Cost-effectiveness of a novel, non-active implantable device as a treatment for refractory gastro-esophageal reflux disease

References

• Boulton KHA, Dettmar PW. A narrative review of the prevalence of gastroesophageal reflux disease (GERD). Ann Esophagus. 2022;5:7–7.
   Google Scholar
• Dirac MA, Safiri S, Tsoi D, et al. The global, regional, and national burden of gastro-oesophageal reflux disease in 195 countries and territories, 1990–2017: a systematic analysis for the global burden of disease study 2017. Lancet Gastroenterol Hepatol. 2020;5(6):561–581.
   PubMed Web of Science ®Google Scholar
• Shaheen N, Ransohoff DF. Gastroesophageal reflux, barrett esophagus, and esophageal cancer. JAMA. 2002;287(15):1972–1981.
   PubMedGoogle Scholar
• Eusebi LH, Cirota GG, Zagari RM, et al. Global prevalence of barrett’s oesophagus and oesophageal cancer in individuals with gastro-oesophageal reflux: a systematic review and meta-analysis. Gut. 2021;70(3):456–463.
   PubMed Web of Science ®Google Scholar
• National Institute for Health and Care Excellence. Clinical guideline [CG184]: gastro-oesophageal reflux disease and dyspepsia in adults: investigation and management. 2019. https://www.nice.org.uk/guidance/cg184
   Google Scholar
• Delshad SD, Almario CV, Chey WD, et al. Prevalence of gastroesophageal reflux disease and proton pump Inhibitor-Refractory symptoms. Gastroenterology. 2020;158(5):1250–1261.e2.
   PubMed Web of Science ®Google Scholar
• Thompson SK, Watson DI. We asked the experts: “when is a laparoscopic fundoplication warranted for gastroesophageal reflux disease?” World J Surg. 2022;46(7):1711–1712.
   PubMed Web of Science ®Google Scholar
• Bonavina L, Horbach T, Schoppmann SF, et al. Three-year clinical experience with magnetic sphincter augmentation and laparoscopic fundoplication. Surg Endosc. 2021;35(7):3449–3458.
   PubMed Web of Science ®Google Scholar
• Skubleny D, Switzer NJ, Dang J, et al. LINX® magnetic esophageal sphincter augmentation versus nissen fundoplication for gastroesophageal reflux disease: a systematic review and meta-analysis. Surg Endosc. 2017;31(8):3078–3084.
   PubMed Web of Science ®Google Scholar
• National Institute for Health and Care Excellence. Interventional procedures guidance [IPG749]: laparoscopic insertion of a magnetic ring for gastrooesophageal reflux disease. 2023. https://www.nice.org.uk/guidance/ipg749
   Google Scholar
• Bjelović M, Harsányi L, Altorjay Á, et al. Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results: refluxStop™ device; a new method in acid reflux surgery obtaining CE mark. BMC Surg. 2020;20(1):159.
   PubMed Web of Science ®Google Scholar
• Implantica. Implantica receives CE Mark Approval for RefluxStop™, a potential Paradigm shift in the Treatment for Acid reflux. 2018. https://www.implantica.com/media/press-releases/2018/implantica-receives-ce-mark-approval-for-refluxstop-a-potential-paradigm-shift-in-the-treatment-for-acid-reflux/
   Google Scholar
• National Institute for Health and Care Excellence. Process and methods [PMG36]: NICE health technology evaluations: the manual. 2022. https://www.nice.org.uk/process/pmg36/chapter/introduction-to-health-technology-evaluation
   Google Scholar
• Epstein D, Bojke L, Sculpher MJ, REFLUX trial group. Laparoscopic fundoplication compared with medical management for gastro-oesophageal reflux disease: cost effectiveness study. BMJ. 2009;339:b2576.
   PubMedGoogle Scholar
• Bojke L, Hornby E, Sculpher M, REFLUX Trial Team A comparison of the cost effectiveness of pharmacotherapy or surgery (laparoscopic fundoplication) in the treatment of GORD. Pharmacoeconomics. 2007;25(10):829–841.
