Skip to main content

Advertisement

SpringerLink
Log in

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

  • Original Article
  • Published:
European Journal of Clinical Microbiology & Infectious Diseases Aims and scope Submit manuscript

Abstract

The objective of this paper was to assess the cost–utility of fidaxomicin versus vancomycin in the treatment of Clostridium difficile infection (CDI) in three specific CDI patient subgroups: those with cancer, treated with concomitant antibiotic therapy or with renal impairment. A Markov model with six health states was developed to assess the cost–utility of fidaxomicin versus vancomycin in the patient subgroups over a period of 1 year from initial infection. Cost and outcome data used to parameterise the model were taken from Spanish sources and published literature. The costs were from the Spanish hospital perspective, in Euros (€) and for 2013. For CDI patients with cancer, fidaxomicin was dominant versus vancomycin [gain of 0.016 quality-adjusted life-years (QALYs) and savings of €2,397 per patient]. At a cost-effectiveness threshold of €30,000 per QALY gained, the probability that fidaxomicin was cost-effective was 96 %. For CDI patients treated with concomitant antibiotic therapy, fidaxomicin was the dominant treatment versus vancomycin (gain of 0.014 QALYs and savings of €1,452 per patient), with a probability that fidaxomicin was cost-effective of 94 %. For CDI patients with renal impairment, fidaxomicin was also dominant versus vancomycin (gain of 0.013 QALYs and savings of €1,432 per patient), with a probability that fidaxomicin was cost-effective of 96 %. Over a 1-year time horizon, when fidaxomicin is compared to vancomycin in CDI patients with cancer, treated with concomitant antibiotic therapy or with renal impairment, the use of fidaxomicin would be expected to result in increased QALYs for patients and reduced overall costs.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

References

  1. Louie TJ, Miller MA, Mullane KM, Weiss K, Lentnek A, Golan Y, Gorbach S, Sears P, Shue YK; OPT- 80-003 Clinical Study Group (2011) Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med 364:422–431

    Article  CAS  PubMed  Google Scholar 

  2. Cornely OA, Crook DW, Esposito R, Poirier A, Somero MS, Weiss K, Sears P, Gorbach S; OPT-80-004 Clinical Study Group (2012) 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 12:281–289

    Article  CAS  PubMed  Google Scholar 

  3. Cornely OA, Miller MA, Fantin B, Mullane K, Kean Y, Gorbach S (2013) Resolution of Clostridium difficile-associated diarrhea in patients with cancer treated with fidaxomicin or vancomycin. J Clin Oncol 31:2493–2499

    Article  CAS  PubMed  Google Scholar 

  4. Mullane KM, Miller MA, Weiss K, Lentnek A, Golan Y, Sears PS, Shue YK, Louie TJ, Gorbach SL (2011) Efficacy of fidaxomicin versus vancomycin as therapy for Clostridium difficile infection in individuals taking concomitant antibiotics for other concurrent infections. Clin Infect Dis 53:440–447

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  5. Mullane KM, Cornely OA, Crook DW, Golan Y, Louie TJ, Miller MA, Josephson MA, Gorbach SL (2013) Renal impairment and clinical outcomes of Clostridium difficile infection in two randomized trials. Am J Nephrol 38:1–11

    Article  PubMed  Google Scholar 

  6. Monge D, Millán I, González-Escalada A, Asensio A (2013) The effect of Clostridium difficile infection on length of hospital stay. A cohort study. Enferm Infecc Microbiol Clin 31(10):660–664

    Article  PubMed  Google Scholar 

  7. Campbell R, Dean B, Nathanson B, Haidar T, Strauss M, Thomas S (2013) Length of stay and hospital costs among high-risk patients with hospital-origin Clostridium difficile-associated diarrhea. J Med Econ 16:440–448

    Article  PubMed  Google Scholar 

  8. Bujanda L, Cosme Á (2009) Diarrea asociada a Clostridium difficile. Gastroenterol Hepatol 32:48–56

    Article  PubMed  Google Scholar 

  9. Asensio A, Monge D (2012) Epidemiología de la infección por Clostridium difficile en España. Enferm Infecc Microbiol Clin 30:333–337

