Absolute Insurer Denial of Direct-Acting Antiviral Therapy for Hepatitis C: A National Specialty Pharmacy Cohort Study

Abstract

BackgroundDespite the availability of new direct-acting antiviral (DAA) regimens, changes in DAA reimbursement criteria, and a public health focus on hepatitis C virus (HCV) elimination, it remains unclear if public and private insurers have increased access to these therapies over time. We evaluated changes in the incidence of absolute denial of DAA therapy over time and by insurance type.MethodsWe 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 United States. The main outcome was absolute denial of DAA prescription, defined as lack of fill approval by the insurer. We calculated the incidence of absolute denial, overall and by insurance type (Medicaid, Medicare, commercial), for the 16-month study period and each quarter.ResultsAmong 9025 patients from 45 states prescribed a DAA regimen (4702 covered by Medicaid, 1821 Medicare, 2502 commercial insurance), 3200 (35.5%; 95% confidence interval, 34.5%–36.5%) were absolutely denied treatment. Absolute denial was more common among patients covered by commercial insurance (52.4%) than Medicaid (34.5%, P < .001) or Medicare (14.7%, P < .001). The incidence of absolute denial increased across each quarter of the study period, overall (27.7% in first quarter to 43.8% in last quarter; test for trend, P < .001) and for each insurance type (test for trend, P < .001 for each type).ConclusionsDespite the availability of new DAA regimens and changes in restrictions of these therapies, absolute denials of DAA regimens by insurers have remained high and increased over time, regardless of insurance type.

Limitations of non-invasive tests for assessment of liver fibrosis

“…Moreover, given the significant HCV-associated disease burden in many countries such as the United States, there is a continued need for NITs that can monitor fibrosis progression in patients that are still awaiting 62 or have been declined treatment. 63 Many patients with advanced disease that have been treated remain at risk of disease progression from co-morbid, metabolic, and behavioural factors following sustained virologic response (SVR). 64 Although compensated cirrhosis may regress to an earlier fibrosis stage following antiviral therapy, 65 stellate cell activation, portal inflammation, and sinusoidal capillarisation may persist for several years following SVR.…”

Ultra-short duration direct acting antiviral prophylaxis to prevent virus transmission from hepatitis C viremic donors to hepatitis C negative kidney transplant recipients

“…Finally, we considered cost‐effectiveness and real‐world feasibility in our approach. It had been our previous experience as well as from published reports that insurance coverage for DAA drugs might frequently be denied due to a presumed lack of “medical necessity.” Thus, a prophylactic strategy that mitigates the need for a full course of DAA therapy might make this transplant option more appealing to patients and providers and increase availability to a larger number of patients including in many parts of the world where there are significant cost barriers to DAA drug access.…”

Validation of a modified Berger HIV stigma scale for use among patients with hepatitis C virus (HCV) infection

“…HCV-associated mortality now exceeds death from 60 other combined notifiable infectious diseases, including human immunodeficiency virus (HIV) infection [2]. Despite national action plans to eliminate HCV infection as a major public health threat by 2030 [5][6][7], fewer than half of HCV-infected persons in the US have been diagnosed or are aware of their infection [8], and treatment uptake remains <15% [9][10][11][12][13], undermining public health efforts.…”