   PubMed Web of Science ®Google Scholar
• National Institute for Health and Care Excellence (NICE). Dyspepsia and gastro-oesophageal reflux disease. Appendix H: full Health Economics Report. 2014. https://www.nice.org.uk/guidance/cg184/evidence/appendix-h-full-health-economics-report-pdf-6955335252
   Google Scholar
• Wahlqvist P, Junghard O, Higgins A, et al. Cost effectiveness of proton pump inhibitors in gastro-oesophageal reflux disease without oesophagitis: comparison of on-demand esomeprazole with conventional omeprazole strategies. Pharmacoeconomics. 2002;20(4):267–277.
   PubMed Web of Science ®Google Scholar
• Grant A, Wileman S, Ramsay C, et al. The effectiveness and cost-effectiveness of minimal access surgery amongst people with gastro-oesophageal reflux disease - a UK collaborative study. The REFLUX trial. Health Technol Assess. 2008;12(31):1–181.
   PubMed Web of Science ®Google Scholar
• Spechler SJ, Hunter JG, Jones KM, et al. Randomized trial of medical versus surgical treatment for refractory heartburn. N Engl J Med. 2019;381(16):1513–1523.
   PubMed Web of Science ®Google Scholar
• Implantica. RefluxStop CE mark trial - 3 year data. Data on File. 2022.
   Google Scholar
• Karolinska Institute. Literature review and analysis: laparoscopic Nissen Fundoplication. [unpublished]. (Version KILNF001). 2017.
   Google Scholar
• Trifan A, Stanciu C, Girleanu I, et al. Proton pump inhibitors therapy and risk of Clostridium difficile infection: systematic review and meta-analysis. World J Gastroenterol. 2017;23(35):6500–6515.
   PubMed Web of Science ®Google Scholar
• Nassar Y, Richter S. Proton-pump inhibitor use and fracture risk: an updated systematic review and meta-analysis. J Bone Metab. 2018;25(3):141–151.
   PubMedGoogle Scholar
• Nguyen PA, Islam M, Galvin CJ, et al. Meta-analysis of proton pump inhibitors induced risk of community-acquired pneumonia. Int J Qual Health Care. 2020;32(5):292–299.
   PubMed Web of Science ®Google Scholar
• Poly TN, Lin MC, Syed-Abdul S, et al. Proton pump inhibitor use and risk of gastric cancer: current evidence from epidemiological studies and critical appraisal. Cancers. 2022;14(13):3052.
   PubMed Web of Science ®Google Scholar
• Nochaiwong S, Ruengorn C, Awiphan R, et al. The association between proton pump inhibitor use and the risk of adverse kidney outcomes: a systematic review and meta-analysis. Nephrol Dial Transplant. 2018;33(2):331–342.
   PubMed Web of Science ®Google Scholar
• Batchelor R, Kumar R, Gilmartin-Thomas JFM, et al. Systematic review with meta-analysis: risk of adverse cardiovascular events with proton pump inhibitors independent of clopidogrel. Aliment Pharmacol Ther. 2018;48(8):780–796.
   PubMed Web of Science ®Google Scholar
• Yousef F, Cardwell C, Cantwell MM, et al. The incidence of esophageal cancer and high-grade dysplasia in barrett’s esophagus: a systematic review and meta-analysis. Am J Epidemiol. 2008;168(3):237–249.
   PubMed Web of Science ®Google Scholar
• Office for National Statistics (ONS). Cancer survival by NHS England Area Team- Adults diagnosed: 1997-2012, followed up to 2013. 2014. https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/conditionsanddiseases/bulletins/cancersurvivalbynhsenglandareateamadultsdiagnosed/2014-12-16#oesophageal-cancer
   Google Scholar
• Shiraev TP, Bullen A. Proton pump inhibitors and cardiovascular events: a systematic review. Heart Lung Circ. 2018;27(4):443–450.
   PubMed Web of Science ®Google Scholar
• NHS England. 2019/20 National Cost Collection Data Publication. 2022. https://www.england.nhs.uk/publication/2019-20-national-cost-collection-data-publication/
   Google Scholar
• Jones K, Burns A. Unit costs of health and social care 2021. Kent: personal Social Services Research Unit (PSSRU); 2021.
