A retrospective budget impact analysis of fidaxomicin treatment for Clostridioides difficile infections (CDI) in Germany

References

• Kelly CP, LaMont JT. Clostridium difficile–more difficult than ever. N Engl J Med. 2008;359(18):1932–1940. doi: 10.1056/NEJMra0707500
   PubMed Web of Science ®Google Scholar
• Bauer MP, Notermans DW, van Benthem BH, et al. Clostridium difficile infection in Europe: a hospital-based survey. Lancet. 2011;377(9759):63–73. doi: 10.1016/S0140-6736(10)61266-4
   PubMed Web of Science ®Google Scholar
• Barbut F, Mastrantonio P, Delmée M, et al. Prospective study of clostridium difficile infections in Europe with phenotypic and genotypic characterisation of the isolates. Clin Microbiol Infect. 2007;13(11):1048–1057. doi: 10.1111/j.1469-0691.2007.01824.x
   PubMed Web of Science ®Google Scholar
• Reveles KR, Lee GC, Boyd NK, et al. The rise in clostridium difficile infection incidence among hospitalized adults in the United States: 2001-2010. Am J Infect Control. 2014;42(10):1028–1032. doi: 10.1016/j.ajic.2014.06.011
   PubMed Web of Science ®Google Scholar
• Davies K, Lawrence J, Berry C, et al. Risk factors for primary clostridium difficile Infection; results from the observational study of risk factors for clostridium difficile infection in hospitalized patients with infective diarrhea (ORCHID). Front Public Health. 2020;8:293. doi: 10.3389/fpubh.2020.00293
   PubMed Web of Science ®Google Scholar
• Elliott B, Chang BJ, Golledge CL, et al. Clostridium difficile-associated diarrhoea. Int Med J. 2007;37(8):561–568. doi: 10.1111/j.1445-5994.2007.01403.x
   Google Scholar
• van Prehn J, Reigadas E, Vogelzang EH, et al. European society of clinical microbiology and infectious diseases: 2021 update on the treatment guidance document for clostridioides difficile infection in adults. Clin Microbiol Infect. 2021;27 Suppl 2:S1–S21. doi: 10.1016/j.cmi.2021.09.038
   PubMed Web of Science ®Google Scholar
• McFarland LV, Surawicz CM, Rubin M, et al. Recurrent clostridium difficile disease: epidemiology and clinical characteristics. Infect Control Hosp Epidemiol. 1999;20(1):43–50. doi: 10.1086/501553
   PubMed Web of Science ®Google Scholar
• Vardakas KZ, Polyzos KA, Patouni K, et al. Treatment failure and recurrence of clostridium difficile infection following treatment with vancomycin or metronidazole: a systematic review of the evidence. Int J Antimicrob Agents. 2012 Jul;40(1):1–8. doi: 10.1016/j.ijantimicag.2012.01.004
   PubMed Web of Science ®Google Scholar
• Johnson S. Recurrent clostridium difficile infection: a review of risk factors, treatments, and outcomes. J Infect. 2009 Jun;58(6):403–410. doi: 10.1016/j.jinf.2009.03.010
   PubMed Web of Science ®Google Scholar
• Heimann SM, Vehreschild JJ, Cornely OA, et al. Economic burden of clostridium difficile associated diarrhoea: a cost-of-illness study from a German tertiary care hospital. Infection. 2015;43(6):707–714. doi: 10.1007/s15010-015-0810-x
   PubMed Web of Science ®Google Scholar
• Le Monnier A, Duburcq A, Zahar JR, et al. Hospital cost of clostridium difficile infection including the contribution of recurrences in French acute-care hospitals. J Hosp Infect. 2015;91(2):117–122. doi: 10.1016/j.jhin.2015.06.017
   PubMed Web of Science ®Google Scholar
• Feuerstadt P, Boules M, Stong L, et al. Clinical complications in patients with primary and recurrent clostridioides difficile infection: a real-world data analysis. SAGE Open Med. 2021;9:2050312120986733. doi: 10.1177/2050312120986733
   Web of Science ®Google Scholar
• Feuerstadt P, Stong L, Dahdal DN, et al. Healthcare resource utilization and direct medical costs associated with index and recurrent clostridioides difficile infection: a real-world data analysis. J Med Econ. 2020;23(6):603–609. doi: 10.1080/13696998.2020.1724117
   PubMed Web of Science ®Google Scholar
