Despite the availability of new, highly successful direct-acting antiviral (DAA) regimens, more than one third of chronic hepatitis C (HCV) patients are denied access to treatment by their insurance provider, according to a new study.
Some 35.5 percent of patients who were prescribed a DAA regimen for chronic HCV were denied the treatment by their insurer. Denials of treatment were more common among patients with commercial insurance (52.4 percent) compared with those with Medicaid (34.5 percent) or Medicare (14.7 percent).
What’s more, the proportion of HCV patients whose DAA prescriptions were denied by their insurance company increased over a period of 16 months. The incidence of absolute denial increased across the study period from 27.7 percent in the first quarter to 43.8 percent in the last quarter.
“Absolute denials of DAA regimens by insurers have remained high and increased over time, regardless of type of insurance. These data provide evidence of a continued lack of access to HCV therapy across insurance types. To achieve the goal of HCV elimination, access to antiviral treatment must be improved,” stated the authors, led by senior author Vincent Lo Re, III, MD, MSCE, associate professor of medicine at the University of Pennsylvania.
The researchers published their results on June 1, 2018 in Open Forum Infectious Diseases.
Lo Re and colleagues conducted a prospective cohort study among patients who had a DAA prescription submitted from January 2016 to April 2017 to Diplomat Pharmacy, Inc., which provides HCV pharmacy services across the country. The main outcome was absolute denial of DAA prescription, defined as lack of fill approval by the insurer. They calculated the incidence of absolute denial, overall and by insurance type, for the 16-month study period and each quarter.
The system received prescriptions for DAAs from 9,025 patients, median 57 years old, including 4,702 covered by Medicaid, 2,502 covered by commercial insurance, and 1,812 covered by Medicare. More than half of the patients were prescribed a combination of sofosbuvir-ledipasvir, with or without ribavirin.
A total of 45 states were examined where a DAA prescription was submitted. Eight states contributed the vast majority (90 percent) of prescriptions. Pennsylvania had the highest proportion (31.5 percent), followed by California (23.6 percent) and Michigan (14.3 percent). In terms of overall incidence of absolute DAA denial in these eight states, Maryland had the highest incidence (51.5 percent), followed by Delaware (49.1 percent), New Jersey (47.2 percent), and Pennsylvania (45.7 percent).
The reasons for this increase in coverage denials remain unclear. “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,” they state.
The study has important clinical implications. “Persons denied access to HCV therapy remain at risk for the development of hepatic fibrosis, cirrhosis, liver decompensation, and hepatocellular carcinoma. Denial of DAA treatment can also lead to ongoing HCV-associated inflammation, which might increase the risk of extrahepatic complications,” state the authors.
They also recommended that “public and private insurers should remove restrictions to DAAs that are not medically indicated and offer treatment to all chronic HCV-infected patients.”