Financial, insurance issues hinder HCV treatment study says

Financial and insurance issues remain the most important reasons why patients infected with hepatitis C virus (HCV) do not start taking direct-acting antiviral agents (DAA), according to a new study.

“Treatment of HCV has been revolutionized as a result of the high efficacy and excellent tolerability of DAAs. The next challenge is to identify infected patients and remove the potential barriers to treatment providing these highly curative regimens,” Zobair M. Younossi of the Center for Liver Diseases, Department of Medicine at Inova Fairfax Hospital in Falls Church, Virginia, told Medical Economics.

Despite the real-world success of oral HCV therapy, with response rates approaching those seen in clinical trials, many payers have limited patient access to therapy, said Younossi.

He led a study that evaluated data for 3,841 HCV patients who were prescribed a sofosbuvir-containing regimen between December 2013 and September 2014. Some 315 (8%) patients did not start the sofosbuvir-containing therapy, which was the approved regimen for HCV at that time. Insurance-related processes and financial reasons accounted for 254 (81%) of the 315 non-starts, he said.

The researchers published their results in the June 2016 Journal of Viral Hepatitis.

More than one-third of those who did not start were Medicaid recipients. Just under half (45%) of the non-start patients had a commercial plan as their primary insurance, and about the same amount (44%) were primarily covered by Medicaid; less than 10% were primarily covered by Medicare or were without coverage or had unspecified coverage. In a matched comparison, patients with commercial coverage were 6.5 times as likely to start sofosbuvir-based therapy compared to patients with Medicaid.

“Almost half of the non-starters had an advanced fibrosis score, which puts them at risk for liver transplantation, liver cancer or death. They should have been prioritized to start treatment,” said Younossi.

In a subsequent study recently presented at Digestive Disease Week in San Diego, Younossi and colleagues assessed treatment of 2,011 patients from May 2014 to March 2015 who received various combinations of DAAs. About 22% of these patients, the majority of them younger males with an advanced fibrosis score of 4 or higher, were non-starters.

“We can see the landscape has changed in some aspects. In the newer study, some Medicaid programs were less restrictive, and with Medicare it was easy to get access to treatment,” said Younossi.

Yet, one barrier that still remains is identifying patients and linking them to care. “We have not identified a large number of HCV infected patients in the U.S. because of lack of screening as recommended by the [Centers for Disease Control and Prevention]” he said. “The challenge is to identify HCV patients, link them to care and get them access to drugs.”

To overcome barriers, the most important issue for primary care physicians is “to implement the recommendations to screen patients for HCV. Primary care physicians can screen and treat HCV patients if they know the drug regimens and side effect issues,” Younossi said. Or they can refer patients to a gastroenterologist or HCV expert.

 “DAA treatment cures 98% of patients, is well-tolerated and is cost-effective from a societal perspective to prevent the future burden of the ravages of advanced liver disease,” said Younossi.