From the Journals

Insurer denials of DAA therapy for HCV on the rise



Insurance denials of direct-acting antiviral (DAA) prescriptions remain high and have increased over time, according to a prospective cohort study.

About one in three patients had lack of fill approval by insurers, contributing to a continued lack of access to hepatitis C virus (HCV) therapy across insurance types, despite availability of new, highly effective regimens and relaxation of restrictions on reimbursement, according to Charitha Gowda, MD, of Ohio State University, Columbus, and her coauthors.

“To achieve the goal of HCV elimination, access to antiviral treatment must be improved,” they wrote.

The study by Dr. Gowda and colleagues included 9,025 patients in 45 states who had a DAA prescription submitted to one large, independent pharmacy provider between January 2016 and April 2017. Of those patients, most (4,702) were covered by Medicaid, while 2,502 were covered commercially, and 1,821 were covered by Medicare.

Over the 16-month study period, 3,200 patients (35.5%) had an absolute denial of treatment, defined as lack of fill approval by the insurer.

Absolute denials were significantly more frequent in patients with commercial insurance (52.4%), as compared with Medicaid (34.5%) and Medicare (14.7%).

Absolute denials increased significantly over the 16-month study period, from 27.7% in the first quarter evaluated to 43.8% in the last, researchers noted, adding that each insurance type had a significant increase in absolute denials over time.

While DAAs are associated with very high cure rates, their high costs have led to restrictions to access by both private and public insurers. However, over the past few years, restrictions in DAA reimbursement have been relaxed in a variety of settings because of advocacy efforts, greater price competition, and class action lawsuits/threats of legal action, Dr. Gowda and colleagues noted.

“The reason for this higher than expected denial rate is unclear, but may be due to attempts to treat chronic HCV-infected patients who have less advanced liver fibrosis, have not met sobriety restrictions, or have not had consultation with a specialist,” Dr. Gowda and colleagues wrote in their report.

The study was supported by the Penn Center for AIDS Research and the National Institutes of Health. Dr. Gowda had no conflicts of interest to report. Two coauthors reported grant support and/or advisory board fees from Gilead.

SOURCE: Gowda C et al. Open Forum Infect Dis. 2018 Jun 7 doi: 10.1093/ofid/ofy076.

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