Infection Control & Hospital Epidemiology (2018), 39, 924–930 doi:10.1017/ice.2018.139
Original Article
Cost-effectiveness of three different strategies for the treatment of first recurrent Clostridium difficile infection diagnosed in a community setting
Simon W. Lam PharmD, MS-AHEOR, FCCM1, Elizabeth A. Neuner PharmD, BCPS (AQ-ID)1, Thomas G. Fraser MD2,
David Delgado PhD3 and Donald B. Chalfin MD, MS, MPH, FCCP, FCCM3 1Department of Pharmacy, Cleveland Clinic, Cleveland, Ohio, 2Department of Infectious Diseases, Cleveland Clinic, Cleveland, Ohio and 3Thomas Jefferson University, Philadelphia, Pennsylvania
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.
(Received 20 February 2018; accepted 16 May 2018; electronically published July 2, 2018)
Clostridium difficile infection (CDI) is the leading cause of healthcare-associated diarrhea in the United States leading to significant morbidity and mortality.1,2 The economic burden associated with CDI is estimated to be $1.2–$5.9 billion annually in United States, with similar burdens observed in Europe.3,4 For a first episode of CDI, the standard of treatment is either oral vancomycin or fidaxomicin.5 However, when CDI recurs, the treatment approach is less clear. Recurrence is common, with reported rates ranging from 5% to 50% for healthcare-associated CDI, and most studies reporting between 10% and 30%.6,7 Fur- thermore, recurring patients have a higher risk for subsequent recurrences, which may contribute to diminished quality of life and further financial burden on the healthcare system.8 Evidence supporting the use of different treatments for
recurrent CDI is lacking. Current European Society of Clinical Microbiology and Infectious Diseases guidelines recommend treating the first recurrence of CDI with either oral vancomycin
Author for correspondence: Simon W. Lam, Cleveland Clinic, Department of Pharmacy, 9500 Euclid Avenue, JJN-01, Cleveland, OH 44195. E-mail:
lams@ccf.org Cite this article: Simon W. Lam et al. (2018). Cost-effectiveness of three different
strategies for the treatment of first recurrent Clostridium difficile infection diagnosed in a community setting. Infection Control & Hospital Epidemiology 2018, 39, 924–930. doi: 10.1017/ice.2018.139
© 2018 by The Society for Healthcare Epidemiology of America. All rights reserved.
or oral fidaxomicin9; whereas the Infectious Disease Society of America Guidelines recommend treatment of first recurrence of CDI with either vancomycin, vancomycin taper, or fidaxomicin.10 For subsequent recurrences, the IDSA guidelines also mention the possibility of using tapered doses of oral vancomycin, fidax- omicin, or FMT.5 Recently, bezlotoxumab was FDA approved to reduce the recurrence of CDI, when used in combination with other CDI treatments. In a report of two phase 3 clinical studies, bezlotoxumab was associated with substantially lower rates of recurrent infection than placebo (MODIFY I: 17% vs 28%, P<.001; MODIFY II: 16 vs 26%, P<.001).11 Although bezlotoxumab is associated with lower rates of
recurrence, it is associated with substantial cost, approximately $4,500 per patient course. Given the substantial cost associated with the treatment, the lack of guideline consistency for the treatment of recurrent CDI, and the paucity of studies comparing existing therapies for the treatment of recurrent disease, a cost-effectiveness analysis (CEA) may be helpful to elucidate which regimen repre- sents the most efficient use of resources. Several CEAs have been performed regarding treatments of recurrent CDI12–16;however, only 1 has included bezlotoxumab as a treatment option, and this CEA did not specifically evaluate its use for recurrent CDI.16 As such, more cost-effectiveness data are necessary.
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