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Published in: Infection 5/2016

Open Access 01-10-2016 | Original Paper

A cost-effectiveness and budget impact analysis of first-line fidaxomicin for patients with Clostridium difficile infection (CDI) in Germany

Authors: Maureen Watt, Charles McCrea, Sukhvinder Johal, John Posnett, Jameel Nazir

Published in: Infection | Issue 5/2016

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Abstract

Purpose

Clostridium difficile infection (CDI) represents a significant economic healthcare burden, especially the cost of recurrent disease. Fidaxomicin produced significantly lower recurrence rates and higher sustained cure rates in clinical trials. We evaluated the cost-effectiveness and budget impact of fidaxomicin compared with vancomycin in Germany in the first-line treatment of patient subgroups with CDI at increased risk of recurrence.

Methods

A semi-Markov model was used to compare the cost-effectiveness and budget impact of fidaxomicin vs. vancomycin from a payer perspective in Germany. The model cycle length was 10 days. The time horizon was 1 year. Model inputs were probability of clinical cure, 30-day probability of recurrence, and 30-day attributable mortality based on evidence from two randomized controlled trials comparing fidaxomicin and vancomycin in patients with CDI. Cost-effectiveness outcomes were cost per quality-adjusted life year gained, cost per bed-day saved, and cost per recurrence avoided.

Results

Despite higher drug acquisition costs, fidaxomicin was dominant in the cancer subgroup (less costly and more effective) and cost-effective in the other subgroups, with incremental cost-effectiveness ratios vs. vancomycin ranging from €26,900 to €44,500. Hospitalization costs of the first-line treatment of CDI with fidaxomicin vs. vancomycin were lower in every patient subgroup, resulting in budget impacts ranging from −€1325 (in patients ≥65 years) to −€2438 (in cancer patients). Reductions in the cost of treating recurrence with fidaxomicin ranged from −€574.32 per patient in those receiving concomitant antibiotics to −€1500.68 per patient in renally impaired patients.