   Google Scholar
• Pollit V, Graham D, Leonard C, et al. A cost-effectiveness analysis of endoscopic eradication therapy for management of dysplasia arising in patients with barrett’s oesophagus in the United Kingdom. Curr Med Res Opin. 2019;35(5):805–815.
   PubMed Web of Science ®Google Scholar
• The Royal College of Surgeons of England. From innovation to adoption. Successfully spreading surgical innovation. 2014. https://www.rcseng.ac.uk/-/media/files/rcs/library-and-publications/non-journal-publications/rcs_innovation_to_adoption_2014_web-(1).pdf
   Google Scholar
• McCulloch P, Taylor I, Sasako M, et al. Randomised trials in surgery: problems and possible solutions. BMJ. 2002;324(7351):1448–1451.
   PubMed Web of Science ®Google Scholar
• Asaria M, Griffin S, Cookson R, et al. Distributional Cost-Effectiveness analysis of health care Programmes - A methodological case study of the UK bowel cancer screening programme. Health Econ. 2015;24(6):742–754.
   PubMed Web of Science ®Google Scholar
• Lee K-S, Park E-C. Cost effectiveness of colorectal cancer screening interventions with their effects on health disparity being considered. Cancer Res Treat. 2016;48(3):1010–1019.
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration (FDA). Summary of Safety and Effectiveness Data (SSED) for LINX Reflux Management System. 2012.
   Google Scholar
• WHO CVD Risk Chart Working Group World health organization cardiovascular disease risk charts: revised models to estimate risk in 21 global regions. Lancet Glob Health. 2019;7(10):e1332–e1345.
   PubMed Web of Science ®Google Scholar
• Collins G, Altman D. Predicting the risk of chronic kidney disease in the UK: an evaluation of QKidney® scores using a primary care database. Br J Gen Pract. 2012;62(597):e243–e250.
   PubMed Web of Science ®Google Scholar
• Hussain S, Sing A, Habib A, et al. Proton pump inhibitors use and risk of chronic kidney disease: evidence-based meta-analysis of observational studies. Clin Epidemiol Glob. 2019;7(1):46–52. Mar
   Web of Science ®Google Scholar
• Kanis JA, Johnell O, Oden A, et al. FRAX and the assessment of fracture probability in men and women from the UK. Osteoporos Int. 2008;19(4):385–397.
   PubMed Web of Science ®Google Scholar
• Zhou B, Huang Y, Li H, et al. Proton-pump inhibitors and risk of fractures: an update meta-analysis. Osteoporos Int. 2016;27(1):339–347.
   PubMed Web of Science ®Google Scholar
• Sun X, Douiri A, Gulliford M. Pneumonia incidence trends in UK primary care from 2002 to 2017: population-based cohort study. Epidemiol Infect. 2019;147:e263.
   PubMed Web of Science ®Google Scholar
• Lambert AA, Lam JO, Paik JJ, et al. Risk of community-acquired pneumonia with outpatient proton-pump inhibitor therapy: a systematic review and meta-analysis. PLoS One. 2015;10(6):e0128004.
   PubMed Web of Science ®Google Scholar
• Public Health England. Clostridium difficile infection: mandatory surveillance 2017/18. 2018. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/724368/CDI_summary_2018.pdf
   Google Scholar
• Janarthanan S, Ditah I, Adler DG, et al. Clostridium difficile-associated diarrhea and proton pump inhibitor therapy: a meta-analysis. Am J Gastroenterol. 2012;107(7):1001–1010.
   PubMed Web of Science ®Google Scholar
• Brusselaers N, Wahlin K, Engstrand L, et al. Maintenance therapy with proton pump inhibitors and risk of gastric cancer: a nationwide population-based cohort study in Sweden. BMJ Open. 2017;7(10):e017739.
