Patients with both private and public insurers face high denial rates across the United States for life-saving hepatitis C drugs, despite changes in restrictions and increased price competition.
More than half of patients with hepatitis C are denied coverage by private insurers for life-saving treatments, according to a new study published in Open Forum Infectious Diseases.1 The number of patients denied coverage from public insurance also remains high.
Researchers from the Perelman School of Medicine at the University of Pennsylvania conducted a prospective analysis using data from more than 9000 prescriptions submitted to a national specialty pharmacy between January 2016 and April 2017.
Although highly effective, direct-acting antiviral drugs (DAAs) that treat hepatitis C are pricey, costing between $40,000 and $100,000. Both public and private insurers have restricted access to these life-saving medications due to the cost. Often, access is only approved to patients with evidence of advanced liver fibrosis and/or abstinence from alcohol or illicit drug use. Patients with chronic hepatitis C who are denied therapy can experience continued progression and remain at risk for the development of liver complications, as well as adverse effects on organ systems outside of the liver.
However, changes in some of the restrictions along with greater drug price competition have raised hopes among experts that insurers would increase access to these medications. Despite this, analysis of the data indicates that insurers continue to deny coverage at high rates.
Among 9025 patients from 45 states, 4702 were covered by Medicaid, 1821 by Medicare, and 2502 by commercial insurance. Overall, 35.5% were denied treatment.
Private insurers had the highest denial rates, with 52.4% of patients denied coverage. Medicaid denied 34.5% of patients and Medicare denied 14.7%.
The researchers found a growing trend in denial rates, citing that incidence of denials across all insurance types increased during the study period from 27.7% in the first quarter to 43.8% in the final quarter.
A 2015 Penn Medicine study found that 46% of Medicaid patients were denied coverage.2 According to the 2015 study, the most common reasons for denial by Medicaid were “insufficient information to assess medical need” (48%), “lack of medical necessity” (31%), and positive alcohol/drug screen (4%).
Although the researchers are unsure of the exact reason for high denial rates, they speculated that it may be due to the varying restrictions on reimbursements that exist among the states.
“It warrants continued attention from a public health standpoint to have more transparency about the criteria for reimbursement of these drugs and fewer restrictions, particularly in private insurance and certainly to continue the push in public insurance, if we want to improve hepatitis C drug access across all states,” Vincent Lo Re III, MD, MSCE, an associate professor of Infectious Disease and Epidemiology, senior author, said in a press release.3
For hepatitis C to be eliminated in the United States, at least 260,000 patients with chronic hepatitis C must be treated yearly, according to a report from the National Academies of Science, Engineering, and Medicine. To achieve this goal, experts are urging public and private insurers to remove restrictions to access for hepatitis C treatments.
“Eliminating hepatitis C in the US is a feasible goal,” Dr Lo Re said in the press release, “but that’s going to be hard to achieve if payers are not reimbursing for treatment.”3
1. Gowda C, Lott S, Grigorian M, et al. Absolute insurer denial of direct-acting antiviral therapy for hepatitis C: a national specialty pharmacy cohort study. Open Forum Infectious Diseases. 2018. https://doi.org/10.1093/ofid/ofy076
2. Half of Hepatitis C Patients with Private Insurance Denied Life-Saving Drugs [news release]. Penn Medicine’s website. https://www.pennmedicine.org/news/news-releases/2018/june/half-of-hepatitis-c-patients-with-private-insurance-denied-life-saving-drugs. Accessed June 7, 2018.
3. Nearly Half of Hepatitis C Patients on Medicaid Denied Coverage for Life-Saving Drugs, Penn Researchers Report. Penn Medicine’s website. https://www.pennmedicine.org/news/news-releases/2015/november/nearly-half-of-hepatitis-c-pat. Accessed June 7, 2018.