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DOI: 10.1055/a-2495-2813
Hemostatic powder TC-325 as first-line treatment option for malignant gastrointestinal bleeding: a cost–utility analysis in the United Kingdom
Abstract
Background
Randomized controlled trials have shown that hemostatic powder (TC-325) results in greater immediate hemostasis and lower 30-day rebleeding rates than standard endoscopic therapy (SET) for management of malignant upper gastrointestinal bleeding (MUGIB). We explored whether TC-325 would be a cost-effective first-line option for patients with MUGIB compared with SET in the United Kingdom.
Methods
A decision tree was developed for patients with MUGIB, assessing initial therapy with TC-325 or SET over a 30-day period. Patients with failed initial hemostasis or a rebleed within 30 days underwent further endoscopic treatment, escalation to either transcatheter arterial embolization or surgery, or radiotherapy. Overall 30-day mortality was applied. Costs, in GBP, were based on the United Kingdom National Health Services costs for 2023/2024. Results were reported as incremental differences in cost, quality-adjusted life years (QALY), and net monetary benefit. Deterministic and probabilistic sensitivity analyses and scenario analyses were performed.
Results
The cost of treating MUGIB patients with TC-325 was £245.88 lower than treatment with SET, with an incremental increase of 0.001 QALYs. TC-325 remained a cost-saving approach in sensitivity and scenario analyses. Probabilistic sensitivity analysis revealed that TC-325 was more effective and cost saving in 80.1% of simulations (range 67.5%–98.63%).
Conclusions
Initial treatment of MUGIB with TC-325 compared with SET was more effective (higher primary hemostasis and lower 30-day rebleeding) and cost saving owing to the requirement for fewer interventions, readmissions, and length of stay. Additional studies are needed to address model uncertainties in the follow-up management of these complex patients.
Publication History
Received: 29 August 2024
Accepted after revision: 28 November 2024
Accepted Manuscript online:
03 December 2024
Article published online:
15 January 2025
© 2025. 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 Chatten K, Purssell H, Banerjee AK. et al. Glasgow Blatchford Score and risk stratifications in acute upper gastrointestinal bleed: can we extend this to 2 for urgent outpatient management?. Clin Med (Lond) 2018; 18: 118-122
- 2 National Institute for Health and Care Excellence. Acute upper gastrointestinal bleeding in over 16s: management. Clinical Guideline CG141. London: National Institute for Health and Care Excellence; 2012
- 3 Campbell HE, Stokes EA, Bargo D. et al. Costs and quality of life associated with acute upper gastrointestinal bleeding in the UK: cohort analysis of patients in a cluster randomised trial. BMJ Open 2015; 5: e007230
- 4 Savides TJ, Jensen DM, Cohen J. et al. Severe upper gastrointestinal tumor bleeding: endoscopic findings, treatment, and outcome. Endoscopy 1996; 28: 244-248
- 5 Minhem MA, Nakshabandi A, Mirza R. et al. Gastrointestinal hemorrhage in the setting of gastrointestinal cancer: anatomical prevalence, predictors, and interventions. World J Gastrointest Endosc 2021; 13: 391-406
- 6 Karna R, Deliwala S, Ramgopal B. et al. Efficacy of topical hemostatic agents in malignancy-related GI bleeding: a systematic review and meta-analysis. Gastrointest Endosc 2023; 97: 202-208.e208
- 7 Loftus EV, Alexander GL, Ahlquist DA. et al. Endoscopic treatment of major bleeding from advanced gastroduodenal malignant lesions. Mayo Clin Proc 1994; 69: 736-740
- 8 Song IJ, Kim HJ, Lee JA. et al. Clinical outcomes of endoscopic hemostasis for bleeding in patients with unresectable advanced gastric cancer. J Gastric Cancer 2017; 17: 374-383
- 9 Sheibani S, Kim JJ, Chen B. et al. Natural history of acute upper GI bleeding due to tumours: short-term success and long-term recurrence with or without endoscopic therapy. Aliment Pharmacol Ther 2013; 38: 144-150
- 10 Koh KH, Kim K, Kwon DH. et al. The successful endoscopic hemostasis factors in bleeding from advanced gastric cancer. Gastric Cancer 2013; 16: 397-403
- 11 Pittayanon R, Khongka W, Linlawan S. et al. Hemostatic powder vs standard endoscopic treatment for gastrointestinal tumor bleeding: a multicenter randomized trial. Gastroenterology 2023; 165: 762-772.e762
