title: Access to New Medications for Hepatitis C for Medicaid Members: A Retrospective Cohort Study.
abstract: BACKGROUND
  Sofosbuvir (SOF)- or simeprevir (SIM)-containing regimens are highly effective for treating chronic hepatitis C virus (HCV) infection. These regimens, however, are expensive. Most payers have implemented prior authorization (PA) requirements to ensure that patients who can benefit most have priority for these medications. While many Medicaid programs limit access to those with advanced disease or to members who do not have active substance use disorder (SUD), the Massachusetts Medicaid (MassHealth) Primary Care Clinician (PCC) plan does not limit access based on disease severity or presence of SUD. Evaluating PA requests for SOF and/or SIM among MassHealth members will offer a useful example of early uptake among Medicaid members and will identify patient groups who might face barriers to treatment at the provider or patient level.
  
  
  OBJECTIVE
  To (a) evaluate the percentage of MassHealth PCC members with HCV who had a PA request, along with the percentage of requests approved, and (b) identify characteristics associated with PA requests for SOF or SIM among Massachusetts Medicaid (MassHealth) members with HCV.
  
  
  METHODS
  This retrospective cohort study used enrollment, medical claims, and PA request data from MassHealth PCC members from December 6, 2012, to July 31, 2014. The sample included members with 1 or more claims with an ICD-9-CM code for HCV during this time who were continuously enrolled from December 6, 2013, to July 31, 2014. Enrollment and medical claims data for the cohort with HCV were linked to a database containing information collected from PA requests. The overall percentage of members with HCV and a PA request for SOF and/or SIM between December 6, 2013, and July 31, 2014, and the percentage of requests approved were calculated. Chi-square statistics were used to compare demographic and clinical characteristics among members with HCV who did and did not have a request. Logistic regression was used to estimate the strength of associations between patient characteristics and a PA treatment request, adjusting for clinical and demographic variables.
  
  
  RESULTS
  Of 6,849 members identified with HCV, 346 (5.1%) had a PA request for SOF and/or SIM submitted to MassHealth. Compared with members with HCV who did not have a PA request for SOF or SIM, those with a PA request for these new treatments were more likely to be male (P = 0.01), older (P < 0.001), white race (P = 0.04), have standard MassHealth insurance (P = 0.01), and less likely to be homeless (P < 0.001). Members with a PA request were also more likely to have been treated for HCV in the past year and have advanced disease (hepatic decompensation, cirrhosis, or liver transplant) but less likely to have SUD (P < 0.001 for each). Ninety percent of requests for SOF or SIM were approved; few demographic or clinical characteristics were associated with approval. In adjusted analyses, predictors of PA request were aged 50-64 years (odds ratio (OR) = 2.0, 95% CI = 1.1-3.7 vs. aged < 30 years); hepatic decompensation (OR = 1.6, 95% CI = 1.2-2.3); cirrhosis (OR = 3.0, 95% CI = 2.2-4.1); liver transplant (OR = 3.0, 95% CI = 1.4-6.5); substance use (OR = 0.6, 95% CI = 0.5-0.8); recent HCV treatment (OR = 1.6, 95% CI = 1.0-2.6); comorbidity (OR = 0.95, 95% CI = 0.91-0.98) for 1-unit increase in Diagnostic Cost Group score; and care at a hospital outpatient department (OR = 2.0, 95% CI = 1.2-3.2 vs. group practice).
  
  
  CONCLUSIONS
  Antiviral treatment with SOF and/or SIM was requested for a relatively small proportion of MassHealth members with HCV, with nearly all approved. Prescriber prioritization or patient barriers to care, rather than the PA process, determined access to treatment in this Medicaid population. Support may be needed to ensure patients with SUD benefit from advances in HCV treatment.
  
  
  BACKGROUND
  No outside funding supported this research. Internal funding was provided by the Commonwealth of Massachusetts. Lavitas has received compensation from University of Tennessee Advanced Studies in Medicine for development of CPE activity. Graham has consulted for the National Viral Hepatitis Roundtable and the Department of Health and Human Services, has received payment from Medscape for CME development, and is employed by Trek Therapeutics. Jeffrey has received payment for guest lectures at Boston University and Harvard University. Study concept and design were primarily contributed by Clark and Clements, along with Graham, Lenz, and Jeffrey. Kunte collected the data, which were interpreted by Graham, Lenz, and Jeffrey, with assistance from Lavitas, Clark, and Clements. The manuscript was written primarily by Clements, along with O'Connell and assisted by Graham, and revised by all the authors.
authors.affiliation: 1 Center for Health Policy and Research, University of Massachusetts Medical School, Shrewsbury.
authors.forename: Karen M
authors.initials: KM
authors.lastname: Clements
authors.affiliation: 2 Department of Family Medicine and Community Health, University of Massachusetts Medical School, Shrewsbury.
authors.forename: Robin E
authors.initials: RE
authors.lastname: Clark
authors.affiliation: 3 Clinical Pharmacy Services, University of Massachusetts Medical School, Shrewsbury.
authors.forename: Pavel
authors.initials: P
authors.lastname: Lavitas
authors.affiliation: 1 Center for Health Policy and Research, University of Massachusetts Medical School, Shrewsbury.
authors.forename: Parag
authors.initials: P
authors.lastname: Kunte
authors.affiliation: 4 Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Camilla S
authors.initials: CS
authors.lastname: Graham
authors.affiliation: 1 Center for Health Policy and Research, University of Massachusetts Medical School, Shrewsbury.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: O'Connell
authors.affiliation: 5 Office of Clinical Affairs, University of Massachusetts Medical School, Shrewsbury.
authors.forename: Kimberly
authors.initials: K
authors.lastname: Lenz
authors.affiliation: 6 Office of Clinical Affairs, University of Massachusetts Medical School, Shrewsbury.
authors.forename: Paul
authors.initials: P
authors.lastname: Jeffrey
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D015331:Cohort Studies; D005260:Female; D006297:Health Services Accessibility / Q000706:statistics & numerical data; D006526:Hepatitis C / Q000188:drug therapy* / Q000453:epidemiology*; D006801:Humans; D007345:Insurance Claim Review / Q000706:statistics & numerical data; D008297:Male; D008484:Medicaid / Q000706:statistics & numerical data; D008875:Middle Aged; D012189:Retrospective Studies; D014481:United States / Q000453:epidemiology
chemical_list: D000998:Antiviral Agents