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Reuters Health Information: Insurers increasingly deny coverage for all-oral hepatitis C regimens

Insurers increasingly deny coverage for all-oral hepatitis C regimens

Last Updated: 2018-06-15

By Anne Harding

NEW YORK (Reuters Health) - U.S. health insurers frequently refuse to cover all-oral direct-acting antiviral (DAA) regimens for patients with hepatitis C, a new nationwide study shows.

Researchers also found a steady climb in rates of absolute denial over time, although they had hypothesized that denials would decline.

"Despite the availability of effective antiviral treatment for chronic hepatitis C, despite the attention that has been paid to access to these therapies, and despite the release of new direct-acting antiviral agents, which has spurred competition, denials of these drugs continue to remain high and have increased over time," Dr. Vincent Lo Re of the Perelman School of Medicine at the University of Pennsylvania, the study's senior author, told Reuters Health by phone. "We've now lost an opportunity as providers to engage people in health care."

An eight- to 12-week course of treatment with DAA regimens will eradicate HCV in 95% of patients, preventing further transmission of the virus, reducing hepatic and extra-hepatic complications, and extending survival, Dr. Lo Re and his team note in Open Forum Infectious Diseases, online June 7.

A course of treatment costs $30,000 to $90,000, and insurers have put a variety of criteria in place to limit access to the drugs, for example only covering DAAs for patients with advanced liver fibrosis and requiring a person to be abstinent from alcohol and drugs in order to be covered.

DAAs were released in 2014, and reports of insurers refusing coverage led to class-action lawsuits and pressure from patient advocacy groups. To determine if rates of DAA coverage had changed since then, the authors reviewed data from Diplomat Pharmacy, Inc., on 9,025 patients from 45 states who were prescribed DAA therapy between 2016 and 2017.

Overall, insurers absolutely denied 35.5% of DAA prescriptions. Denial rates were highest for commercially insured patients, at 52.4%, while Medicaid and Medicare refused to cover DAAs 34.5% and 14.7% of the time, respectively.

The incidence of absolute denial rose from 27.7% in the first quarter of the study period to 43.8% in the last quarter (P<0.001), and each insurer type showed an increase.

"The most important thing to note in all of this is that cost-effectiveness analyses have been done that show even at minimal liver fibrosis, these hepatitis C treatments are cost-effective," Dr. Lo Re said. "When you factor in the downstream costs of liver transplants, hospitalizations for liver complications like decompensating cirrhosis, liver cancer, all of the attendant procedures that need to be done when patients have liver failure . . . these costs far outweigh the upfront costs of treatment."

The World Health Organization has called for the elimination of hepatitis C as a public health problem by 2020. In 2017, the National Academies of Sciences, Engineering and Medicine stated that the U.S. could achieve this goal by treating 260,000 HCV patients annually. But currently, Dr. Lo Re noted, less than 10% of people in the U.S. with HCV have received treatment.

"These denials of treatment are going to impede our ability to eliminate hepatitis C as a public health problem," he said. While "creative plans" have been suggested for improving access to DAAs in the U.S., he added, "it takes will and it takes effort, and quite frankly the government currently has not sought to enhance health care but has actually sought to pull back on health care. It's a heavy lift to say that this government is going to do anything right now."


Open Forum Infect Dis 2018.

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