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doi:10.1111/jgh.15483

GASTROENTEROLOGY

Cost-effectiveness analysis of sequential fecal microbiota

transplantation for fulminant Clostridioides difficile infection
Sanchit Gupta,*,† Jinyi Zhu,‡ Thomas R McCarty,*,† Jordan Pruce,* Zain Kassam,§ Colleen Kelly,¶,**
††
Monika Fischer and Jessica R Allegretti*,†
*Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women’s Hospital, †Harvard Medical School, ‡Center for Health Decision Science,
Harvard School of Public Health, Boston, §Finch Therapeutics, Somerville, Massachusetts, ¶Women’s Medicine Collaborative, Lifespan, **Alpert Medical
School, Brown University, Providence, Rhode Island, and ††Division of Gastroenterology, Indiana University, Indianapolis, Indiana, USA

Key words
Clostridioides difficile, Clostridioides difficile
infection, Cost–benefit, Cost-effectiveness
analysis, Fecal microbiota transplantation,
Intestinal microbiota transfer.
Accepted for publication 3 February 2021.
Correspondence
Dr Jessica R Allegretti, 850 Boylston Street,
Suite 201, Chestnut Hill, MA 02467, USA.
Email: jallegretti@bwh.harvard.edu
Declaration of conflict of interest: J. R. A. is a
scientific advisor to OpenBiome and a
consultant for Finch Therapeutics. Z. K. is an
employee and shareholder of Finch
Therapeutics. M. F. and C. K. are scientific
advisors to OpenBiome. S. G., J. Z., T. R. M.,
and J. P. have no conflicts of interest.
Financial support: S. G. was supported by NIH
Training Grant National Institute of Diabetes
and Digestive and Kidney Diseases (NIDDK)
T32DK007533-35.
Abstract
Background and Aim: Fulminant Clostridioides difficile infections (FCDI) account for
8% of cases and substantial healthcare burden. Fecal microbiota transplantation is
recommended for recurrent CDI, but emerging data support use for FCDI. We aimed to
assess the cost-effectiveness of a sequential fecal microbiota transplantation (sFMT)
protocol for FCDI compared with current standard therapy.
Methods: A Markov model simulated patients with FCDI in a 1-year time horizon. The
treatment algorithm for up to three sFMTs, clinical probabilities, and direct costs were used
from published sources. Outcomes were quality-adjusted life years (QALYs) and costs. The
healthcare sector perspective was used with a willingness-to-pay threshold of $100 000 per
QALY.
Results: Sequential fecal microbiota transplantation (FMT) for FCDI was associated with
lower overall cost ($28 309 vs $33 980) and higher QALY (0.765 vs 0.686) compared with
standard therapy. sFMT is cost-effective in 100% of iterations. sFMT remained
cost-effective at cure rates > 44.8% for the first FMT and at stool preparation cost < $6944
per instillation. We find a wide range of efficacies for the first versus second FMT at which
sFMT is still preferred. Value of information analysis estimates the expected value of
perfect information to be low at $1.89 per person, quantified with net monetary benefit.
Conclusions: An sFMT strategy strongly dominates standard therapy, with lower cost and
higher QALY. Sensitivity analysis demonstrates benefit even if FMT cure rates are lower
than expected and when multiple FMTs are required. FMT material in 2020 was priced
at $1695 per treatment but remains cost-effective at a much higher cost.

Introduction Various data indicate that FMT protocols, including

Clostridioides difficile infection (CDI) is a major contributor to
healthcare-associated infections in the USA.1 Up to 8% of patients
progress to fulminant CDI (FCDI), previously termed
severe-complicated CDI, with a 35% mortality rate.2,3 These pa-
tients are characterized by hypotension or shock, ileus, megacolon,
admission to intensive care unit, fever > 38.5 °C, mental status
changes, serum lactate > 2.2 mmol/L, leukocytosis > 35 000 μL,
or signs of end-stage organ failure.4,5 Management of CDI, includ-
ing patients with FCDI, is estimated to require 2.4 million days of
inpatient stay and cost $6.3bn annually.6
Approved treatment options for FCDI are limited to vancomycin
by mouth and/or by rectum, intravenous metronidazole, and possi-
ble colectomy.4 Fecal microbiota transplantation (FMT) is guide-
line recommended only for treating multiple recurrences of CDI
and allowed under Food and Drug Administration enforcement
discretion as an investigational therapy.4 Multiple analyses have
demonstrated cost-effectiveness of this approach in the first and
second recurrence of CDI.7–9
multiple-infusion and pseudomembrane-guided protocols, are
effective for FCDI with decreased colectomy and mortality
rates.10–16 This suggests that FMT may be considered to treat
patients with FCDI. Cost of material from a universal stool bank
has increased over time, raising concerns regarding the
cost-effectiveness of FMT.7 While FMTs can be lifesaving, to
our knowledge, there have been no studies examining the
cost-effectiveness of this approach in FCDI.
Accordingly, we assessed the cost-effectiveness of a sequential
FMT (sFMT) protocol for FCDI compared with standard therapy
using oral vancomycin and intravenous metronidazole, with
colectomy for patients not responding to antibiotics.
Methods
Design. We simulated a hypothetical cohort of adult patients
with median age 65 with FCDI using a Markov model. Patients
meeting the 2018 Infectious Diseases Society of America/Society