Conclusions

In patient subgroups with CDI at increased recurrence risk, fidaxomicin was cost-effective vs. vancomycin, and less costly and more effective in patients with cancer.
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Literature
1.
go back to reference Wiegand PN, Nathwani D, Wilcox MH, Stephens J, Shelbaya A, Haider S. Clinical and economic burden of Clostridium difficile infection in Europe: a systematic review of healthcare-facility-acquired infection. J Hosp Infect. 2012;81:1–14.CrossRefPubMed Wiegand PN, Nathwani D, Wilcox MH, Stephens J, Shelbaya A, Haider S. Clinical and economic burden of Clostridium difficile infection in Europe: a systematic review of healthcare-facility-acquired infection. J Hosp Infect. 2012;81:1–14.CrossRefPubMed
2.
go back to reference Kwon JH, Olsen MA, Dubberke ER. The morbidity, mortality, and costs associated with Clostridium difficile infection. Infect Dis Clin North Am. 2015;29:123–34.CrossRefPubMed Kwon JH, Olsen MA, Dubberke ER. The morbidity, mortality, and costs associated with Clostridium difficile infection. Infect Dis Clin North Am. 2015;29:123–34.CrossRefPubMed
3.
go back to reference Louie TJ, Miller MA, Mullane KM, Weiss K, Lentnek A, Golan Y, et al. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med. 2011;364:422–31.CrossRefPubMed Louie TJ, Miller MA, Mullane KM, Weiss K, Lentnek A, Golan Y, et al. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med. 2011;364:422–31.CrossRefPubMed
4.
go back to reference Lowy I, Molrine DC, Leav BA, Blair MB, Baxter R, Gerding DN, et al. Treatment with monoclonal antibodies against Clostridium difficile toxins. N Engl J Med. 2010;362:197–205.CrossRefPubMed Lowy I, Molrine DC, Leav BA, Blair MB, Baxter R, Gerding DN, et al. Treatment with monoclonal antibodies against Clostridium difficile toxins. N Engl J Med. 2010;362:197–205.CrossRefPubMed
5.
go back to reference Bouza E. Consequences of Clostridium difficile infection: understanding the healthcare burden. Clin Microbiol Infect. 2012;18:5–12.CrossRefPubMed Bouza E. Consequences of Clostridium difficile infection: understanding the healthcare burden. Clin Microbiol Infect. 2012;18:5–12.CrossRefPubMed
6.
go back to reference Surawicz CM, Alexander J. Treatment of refractory and recurrent Clostridium difficile infection. Nat Rev Gastroenterol Hepatol. 2011;8:330–9.CrossRefPubMed Surawicz CM, Alexander J. Treatment of refractory and recurrent Clostridium difficile infection. Nat Rev Gastroenterol Hepatol. 2011;8:330–9.CrossRefPubMed
7.
go back to reference Mullane KM, Miller MA, Weiss K, Lentnek A, Golan Y, Sears PS, et al. Efficacy of fidaxomicin versus vancomycin as therapy for Clostridium difficile infection in individuals taking concomitant antibiotics for other concurrent infections. Clin Infect Dis. 2011;53:440–7.CrossRefPubMedPubMedCentral Mullane KM, Miller MA, Weiss K, Lentnek A, Golan Y, Sears PS, et al. Efficacy of fidaxomicin versus vancomycin as therapy for Clostridium difficile infection in individuals taking concomitant antibiotics for other concurrent infections. Clin Infect Dis. 2011;53:440–7.CrossRefPubMedPubMedCentral
8.
go back to reference Eyre DW, Walker AS, Wyllie D, Dingle KE, Griffiths D, Finney J, et al. Predictors of first recurrence of Clostridium difficile infection: implications for initial management. Clin Infect Dis. 2012;55:S77–87.CrossRefPubMedPubMedCentral Eyre DW, Walker AS, Wyllie D, Dingle KE, Griffiths D, Finney J, et al. Predictors of first recurrence of Clostridium difficile infection: implications for initial management. Clin Infect Dis. 2012;55:S77–87.CrossRefPubMedPubMedCentral
10.
go back to reference Debast SB, Bauer MP, Kuijper EJ, European Society of Clinical Microbiology and Infectious Diseases. European Society of Clinical Microbiology and Infectious Diseases: update of the treatment guidance document for Clostridium difficile infection. Clin Microbiol Infect. 2014;20:1–26.CrossRefPubMed Debast SB, Bauer MP, Kuijper EJ, European Society of Clinical Microbiology and Infectious Diseases. European Society of Clinical Microbiology and Infectious Diseases: update of the treatment guidance document for Clostridium difficile infection. Clin Microbiol Infect. 2014;20:1–26.CrossRefPubMed
