title: Disparities in Absolute Denial of Modern Hepatitis C Therapy by Type of Insurance.
abstract: 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.
  
  
  
  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 a lack of approval of a prescription fill by the insurer, according to type of insurance (US Medicaid, US Medicare, or commercial insurance). Multivariable Poisson regression was used to estimate adjusted relative risks of absolute denial associated with patient characteristics.
  
  
  
  Among 2321 patients prescribed a DAA regimen (503 covered by Medicaid, 795 covered by Medicare, and 1023 covered 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 relative risk, 4.14; 95% confidence interval, 3.38-5.08) and absence of cirrhosis (adjusted relative risk, 1.96; 95% confidence interval, 1.53-2.50) were associated with absolute denial.
  
  
  
  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.
authors.affiliation: Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Center for AIDS Research, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: vincentl@mail.med.upenn.edu.
authors.forename: Vincent
authors.initials: V
authors.lastname: Lo Re
authors.affiliation: Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Center for AIDS Research, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Charitha
authors.initials: C
authors.lastname: Gowda
authors.affiliation: Burman's Specialty Pharmacy, Diplomat Pharmacy, Inc, Brookhaven, Pennsylvania.
authors.forename: Paul N
authors.initials: PN
authors.lastname: Urick
authors.affiliation: Burman's Specialty Pharmacy, Diplomat Pharmacy, Inc, Brookhaven, Pennsylvania.
authors.forename: Joshua T
authors.initials: JT
authors.lastname: Halladay
authors.affiliation: Department of Pharmacy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Amanda
authors.initials: A
authors.lastname: Binkley
authors.affiliation: Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Dean M
authors.initials: DM
authors.lastname: Carbonari
authors.affiliation: Burman's Specialty Pharmacy, Diplomat Pharmacy, Inc, Brookhaven, Pennsylvania.
authors.forename: Kathryn
authors.initials: K
authors.lastname: Battista
authors.affiliation: Burman's Specialty Pharmacy, Diplomat Pharmacy, Inc, Brookhaven, Pennsylvania.
authors.forename: Cassandra
authors.initials: C
authors.lastname: Peleckis
authors.affiliation: Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Jody
authors.initials: J
authors.lastname: Gilmore
authors.affiliation: Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Jason A
authors.initials: JA
authors.lastname: Roy
authors.affiliation: Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Center for AIDS Research, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Jalpa A
authors.initials: JA
authors.lastname: Doshi
authors.affiliation: Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Peter P
authors.initials: PP
authors.lastname: Reese
authors.affiliation: Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: K Rajender
authors.initials: KR
authors.lastname: Reddy
authors.affiliation: Center for AIDS Research, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; John Bell Health Center, Philadelphia Field Initiating Group for HIV Trials, Philadelphia, Pennsylvania.
authors.forename: Jay R
authors.initials: JR
authors.lastname: Kostman
mesh_terms: D000368:Aged; D000998:Antiviral Agents / Q000191:economics / Q000627:therapeutic use*; D005260:Female; D006297:Health Services Accessibility; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D007348:Insurance, Health; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D014481:United States
chemical_list: D000998:Antiviral Agents
keywords: Direct-Acting Antiviral; Hepatitis C; Insurance