Medicaid patients often denied new hepatitis C drugs

Last Updated: 2015-11-23

By Megan Brooks

NEW YORK (Reuters Health) - Nearly half of Medicaid patients with chronic hepatitis C virus (HCV) are being denied access to new direct-acting antiviral agents, often because the expensive drugs aren't considered necessary or because the patients test positive for alcohol or drugs, according to a new study.

"We had hypothesized that denials would be more common among patients with Medicaid coverage but we were somewhat surprised at the magnitude of the difference in denial. It was very striking," Dr. Vincent Lo Re, III, of the University of Pennsylvania Perelman School of Medicine, told Reuters Health.

He reported the study November 16 in a late-breaking oral abstract at the American Association for the Study of Liver Diseases (AASLD) in San Francisco.

Direct-acting antiviral hepatitis C drugs have high cure rates but cost up to $90,000 for a 12-week course.

To gauge insurance coverage denial rates, Dr. Lo Re and colleagues analyzed prescriptions from 2,342 patients submitted to a specialty pharmacy that serves patients in Pennsylvania, New Jersey, Delaware and Maryland. Among those patients, 517 were covered by Medicaid, 800 by Medicare, and 1,025 by commercial insurers.

Twenty-one patients had incomplete data. Of the remaining 2,321, coverage for direct-acting antiviral drugs was denied in 377 (16%). In the Medicaid group, 46% received a denial, compared with 5% of those who had Medicare, and 10% among the privately insured.

The most common reasons for denial by Medicaid were insufficient information to assess medical need, lack of medical necessity, and positive alcohol or drug test.

Dr. Lo Re told Reuters Health his team had not studied the consequences of the denials. But there may be some "serious downstream" adverse outcomes, including "progression of liver disease to advanced liver fibrosis/cirrhosis and risk for liver decompensation and liver cancer," he said.

"Also, if you don't treat and cure these people, they could potentially transmit the disease to other people. And, if you take the paradigm that chronic hepatitis is an inflammatory disease and has been associated with other extra-hepatic complications like bone disease, cardiovascular disease, kidney disease, neuropsychiatric disease, they are still going to be at risk for all these complications," Dr. Lo Re said.

Patients who did receive direct-acting antiviral therapy through Medicaid had to wait 10 days longer to have their prescriptions filled compared to Medicare and privately insured patients, the study found.

At least 3 million Americans have hepatitis C infection and many are on Medicaid. Restrictions for direct-acting antiviral hepatitis C drugs vary widely across states' Medicaid programs and may violate federal law. Earlier this month, the U.S. Centers for Medicare and Medicaid Services sent a letter to all the directors of state Medicaid programs highlighting this fact, Dr. Lo Re noted.

"They sent separate letters to the drug manufacturers for the direct-acting antivirals urging them to come to the table to try to (figure out) how to make these drugs more affordable, particularly for Medicaid patients. Something has to be done," he said.