Vincent Lo Re
Despite the availability of highly effective direct-acting antiviral therapy for chronic hepatitis C virus infection, both public and private health insurers in the United States continue to deny coverage for the drugs at increasingly high rates, according to a study published today in Open Forum Infectious Diseases.
Vincent Lo Re, MD, associate professor of infectious disease and epidemiology at the University of Pennsylvania Perelman School of Medicine, and colleagues said their findings highlight the need to improve access to direct-acting antiviral (DAA) therapy for patients with chronic infection, who are at risk for HCV-related complications.
“From a clinical standpoint, patients who are denied access to hepatitis C treatment are going to remain at risk for the development of liver complications like cirrhosis, hepatic decompensation and liver cancer,” Lo Re said in a news release. “The denial of this treatment can also lead to ongoing hepatitis C-associated liver and systemic inflammation, which could increase the risk of other extrahepatic complications, like cardiovascular disease, bone and joint disease, and kidney disease.”
“Failure to treat and cure chronic hepatitis C infection also maintains a reservoir for transmission, which certainly can add to increasing incidence of the infection, especially given the growing opioid epidemic,” Lo Re added.
DAAs have been available for patients with chronic HCV infection since 2014. They are associated with a high clinical cure rate of at least 94%, according to the researchers. However, the drugs are costly, leading public and private insurers in the U.S. to restrict access to the medications.
“Insurers established varying criteria for reimbursement of DAAs, such as evidence of advanced liver fibrosis, consultation with a specialist, and/or abstinence from alcohol or illicit drug use,” the researchers wrote.
Nevertheless, the Infectious Diseases Society of America and American Association for the Study of Liver Diseases currently recommend that all patients with chronic HCV receive DAA therapy. A report published last year by the National Academies of Sciences, Engineering and Medicine concluded that DAA therapy must be given to at least 260,000 patients with chronic infection in the U.S. each year to achieve the goal of HCV elimination in the country by 2030.
Over the past 2 years, advocacy efforts, threats of legal action, lawsuits and an increasingly competitive drug marketplace have influenced insurers to relax restrictions on DAA reimbursement. Consequently, Lo Re and colleagues hypothesized that the incidence of insurance denials have decreased over time.
To investigate their theory, the researchers reviewed records from HCV pharmacy services in 45 U.S. states. The analysis included data on 9,025 patients who were prescribed a DAA from January 2016 to April 2017.
Over the 16-month study period, 3,200 patients — or 35.5% (95% CI, 34.5%-36.5%) — were denied treatment with DAAs. Commercial insurers were more likely to deny coverage than Medicaid or Medicare (P < .001). More than half of patients with commercial insurance were denied treatment vs. 34.5% of Medicaid beneficiaries and 14.7% of Medicare beneficiaries. The rate of insurance denials significantly increased over time from 27.7% to 43.8% (P < .001). This increase was observed among all three insurance types.
Eight of the 45 states accounted for 90% of all DAA prescriptions. These states included Pennsylvania (31.5%), California (23.6%), Michigan (14.3%), Massachusetts (6.2%), New Jersey (6.1%), Delaware (3.5%), Oregon (2.6%) and Maryland (1.9%). Insurance denial rates were highest in Maryland (51.5%), Delaware (49.1%), New Jersey (47.2%) and Pennsylvania (45.7%).
A lack of data prevented the researchers from being able to identify factors that were independently associated with insurance denial. Therefore, they reported, the reasons for high and increasing rates remain uncertain.
“The combination of cost and demand for DAA treatments has strained the budgets of many payers since these drugs became available,” they wrote. “As a result, insurers may be electing to prioritize certain patient populations, such as those who have advanced hepatic fibrosis/cirrhosis or who abstain from alcohol and injection drug use, when deciding whether to allocate DAA treatments. Future studies should evaluate the reasons for the increasing denials across insurance plans as well as denial rates in specific patient groups.” – by Stephanie Viguers
Lo Re reports no relevant financial disclosures. Please see the full study for all other authors’ relevant financial disclosures.