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Cost-effectiveness of fecal transplant
for Healthcare Epidemiology of America and 2013 American
College of Gastroenterology criteria for fulminant/severe-
complicated CDI were assessed by two strategies: standard of care
with medical therapy and/or colectomy, and an sFMT protocol for
those not responding to antibiotics.
We utilized TREEAGE PRO 2019 (TreeAge Software, Inc.,
Williamstown, MA) and a healthcare sector perspective. We com-
pared direct costs and quality-adjusted life years (QALYs) of these
strategies over a 1-year time horizon. A secondary analysis was
conducted over a lifetime horizon, using a half-cycle correction,
3% discount rate, and average projected annual health costs.
A willingness-to-pay threshold of $100 000 was considered
cost-effective. We assessed the impact of sFMT on costs, effective-
ness, and cost-effectiveness versus standard therapy for FCDI and
validated our model by comparing predicted colectomy rates and
mortality in standard therapy and sFMT strategies with observed
rates in recent CDI cohorts.11,16,17
Model structure. Figure 1 shows a state-transition diagram
of the model. In the standard therapy treatment algorithm, patients
were treated with oral vancomycin 500 mg four times per day and
intravenous metronidazole 1500 mg/day for 14 days. Patients with
refractory disease underwent colectomy. The treatment algorithm
for up to three sFMTs in addition to antibiotics was adapted from
a published protocol.10 Patients without response after 3 days of
antibiotics underwent FMT via colonoscopy with evaluation for
pseudomembranous colitis. If symptoms persisted after an
additional 3 days of medical treatment, a second FMT was
performed. For patients without improvement after a third 3-day
course of antibiotics and evidence of pseudomembranous colitis,
a third FMT was performed. Patients without pseudomembranes
on initial FMT and without improvement underwent a second
FMT; if there was no improvement, they underwent colectomy.
Patients without response after a third FMT and an additional
3 days of antibiotics underwent colectomy. If an FMT via colonos-
copy was complicated by bowel perforation, the patient underwent
colectomy. Our outcomes included cure, colectomy, or death after
Figure 1 State-transition diagram of a patient with fulminant Clostridiodies difficile infection.
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S Gupta et al.
8 weeks. For this analysis, we did not assess risk of new incident
cases or recurrent CDI after this 8-week period.
Model parameters. Data regarding clinical outcomes, costs,
and utilities were used from published sources (Table 1). Probabil-
ities of FMT efficacy and each sFMT required based on symptoms
or pseudomembranes were calculated for patients with FCDI from
data extracted from Fisher et al. after excluding patients with se-
vere CDI.10 Perforation risk due to diagnostic colonoscopy was
included.21
Published medication costs were used from the
Micromedex/RED BOOK database with a 40% discount to the av-
erage wholesale price as per convention.24,35 Costs per day of
treatment of oral vancomycin 500 mg four times per day and intra-
venous metronidazole 500 mg every 8 h were calculated. Antibi-
otics were administered for 14 days in standard therapy and
3-day courses for sFMT.
Hospitalization cost per day was calculated from economic data
related to CDI and length of stay estimates by weighted averages
from multiple sources.8,10,14,16,18,27 Length of stay for patients re-
ceiving antibiotics has ranged from 12 to 32 days, while length of
stay for patients undergoing FMT has ranged from 9 to 14 days.
We used a conservative estimate of a 14-day hospitalization for
both standard therapy and sFMT, so that expense due to hospital-
ization duration would not skew the analysis. Length of stay was
multiplied by cost per day of hospitalization. Possible costs attrib-
utable to intensive care utilization were not included. Cost of
colectomy was added separately in case of that event.
Data regarding cost of inpatient procedures including colonos-
copy are limited, and despite requirements for posting prices via
the hospital chargemaster, these are unlikely reliable estimates.36
We extrapolated national data for diagnostic colonoscopy cost
from the Centers for Medicare and Medicaid Services using Cur-
rent Procedural Terminology code 45378 to more appropriately es-
timate cost. Cost of FMT stool product was taken from
OpenBiome, the most commonly used stool bank with an
established safety screening process, and included the 2020 cost
S Gupta et al. Cost-effectiveness of fecal transplant

