Teresa L Kauf1, Robert S Svatek2, Gilad Amiel3, Timothy L Beard4, Sam S Chang5, Amr Fergany6, R Jeffrey Karnes7, Michael Koch8, Jerome O'Hara6, Cheryl T Lee9, Wade J Sexton10, Joel W Slaton11, Gary D Steinberg12, Shandra S Wilson13, Lee Techner1, Carolyn Martin14, Jessica Moreno1, Ashish M Kamat15. 1. Cubist Pharmaceuticals, Lexington, Massachusetts. 2. University of Texas Health Science Center at San Antonio, San Antonio, Texas. 3. Baylor University, Baylor College of Medicine, Houston, Texas. 4. Bend Memorial Clinic, Bend, Oregon. 5. Vanderbilt University Medical Center, Nashville, Tennessee. 6. Cleveland Clinic Foundation, Cleveland, Ohio. 7. Mayo Clinic, Rochester, Minnesota. 8. Indiana University Medical Center, Indianapolis, Indiana. 9. University of Michigan, Ann Arbor, Michigan. 10. H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida. 11. University of Oklahoma College of Medicine, Oklahoma City, Oklahoma. 12. University of Chicago Medical Center, Chicago, Illinois. 13. University of Colorado Health Science Center, Aurora, Colorado. 14. Optum, Eden Prairie, Minnesota. 15. University of Texas M.D. Anderson Cancer Center, Houston, Texas. Electronic address: akamat@mdanderson.org.
Abstract
PURPOSE: We evaluated the effect of alvimopan treatment vs placebo on health care utilization and costs related to gastrointestinal recovery in patients treated withradical cystectomy in a randomized, phase 4 clinical trial. MATERIALS AND 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 withradical cystectomy alvimopan decreased hospitalization cost by reducing the health care services associated with postoperative ileus and decreasing the hospital stay.
RCT Entities:
PURPOSE: 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. MATERIALS AND 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.
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