• Wingen-Heimann SM, Davies K, Viprey VF, et al. Clostridioides difficile infection (CDI): a pan-European multi-center cost and resource utilization study, results from the combatting bacterial resistance in Europe CDI (COMBACTE-CDI). Clin Microbiol Infect. 2023;29(5):.e651.1–.e651.8. doi: 10.1016/j.cmi.2022.12.019
   Web of Science ®Google Scholar
• Cornely OA, Crook DW, Esposito R, et al. Fidaxomicin versus vancomycin for infection with clostridium difficile in Europe, Canada, and the USA: a double-blind, non-inferiority, randomised controlled trial. Lancet Infect Dis. 2012;12(4):281–289. doi: 10.1016/S1473-3099(11)70374-7
   PubMed Web of Science ®Google Scholar
• Johnson S, Lavergne V, Skinner AM, et al. Clinical practice guideline by the infectious diseases society of America (IDSA) and society for healthcare epidemiology of America (SHEA): 2021 focused update guidelines on management of clostridioides difficile infection in adults. Clin Infect Dis. 2021;73(5):e1029–e1044. doi: 10.1093/cid/ciab549
   PubMed Web of Science ®Google Scholar
• Lapointe-Shaw L, Tran KL, Coyte PC, et al. Cost-effectiveness analysis of six strategies to treat recurrent clostridium difficile infection. PLOS ONE. 2016;11(2):e0149521. doi: 10.1371/journal.pone.0149521
   PubMed Web of Science ®Google Scholar
• Chen J, Gong CL, Hitchcock MM, et al. Cost-effectiveness of bezlotoxumab and fidaxomicin for initial clostridioides difficile infection. Clin Microbiol Infect. 2021;27(10):1448–1454. doi: 10.1016/j.cmi.2021.04.004
   PubMed Web of Science ®Google Scholar
• Watt M, McCrea C, Johal S, et al. A cost-effectiveness and budget impact analysis of first-line fidaxomicin for patients with clostridium difficile infection (CDI) in Germany. Infection. 2016;44(5):599–606. doi: 10.1007/s15010-016-0894-y
   PubMed Web of Science ®Google Scholar
• Mauskopf JA, Sullivan SD, Annemans L, et al. Principles of good practice for budget impact analysis: report of the ISPOR task force on good research practices - budget impact analysis. Value Health. 2007;10(5):336–347. doi: 10.1111/j.1524-4733.2007.00187.x
   PubMed Web of Science ®Google Scholar
• Husereau D, Drummond M, Augustovski F, et al. Consolidated health economic evaluation reporting standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations. Value Health. 2022;25(1):3–9. doi: 10.1016/j.jval.2021.11.1351
   PubMed Web of Science ®Google Scholar
• Institute for Quality and Efficiency in Health Care (IQWiG). General methods. Version 6.1 of 24 January 2022 2022. 2022 Dec 27. Available from: https://www.iqwig.de/methoden/general-methods_version-6-1.pdf
   Google Scholar
• Drummond MF, Sculpher MJ, Claxton K, et al. Methods for the economic evaluation of health care programmes. 4th ed. Oxford: Oxford University Press; 2015.
   Google Scholar
• Cornely OA, Miller MA, Louie TJ, et al. Treatment of first recurrence of clostridium difficile infection: fidaxomicin versus vancomycin. Clin Infect Dis. 2012;55(suppl_2):S154–S161. doi: 10.1093/cid/cis462
   PubMedGoogle Scholar
• Institut für das Entgeltsystem im Krankenhaus. DRG Systemjahr 2017 Datenjahr 2015 2017. 2023 Jul 17. Available from: https://www.g-drg.de/archiv/drg-systemjahr-2017-datenjahr-2015#sm2
   Google Scholar
• Institut für das Entgeltsystem im Krankenhaus. DRG Systemjahr 2018 Datenjahr 2016 2018. 2023 Jul 17. Available from: https://www.g-drg.de/archiv/drg-systemjahr-2018-datenjahr-2016#sm2
   Google Scholar
• Institut für das Entgeltsystem im Krankenhaus. DRG Systemjahr 2019 Datenjahr 2017 2019. 2023 Jul 17. Available from: https://www.g-drg.de/archiv/drg-systemjahr-2019-datenjahr-2017#sm2
   Google Scholar
• GKV-Spitzenverband, Deutsche Krankenhausgesellschaft e.V. Vereinbarung gemäß § 10 Abs. 9 KHEntgG für den Vereinbarungszeitraum 2019 [Internet]. [cited 2024 Apr 30]. Available from: https://www.gkv-spitzenverband.de/media/dokumente/krankenversicherung_1/krankenhaeuser/budgetverhandlungen/bundesbasisfallwert/KH_BBFW_2019.pdf
   Google Scholar