Table 1 Parameter probabilities, costs, and utilities

Parameter Mean Range (95% CI) Distribution Source

Clinical probabilities
18–20
Standard therapy cure 0.623 0.589–0.654 Beta Zilberberg et al., Rokas et al., and Wang et al.
10
Pseudomembranes at FMT #1 0.568 0.408–0.721 Beta Fischer et al.
10
Pseudomembranes at FMT #2 0.235 0.072–0.456 Beta Fischer et al.
10
FMT #2 if no pseudomembranes 0.143 0.032–0.317 Beta Fischer et al.
10
Cure after FMT #1 0.810 0.621–0.943 Beta Fischer et al.
10
Cure after FMT #2 0.770 0.516–0.945 Beta Fischer et al.
10
Cure after FMT #3 0.750 0.292–0.992 Beta Fischer et al.
21
Bowel perforation 0.001 0.00003–0.004 Beta Panteris et al.
10
Death after FMT #1 0.048 0.001–0.168 Beta Fischer et al.
10
Death after FMT #2 0.077 0.002–0.265 Beta Fischer et al.
10
Death after FMT #3 0.250 0.008–0.701 Beta Fischer et al.
22,23
Colectomy survival 0.644 0.610–0.677 Beta Peprah et al. and Dallas et al.
Costs (2019 USD)
24
Vancomycin for 14 days $40.72 $5.42–$43.43 Gamma Micromedex
24
Metronidazole for 14 days $49.68 $9.94–$79.50 Gamma Micromedex
24
Vancomycin for 3 days $15.17 $10.16–$21.16 Gamma Micromedex
24
Metronidazole for 3 days $26.61 $7.99–$56.23 Gamma Micromedex
25,26
FMT via colonoscopy $2339 $1754–$2923 Gamma OpenBiome and CMS
Hospitalization for 14 days $23 784 $20 297–$28 625 Gamma Rajasingham et al., Fischer et al., Ianiro et al.,
8,10,14,27
and McGlone et al.
Hospitalization for 20 days $33 978 $28 995–$40 892 Gamma Rajasingham et al., Ianiro et al., Cheng et al.,
8,14,16,18,27
Zilberberg et al., and McGlone et al.
27
Colectomy $39 047 $31 768–$47 065 Gamma McGlone et al.
Utilities
28,29
Healthy/well (median age 65) 0.88 0.86–0.92 Triangular Tengs and Wallace and Fryback et al.
9,30,31
Fulminant CDI 0.42 0.30–0.57 Triangular Varier et al., Wilcox et al., and Slobogean et al.
Post-colectomy 0.60 0.54–0.79 Triangular Hayes and Hansen, Brown et al.,
32–34
and Punekar and Hawkins
Death 0

CDI, Clostridioides difficile infection; CI, confidence interval; FMT, fecal microbiota transplantation.

adjustment.25,37 To account for inflation, all costs were converted
to 2019 US dollars using the consumer price index inflation calcu-
lator. Beta and gamma distributions were calculated using PARAM-
ETER SOLVER version 3.0 (MD Anderson Cancer Center, Houston,
TX). For sensitivity analysis of costs of FMT via colonoscopy and
colectomy, putative ranges of 25% below and above mean values
were calculated. Utility weights to calculate QALYs were obtained
from published sources. Patients alive at the end of the 1-year time
horizon were assumed to carry average remaining lifetime mortal-
ity risk and healthcare costs.38,39
We conducted a probabilistic sensitivity analysis (PSA) to as-
sess for input uncertainty with 10 000 iterations of a
second-order Monte Carlo simulation. We evaluated probability
distributions of parameter inputs and their impact on model results.
Parameter distributions were calculated and PSA conducted using
a beta distribution for clinical probabilities, gamma distribution for
costs, and triangular distribution for utilities.
Lastly, we conducted a value of information analysis using PSA
for uncertainty distributions and the Sheffield Accelerated Value of
Information to evaluate the value of future research into this
question.40 The estimates describe the expected value of perfect
information (EVPI) and value of removing decision uncertainty.

