The lawsuit (case number 0:15-cv-61118) was filed by Janie Kondell, who has had hepatitis C for 10 years. Although Harvoni has been approved by the U.S. Food and Drug Administration (FDA) as a treatment for hepatitis C, and is deemed an effective treatment with few side effects, Blue Cross reportedly refused coverage of the drug because her liver had not “sufficiently deteriorated.”
Hepatitis C is a contagious liver disease that is linked to serious health problems including liver damage, liver cancer and death. It is also linked to cirrhosis of the liver, which can lead to liver failure. Harvoni was approved by the FDA in October 2014 to treat hepatitis C due to data showing it cured 95 percent to 99 percent of Hepatitis C cases.
Even better for patients, it comes with few side effects and can cure hepatitis C in as little as 8 to 12 weeks. The issue is the price: Harvoni treatment costs between $64,000 and $99,000.
According to court documents, in February 2015, Kondell’s doctor prescribed Harvoni treatment. Blue Cross denied the treatment, arguing the medication was not medically necessary.
“Defendant decided that Ms. Kondell hadn’t suffered enough, and her liver hadn’t been damaged enough, by a disease that causes irreparable harm and death, for which a cure is finally available,” the lawsuit argues. “Florida Blue said it would not consider approving Harvoni for Kondell until her liver has a certain amount of scarring (advanced fibrosis of stage F3 or greater) on a liver biopsy.”
Kondell and her doctor appealed the denial, which was affirmed repeatedly, with Blue Cross claiming the treatment was not yet medically necessary.
“Never in [Dr.] Migicovsky's 25-plus years of practice had he witnessed Florida Blue, or any insurer, take the position that a patient’s disease must get worse, and cause irreparable harm, before it would approve treatment that could arrest the progression of the disease and prevent that harm” (bold and italics in court documents).
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Blue Cross also faces a lawsuit filed by Shima Andre, who alleged her claim for Harvoni treatment was unreasonably denied by Blue Cross.
“Blue Cross prefers that its insureds get much worse before paying for treatment almost guaranteed to cure their disease,” Andre’s lawsuit argues.
The Shima Andre lawsuit is Andre v. Blue Cross of California et al., case number BC583063 in Superior Court for the State of California for the County of Los Angeles.