    Article  PubMed  Google Scholar 

  10. Davies KA, Longshaw CM, Davis GL, Bouza E, Barbut F, Barna Z, Delmée M, Fitzpatrick F, Ivanova K, Kuijper E, Macovei IS, Mentula S, Mastrantonio P, von Müller L, Oleastro M, Petinaki E, Pituch H, Norén T, Nováková E, Nyč O, Rupnik M, Schmid D, Wilcox MH (2014) Underdiagnosis of Clostridium difficile across Europe: the European, multicentre, prospective, biannual, point-prevalence study of Clostridium difficile infection in hospitalised patients with diarrhoea (EUCLID). Lancet Infect Dis 14:1208–1219

    Article  PubMed  Google Scholar 

  11. Monge D, Morosini M, Millán I, Pérez Canosa C, Manso M, Guzman MF, Asensio A (2011) Factores de riesgo de infección por Clostridium difficile en pacientes hospitalizados. Med Clin (Barc) 137:575–580

    Article  Google Scholar 

  12. Asensio Á, Bouza E, Grau S, Rubio-Rodríguez D, Rubio-Terrés C (2013) Coste de la diarrea asociada a Clostridium difficile en España. Rev Esp Salud Publica 87:25–33

    Article  PubMed  Google Scholar 

  13. Johnson AP, Wilcox MH (2012) Fidaxomicin: a new option for the treatment of Clostridium difficile infection. J Antimicrob Chemother 67:2788–2792

    Article  CAS  PubMed  Google Scholar 

  14. Kelly CP (2012) Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect 18(Suppl 6):21–27. doi:10.1111/1469-0691.12046

    Article  PubMed  Google Scholar 

  15. Crawford T, Huesgen E, Danziger L (2012) Fidaxomicin: a novel macrocyclic antibiotic for the treatment of Clostridium difficile infection. Am J Health Syst Pharm 69:933–943

    Article  CAS  PubMed  Google Scholar 

  16. Real Decreto-ley 16/2012, de 20 de abril, de medidas urgentes para garantizar la sostenibilidad del Sistema Nacional de Salud y mejorar la calidad y seguridad de sus prestaciones. B.O.E. N° 98, 24 de abril de 2012: 31278.

  17. Nathwani D, Cornely OA, Van Engen AK, Odufowora-Sita O, Retsa P, Odeyemi IA (2014) Cost-effectiveness analysis of fidaxomicin versus vancomycin in Clostridium difficile infection. J Antimicrob Chemother 69:2901–2912

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  18. fidaxomicin (Dificlir®) 200 mg film-coated tablet. All Wales Medicines Strategy Group, 1 June 2012

  19. Scottish Medicines Consortium. fidaxomicin 200mg film-coated tablets (Dificlir®). SMC No. (791/12). Available online at: http://www.scottishmedicines.org.uk/files/advice/fidaxomicin_Dificlir_FINAL_June_2012_for_website.pdf. Accessed 23 Sep 2014

  20. Lamotte M, Vellopoulou K, Richir K, Smets J, Grabe K, Coppens K (2013) The cost–utility of fidaxomicin as compared to current standard treatment in the management of Clostridium difficile infections in Belgium. Value Health 16:A498

  21. Van Engen A, Casamayor M, Loftus F, Crimin E, Lacey L (2013) Economic evaluation of fidaxomicin for the treatment of Clostridium difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in Ireland. Value Health 16:A353

    Article  Google Scholar 

  22. Debast SB, Bauer MP, Kuijper EJ; European Society of Clinical Microbiology and Infectious Diseases (2014) European Society of Clinical Microbiology and Infectious Diseases: update of the treatment guidance document for Clostridium difficile infection. Clin Microbiol Infect 20(Suppl 2):1–26

    Article  CAS  PubMed  Google Scholar 

  23. Eckmann C, Wasserman M, Latif F, Roberts G, Beriot-Mathiot A (2013) Increased hospital length of stay attributable to Clostridium difficile infection in patients with four co-morbidities: an analysis of hospital episode statistics in four European countries. Eur J Health Econ 14(5):835–846

    Article  PubMed  Google Scholar 

  24. Hart WM, Asensio A, Isidoro B, Watt M, Nazir J (2013) The burden of Clostridium difficile in Spain: a retrospective matched-cohort study. PIN 50. ISPOR 16th Annual European Congress. Dublin, pp 2–6