Sensitivity analysis. Multiple sensitivity analyses were per-

formed. A one-way sensitivity analysis identified the threshold at
which cure rate of the first FMT is cost-effective. We further
assessed the FMT efficacy range with a two-way sensitivity analy-
sis to evaluate cure rates of the first and second FMTs that would
be cost-effective. Additionally, due to increases in cost of FMT
product, we assessed the threshold at which FMT product may
be prohibitively expensive. A secondary, exploratory threshold
analysis for FMT product cost was conducted with adjusted total
hospitalization costs using length of stay of 14 days for sFMT
and 20 days for standard therapy.
Results
Model validation. Our simulation predicted that patients
with FCDI who underwent standard treatment had a colectomy
rate of 15.1% and mortality rate of 15.3%, similar to observed
colectomy rates of 15.7% and mortality rates of 14.8–
21.3%.16,17 Patients with FCDI who underwent sFMT were pre-
dicted to have a colectomy rate of 2.0% and mortality rate 8.5%,
similar to observed colectomy rates after institution of an FMT
program of 0.7–5.5% and mortality rate 9.1%.11,16

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Table 2 Results

Base-case analysis
Treatment Cost QALY ICER
Sequential FMT 28 309 0.765 —
Standard therapy 33 980 0.686 Dominated
Probabilistic sensitivity analysis
Treatment Cost (95% CI) QALY (95% CI) ICER
Sequential FMT 28 402 (23 875–33 477) 0.765 (0.726–0.796) —
Standard therapy 33 960 (28 968–39 322) 0.686 (0.649–0.721) Dominated
One-way sensitivity analysis
1st FMT cure rate > 44.8%
Stool preparation cost < $6944
Stool preparation cost (14- vs 20-day hospitalization) < $15 601
Value of information analysis
Expected value of perfect information $1.89 per person
Value of removing decision uncertainty $942 978
Lifetime horizon analysis
Treatment Cost QALY ICER
Sequential FMT 223 956 16.77 4983
Standard therapy 214 481 14.87 —

CI, confidence interval; FMT, fecal microbiota transplantation; ICER, incremental cost-effectiveness ratio; QALY, quality-adjusted life year.

Figure 2 Net monetary benefit (NMB) evaluates the health benefits compared with incremental cost. Sequential fecal microbiota transplantation is
favored at each willingness-to-pay threshold. , sequential fecal microbiota transplantation; , standard treatment. [Color figure can be viewed at
wileyonlinelibrary.com]

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S Gupta et al. Cost-effectiveness of fecal transplant

Model output. Model output is described in Table 2. The
base-case analysis demonstrates that sFMT for FCDI was associ-
ated with higher QALY (0.765 vs 0.686) and lower overall cost
($28 309 vs $33 980) when compared with standard treatment in
a 1-year time horizon. The net monetary benefit at $100 000 per
QALY is $48 144 for FMT versus $34 602 for standard therapy,
and sFMT is favored at all willingness-to-pay thresholds (Fig. 2).
For the secondary analysis over a lifetime horizon, sFMT has a
higher QALY (16.77 vs 14.87) with higher cost ($223 956 vs
$214 481) compared with standard therapy, with an incremental
cost-effectiveness ratio of $4983 per QALY, far below the
willingness-to-pay threshold of $100 000 per QALY.
Sensitivity analysis. One-way sensitivity analysis demon-
strates that FMT remained cost-effective at cure rates > 44.8%
for the first FMT and at stool preparation cost < $6944 using
14-day hospitalization (Table 2). In the secondary threshold analy-
sis, when a standard treatment hospitalization estimated at 20 days
while an sFMT hospitalization estimated at 14 days, FMT is
cost-effective at stool preparation cost < $15 601. Stool prepara-
tion costs do not include colonoscopy cost. The two-way
sensitivity analysis for efficacy of the first two FMTs demonstrates
a wide range of varying efficacies at which sFMT will be success-
ful (Fig. 3).
The cost-effectiveness acceptability curve from the PSA demon-
strates that sFMT is the preferred strategy in 100% of iterations up
to and far beyond the willingness-to-pay threshold of $100 000
(Fig. 4). The probability FMT that is cost saving is 0.994. With un-
certainty distributions, we find that QALYs gained with sFMT
(0.765, 95% confidence interval [CI] 0.726–0.796) are higher than
standard therapy (0.686, 95% CI 0.649–0.721) and cost is lower
with sFMT ($28 402, 95% CI $23 875–$33 477) than standard
therapy ($33 960, 95% CI $28 968–$39 322). Despite some over-
lap in CIs due to parameter uncertainties in these 10 000 iterations,
we see that sFMT overall maintains a higher QALY and lower cost
(Fig. 5).
Value of information analysis. The EVPI is $1.89 per
person, equivalent to 0.00002 QALYs per person. Assuming that
the annual number of cases of FCDI in the USA is 25 0001,2 and
that FMT may be used for the next 20 years, the overall expected
value of removing decision uncertainty would be $942 978. This is

