title: Economic Evaluation of Linaclotide for the Treatment of Adult Patients With Chronic Idiopathic Constipation in the United States.
abstract: OBJECTIVE
  To evaluate the effectiveness and costs of linaclotide (Linzess) versus lubiprostone (Amitiza) in the treatment of adult patients with chronic idiopathic constipation (CIC).
  
  
  METHODS
  A decision-tree model using model inputs derived from published literature, linaclotide phase 3 trial data, and a physician survey.
  
  
  METHODS
  Measures of treatment efficacy were selected based on comparability between trial data, with posthoc analyses of linaclotide required to ensure comparability with available lubiprostone data. Response to therapy was defined as (1) having one of the best two satisfaction answers of a 5-point global treatment satisfaction scale at Week 4 or (2) having a weekly spontaneous bowel movement (SBM) frequency 4 at Week 4. Patients who do not respond to therapy are assumed to accrue costs associated with a treatment failure. Model time horizon is aligned with the lubiprostone clinical trial duration of 4 weeks. Model outputs include response rates, quality-adjusted life-years (QALYs) and direct costs.
  
  
  RESULTS
  Linaclotide was associated with lower per-patient costs vs lubiprostone for both definitions of response ($946 vs $1,015 for global assessment and $727 vs $737 for SBM frequency). When treatment response was based on a global assessment of treatment satisfaction, linaclotide was associated with higher effectiveness (response: 39.3% vs 35.0%). For SBM frequency, linaclotide was slightly less effective compared to lubiprostone (response: 58.6% vs 59.6%), but also less costly. Base-case results were robust in sensitivity analysis.
  
  
  CONCLUSIONS
  Linaclotide is less expensive with similar effectiveness when compared to lubiprostone for the treatment of CIC in adult patients.
authors.forename: Huan
authors.initials: H
authors.lastname: Huang
authors.forename: Douglas C Aa
authors.initials: DC
authors.lastname: Taylor
authors.forename: Robyn T
authors.initials: RT
authors.lastname: Carson
authors.forename: Phil
authors.initials: P
authors.lastname: Sarocco
authors.forename: Mark
authors.initials: M
authors.lastname: Friedman
authors.forename: Michael
authors.initials: M
authors.lastname: Munsell
authors.forename: Steven I
authors.initials: SI
authors.lastname: Blum
authors.forename: Joseph
authors.initials: J
authors.lastname: Menzin
mesh_terms: D000328:Adult; D002908:Chronic Disease / Q000188:drug therapy*; D003248:Constipation / Q000188:drug therapy*; D003362:Cost-Benefit Analysis; D003663:Decision Trees; D019538:Health Care Surveys; D006801:Humans; D010455:Peptides / Q000191:economics* / Q000627:therapeutic use*; D014481:United States
chemical_list: D010455:Peptides; C523483:linaclotide