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CC BY-NC-ND 4.0 · Endosc Int Open 2022; 10(07): E923-E932
DOI: 10.1055/a-1783-9378
Original article

Transoral incisionless fundoplication is cost-effective for treatment of gastroesophageal reflux disease

Thomas R. McCarty
1   Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Boston, Massachusetts, United States
2   Harvard Medical School, Boston, Massachusetts, United States
,
Pichamol Jirapinyo
1   Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Boston, Massachusetts, United States
2   Harvard Medical School, Boston, Massachusetts, United States
,
Lyndon P. James
3   Center for Health Decision Science, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, United States
4   PhD Program in Health Policy, Harvard University, Cambridge, Massachusetts, United States
,
Sanchit Gupta
1   Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Boston, Massachusetts, United States
2   Harvard Medical School, Boston, Massachusetts, United States
,
Walter W. Chan
1   Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Boston, Massachusetts, United States
2   Harvard Medical School, Boston, Massachusetts, United States
,
Christopher C. Thompson
1   Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Boston, Massachusetts, United States
2   Harvard Medical School, Boston, Massachusetts, United States
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Abstract

Background and study aims Given the sizable number of patients with symptomatic gastroesophageal reflux disease (GERD) despite proton pump inhibitor (PPI) therapy, non-pharmacologic treatment has become increasingly utilized. The aim of this study was to analyze the cost-effectiveness of medical, endoscopic, and surgical treatment of GERD.

Patients and methods A deterministic Markov cohort model was constructed from the US healthcare payer’s perspective to evaluate the cost-effectiveness of three competing strategies: 1) omeprazole 20 mg twice daily; 2) transoral incisionless fundoplication (TIF 2.0); and 3) laparoscopic Nissen fundoplication [LNF]. Cost was reported in US dollars with health outcomes recorded in quality-adjusted life years (QALYs). Ten-year and lifetime time horizons were utilized with 3 % discount rate and half-cycle corrections applied. The main outcome was incremental cost-effectiveness ratio (ICER) with a willingness-to-pay threshold of $ 100,000 per QALY. Probabilistic sensitivity analyses were also performed.

Results In our base-case analysis, the average cost of TIF 2.0 was $ 13,978.63 versus $ 17,658.47 for LNF and $ 10,931.49 for PPI. Compared to the PPI strategy, TIF 2.0 was cost-effective with an incremental cost of $ 3,047 and incremental effectiveness of 0.29 QALYs, resulting in an ICER of $ 10,423.17 /QALY gained. LNF was strongly dominated by TIF 2.0. Over a lifetime horizon, TIF 2.0 remained the cost-effective strategy for patients with symptoms despite twice-daily 20-mg omeprazole. TIF 2.0 remained cost-effective after varying parameter inputs in deterministic and probabilistic sensitivity analyses and for scenario analyses in multiple age groups.

Conclusions Based upon this study, TIF 2.0 was cost-effective for patients with symptomatic GERD despite low-dose, twice-daily PPI.

Supplementary material



Publikationsverlauf

Eingereicht: 14. Juli 2021

Angenommen nach Revision: 19. Oktober 2021

Artikel online veröffentlicht:
15. Juli 2022

© 2022. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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  • References