  25. Hospital Episode Statistics (HES). Health & Social Care Information Centre (HSCIC). Available online at: http://www.hscic.gov.uk/hes. Accessed 19 Nov 2013

  26. Consejo General de Colegios de Farmacéuticos. BOT Plus 2.0. Available online at: https://botplusweb.portalfarma.com/. Accessed 16 Oct 2013

  27. Ambulatory Diagnosis-Related Groups of the NHS. General Directorate of Public Health, Quality and Innovation. Specialized outpatient care in the National Health System. Weights and costs of outpatient procedures. IR-GRD 2.3. Ministry of Health, Social Services and Equality, Madrid. September 2013

  28. Pubic prices of Extremadura. Order of 7 February, 2014, publishing the updated list of public rates and prices of the Autonomous Community of Extremadura by virtue of the provisions of the General Budgets Law of the Autonomous Community of Extremadura for 2014. DOE no. 34, of 19 February, 2014

  29. Public prices of Madrid. Order 731/2013 of 6 September, of the Ministry of Health, setting the public prices for the rendering of health services and activities of the Network of Centres of the Community of Madrid. DOE no. 215, of 30 September, 2013

  30. Slobogean GP, O’Brien PJ, Brauer CA (2010) Single-dose versus multiple-dose antibiotic prophylaxis for the surgical treatment of closed fractures. Acta Orthop 81:256–262

    Article  PubMed Central  PubMed  Google Scholar 

  31. Henrich TJ, Krakower D, Bitton A, Yokoe DS (2009) Clinical risk factors for severe Clostridium difficile-associated disease. Emerg Infect Dis 15:415–422

    Article  PubMed Central  PubMed  Google Scholar 

  32. Karas JA, Enoch DA, Aliyu SH (2010) A review of mortality due to Clostridium difficile infection. J Infect 61:1–8

    Article  CAS  PubMed  Google Scholar 

  33. Perras C, Tsakonas E, Ndegwa S, Conly J, Valiquette L, Farrah K (2011) Vancomycin or metronidazole for treatment of Clostridium difficile infection: clinical and economic analyses. Canadian Agency for Drugs and Technologies in Health (CADTH), Ottawa (technology report; no. 136). Available online at: http://www.cadth.ca/media/pdf/H0499_Cdifficile_tr_e.pdf. Accessed 4 Dec 2013

  34. The human mortality database. Available online at: http://www.mortality.org/hmd/ESP/STATS/bltper_1x1.txt. Accessed 17 Oct 2013

  35. Zar FA, Bakkanagari SR, Moorthi KM, Davis MB (2007) A comparison of vancomycin and metronidazole for the treatment of Clostridium difficile-associated diarrhea, stratified by disease severity. Clin Infect Dis 45:302–307

    Article  CAS  PubMed  Google Scholar 

  36. Greiner W, Weiinen T, Nieuwenhuizen M, Oppe S, Badia X, Busschbach J, Buxton M, Dolan P, Kind P, Krabbe P, Ohinmaa A, Parkin D, Roset M, Sintonen H, Tsuchiya A, de Charro F (2003) A single European currency for EQ-5D health states. Results from a six-country study. Eur J Health Econ 4:222–231

    Article  PubMed  Google Scholar 

  37. Sacristán JA, Oliva J, Del Llano J, Prieto L, Pinto JL (2002) ¿Qué es una tecnología eficiente en España? Gac Sanit 16:334–343

    Article  PubMed  Google Scholar 

  38. Briggs A, Claxton K, Sculpher M (2006) Decision modelling for health economic evaluation. Oxford University Press, Oxford

    Google Scholar 

  39. Rubio-Terrés C, Cobo E, Sacristán JA, Prieto L, del Llano J, Badia X; Grupo ECOMED (2004) Análisis de la incertidumbre en las evaluaciones económicas de intervenciones sanitarias. Med Clin (Barc) 122:668–674

    Article  Google Scholar 

  40. Dubberke ER, Wertheimer AI (2009) Review of current literature on the economic burden of Clostridium difficile infection. Infect Control Hosp Epidemiol 30:57–66