12.
go back to reference Cornely OA, Miller MA, Fantin B, Mullane K, Kean Y, Gorbach S. Resolution of Clostridium difficile-associated diarrhea in patients with cancer treated with fidaxomicin or vancomycin. J Clin Oncol. 2013;31:2493–9.CrossRefPubMed Cornely OA, Miller MA, Fantin B, Mullane K, Kean Y, Gorbach S. Resolution of Clostridium difficile-associated diarrhea in patients with cancer treated with fidaxomicin or vancomycin. J Clin Oncol. 2013;31:2493–9.CrossRefPubMed
13.
go back to reference Mullane KM, Cornely OA, Crook DW, Golan Y, Louie TJ, Miller MA, et al. Renal impairment and clinical outcomes of Clostridium difficile infection in two randomized trials. Am J Nephrol. 2013;38:1–11.CrossRefPubMed Mullane KM, Cornely OA, Crook DW, Golan Y, Louie TJ, Miller MA, et al. Renal impairment and clinical outcomes of Clostridium difficile infection in two randomized trials. Am J Nephrol. 2013;38:1–11.CrossRefPubMed
14.
go back to reference Ghantoji SS, Sail K, Lairson DR, DuPont HL, Garey KW. Economic healthcare costs of Clostridium difficile infection: a systematic review. J Hosp Infect. 2010;74:309–18.CrossRefPubMed Ghantoji SS, Sail K, Lairson DR, DuPont HL, Garey KW. Economic healthcare costs of Clostridium difficile infection: a systematic review. J Hosp Infect. 2010;74:309–18.CrossRefPubMed
16.
go back to reference Heimann SM, Vehreschild JJ, Cornely OA, Wisplinghoff H, Hallek M, Goldbrunner R, et al. Economic burden of Clostridium difficile associated diarrhoea: a cost-of-illness study from a German tertiary care hospital. Infection. 2015;43:707–14.CrossRefPubMed Heimann SM, Vehreschild JJ, Cornely OA, Wisplinghoff H, Hallek M, Goldbrunner R, et al. Economic burden of Clostridium difficile associated diarrhoea: a cost-of-illness study from a German tertiary care hospital. Infection. 2015;43:707–14.CrossRefPubMed
17.
go back to reference Cornely OA, Crook DW, Esposito R, Poirier A, Somero MS, Weiss K, 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;12:281–9.CrossRefPubMed Cornely OA, Crook DW, Esposito R, Poirier A, Somero MS, Weiss K, 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;12:281–9.CrossRefPubMed
18.
go back to reference Nathwani D, Cornely OA, Van Engen AK, Odufowora-Sita O, Retsa P, Odeyemi IA. Cost-effectiveness analysis of fidaxomicin versus vancomycin in Clostridium difficile infection. J Antimicrob Chemother. 2014;69:2901–12.CrossRefPubMedPubMedCentral Nathwani D, Cornely OA, Van Engen AK, Odufowora-Sita O, Retsa P, Odeyemi IA. Cost-effectiveness analysis of fidaxomicin versus vancomycin in Clostridium difficile infection. J Antimicrob Chemother. 2014;69:2901–12.CrossRefPubMedPubMedCentral
19.
go back to reference van Engen A, Casamayor M, Loftus F, Coen M, Garnham A, Watt M, Lacey L. Economic evaluation of fidaxomicin for the treatment of Clostridium difficile infection (C. difficile-associated diarrhoea) in Ireland. JHEOR. 2015;2:192–206. van Engen A, Casamayor M, Loftus F, Coen M, Garnham A, Watt M, Lacey L. Economic evaluation of fidaxomicin for the treatment of Clostridium difficile infection (C. difficile-associated diarrhoea) in Ireland. JHEOR. 2015;2:192–206.
20.
go back to reference Kuijper EJ, Coignard B, Tüll P, the ESCMID Study Group for Clostridium difficile (ESGCD) and EU Member States and the European Centre for Disease Prevention and Control (ECDC). Emergence of Clostridium difficile-associated disease in North America and Europe. Clin Microbiol Infect. 2006;12:2–18. Kuijper EJ, Coignard B, Tüll P, the ESCMID Study Group for Clostridium difficile (ESGCD) and EU Member States and the European Centre for Disease Prevention and Control (ECDC). Emergence of Clostridium difficile-associated disease in North America and Europe. Clin Microbiol Infect. 2006;12:2–18.
21.