  • 1 Zagari RM, Fuccio L, Wallander MA. et al. Gastro-oesophageal reflux symptoms, oesophagitis and Barrettʼs oesophagus in the general population: the Loiano-Monghidoro study. Gut 2008; 57: 1354-1359
    CrossrefPubMedSuche in Google Scholar
  • 2 Camilleri M, Dubois D, Coulie B. et al. Prevalence and socioeconomic impact of upper gastrointestinal disorders in the United States: results of the US Upper Gastrointestinal Study. Clin Gastroenterol Hepatol 2005; 3: 543-552
    CrossrefPubMedSuche in Google Scholar
  • 3 Flook N, Jones R, Vakil N. Approach to gastroesophageal reflux disease in primary care: Putting the Montreal definition into practice. Can Fam Physician 2008; 54: 701-705
    PubMedSuche in Google Scholar
  • 4 Pace F, Bazzoli F, Fiocca R. et al. The Italian validation of the Montreal Global definition and classification of gastroesophageal reflux disease. Eur J Gastroenterol Hepatol 2009; 21: 394-408
    CrossrefPubMedSuche in Google Scholar
  • 5 Vakil N, van Zanten SV, Kahrilas P. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol 2006; 101: 1900-1920 ; quiz 43
    CrossrefPubMedSuche in Google Scholar
  • 6 Gomez JE. Typical and atypical presentations of gastroesophageal reflux disease and its management. Bol Asoc Med P R 2004; 96: 264-269
    PubMedSuche in Google Scholar
  • 7 Richter JE. Typical and atypical presentations of gastroesophageal reflux disease. The role of esophageal testing in diagnosis and management. Gastroenterol Clin North Am 1996; 25: 75-102
    CrossrefPubMedSuche in Google Scholar
  • 8 Shaheen NJ, Hansen RA, Morgan DR. et al. The burden of gastrointestinal and liver diseases, 2006. Am J Gastroenterol 2006; 101: 2128-2138
    CrossrefPubMedSuche in Google Scholar
  • 9 Peery AF, Crockett SD, Murphy CC. et al. Burden and Cost of Gastrointestinal, Liver, and Pancreatic Diseases in the United States: Update 2018. Gastroenterology 2019; 156: 254-272 e11
    CrossrefPubMedSuche in Google Scholar
  • 10 Gawron AJ, Bell R, Abu Dayyeh BK. et al. Surgical and endoscopic management options for patients with GERD based on proton pump inhibitor symptom response: recommendations from an expert U. S. panel. Gastrointest Endosc 2020; 92: 78-87 e2
    CrossrefPubMedSuche in Google Scholar
  • 11 El-Serag H, Becher A, Jones R. Systematic review: persistent reflux symptoms on proton pump inhibitor therapy in primary care and community studies. Aliment Pharmacol Ther 2010; 32: 720-737
    CrossrefPubMedSuche in Google Scholar
  • 12 Crawley JA, Schmitt CM. How satisfied are chronic heartburn sufferers with their prescription medications? Results of the patient unmet needs study. . J Clin Outcomes Manag 2000; 7: 29
    PubMedSuche in Google Scholar
  • 13 The Gallup Organization I. The 2000 Gallup study of consumersʼ use of stomach relief products. Princeton, NJ: The Gallup Organization; 2000
    Suche in Google Scholar
  • 14 Fass R. Proton-pump inhibitor therapy in patients with gastro-oesophageal reflux disease: putative mechanisms of failure. Drugs 2007; 67: 1521-1530
    CrossrefPubMedSuche in Google Scholar
  • 15 Lu M, Malladi V, Agha A. et al. Failures in a proton pump inhibitor therapeutic substitution program: lessons learned. Dig Dis Sci 2007; 52: 2813-2820
    CrossrefPubMedSuche in Google Scholar
  • 16 Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol 2013; 108: 308-328 ; quiz 29
    CrossrefPubMedSuche in Google Scholar
  • 17 Galmiche JP, Hatlebakk J, Attwood S. et al. Laparoscopic antireflux surgery vs esomeprazole treatment for chronic GERD: the LOTUS randomized clinical trial. JAMA 2011; 305: 1969-1977
    CrossrefPubMedSuche in Google Scholar