• GKV-Spitzenverband, Deutsche Krankenhausgesellschaft e.V. Vereinbarung gemäß § 10 Abs. 9 KHEntgG für den Vereinbarungszeitraum 2018 [Internet]. [cited 2024 Apr 30]. Available from: https://gkv-spitzenverband.de/media/dokumente/krankenversicherung_1/krankenhaeuser/budgetverhandlungen/bundesbasisfallwert/KH_BBFW_2018.pdf
   Google Scholar
• GKV-Spitzenverband, Deutsche Krankenhausgesellschaft e.V. Vereinbarung gemäß § 10 Abs. 9 KHEntgG für den Vereinbarungszeitraum 2017 [Internet]. [cited 2024 Apr 30]. Available from: https://gkv-spitzenverband.de/media/dokumente/krankenversicherung_1/krankenhaeuser/budgetverhandlungen/bundesbasisfallwert/BBFW_2017.pdf
   Google Scholar
• Gallagher JC, Reilly JP, Navalkele B, et al. Clinical and economic benefits of fidaxomicin compared to vancomycin for clostridium difficile infection. Antimicrob Agents Chemother. 2015;59(11):7007–7010. doi: 10.1128/AAC.00939-15
   PubMed Web of Science ®Google Scholar
• Ministerium des Innern des Landes Nordrhein-Westfalen. Gesetz zum Schutz personenbezogener Daten im Gesundheitswesen (Gesundheitsdatenschutzgesetz - GSDG NW): §6 Datenverarbeitung für wissenschaftliche Zwecke. [cited 2024 Apr 30]. Available from: https://recht.nrw.de/lmi/owa/br_text_anzeigen?v_id=10000000000000000495
   Google Scholar
• Wingen-Heimann SM, van Prehn J, Kuijper EJ, et al. The need for a holistic view on management of clostridioides difficile infection. Clin Microbiol Infect. 2021;27(10):1383–1385. doi: 10.1016/j.cmi.2021.07.014
   PubMed Web of Science ®Google Scholar
• Heimann SM, Cruz Aguilar MR, Mellinghof S, et al. Economic burden and cost-effective management of Clostridium difficile infections. Med Mal Infect. 2018;48(1):23–29. doi: 10.1016/j.medmal.2017.10.010
   PubMed Web of Science ®Google Scholar
• Shah DN, Aitken SL, Barragan LF, et al. Economic burden of primary compared with recurrent Clostridium difficile infection in hospitalized patients: a prospective cohort study. J Hosp Infect. 2016;93(3):286–289. doi: 10.1016/j.jhin.2016.04.004
   PubMed Web of Science ®Google Scholar
• Nathwani D, Cornely OA, Van Engen AK, et al. Cost-effectiveness analysis of fidaxomicin versus vancomycin in clostridium difficile infection. J Antimicrob Chemother. 2014;69(11):2901–2912. doi: 10.1093/jac/dku257
   PubMed Web of Science ®Google Scholar
• Cornely OA, Watt M, McCrea C, et al. Extended-pulsed fidaxomicin versus vancomycin for clostridium difficile infection in patients aged ≥60 years (EXTEND): analysis of cost-effectiveness. J Antimicrob Chemother. 2018;73(9):2529–2539. doi: 10.1093/jac/dky184
   PubMed Web of Science ®Google Scholar
• Watt M, Dinh A, Le Monnier A, et al. Cost-effectiveness analysis on the use of fidaxomicin and vancomycin to treat clostridium difficile infection in France. J Med Econ. 2017;20(7):678–686. doi: 10.1080/13696998.2017.1302946
   PubMed Web of Science ®Google Scholar
• Swart N, Sinha AM, Bentley A, et al. A cost-utility analysis of two clostridioides difficile infection guideline treatment pathways. Clin Microbiol Infect. 2023;29(10):1291–1297. doi: 10.1016/j.cmi.2023.06.018
   PubMed Web of Science ®Google Scholar
• Summers BB, Yates M, Cleveland KO, et al. Fidaxomicin compared with oral vancomycin for the treatment of severe clostridium difficile-associated diarrhea: a retrospective review. Hosp Pharm. 2020 Aug;55(4):268–272. doi: 10.1177/0018578719844165
   PubMed Web of Science ®Google Scholar
• Whitney L, Nesnas J, Planche T. Real-world budget impact of Fidaxomicin versus vancomycin or metronidazole for In-hospital treatment of clostridioides difficile infection. Antibiotics. 2023;12(1):106. doi: 10.3390/antibiotics12010106
   Google Scholar
• Gonzales-Luna AJ, Skinner AM, Alonso CD, et al. Redefining clostridioides difficile infection antibiotic response and clinical outcomes. Lancet Infect Dis. 2023;23(7):e259–e265. doi: 10.1016/S1473-3099(23)00047-6
   PubMed Web of Science ®Google Scholar