title: Costs and Resource Utilization Associated With Anemia and Rash in Chronic Hepatitis C Patients Treated With Direct-Acting Antiviral Agents in the United States.
abstract: OBJECTIVE
  The addition of 2 direct-acting antiviral (DAA) agents, telaprevir and boceprevir, to peginterferon and ribavirin therapy significantly improves sustained virologic response rates in patients treated for chronic hepatitis C virus (CHC) but is associated with a higher risk of adverse events (AEs), including anemia and rash. Using a large administrative claims database, this study compared the health care resource utilization and costs among CHC patients who developed anemia and/or rash while receiving DAA-based therapies (telaprevir and boceprevir) versus those who did not develop anemia or rash. Adjusted costs were compared by using regression analysis.
  
  
  METHODS
  Adult patients with ≥1 CHC diagnosis and a prescription for boceprevir or telaprevir were selected from a US-based claims database. The date of the first DAA fill after May 13, 2011, was defined as the index date. Patients were required to have continuous eligibility and no claims for hepatitis B treatment during the 6 months before (baseline) and 12 months after (study period) the index date. Patients were categorized into 4 cohorts based on the development of anemia only, rash only, both anemia and rash (anemia/rash), or neither anemia nor rash (NAR) while receiving DAA-based therapies. Baseline characteristics and study period health care utilization and costs were compared by using univariate statistics between cohorts that developed anemia only, rash only, or anemia/rash and the cohort that did not develop anemia or rash. Adjusted costs were compared by using multivariable regressions.
  
  
  RESULTS
  A total of 2862 patients were identified and categorized into 4 cohorts: 1204 anemia only, 131 rash only, 188 anemia/rash, and 1339 NAR patients. During the study period, patients developing anemia and/or rash incurred significantly more outpatient, dermatologist, and total medical visits compared with the NAR cohort. The anemia-only and anemia/rash cohorts also had significantly more inpatient, emergency department, and hematologist visits, as well as significantly higher adjusted total medical costs ($18,285 and $21,435 vs $11,253), total drug costs ($76,723 and $79,689 vs $63,001), and non-CHC drug costs ($10,391 and $10,475 vs $2437). The rash-only cohort had comparable adjusted total medical and drug costs.
  
  
  CONCLUSIONS
  CHC patients who developed anemia while receiving DAA-based therapies incurred significantly higher resource utilization and costs compared with those who did not. The study highlights the need for new CHC treatment regimens that are associated with fewer and less severe AEs, particularly anemia.
authors.affiliation: Bristol-Myers Squibb, Princeton, New Jersey.
authors.forename: T Kim
authors.initials: TK
authors.lastname: Le
authors.affiliation: Analysis Group, Inc, New York, New York. Electronic address: Dendy.Macaulay@analysisgroup.com.
authors.forename: Dendy
authors.initials: D
authors.lastname: Macaulay
authors.affiliation: Bristol-Myers Squibb, Princeton, New Jersey.
authors.forename: Anupama
authors.initials: A
authors.lastname: Kalsekar
authors.affiliation: Bristol-Myers Squibb, Princeton, New Jersey.
authors.forename: Yong
authors.initials: Y
authors.lastname: Yuan
authors.affiliation: Analysis Group, Inc, New York, New York.
authors.forename: Rachael A
authors.initials: RA
authors.lastname: Sorg
authors.affiliation: Analysis Group, Inc, New York, New York.
authors.forename: Jin
authors.initials: J
authors.lastname: Wei
authors.affiliation: Analysis Group, Inc, Boston, Massachusetts.
authors.forename: Eric Q
authors.initials: EQ
authors.lastname: Wu
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced* / Q000191:economics; D000998:Antiviral Agents / Q000009:adverse effects* / Q000627:therapeutic use; D016208:Databases, Factual; D016527:Drug Costs / Q000706:statistics & numerical data; D003875:Drug Eruptions / Q000191:economics / Q000209:etiology*; D004359:Drug Therapy, Combination; D005260:Female; D017048:Health Care Costs / Q000706:statistics & numerical data*; D006295:Health Resources / Q000706:statistics & numerical data*; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000009:adverse effects / Q000627:therapeutic use; D011392:Proline / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D012254:Ribavirin / Q000627:therapeutic use; D014481:United States
chemical_list: D000998:Antiviral Agents; D009842:Oligopeptides; D012254:Ribavirin; C486464:telaprevir; C512204:N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; D011392:Proline
keywords: CHC; DAA; anemia; cost; rash; resource utilization