  • 18 Grant AM, Cotton SC, Boachie C. et al. Minimal access surgery compared with medical management for gastro-oesophageal reflux disease: five year follow-up of a randomised controlled trial (REFLUX). BMJ 2013; 346: f1908
    CrossrefPubMedSuche in Google Scholar
  • 19 Garg SK, Gurusamy KS. Laparoscopic fundoplication surgery versus medical management for gastro-oesophageal reflux disease (GORD) in adults. Cochrane Database Syst Rev 2015;
    CrossrefPubMedSuche in Google Scholar
  • 20 Spechler SJ, Hunter JG, Jones KM. et al. Randomized Trial of medical versus surgical treatment for refractory heartburn. N Engl J Med 2019; 381: 1513-1523
    CrossrefPubMedSuche in Google Scholar
  • 21 Funk LM, Zhang JY, Drosdeck JM. et al. Long-term cost-effectiveness of medical, endoscopic and surgical management of gastroesophageal reflux disease. Surgery 2015; 157: 126-136
    CrossrefPubMedSuche in Google Scholar
  • 22 Arguedas MR, Heudebert GR, Klapow JC. et al. Re-examination of the cost-effectiveness of surgical versus medical therapy in patients with gastroesophageal reflux disease: the value of long-term data collection. Am J Gastroenterol 2004; 99: 1023-1028
    CrossrefPubMedSuche in Google Scholar
  • 23 Epstein D, Bojke L, Sculpher MJ. et al. Laparoscopic fundoplication compared with medical management for gastro-oesophageal reflux disease: cost effectiveness study. BMJ 2009; 339: b2576
    CrossrefPubMedSuche in Google Scholar
  • 24 Siebert U, Alagoz O, Bayoumi AM. et al. State-transition modeling: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force-3. Med Decis Making 2012; 32: 690-700
    CrossrefPubMedSuche in Google Scholar
  • 25 Weinstein MC, Siegel JE, Gold MR. et al. Recommendations of the Panel on Cost-effectiveness in Health and Medicine. JAMA 1996; 276: 1253-1258
    CrossrefPubMedSuche in Google Scholar
  • 26 Carias C, Chesson HW, Grosse SD. et al. Recommendations of the Second Panel on Cost Effectiveness in Health and Medicine: A Reference, Not a Rule Book. Am J Prev Med 2018; 54: 600-602
    CrossrefPubMedSuche in Google Scholar
  • 27 Sifrim D, Zerbib F. Diagnosis and management of patients with reflux symptoms refractory to proton pump inhibitors. Gut 2012; 61: 1340-1354
    CrossrefPubMedSuche in Google Scholar
  • 28 Bate CM, Booth SN, Crowe JP. et al. Does 40 mg omeprazole daily offer additional benefit over 20 mg daily in patients requiring more than 4 weeks of treatment for symptomatic reflux oesophagitis?. Aliment Pharmacol Ther 1993; 7: 501-507
    CrossrefPubMedSuche in Google Scholar
  • 29 Cho YK, Choi MG, Bak YT. et al. Efficacy of S-pantoprazole 20 mg compared with pantoprazole 40 mg in the treatment of reflux esophagitis: a randomized, double-blind comparative trial. Dig Dis Sci 2012; 57: 3189-3194
    CrossrefPubMedSuche in Google Scholar
  • 30 Cadiere GB, Buset M, Muls V. et al. Antireflux transoral incisionless fundoplication using EsophyX: 12-month results of a prospective multicenter study. World J Surg 2008; 32: 1676-1688
    CrossrefPubMedSuche in Google Scholar
  • 31 Cadiere GB, Rajan A, Rqibate M. et al. Endoluminal fundoplication (ELF) -- evolution of EsophyX, a new surgical device for transoral surgery. Minim Invasive Ther Allied Technol 2006; 15: 348-355
    CrossrefPubMedSuche in Google Scholar
  • 32 McCarty TR, Itidiare M, Njei B. et al. Efficacy of transoral incisionless fundoplication for refractory gastroesophageal reflux disease: a systematic review and meta-analysis. Endoscopy 2018; 50: 708-725
    Thieme ConnectPubMedSuche in Google Scholar
  • 33 Cost-Effectiveness Analysis (CEA) Registry. Center for the Evaluation of Value and Risk in Health. Tufts Medical Center. Available at: https://cevr.tuftsmedicalcenter.org/databases/cea-registry
