title: Alvimopan, a peripherally acting μ-opioid receptor antagonist, is associated with reduced costs after radical cystectomy: economic analysis of a phase 4 randomized, controlled trial.
abstract: OBJECTIVE
  We evaluated the effect of alvimopan treatment vs placebo on health care utilization and costs related to gastrointestinal recovery in patients treated with radical cystectomy in a randomized, phase 4 clinical trial.
  
  
  METHODS
  Resource utilization data were prospectively collected and evaluated by cost consequence analysis. Hospital costs were estimated from 2012 Medicare reimbursement rates and medication wholesale acquisition costs. Differences in base case mean costs between the study cohorts for total postoperative ileus related costs (hospital days, study drug, nasogastric tubes, postoperative ileus related concomitant medication and postoperative ileus related readmissions) and total combined costs (postoperative ileus related, laboratory, electrocardiograms, nonpostoperative ileus related concomitant medication and nonpostoperative ileus related readmission) were evaluated by probabilistic sensitivity analysis using a bootstrap approach.
  
  
  RESULTS
  Mean hospital stay was 2.63 days shorter for alvimopan than placebo (mean±SD 8.44±3.05 vs 11.07±8.23 days, p=0.005). Use of medications or interventions likely intended to diagnose or manage postoperative ileus was lower for alvimopan than for placebo, eg total parenteral nutrition 10% vs 25% (p=0.001). Postoperative ileus related health care costs were $2,340 lower for alvimopan and mean total combined costs were decreased by $2,640 per patient for alvimopan vs placebo. Analysis using a 10,000-iteration bootstrap approach showed that the mean difference in postoperative ileus related costs (p=0.04) but not total combined costs (p=0.068) was significantly lower for alvimopan than for placebo.
  
  
  CONCLUSIONS
  In patients treated with radical cystectomy alvimopan decreased hospitalization cost by reducing the health care services associated with postoperative ileus and decreasing the hospital stay.
authors.affiliation: Cubist Pharmaceuticals, Lexington, Massachusetts.
authors.forename: Teresa L
authors.initials: TL
authors.lastname: Kauf
authors.affiliation: University of Texas Health Science Center at San Antonio, San Antonio, Texas.
authors.forename: Robert S
authors.initials: RS
authors.lastname: Svatek
authors.affiliation: Baylor University, Baylor College of Medicine, Houston, Texas.
authors.forename: Gilad
authors.initials: G
authors.lastname: Amiel
authors.affiliation: Bend Memorial Clinic, Bend, Oregon.
authors.forename: Timothy L
authors.initials: TL
authors.lastname: Beard
authors.affiliation: Vanderbilt University Medical Center, Nashville, Tennessee.
authors.forename: Sam S
authors.initials: SS
authors.lastname: Chang
authors.affiliation: Cleveland Clinic Foundation, Cleveland, Ohio.
authors.forename: Amr
authors.initials: A
authors.lastname: Fergany
authors.affiliation: Mayo Clinic, Rochester, Minnesota.
authors.forename: R Jeffrey
authors.initials: RJ
authors.lastname: Karnes
authors.affiliation: Indiana University Medical Center, Indianapolis, Indiana.
authors.forename: Michael
authors.initials: M
authors.lastname: Koch
authors.affiliation: Cleveland Clinic Foundation, Cleveland, Ohio.
authors.forename: Jerome
authors.initials: J
authors.lastname: O'Hara
authors.affiliation: University of Michigan, Ann Arbor, Michigan.
authors.forename: Cheryl T
authors.initials: CT
authors.lastname: Lee
authors.affiliation: H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.
authors.forename: Wade J
authors.initials: WJ
authors.lastname: Sexton
authors.affiliation: University of Oklahoma College of Medicine, Oklahoma City, Oklahoma.
authors.forename: Joel W
authors.initials: JW
authors.lastname: Slaton
authors.affiliation: University of Chicago Medical Center, Chicago, Illinois.
authors.forename: Gary D
authors.initials: GD
authors.lastname: Steinberg
authors.affiliation: University of Colorado Health Science Center, Aurora, Colorado.
authors.forename: Shandra S
authors.initials: SS
authors.lastname: Wilson
authors.affiliation: Cubist Pharmaceuticals, Lexington, Massachusetts.
authors.forename: Lee
authors.initials: L
authors.lastname: Techner
authors.affiliation: Optum, Eden Prairie, Minnesota.
authors.forename: Carolyn
authors.initials: C
authors.lastname: Martin
authors.affiliation: Cubist Pharmaceuticals, Lexington, Massachusetts.
authors.forename: Jessica
authors.initials: J
authors.lastname: Moreno
authors.affiliation: University of Texas M.D. Anderson Cancer Center, Houston, Texas. Electronic address: akamat@mdanderson.org.
authors.forename: Ashish M
authors.initials: AM
authors.lastname: Kamat
mesh_terms: D000284:Administration, Oral; D003365:Costs and Cost Analysis; D015653:Cystectomy / Q000191:economics* / Q000379:methods; D004311:Double-Blind Method; D005500:Follow-Up Studies; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000627:therapeutic use; D017721:Hospital Costs / Q000639:trends*; D006801:Humans; D045823:Ileus / Q000191:economics / Q000453:epidemiology / Q000517:prevention & control*; D015994:Incidence; D010342:Patient Acceptance of Health Care / Q000706:statistics & numerical data*; D010880:Piperidines / Q000008:administration & dosage / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000191:economics / Q000453:epidemiology / Q000517:prevention & control*; D011446:Prospective Studies; D017450:Receptors, Opioid, mu / Q000037:antagonists & inhibitors; D014481:United States / Q000453:epidemiology
chemical_list: D005765:Gastrointestinal Agents; D010880:Piperidines; D017450:Receptors, Opioid, mu; C419502:alvimopan
keywords: cost-benefit analysis; gastrointestinal tract; ileus; postoperative complications; urinary bladder