title: Cost-effectiveness of Telaprevir combination therapy for chronic hepatitis C.
abstract: OBJECTIVE
  To explore the expected long-term health and economic outcomes of telaprevir (TVR) plus peginterferon alfa-2a and ribavirin (PR), a regimen that demonstrated substantially increased sustained virologic response (SVR) compared with PR alone in adults with chronic genotype 1 hepatitis C virus (HCV) and compensated liver disease in the Phase III studies ADVANCE (treatment-naïve patients) and REALIZE (relapsers, partial responders, and null responders to previous PR treatment).
  
  
  METHODS
  A decision-analytic model was developed to assess the cost-effectiveness of TVR+PR vs. PR in the United States (US).
  
  
  METHODS
  Patients first moved through the 72-week decision-tree treatment phase of the model and then entered the cyclic Markov post-treatment phase. Clinical data (patient characteristics, SVR rates, and adverse event rates and durations) were obtained from ADVANCE and REALIZE. Health-state transition probabilities, drug and other costs (in 2012/2013 US dollars), and utility values were obtained from the trials, published studies, and publicly available sources. Outcomes were discounted at 3% per year.
  
  
  RESULTS
  Regardless of treatment history, patients receiving TVR+PR were projected to experience fewer liver-disease complications, more life-years, and more quality-adjusted life-years (QALYs) than patients receiving PR. In prior relapsers, TVR+PR was dominant, with lower total medical costs and more QALYs. For the other patient subgroups, incremental costs per QALY gained were between $16,778 (treatment-naïve patients) and $34,279 (prior null responders). Extensive sensitivity analyses confirmed robust model results.
  
  
  CONCLUSIONS
  At standard willingness-to-pay thresholds, TVR+PR represents a cost-effective treatment option compared with PR alone for patients with chronic genotype 1 HCV and compensated liver disease in the US. Future analyses are needed to compare TVR+PR with all existing HCV treatment options.
authors.affiliation: RTI Health Solutions, Research Triangle Park, North Carolina, United States of America.
authors.forename: Anita J
authors.initials: AJ
authors.lastname: Brogan
authors.affiliation: RTI Health Solutions, Research Triangle Park, North Carolina, United States of America.
authors.forename: Sandra E
authors.initials: SE
authors.lastname: Talbird
authors.affiliation: RTI Health Solutions, Research Triangle Park, North Carolina, United States of America.
authors.forename: James R
authors.initials: JR
authors.lastname: Thompson
authors.affiliation: RTI Health Solutions, Waltham, Massachusetts, United States of America.
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: Miller
authors.affiliation: Vertex Pharmaceuticals Incorporated, Cambridge, Massachusetts, United States of America.
authors.forename: Jaime
authors.initials: J
authors.lastname: Rubin
authors.affiliation: Vertex Pharmaceuticals Incorporated, Cambridge, Massachusetts, United States of America.
authors.forename: Baris
authors.initials: B
authors.lastname: Deniz
mesh_terms: D000740:Anemia / Q000139:chemically induced; D017326:Clinical Trials, Phase III as Topic; D003362:Cost-Benefit Analysis; D004359:Drug Therapy, Combination / Q000191:economics; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D005500:Follow-Up Studies; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D018803:Models, Economic; D015337:Multicenter Studies as Topic; D009842:Oligopeptides / Q000009:adverse effects / Q000627:therapeutic use*; D017063:Outcome Assessment, Health Care / Q000191:economics; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D019057:Quality-Adjusted Life Years; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D016898:Interferon-alpha; D009842:Oligopeptides; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C486464:telaprevir; C100416:peginterferon alfa-2a