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.
READ MORE HARVONI DENIED CLAIM LEGAL NEWS
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.