   PubMed Web of Science ®Google Scholar
• National Institute for Health and Care Excellence. Interventional procedures guidance [IPG585]: laparoscopic insertion of a magnetic titanium ring for gastro-oesophageal reflux disease. 2017. https://www.nice.org.uk/guidance/ipg585
   Google Scholar
• Alicuben ET, Bell RCW, Jobe BA, et al. Worldwide experience with erosion of the magnetic sphincter augmentation device. J Gastrointest Surg. 2018;22(8):1442–1447.
   PubMed Web of Science ®Google Scholar
• Kind P, Hardman G, Macran S. UK population norms for EQ-5D: university of York. Centre for Health Economics. 1999. https://www.york.ac.uk/che/pdf/DP172.pdf
   Google Scholar
• Ainslie WG, Catton JA, Davides D, et al. Micropuncture cholecystectomy vs conventional laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2003;17(5):766–772.
   PubMed Web of Science ®Google Scholar
• Bouvy JC, Ebbers HC, Schellekens H, et al. The cost-effectiveness of periodic safety update reports for biologicals in Europe. Clin Pharmacol Ther. 2013;93(5):433–442.
   PubMed Web of Science ®Google Scholar
• Ayazi S, Zheng P, Zaidi AH, et al. Magnetic sphincter augmentation and postoperative dysphagia: characterization, clinical risk factors, and management. J Gastrointest Surg. 2020;24(1):39–49.
   PubMed Web of Science ®Google Scholar
• Tsai C, Steffen R, Kessler U, et al. Postoperative dysphagia following magnetic sphincter augmentation for gastroesophageal reflux disease. Surg Laparosc Endosc Percutan Tech. 2020;30(4):322–326.
   PubMed Web of Science ®Google Scholar
• National Institute for Health and Care Excellence. British National Formulary (BNF). 2020. https://bnf.nice.org.uk/
   Google Scholar
• Palser TR, Ceney A, Navarro A, et al. Variation in laparoscopic anti-reflux surgery across England: a 5-year review. Surg Endosc. 2018;32(7):3208–3214.
   PubMed Web of Science ®Google Scholar
• Kerr M, Bray B, Medcalf J, et al. Estimating the financial cost of chronic kidney disease to the NHS in England. Nephrol Dial Transplant. 2012;27 (Suppl 3):iii73–80.
   PubMed Web of Science ®Google Scholar
• Kent S, Schlackow I, Lozano-Kühne J, et al. What is the impact of chronic kidney disease stage and cardiovascular disease on the annual cost of hospital care in moderate-to-severe kidney disease? BMC Nephrol. 2015;16:65.
   PubMed Web of Science ®Google Scholar
• Kidneyfailurerisk. The kidney failure risk equation. 2022. https://kidneyfailurerisk.com/
   Google Scholar
• Danese MD, Gleeson M, Kutikova L, et al. Estimating the economic burden of cardiovascular events in patients receiving lipid-modifying therapy in the UK. BMJ Open. 2016;6(8):e011805.
   PubMed Web of Science ®Google Scholar
• National Institute for Health and Care Excellence (NICE). Technology appraisal guidance [TA464]: bisphosphonates for treating osteoporosis. 2017. https://www.nice.org.uk/guidance/ta464
   Google Scholar
• Svedbom A, Hernlund E, Ivergård M, et al. Osteoporosis in the european union: a compendium of country-specific reports. Arch Osteoporos. 2013;8(1):137.
   PubMed Web of Science ®Google Scholar
• National Institute for Health and Care Excellence. Quality standard [QS110]: Pneumonia in adults. 2016. https://www.nice.org.uk/guidance/qs110
   Google Scholar
• National Institute for Health and Care Excellence (NICE). Technology appraisal guidance [TA378]: ramucirumab for treating advanced gastric cancer or gastro–oesophageal junction adenocarcinoma previously treated with chemotherapy. 2016. https://www.nice.org.uk/guidance/ta378
   Google Scholar
• Laudicella M, Walsh B, Munasinghe A, et al. Impact of laparoscopic versus open surgery on hospital costs for Colon cancer: a population-based retrospective cohort study. BMJ Open. 2016;6(11):e012977.
   PubMed Web of Science ®Google Scholar