go back to reference Grube RF, Heinlein W, Scheffer H, Rathmayer M, Schepp W, Lohse AW, et al. Economic burden of Clostridium difficile enterocolitis in German hospitals based on routine DRG data. Z Gastroenterol. 2015;53:391–7.CrossRefPubMed Grube RF, Heinlein W, Scheffer H, Rathmayer M, Schepp W, Lohse AW, et al. Economic burden of Clostridium difficile enterocolitis in German hospitals based on routine DRG data. Z Gastroenterol. 2015;53:391–7.CrossRefPubMed
22.
go back to reference Gravel D, Miller M, Simor A, Taylor G, Gardam M, McGeer A, et al. Health care-associated Clostridium difficile infection in adults admitted to acute care hospitals in Canada: a Canadian Nosocomial Infection Surveillance Program Study. Clin Infect Dis. 2009;48:568–76.CrossRefPubMed Gravel D, Miller M, Simor A, Taylor G, Gardam M, McGeer A, et al. Health care-associated Clostridium difficile infection in adults admitted to acute care hospitals in Canada: a Canadian Nosocomial Infection Surveillance Program Study. Clin Infect Dis. 2009;48:568–76.CrossRefPubMed
23.
go back to reference Kenneally C, Rosini JM, Skrupky LP, Doherty JA, Hollands JM, Martinez E, et al. Analysis of 30-day mortality for Clostridium difficile-associated disease in the ICU setting. Chest. 2007;132:418–24.CrossRefPubMed Kenneally C, Rosini JM, Skrupky LP, Doherty JA, Hollands JM, Martinez E, et al. Analysis of 30-day mortality for Clostridium difficile-associated disease in the ICU setting. Chest. 2007;132:418–24.CrossRefPubMed
24.
go back to reference Loo VG, Poirier L, Miller MA, Oughton M, Libman MD, Michaud S, et al. A predominantly clonal multi-institutional outbreak of Clostridium difficile-associated diarrhea with high morbidity and mortality. N Engl J Med. 2005;353:2442–9.CrossRefPubMed Loo VG, Poirier L, Miller MA, Oughton M, Libman MD, Michaud S, et al. A predominantly clonal multi-institutional outbreak of Clostridium difficile-associated diarrhea with high morbidity and mortality. N Engl J Med. 2005;353:2442–9.CrossRefPubMed
26.
go back to reference Patel S, Kelly C, Colombel J-F, Atreja A. Comparative cost analysis of fecal microbiota transplant and antibiotic treatment for recurrent Clostridium difficile infection. Am J Gastroenterol. 2013;108:S169. Patel S, Kelly C, Colombel J-F, Atreja A. Comparative cost analysis of fecal microbiota transplant and antibiotic treatment for recurrent Clostridium difficile infection. Am J Gastroenterol. 2013;108:S169.
27.
go back to reference Slobogean GP, Kennedy SA, Davidson D, O’Brien PJ. Single-versus multiple-dose antibiotic prophylaxis in the surgical treatment of closed fractures: a meta-analysis. J Orthop Trauma. 2008;22:264–9.CrossRefPubMed Slobogean GP, Kennedy SA, Davidson D, O’Brien PJ. Single-versus multiple-dose antibiotic prophylaxis in the surgical treatment of closed fractures: a meta-analysis. J Orthop Trauma. 2008;22:264–9.CrossRefPubMed
29.
go back to reference Schwander B. The future health economic potential of next generation artificial vision devices for treating blindness in Germany: an early cost-utility assessment. Poster PSS35 presented at 17th Annual ISPOR European Congress, Amsterdam, The Netherlands; 11th November 2014. Schwander B. The future health economic potential of next generation artificial vision devices for treating blindness in Germany: an early cost-utility assessment. Poster PSS35 presented at 17th Annual ISPOR European Congress, Amsterdam, The Netherlands; 11th November 2014.
30.
go back to reference Crook DW, Walker AS, Kean Y, Weiss K, Cornely OA, Miller MA, et al. Fidaxomicin versus vancomycin for Clostridium difficile infection: meta-analysis of pivotal randomized controlled trials. Clin Infect Dis. 2012;55:S93–103.CrossRefPubMedPubMedCentral Crook DW, Walker AS, Kean Y, Weiss K, Cornely OA, Miller MA, et al. Fidaxomicin versus vancomycin for Clostridium difficile infection: meta-analysis of pivotal randomized controlled trials. Clin Infect Dis. 2012;55:S93–103.CrossRefPubMedPubMedCentral
31.
