Disparities in Absolute Denial of Modern Hepatitis C Therapy by Type of Insurance

Abstract

Background & Aims The high costs of direct-acting antiviral (DAA) agents to treat chronic hepatitis C virus (HCV) infection have resulted in denials of treatment, but it is not clear whether patients’ access to these therapies differs with their type of insurance. Methods We conducted a prospective cohort study among all patients who had a DAA prescription submitted between November 1, 2014 and April 30, 2015 to Burman’s Specialty Pharmacy, which provides HCV pharmacy services to patients in Delaware, Maryland, New Jersey, and Pennsylvania. We determined the incidence of absolute denial of DAA prescription, defined as lack of approval of prescription fill by the insurer, according to type of insurance (US Medicaid, US Medicare, commercial insurance). Multivariable Poisson regression was used to estimate adjusted relative risks (RRs) of absolute denial associated with patient characteristics. Results Among 2321 patients prescribed a DAA regimen (503 covered by Medicaid; 795 by Medicare; 1023 by commercial insurance), 377 (16.2%) received an absolute denial. The most common reasons for absolute denial were insufficient information to assess medical need (134 [35.5%]) and lack of medical necessity (132 [35.0%]). A higher proportion of patients covered by Medicaid received an absolute denial (233 [46.3%]) than those covered by Medicare (40 [5.0%]; P<.001) or commercial insurance (104 [10.2%]; P<.001). Medicaid insurance (adjusted RR, 4.14; 95% confidence interval, 3.38–5.08) and absence of cirrhosis (adjusted RR, 1.96; 95% confidence interval, 1.53–2.50) were associated with absolute denial. Conclusions There are significant disparities in access to DAA-based treatments for HCV infection among patients with different types of insurance. Nearly half of Medicaid beneficiaries in Delaware, Maryland, New Jersey, and Pennsylvania were denied access to these drugs for chronic HCV infection.

Measuring Adherence to Hepatitis C Direct-Acting Antiviral Medications: Using the VAS in an HCV Treatment Clinic

“…43 It also adds to the stress and distress experienced by patients who are waiting to receive treatment. These restrictive policies, however, are contrary to the recommendations of professional medical societies.…”

Update in HIV–hepatitis C virus coinfection in the direct acting antiviral era

“…Analysis of a large French HIV cohort between 2000–12 indicated that 5,562 of 34,308 had HCV infection, but that HCV prevalence had decreased and treatment initiation increased with availability of DAAs, suggesting that HCV prevalence will continue to decline in coming years [89]. A prospective cohort from one specialty pharmacy serving patients in Delaware, Maryland, New Jersey, and Pennsylvania between November 2014 and April 2015 found significant disparities in DAA access based on insurance, with nearly half of Medicaid patients having declined applications [90]. Much effort will continue to be appropriately focused on the question of DAA access and affordability.…”

Pluripotent Stem Cell-Derived Hepatocyte-like Cells: A Tool to Study Infectious Disease

“…In contrast, several effective direct-acting antiviral drugs (DAAs) targeting HCV viral factors efficiently block HCV replication and result in a sustained virological response (viral cure) in over 90 percent of patients [52, 53]. However, due to the high cost of DAA treatment and the lack of a HCV vaccine, HCV eradication is going to be challenging and elusive particularly in the developing world [54, 55]. …”