- 12 Chen YI, Wyse J, Lu Y. et al. TC-325 hemostatic powder versus current standard of care in managing malignant GI bleeding: a pilot randomized clinical trial. Gastrointest Endosc 2020; 91: 321-328.e321
- 13 Barkun AN, Adam V, Lu Y. et al. Using hemospray improves the cost-effectiveness ratio in the management of upper gastrointestinal nonvariceal bleeding. J Clin Gastroenterol 2018; 52: 36-44
- 14 Shah ED, Law R. Valuing innovative endoscopic techniques: hemostatic powder for the treatment of GI tumor bleeding. Gastrointest Endosc 2024; 100: 49-54
- 15 Kim YI, Choi IJ, Cho SJ. et al. Outcome of endoscopic therapy for cancer bleeding in patients with unresectable gastric cancer. J Gastroenterol Hepatol 2013; 28: 1489-1495
- 16 Schatz RA, Rockey DC. Gastrointestinal bleeding due to gastrointestinal tract malignancy: natural history, management, and outcomes. Dig Dis Sci 2017; 62: 491-501
- 17 Paoluzi OA, Cardamone C, Aucello A. et al. Efficacy of hemostatic powders as monotherapy or rescue therapy in gastrointestinal bleeding related to neoplastic or non-neoplastic lesions. Scand J Gastroenterol 2021; 56: 1506-1513
- 18 Gralnek IM, Stanley AJ, Morris AJ. et al. Endoscopic diagnosis and management of nonvariceal upper gastrointestinal hemorrhage (NVUGIH): European Society of Gastrointestinal Endoscopy (ESGE) Guideline – update 2021. Endoscopy 2021; 53: 300-332
- 19 Higgins JPT, Thomas J, Chandler J. et al. Cochrane Handbook for Systematic Reviews of Interventions. 2nd edn. Chichester: John Wiley & Sons; 2019
- 20 Martins BC, Abnader Machado A, Scomparin RC. et al. TC-325 hemostatic powder in the management of upper gastrointestinal malignant bleeding: a randomized controlled trial. Endosc Int Open 2022; 10: E1350-E1357
- 21 Hussein M, Alzoubaidi D, O’Donnell M. et al. Hemostatic powder TC-325 treatment of malignancy-related upper gastrointestinal bleeds: international registry outcomes. J Gastroenterol Hepatol 2021; 36: 3027-3032
- 22 Papaefthymiou A, Aslam N, Hussein M. et al. Hemospray (hemostatic powder TC-325) as monotherapy for acute gastrointestinal bleeding: a multicenter prospective study. Ann Gastroenterol 2024; 37: 418-426
- 23 Drummond MF, Sculpher MJ, Claxton K. et al. Methods for the economic evaluation of health care programmes. 4th edn. Oxford: Oxford University Press; 2015
- 24 Beggs AD, Dilworth MP, Powell SL. et al. A systematic review of transarterial embolization versus emergency surgery in treatment of major nonvariceal upper gastrointestinal bleeding. Clin Exp Gastroenterol 2014; 7: 93-104
- 25 NHS England. Hospital admitted patient care activity. 2022 Accessed December 09, 2024 at: https://digital.nhs.uk/data-and-information/publications/statistical/hospital-admitted-patient-care-activity/2022–23
- 26 NHS England. National tariff. 2023 Accessed December 09, 2024 at: https://www.england.nhs.uk/pay-syst/national-tariff/
- 27 National Institute for Health and Care Excellence. NICE process and methods [PMG9]: Guide to the methods of technology appraisal 2013. London: National Institute for Health and Care Excellence; 2013
- 28 Balic M, Hilbe W, Gusel S. et al. Prevalence of comorbidity in cancer patients scheduled for systemic anticancer treatment in Austria. memo – Magazine of European Medical Oncology 2019; 12: 290-296
- 29 Leontiadis GI, Sreedharan A, Dorward S. et al. Systematic reviews of the clinical effectiveness and cost-effectiveness of proton pump inhibitors in acute upper gastrointestinal bleeding. Health Technol Assess 2007; 11: iii-iv
- 30 Kondoh C, Shitara K, Nomura M. et al. Efficacy of palliative radiotherapy for gastric bleeding in patients with unresectable advanced gastric cancer: a retrospective cohort study. BMC Palliat Care 2015; 14: 37
- 31 Reed SD. Statistical considerations in economic evaluations: a guide for cardiologists. Eur Heart J 2014; 35: 1652-1656
- 32 Jones K, Weatherly H, Birch S. et al. Unit costs of health and social care 2022 manual. Technical report. Personal Social Services Research Unit (University of Kent) and Centre for Health Economics (University of York). 2023
- 33 Roy A, Kim M, Hawes R. et al. The clinical and cost implications of failed endoscopic hemostasis in gastroduodenal ulcer bleeding. United European Gastroenterol J 2017; 5: 359-364