title: Economic evaluation of linaclotide for the treatment of adult patients with irritable bowel syndrome with constipation in the United States.
abstract: OBJECTIVE
  To use techniques of decision-analytic modeling to evaluate the effectiveness and costs of linaclotide vs lubiprostone in the treatment of adult patients with irritable bowel syndrome with constipation (IBS-C).
  
  
  METHODS
  Using model inputs derived from published literature, linaclotide Phase III trial data and a physician survey, a decision-tree model was constructed. Response to therapy was defined as (1) a ≥ 14-point increase from baseline in IBS-Quality-of-Life (IBS-QoL) questionnaire overall score at week 12 or (2) one of the top two responses (moderately/significantly relieved) on a 7-point IBS symptom relief question in ≥ 2 of 3 months. Patients who do not respond to therapy are assumed to fail therapy and accrue costs associated with a treatment failure. Model time horizon is aligned with clinical trial duration of 12 weeks. Model outputs include number of responders, quality-adjusted life-years (QALYs), and total costs (including direct and indirect). Both one-way and probabilistic sensitivity analyses were conducted.
  
  
  RESULTS
  Treatment for IBS-C with linaclotide produced more responders than lubiprostone for both response definitions (19.3% vs 13.0% and 61.8% vs 57.2% for IBS-QoL and symptom relief, respectively), lower per-patient costs ($803 vs $911 and $977 vs $1056), and higher QALYs (0.1921 vs 0.1917 and 0.1909 vs 0.1894) over the 12-week time horizon. Results were similar for most one-way sensitivity analyses. In probabilistic sensitivity analyses, the majority of simulations resulted in linaclotide having higher treatment response rates and lower per-patient costs.
  
  
  CONCLUSIONS
  There are no available head-to-head trials that compare linaclotide with lubiprostone; therefore, placebo-adjusted estimates of relative efficacy were derived for model inputs. The time horizon for this model is relatively short, as it was limited to the duration of available clinical trial data.
  
  
  CONCLUSIONS
  Linaclotide was found to be a less costly option vs lubiprostone for the treatment of adult patients with IBS-C.
authors.affiliation: Boston Health Economics, Inc. , Waltham, MA , USA.
authors.forename: Huan
authors.initials: H
authors.lastname: Huang
authors.forename: Douglas C A
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; D065101:Chloride Channel Agonists / Q000191:economics / Q000627:therapeutic use; D003248:Constipation / Q000188:drug therapy / Q000191:economics* / Q000209:etiology; D003362:Cost-Benefit Analysis; D003663:Decision Trees; D005260:Female; D005765:Gastrointestinal Agents / Q000191:economics / Q000627:therapeutic use; D005102:Health Expenditures / Q000706:statistics & numerical data; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000150:complications / Q000188:drug therapy / Q000191:economics*; D000068238:Lubiprostone / Q000191:economics* / Q000627:therapeutic use; D008297:Male; D018803:Models, Economic; D010455:Peptides / Q000191:economics* / Q000627:therapeutic use; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D065101:Chloride Channel Agonists; D005765:Gastrointestinal Agents; D010455:Peptides; D000068238:Lubiprostone; C523483:linaclotide
keywords: Cost-benefit analysis; Economics; Gastrointestinal disorders; Irritable bowel syndrome with constipation; QALY