Study Finds Large Percentage of Hepatitis C Patients Initially Denied Treatment

Researchers report that nearly one in four patients with hepatitis C are denied initial approval for treatment.

A study out of Yale University found that nearly a quarter of patients were initially denied treatment for chronic hepatitis C though most eventually received insurance approval through an appeals process.

The study was conducted by researchers at Yale School of Medicine, according to a university press release. The findings, which identify a new barrier to caring for patients with hepatitis C, were expected to be published Aug. 27 in Plos One, the release states.

The study shines a light on the tug of war between effective but costly drugs and the need to treat a large population of patients with hepatitis C. Health officials estimate that about 3 million people in the United States and 150 million worldwide are infected with the virus, which can go undetected for years while seriously damaging the liver.

"The first key finding is that upon initial request for treatment, approximately one in four patients are denied," said Albert Do, MD, internal medicine resident and a coauthor of the study. "That proportion is surprising."

The high costs of new antiviral regimens for treatment of hepatitis C virus (HCV) have led insurers to limit approvals for treatment. The study authors hypothesized that while most patients would gain access to antiviral therapy, some approvals would either be delayed or denied altogether, the release states.

Researchers led by Joseph K. Lim, MD, Yale associate professor of medicine and director of the Yale Viral Hepatitis Program, looked at records for 129 patients who were prescribed a combination of two drugs, sofosbuvir an ledipasvir, between October and December 2014. In addition to finding that nearly one fourth of patients were initially denied treatment, they also found that subsets of patients were more likely to receive initial approval, the release states.

The subsets included people with advanced liver disease such as cirrhosis and those who had either Medicare or Medicaid insurance. "It is significant that factors beyond disease state and medical necessity now affect one's likelihood of accessing HCV treatment," said Yash Mittal, MD, coauthor of the study.

Most patients in the study who were initially denied treatment for hepatitis C eventually received approval through the insurance appeals process, the release states. However, Lim noted that time can be critical for patients on the verge of developing cirrhosis or liver failure.

Lim said this study adds to a growing body of literature on hepatitis C, in which attrition happens at every step from diagnosis, confirmation, linkage to care and treatment. He hopes the study encourages more research and discussion about this barrier to hepatitis C care, the release states.

"Delay in access may further challenge our ability to cure hepatitis C in this country," Lim said. "Some patients are told they must wait until they have advanced liver disease before they can undergo potentially curative treatment. We hope these data may help inform national policy discussions on promoting more rational, patient-centered approaches to HCV treatment access."