Washington, DCLawsuits have been filed against the US Food and Drug Administration (FDA) and insurers, alleging patients have been unfairly restricted access to Harvoni, putting them at risk of serious health problems. While those lawsuits gather momentum, news has emerged that Gilead Sciences, maker of Harvoni, has now restricted access to its hepatitis C medication, further fanning the flames of anger about the drug.
Hepatitis C is a contagious liver disease that can be fatal. It is linked to severe liver damage, infections, liver cancer, pain and arthritis. With a 90 percent cure rate, and few known side effects, Harvoni is considered a highly effective cure for hepatitis C, but it comes at a high cost - a 12-week treatment program costs around $99,000.
Insurance companies are accused of unfairly restricting patient access to Harvoni by denying treatment coverage on the grounds that the patient is not sick enough to warrant treatment. Lawsuits filed against insurance companies allege the companies have rejected claims for Harvoni treatment by classifying the treatment “not medically necessary” and refusing to cover Harvoni until the patient’s liver is severely damaged enough. The problem is that once the liver is significantly damaged, patients can suffer life-threatening disease.
Patients who have filed lawsuits against their insurers allege breach of contractual duty to provide coverage and breach of good faith.
But insurers are not the only ones facing lawsuits. According to The Wall Street Journal (6/29/15), the FDA faces a lawsuit filed by two public health advocacy groups, alleging that it didn’t release clinical trial data for Harvoni quickly enough. The groups, Treatment Action Group and Global Health Justice Partnership, applied under a Freedom of Information Act to obtain access to drug trial information on Harvoni and Sovaldi - another hepatitis C drug.
The public advocacy groups say information from drug trials will allow independent analysis of trial data. But even though the drugs were reportedly fast-tracked through the approval process, the advocacy groups were told it would take up to two years to receive the trial data.
Now Gilead is reportedly limiting enrollment in its Support Path assistance program, a program designed to help patients obtain Harvoni treatment when their insurance won’t cover it. The Wall Street Journal (6/16/15) reports that the move might be an attempt to get patients to complain to insurance companies about the failure to cover treatment. Under the restrictions, patients who have insurance but do not meet the insurer’s criteria for coverage will not be eligible for the Patient Assistance Program.
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