    PubMed
  • 34 Arias E, Xu J. United States Life Tables, 2017. National Vital Statistics Reports. 68;7. Available at: https://www.cdc.gov/nchs/data/nvsr/nvsr68/nvsr68_07-508.pdf
    PubMed
  • 35 Hay JW, Smeeding J, Carroll NV. et al. Good research practices for measuring drug costs in cost effectiveness analyses: issues and recommendations: the ISPOR Drug Cost Task Force report -- Part I. Value Health 2010; 13: 3-7
    CrossrefPubMedSuche in Google Scholar
  • 36 Red Book - Healthcare Drug Pricing Resource. Micromedex 2.0. Truven Healthn Analytics, Inc. 2016. Available at: https://www.micromedexsolutions.com/
    PubMed
  • 37 CPI Consumer Price Index. Available at: https://www.bls.gov/cpi/data.htm
    PubMed
  • 38 Doubilet P, Begg CB, Weinstein MC. et al. Probabilistic sensitivity analysis using Monte Carlo simulation. A practical approach. Med Decis Making 1985; 5: 157-177
    CrossrefPubMedSuche in Google Scholar
  • 39 Claxton K, Sculpher M, McCabe C. et al. Probabilistic sensitivity analysis for NICE technology assessment: not an optional extra. Health Econ 2005; 14: 339-347
    CrossrefPubMedSuche in Google Scholar
  • 40 Locke 3rd GR , Talley NJ, Fett SL. et al. Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota. Gastroenterology 1997; 112: 1448-1456
    CrossrefPubMedSuche in Google Scholar
  • 41 El-Serag HB, Sweet S, Winchester CC. et al. Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut 2014; 63: 871-880
    CrossrefPubMedSuche in Google Scholar
  • 42 Ip S, Tatsioni A, Conant A. et al. Predictors of clinical outcomes following fundoplication for gastroesophageal reflux disease remain insufficiently defined: a systematic review. Am J Gastroenterol 2009; 104: 752-758 ; quiz 9
    PubMedSuche in Google Scholar
  • 43 Morgenthal CB, Lin E, Shane MD. et al. Who will fail laparoscopic Nissen fundoplication? Preoperative prediction of long-term outcomes. . Surg Endosc 2007; 21: 1978-1984
    CrossrefPubMedSuche in Google Scholar
  • 44 Chan WW, Haroian LR, Gyawali CP. Value of preoperative esophageal function studies before laparoscopic antireflux surgery. Surg Endosc 2011; 25: 2943-2949
    CrossrefPubMedSuche in Google Scholar
  • 45 Patel A, Sayuk GS, Kushnir VM. et al. GERD phenotypes from pH-impedance monitoring predict symptomatic outcomes on prospective evaluation. Neurogastroenterol Motil 2016; 28: 513-521
    CrossrefPubMedSuche in Google Scholar
  • 46 Bell RC, Mavrelis PG, Barnes WE. et al. A prospective multicenter registry of patients with chronic gastroesophageal reflux disease receiving transoral incisionless fundoplication. J Am Coll Surg 2012; 215: 794-809
    CrossrefPubMedSuche in Google Scholar
  • 47 Trad KS, Barnes WE, Simoni G. et al. Transoral incisionless fundoplication effective in eliminating GERD symptoms in partial responders to proton pump inhibitor therapy at 6 months: the TEMPO Randomized Clinical Trial. Surg Innov 2015; 22: 26-40
    CrossrefPubMedSuche in Google Scholar
  • 48 Richter JE, Kumar A, Lipka S. et al. Efficacy of laparoscopic Nissen fundoplication vs transoral incisionless fundoplication or proton pump inhibitors in patients with gastroesophageal reflux disease: a systematic review and network meta-analysis. Gastroenterology 2018; 154: 1298-1308 e7
    CrossrefPubMedSuche in Google Scholar
  • 49 Du X, Hu Z, Yan C. et al. A meta-analysis of long follow-up outcomes of laparoscopic Nissen (total) versus Toupet (270 degrees ) fundoplication for gastro-esophageal reflux disease based on randomized controlled trials in adults. BMC Gastroenterol 2016; 16: 88
    CrossrefPubMedSuche in Google Scholar