Hostname: page-component-78c5997874-t5tsf Total loading time: 0 Render date: 2024-11-17T17:20:07.019Z Has data issue: false hasContentIssue false

Cost-effectiveness of three different strategies for the treatment of first recurrent Clostridium difficile infection diagnosed in a community setting

Published online by Cambridge University Press:  02 July 2018

Simon W. Lam*
Affiliation:
Department of Pharmacy, Cleveland Clinic, Cleveland, Ohio
Elizabeth A. Neuner
Affiliation:
Department of Pharmacy, Cleveland Clinic, Cleveland, Ohio
Thomas G. Fraser
Affiliation:
Department of Infectious Diseases, Cleveland Clinic, Cleveland, Ohio
David Delgado
Affiliation:
Thomas Jefferson University, Philadelphia, Pennsylvania
Donald B. Chalfin
Affiliation:
Thomas Jefferson University, Philadelphia, Pennsylvania
*
Author for correspondence: Simon W. Lam, Cleveland Clinic, Department of Pharmacy, 9500 Euclid Avenue, JJN-01, Cleveland, OH 44195. E-mail: [email protected]

Abstract

Objective

A significant portion of patients with Clostridium difficile infections (CDI) experience recurrence, and there is little consensus on its treatment. With the availability of newer agents for CDI and the added burdens of recurrent disease, a cost-effectiveness analysis may provide insight on the most efficient use of resources.

Design

A decision-tree analysis was created to compare the cost-effectiveness of 3 possible treatments for patients with first CDI recurrence: oral vancomycin, fidaxomicin, or bezlotoxumab plus vancomycin. The model was performed from a payer’s perspective with direct cost inputs and a timeline of 1 year. A systematic review of literature was performed to identify clinical, utility, and cost data. Quality-adjusted life years (QALY) and incremental cost-effectiveness ratios were calculated. The willingness-to-pay (WTP) threshold was set at $100,000 per QALY gained. The robustness of the model was tested using one-way sensitivity analyses and probabilistic sensitivity analysis.

Results

Vancomycin had the lowest cost ($15,692) and was associated with a QALY gain of 0.8019 years. Bezlotoxumab plus vancomycin was a dominated strategy. Fidaxomicin led to a higher QALY compared to vancomycin, at an incremental cost of $500,975 per QALY gained. Based on our WTP threshold, vancomycin alone was the most cost-effective regimen for treating the first recurrence of CDI. Sensitivity analyses demonstrated the model’s robustness.

Conclusions

Vancomycin alone appears to be the most cost-effective regimen for the treatment of first recurrence of CDI. Fidaxomicin alone led to the highest QALY gained, but at a cost beyond what is considered cost-effective.

