Harvoni Investigation Focuses on Problematic Insurance Industry Practices


. By Heidi Turner

Patients who have a life-threatening illness typically pray for a cure to be found. They don’t tend to expect that if a cure is found and approved by the FDA, that they would then have to fight with insurance companies to have their treatment covered. Unfortunately for many patients with hepatitis C, insurance companies are allegedly denying them access to curative treatments like Harvoni, arguing that patients aren’t sick enough. But some question whether the denials are motivated by profit, instead of patient well-being or medical necessity. “There are patients with hepatitis C whose doctors are prescribing Harvoni as a curative treatment, but they are being denied the treatment by insurance companies,” Anna Haac, attorney at Tycko & Zavareei LLP, says.

Harvoni is a recently approved cure for hepatitis C, a contagious, potentially fatal liver disease. Patients with hepatitis C can develop complications such as liver damage, cirrhosis of the liver and liver cancer.

There wasn’t a widely effective and well-tolerated cure for hepatitis C until October 2014, when the FDA approved Harvoni, designating it a breakthrough therapy. Studies show Harvoni can cure 94 to 99 percent of hepatitis C cases, but it’s an expensive drug.

Treatment with Harvoni can cost up to $99,000 for a 12-week treatment program. But studies have shown it to not only be effective but also have few side effects. As soon as it was approved, doctors began prescribing Harvoni to their hepatitis C patients.

According to reports, 15,000 people die in the US annually from complications linked to hepatitis C. More than three million people in the US have chronic hepatitis C. Once hepatitis C has developed, approximately 70 percent of patients will develop chronic liver disease, which puts them at increased risk of cirrhosis and liver cancer. Even without the disease advancing to life-threatening stages, patients can suffer fatigue, pain, severe headaches and nausea, affecting their daily living and ability to work. Insurance companies have allegedly denied Harvoni treatment arguing that the patient’s liver was too healthy and therefore did not require treatment.

Physicians find these insurance company practices problematic. The American Association for the Study of Liver Disease has condemned the denial of curative hepatitis C treatment by insurance companies, stating in a press release that patients who receive advice from their doctor to take the newest hepatitis C medications should not be denied.
“It is doctors, not insurance companies, who should be determining how best to treat their patients,” Haac says.


Policyholders may have a legal claim against their insurance companies if denied these curative treatments, but they often face legal hurdles in pursuing them. “Patients who have had their insurance claim for curative hepatitis C treatment denied should contact us,” Haac says.


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