drug, Sovaldi, was approved in late 2013 and is also billed as a cure, although it is not suited to all patients. It too is made by Gilead. There are no generic versions.
In the short time since the drugs have become available, physicians and their patients in California have already come up against dozens of denials.
In a little more than a year, there have been 135 independent medical review requests for both drugs to California’s Department of Managed Health Care, which regulates health plans. The requests seek appeals to decisions made by insurance plans and even HMOs. Of 135 reviews, the state overturned a health insurer’s denial 95 times.
“Imagine a health care company telling their patients with hepatitis C that they’re not sick enough yet to get a known cure,” said one of Andre’s attorneys, Ricardo Echeverria. “Blue Cross is simply putting profits over patients.”
Andre filed the lawsuit against Blue Cross in May, accusing them of withholding a cure for hepatitis C based on profits.
A spokesman with Anthem Blue Cross said the company could not comment on a pending lawsuit.
But Echeverria said his law firm has at least 10 more cases they’re looking at. And a lawsuit similar to Andre’s was filed recently on behalf of a man who has had hepatitis C for nearly 40 years. Blue Shield, his health plan, denied his physician’s prescription for Harvoni on the same basis: medical necessity.
He also said it would be less expensive to treat Andre than to wait until she is sicker. A study cited by the National Center for Biotechnology Information found that from 2007 to 2009, 19,907 patients were hospitalized in Los Angeles County due to hepatitis C. Their care cost $58 million, with more than 70 percent charged to government sources.
Meanwhile, it’s unclear how many reviews have been requested among some Medi-Cal managed-care recipients because those figures are not yet available, a spokesman with the Department of Health Care Service said. But among those who are on the Medi-Cal fee-for-service system, the department has received 1,489 treatment authorization requests from pharmacists since June 2014 for Harvoni and Sovaldi. Those requests are on behalf of 749 beneficiaries. Of these requests, 959 were denied by the state. A total of 71 appeals have been received; 12 of them were overturned and approved on appeal, while 53 were upheld and denied, and six are pending review.
The state’s hepatitis C treatment policy, released on July 1, 2014, “authorizes treatment for patients with documented Stage 3 or 4 (advanced hepatitis C), or treatment regardless of stage if the patient has appearances of hepatitis C outside the liver or has had a liver transplant,” among other criteria.
In January, Sovaldi and Harvoni were added to the Medi-Cal Contract Drug List.
“They are the preferred products to be considered when medically necessary for the treatment of a beneficiary who is infected with hepatitis C,” according to a response by the Department of Health Care Services.
While insurance denials for treatment for hepatitis C are receiving most of the current spotlight, physicians’ prescriptions for specialty drugs, even generic ones, are being denied more often, said Dr. Samuel Fink, a Tarzana-based internist who also is past president of the Los Angeles County Medical Association.
“In 2015 we’re witnessing a war among physicians and insurance companies,” Fink said. “I’ve had more denials this year than any year before. I don’t know if it’s Affordable Care Act related. The insurers are trying to control the care and treatment of patients.”
Though he hasn’t had to prescribe Harvoni, he said insurance companies are waiting out a patient’s illness, perhaps even until they sign on to another insurance plan.
“They’re just kicking the can down the road,” Fink said. “It’s extremely disheartening and discouraging, knowing that you can’t help your patient.”
Hepatitis C is a bloodborne infection that causes liver disease. It’s was discovered in 1990 and is usually spread person to person through needles and blood transfusions, among other ways. About 3.2 million people in the United States have chronic hepatitis C infection. According to the federal Centers for Disease Control and Prevention, it is an unrecognized health crisis. It is most prevalent among those born between 1945 and 1965, or the baby boomer generation, with a majority of them likely infected during the 1970s and 1980s when rates were highest, according to the CDC.
But most people don’t seek a cure because they don’t know they’re infected. That’s because most people with hepatitis C are asymptomatic but still may have chronic liver disease. It’s most commonly found when someone tries to donate blood.
The CDC recently urged all baby boomers be tested.
Because health plans have placed specialty drugs on different price tiers, those with chronic illnesses such as diabetes, HIV and even multiple sclerosis have had to pull out their own credit cards to pay hefty prices. That sparked a decision last month by Covered California to help reduce the monthly out-of-pocket costs for enrollees by spreading out the costs so that they don’t have to pay it all at once.
Those who purchased plans through the exchange will see their costs capped at an average of $250 per month per prescription. Overall, the caps will range from $150 to $500. The caps will begin later this year, but the move will be reviewed in 2016 to see if it has helped.
In addition, a proposed state bill, AB 339, mirrors Covered California’s change but would place limits on how much health plans can charge enrollees for outpatient prescriptions permanently. It would set a monthly cap of as little as $124.
As for Andre, she and her husband, Ted, would like to have a child, but she fears spreading the virus to her baby. Had she been given Harvoni last year when her physicians from Cedars-Sinai Medical Center prescribed it and even appealed for her, she would already be cured.
She said she has pursued a lawsuit to bring attention to what insurance plans are doing, but also because she is running out of time.
“This is a miracle drug,” Andre said. “There are thousands of folks going through this.”
Filed under: General Problems
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