go back to reference Chopra T, Neelakanta A, Dombeck C, Awali RA, Sharma S, Kaye KS, Patel P. Burden of Clostridium difficile infection on hospital readmissions and its potential impact under the Hospital Readmission Reduction Program. Am J Infect Control. 2015;43:314–7.CrossRefPubMed Chopra T, Neelakanta A, Dombeck C, Awali RA, Sharma S, Kaye KS, Patel P. Burden of Clostridium difficile infection on hospital readmissions and its potential impact under the Hospital Readmission Reduction Program. Am J Infect Control. 2015;43:314–7.CrossRefPubMed
32.
go back to reference Al-Eidan FA, McElnay JC, Scott MG, Kearney MP. Clostridium difficile-associated diarrhoea in hospitalised patients. J Clin Pharmacy Ther. 2000;25:101–9.CrossRef Al-Eidan FA, McElnay JC, Scott MG, Kearney MP. Clostridium difficile-associated diarrhoea in hospitalised patients. J Clin Pharmacy Ther. 2000;25:101–9.CrossRef
33.
go back to reference Eiland E, Sawyer AJ, Massie NL. Fidaxomicin use and clinical outcomes for clostridium difficile–associated diarrhea. Infect Dis Clin Pract. 2015;23:32–5.CrossRef Eiland E, Sawyer AJ, Massie NL. Fidaxomicin use and clinical outcomes for clostridium difficile–associated diarrhea. Infect Dis Clin Pract. 2015;23:32–5.CrossRef
34.
go back to reference Stranges PM, Hutton DW, Collins CD. Cost-effectiveness analysis evaluating fidaxomicin versus oral vancomycin for the treatment of Clostridium difficile infection in the United States. Value Health. 2013;16:297–304.CrossRefPubMed Stranges PM, Hutton DW, Collins CD. Cost-effectiveness analysis evaluating fidaxomicin versus oral vancomycin for the treatment of Clostridium difficile infection in the United States. Value Health. 2013;16:297–304.CrossRefPubMed
35.
go back to reference Rubio-Terrés C, Cobo Reinoso J, Grau Cerrato S, Mensa Pueyo J, Salavert Lletí M, Toledo A, et al. Economic assessment of fidaxomicin for the treatment of Clostridium difficile infection (CDI) in special populations (patients with cancer, concomitant antibiotic treatment or renal impairment) in Spain. Eur J Clin Microbiol Infect Dis. 2015;34:2213–23.CrossRefPubMed Rubio-Terrés C, Cobo Reinoso J, Grau Cerrato S, Mensa Pueyo J, Salavert Lletí M, Toledo A, et al. Economic assessment of fidaxomicin for the treatment of Clostridium difficile infection (CDI) in special populations (patients with cancer, concomitant antibiotic treatment or renal impairment) in Spain. Eur J Clin Microbiol Infect Dis. 2015;34:2213–23.CrossRefPubMed
36.
go back to reference Olsen MA, Yan Y, Reske KA, Zilberberg MD, Dubberke ER. Recurrent Clostridium difficile infection is associated with increased mortality. Clin Microbiol Infect. 2015;21:164–70.CrossRefPubMed Olsen MA, Yan Y, Reske KA, Zilberberg MD, Dubberke ER. Recurrent Clostridium difficile infection is associated with increased mortality. Clin Microbiol Infect. 2015;21:164–70.CrossRefPubMed
37.
go back to reference Kelly CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012;18:21–7.CrossRefPubMed Kelly CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012;18:21–7.CrossRefPubMed
38.
go back to reference Cornely OA, Nathwani D, Ivanescu C, Odufowora-Sita O, Retsa P, Odeyemi IA. Clinical efficacy of fidaxomicin compared with vancomycin and metronidazole in Clostridium difficile infections: a meta-analysis and indirect treatment comparison. J Antimicrob Chemother. 2014;69:2892–900.CrossRefPubMed Cornely OA, Nathwani D, Ivanescu C, Odufowora-Sita O, Retsa P, Odeyemi IA. Clinical efficacy of fidaxomicin compared with vancomycin and metronidazole in Clostridium difficile infections: a meta-analysis and indirect treatment comparison. J Antimicrob Chemother. 2014;69:2892–900.CrossRefPubMed
Metadata
Title
A cost-effectiveness and budget impact analysis of first-line fidaxomicin for patients with Clostridium difficile infection (CDI) in Germany
Authors
Maureen Watt
Charles McCrea
Sukhvinder Johal
John Posnett
Jameel Nazir
Publication date
01-10-2016
Publisher
Springer Berlin Heidelberg
Published in
Infection / Issue 5/2016
Print ISSN: 0300-8126
Electronic ISSN: 1439-0973
DOI
https://doi.org/10.1007/s15010-016-0894-y

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