Figure 3 Two-way sensitivity analysis of cure rates for the first versus second fecal microbiota transplantation (FMT) for fulminant Clostridioides dif-
ficile infection. , sequential FMT; , standard treatment. [Color figure can be viewed at wileyonlinelibrary.com]

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Cost-effectiveness of fecal transplant S Gupta et al.

Figure 4 Cost-effectiveness (CE) acceptability curve for all iterations of a sequential fecal microbiota transplantation versus standard therapy ap-
proach to treat fulminant Clostridiodes difficile infection. , sequential fecal microbiota transplantation; , standard treatment. [Color figure
can be viewed at wileyonlinelibrary.com]

the cost of removing all decision uncertainty regarding which
strategy is cost-effective (Table 2).
Discussion
We provide the first analysis evaluating the cost-effectiveness of
FMT for FCDI. We find that sFMT for FCDI is more effective
and cost saving compared with standard treatment in a 1-year time
horizon, as sFMT strongly dominates standard therapy with lower
cost and higher QALY. Assessed over a lifetime horizon, sFMT in-
creases QALY with a slightly higher cost, likely due to prolonged
life expectancy and associated non-CDI health expenditure due to
longevity. The incremental cost-effectiveness ratio of $4983 per
QALY is below the willingness-to-pay threshold of $100 000 per
QALY, favoring sFMT. In both the 1-year and lifetime horizons,
sFMT is the preferred strategy.
Our model is validated by the close approximation of our 10 000
iteration Monte Carlo simulation to recently described colectomy
and mortality outcomes. Figures 2 and 4 demonstrate that sFMT
is preferred well beyond the willingness-to-pay threshold of
$100 000, consistent with higher expected net benefit for sFMT,
and indicate that there is little decision uncertainty regarding the
preferred strategy. The cost-effectiveness of sFMT is likely due
to increased efficacy of FMT and lower likelihood of requiring
colectomy than with medical therapy.
Accounting for parameter uncertainties using the PSA and sen-
sitivity analyses confirms our findings. SFMT is favored even if
FMT cure rates are as low as 44.8% for the first FMT; actual cure
rates are much higher.10,13,16 Similarly, for those who need two
FMTs, Figure 3 demonstrates wide ranges of cure rates over which
sFMT is still a cost-effective approach. This is supported by the
superiority of an sFMT protocol in direct comparison with a single
FMT for fulminant disease.13 FMT material from a universal stool
bank with established donor screening protocols was priced at
$1595 per treatment in 2019 and increased in price to $1695 per
treatment in 2020, but remains cost-effective even at a much
higher cost, up to at least $6944.25,37
Based on our findings, we determine that sFMT with up to three
treatments remains cost-effective. Notably, only a small number of
patients will require more than three treatments to achieve
cure.10,13 We surmise that even if more than three FMTs are re-
quired for a small proportion of patients, a reduced colectomy rate
would offset the cost of additional FMTs and favor an sFMT strat-
egy. We find that if an sFMT strategy is associated with decreased
hospital length of stay in FCDI, sFMT for FCDI would be even
more cost-effective than our model indicates. The value of infor-
mation analysis demonstrates that the EVPI is quite low at $1.89