Type
Original Article
Copyright
© 2018 by The Society for Healthcare Epidemiology of America. All rights reserved. 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1. Loo, VG, Poirier, L, Miller, MA, et al. A predominantly clonal multi-institutional outbreak of Clostridium difficile–associated diarrhea with high morbidity and mortality. N Engl J Med 2005;353:24422449.Google Scholar
2. Peery, AF, Dellon, ES, Lund, J, et al. Burden of gastrointestinal disease in the United States: 2012 update. Gastroenterology 2012;143:11791187.Google Scholar
3. Bouza, E. Consequences of Clostridium difficile infection: understanding the healthcare burden. Clin Microbiol Infect 2012;18(Suppl 6):512.Google Scholar
4. Kwon, JH, Olsen, MA, Dubberke, ER. The morbidity, mortality, and costs associated with Clostridium difficile infection. Infect Dis Clin North Am 2015;29:123134.Google Scholar
5. McDonald, LC, Gerding, DN, Johnson, S, et al. Clinical practice guidelines for Clostridium difficile Infection in adults and children: 2017 update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clin Infect Dis 2018;66:987994.Google Scholar
6. Lessa, FC, Mu, Y, Bamberg, WM, et al. Burden of Clostridium difficile infection in the United States. N Engl J Med 2015;372:825834.Google Scholar
7. Aslam, S, Hamill, RJ, Musher, DM. Treatment of Clostridium difficile-associated disease: old therapies and new strategies. Lancet Infect Dis 2005;5:549557.Google Scholar
8. Kelly, CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect 2012;18(Suppl 6):2127.Google Scholar
9. Debast, SB, Bauer, MP, Kuijper, EJ. for the European Society of Clinical Microbiology and Infectious Diseases. Update of the treatment guidance document for Clostridium difficile infection. Clin Microbiol Infect 2014;20(Suppl 2):126.Google Scholar
10. Sheitoyan-Pesant, C, Abou Chakra, CN, Pepin, J, Marcil-Heguy, A, Nault, V, Valiquette, L. Clinical and healthcare burden of multiple recurrences of Clostridium difficile infection. Clin Infect Dis 2016;62:574580.Google Scholar
11. Wilcox, MH, Gerding, DN, Poxton, IR, et al. Bezlotoxumab for prevention of recurrent Clostridium difficile infection. N Engl J Med 2017;376:305317.Google Scholar
12. Baro, E, Galperine, T, Denies, F, et al. Cost-effectiveness analysis of five competing strategies for the management of multiple recurrent community-onset Clostridium difficile infection in France. PLoS One 2017;12:e0170258.Google Scholar
13. Konijeti, GG, Sauk, J, Shrime, MG, Gupta, M, Ananthakrishnan, AN. Cost-effectiveness of competing strategies for management of recurrent Clostridium difficile infection: a decision analysis. Clin Infect Dis 2014;58:15071514.Google Scholar
14. 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:e0149521.Google Scholar
15. Varier, RU, Biltaji, E, Smith, KJ, et al. Cost-effectiveness analysis of fecal microbiota transplantation for recurrent Clostridium difficile infection. Infect Control Hosp Epidemiol 2015;36:438444.Google Scholar
16. Prabhu, VS, Dubberke, ER, Dorr, MB, et al. Cost-effectiveness of bezlotoxumab compared with placebo for the prevention of recurrent Clostridium difficile infection. Clin Infect Dis 2018;66:355362.Google Scholar
17. Briggs, AH, Weinstein, MC, Fenwick, EA, et al. Model parameter estimation and uncertainty: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force–6. Value Health 2012;15:835842.Google Scholar
18. Eddy, DM, Hollingworth, W, Caro, JJ, et al. Model transparency and validation: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force—7. Value Health 2012;15:843850.Google Scholar
19. Roberts, M, Russell, LB, Paltiel, AD, et al. Conceptualizing a model: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force—2. Value Health 2012;15:804811.Google Scholar
20. Siebert, U, Alagoz, O, Bayoumi, AM, et al. State-transition modeling: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force—3. Value Health 2012;15:812820.Google Scholar
21. Johnson, S, Gerding, DN. Fecal fixation: fecal microbiota transplantation for Clostridium difficile infection. Clin Infect Dis 2017;64:272274.Google Scholar
22. Cornely, OA, Miller, MA, Louie, TJ, Crook, DW, Gorbach, SL. Treatment of first recurrence of Clostridium difficile infection: fidaxomicin versus vancomycin. Clin Infect Dis 2012;55(Suppl 2):S154S161.Google Scholar
23. Bhangu, A, Nepogodiev, D, Gupta, A, Torrance, A, Singh, P. West Midlands Research C. Systematic review and meta-analysis of outcomes following emergency surgery for Clostridium difficile colitis. Br J Surg 2012;99:15011513.Google Scholar
24. Cammarota, G, Masucci, L, Ianiro, G, et al. Randomised clinical trial: faecal microbiota transplantation by colonoscopy vs vancomycin for the treatment of recurrent Clostridium difficile infection. Aliment Pharmacol Ther 2015;41:835843.Google Scholar
25. Hota, SS, Sales, V, Tomlinson, G, et al. Oral Vancomycin followed by fecal transplantation versus tapering oral vancomycin treatment for recurrent Clostridium difficile infection: an open-label, randomized controlled trial. Clin Infect Dis 2017;64:265271.Google Scholar
26. Hayes, JL, Hansen, P. Is laparoscopic colectomy for cancer cost-effective relative to open colectomy? ANZ J Surg 2007;77:782786.Google Scholar
27. Tengs, TO, Wallace, A. One thousand health-related quality-of-life estimates. Med Care 2000;38:583637.Google Scholar
28. Mullins, CD, Seal, B, Seoane-Vazquez, E, et al. Good research practices for measuring drug costs in cost-effectiveness analyses: Medicare, Medicaid and other US government payers perspectives: the ISPOR Drug Cost Task Force report—Part IV. Value Health 2010;13:1824.Google Scholar
29. Micromedex Red Book [online database]. Truven Health Analytics website. https://truvenhealth.com/Portals/0/Assets/Brochures/International/INTL_12543_0413_RedbookPS_WEB1.pdf. Published 2013. Accessed October 1, 2017.Google Scholar
30. Services DoHaHSCfMM. Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017 2017; https://www.gpo.gov/fdsys/pkg/FR-2016-11-15/pdf/2016-26668.pdf. Published 2016. Accessed May 22, 2018.Google Scholar
31. Briggs, AH, Goeree, R, Blackhouse, G, O’Brien, BJ. Probabilistic analysis of cost-effectiveness models: choosing between treatment strategies for gastroesophageal reflux disease. Med Decis Making 2002;22:290308.Google Scholar
32. Marsh, JW, Arora, R, Schlackman, JL, Shutt, KA, Curry, SR, Harrison, LH. Association of relapse of Clostridium difficile disease with BI/NAP1/027. J Clin Microbiol 2012;50:40784082.Google Scholar