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Gilead Sciences Inc., the company that makes Harvoni, has limited access to a program designed to help patients gain access to the expensive but desperately needed Hepatitis C treatment medication.

What’s the Problem?

Studies have found that Harvoni is highly effective at curing Hepatitis C, a life-threatening liver disease that affects more than 3 million Americans. However, the drug is extremely expensive — $1,125 per pill, or about $94,500 for a 12-week regimen.

Due to the high cost of Harvoni, insurance companies have restricted access to the medication by denying coverage to patients deemed not to be sick enough to warrant treatment. Lawsuits accuse insurers of breach of contractual duty by classifying Harvoni as “not medically necessary,” and by refusing to cover the drug until the patient’s liver is severely damaged. The problem is that once the liver is significantly damaged, Hep C is essentially irreversible.

Insurance companies are not the only ones facing lawsuits over Harvoni. According to an article published in the Wall Street Journal, a complaint has been filed against the U.S. Food & Drug Administration (FDA) by 2 public advocacy groups claiming it didn’t release clinical trial data for Harvoni quickly enough. The organizations, Treatment Action Group (TAG) and Global Health Justice Partnership (GHJP), applied under the Freedom of Information Act to obtain access to trial data on Harvoni and Sovaldi – another Hepatitis C treatment drug.

The groups say information from drug trials will allow independent analysis of the data. However, even though Harvoni and Sovaldi were reportedly fast-tracked to approval, the FDA said it would take up to 2 years to receive the information.

Now Gilead is reportedly limiting enrollment in its Support Path Assistance Program, which is designed to help patients obtain access to Harvoni treatment when their insurance company won’t cover it. It has been speculated that the move might be an attempt to get patients to complain to insurers about the failure to cover treatment. Under Gilead’s support program, patients who have insurance but do not meet the insurer’s criteria will not be eligible for coverage.

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