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Figure 5 Scatterplot of results from 10 000 iterations of the probabilistic sensitivity analysis. Probabilistic sensitivity analysis results account for pa-
rameter uncertainties and show that the distribution of costs versus quality-adjusted life years (QALYs) overall favor a sequential fecal microbiota trans-
plantation strategy in the treatment of fulminant Clostridiodes difficile infection. , sequential fecal microbiota transplantation; , standard treatment.
[Color figure can be viewed at wileyonlinelibrary.com]

per person with an expected burden of removing decision uncer-
tainty at $942 978. Given the lack of decision uncertainty that
we find, research at this cost or more may not impact treatment
strategy delineation.
There are multiple limitations to our study. First, and most nota-
bly, our parameter estimates rely heavily on one single-center pro-
tocol with small sample size, using only data from patients with
FCDI and excluding patients with severe CDI.10 Our parameter ef-
fect sizes may be skewed by bias and may not be generalizable to
nonexpert centers; nevertheless, this prospective study was felt to
provide a robust basis for our model. This is confirmed by the val-
idation of our outcomes in Monte Carlo simulation with recent,
large cohort data. The PSA helps account for parameter uncer-
tainty, which is also included in the value of information analysis.
Because our findings suggest cost-effectiveness of sFMT despite
the large parameter uncertainty and even if the first FMT cure rates
are low, sFMT may be beneficial in a community without an ex-
pert FMT provider. Furthermore, protocol heterogeneity and lack
of specificity regarding outcomes per each sequential FMT in
FCDI alone in other studies precluded use of these data in our
model.11–13,15 Our analysis is also limited by lack of data to in-
form risk of CDI recurrence after a treatment course, which has
implications for long-term consequences of FMT. This is due to
uncertainty regarding the risk of recurrent CDI after sFMT for pa-
tients with FCDI. While current data suggest that FMT for recur-
rent CDI is associated with lower rates of posttreatment
recurrence than medical therapy, this needs to be studied in pa-
tients who undergo FMT for FCDI.12,41–45
The only risk of FMT we account for is possible perforation via
colonoscopy. Research to ensure long-term safety of FMT is still
being assessed, and so additional possible risks of FMT are not
yet accounted for.46 It appears that the risk of adverse events asso-
ciated with FMT is low, with one case report abstract of a bowel
perforation associated with FMT.47,48 The limited details pub-
lished regarding this case do not specify the method of FMT,
though the authors mention a protocol that appears to utilize
FMT via nasogastric tube only.48–50 Thus, it is unclear if the re-
ported bowel perforation was indeed a consequence of FMT itself,
and we felt that perforation due to diagnostic colonoscopy better
estimated this risk. Still, perforation during FMT is a risk that

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Cost-effectiveness of fecal transplant
requires careful consideration in FCDI and may be more likely in
the absence of sufficient FMT expertise.
There are uncertainties regarding cost data. Because
OpenBiome is currently the only commercially available product
and further sources are not available for comparison, variations re-
garding stool preparation cost are difficult to assess. Additionally,
the cost continues to increase, as safety considerations require rig-
orous screening of stool.37 As OpenBiome can continue providing
FMT material for emergency cases such as FCDI despite the coro-
navirus disease 2019 pandemic at listed prices, we do not antici-
pate immediate price changes that would substantially impact
our findings, especially because we find that sFMT is
cost-effective up to almost $7000 per treatment. We did not in-
clude the cost of rectal vancomycin, recommended for patients
with ileus with variable use.4 Given the low cost of medications
compared with stool, colonoscopy, hospitalization, and colectomy,
cost of possible rectal vancomycin would not likely change any
outcome estimates. Lastly, our assumptions regarding cost of inpa-
tient colonoscopy may underestimate the real cost of the procedure
in the inpatient setting compared with the outpatient setting, which
is otherwise unknown.
Our simulation model is grounded in a real-world protocol and
is the first to evaluate cost-effectiveness of FMT for FCDI and
consider adverse events of FMT via colonoscopy. The value of in-
formation analysis indicates that despite our reliance on limited
data with wide uncertainty guiding parameter estimates of FMT
for FCDI, there is little societal benefit to be gained by pursuing
a randomized clinical trial, which would be fraught with logistic,
cost, and ethical concerns. It is worth noting that recommendations
for maximum medical therapy with oral vancomycin, intravenous
metronidazole, and possibly rectal vancomycin for FCDI have not
been guided by data from randomized controlled trials.4 Moreover,
given our findings, there may be greater risk from a healthcare sec-
tor perspective with standard therapy and forgoing FMT. Despite
the current recommendation for FMT only in multiply recurrent
CDI, we expect that more clinicians will turn to FMT in FCDI,
particularly as more data support its safety and efficacy. Our find-
ings support the growing body of evidence that FMT can be con-
sidered for the treatment of patients with FCDI.
Acknowledgment
The authors would like to thank Professor Myriam Hunink for her
support.
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