    Article  PubMed  Google Scholar 

  41. Kuijper EJ, Coignard B, Tüll P; ESCMID Study Group for Clostridium difficile; EU Member States; European Centre for Disease Prevention and Control (2006) Emergence of Clostridium difficile-associated disease in North America and Europe. Clin Microbiol Infect 12(Suppl 6):2–18

    Article  CAS  PubMed  Google Scholar 

  42. Wiegand PN, Nathwani D, Wilcox MH, Stephens J, Shelbaya A, Haider S (2012) Clinical and economic burden of Clostridium difficile infection in Europe: a systematic review of healthcare-facility-acquired infection. J Hosp Infect 81:1–14

    Article  CAS  PubMed  Google Scholar 

  43. Konijeti GG, Sauk J, Shrime MG, Gupta M, Ananthakrishnan AN (2014) Cost-effectiveness of competing strategies for management of recurrent Clostridium difficile infection: a decision analysis. Clin Infect Dis 58:1507–1514

    Article  PubMed Central  PubMed  Google Scholar 

  44. Di Bella S, Drapeau C, García-Almodóvar E, Petrosillo N (2013) Fecal microbiota transplantation: the state of the art. Infect Dis Rep 5:43–45

    Article  Google Scholar 

  45. McCune VL, Struthers JK, Hawkey PM (2014) Faecal transplantation for the treatment of Clostridium difficile infection: a review. Int J Antimicrob Agents 43:201–206

    Article  CAS  PubMed  Google Scholar 

  46. Bartsch SM, Umscheid CA, Fishman N, Lee BY (2013) Is fidaxomicin worth the cost? An economic analysis. Clin Infect Dis 57:555–561

  47. Rubio Terrés C (2006) Métodos para la realización de evaluaciones económicas de intervenciones sanitarias. GH Contin 5:302–306

    Google Scholar 

Download references

Acknowledgements

Financial support for this manuscript was provided by Astellas Pharma Spain. Astellas Pharma is the holder of marketing authorisation for fidaxomicin in Spain.

Conflict of interest

A. Toledo and P. Anguita were employees of Astellas Pharma Spain and M. Watt and R. Gani were employees of Astellas Pharma EMEA at the time of preparing this manuscript. C. Rubio-Terrés and D. Rubio-Rodríguez received an honorarium from Astellas Pharma Spain in connection with the development of this manuscript. The remaining authors have no conflicts of interest.

Contributions of the authors

A. Toledo, C. Rubio-Terrés and D. Rubio-Rodríguez made the adaptation of the economic model. C. Rubio-Terrés, D. Rubio-Rodríguez and A. Toledo wrote the first and subsequent versions of the manuscript. All the authors contributed to the fruitful discussion of the results and to the review of the different versions of the manuscript. C. Rubio-Terrés is the guarantor of the overall content of the paper.

Author information

Authors and Affiliations

  1. Health Value, C/-Virgen de Aránzazu, 21, 5°B, 28034, Madrid, Spain

    C. Rubio-Terrés & D. Rubio-Rodríguez

  2. Infectious Diseases Department, Hospital Universitario Ramón y Cajal, Madrid, Spain

    J. Cobo Reinoso

  3. Pharmacy Department (IRYCIS), Hospital del Mar, Barcelona, Spain

    S. Grau Cerrato

  4. Infectious Diseases Department, Hospital Clínic, Barcelona, Spain

    J. Mensa Pueyo

  5. Infectious Diseases Unit, Hospital Universitario La Fe, Valencia, Spain

    M. Salavert Lletí

  6. Astellas Pharma, Madrid, Spain

    A. Toledo & P. Anguita

  7. Astellas Pharma EMEA, London, UK

    M. Watt & R. Gani

Authors
  1. C. Rubio-Terrés
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. J. Cobo Reinoso
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. S. Grau Cerrato
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. J. Mensa Pueyo
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. M. Salavert Lletí
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. A. Toledo
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. P. Anguita
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. D. Rubio-Rodríguez
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. M. Watt
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. R. Gani
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to D. Rubio-Rodríguez.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Rubio-Terrés, C., Cobo Reinoso, J., Grau Cerrato, S. 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 34, 2213–2223 (2015). https://doi.org/10.1007/s10096-015-2472-0

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10096-015-2472-0

Keywords

Search

Navigation