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. 2023 Jun;40(6):2784-2800.
doi: 10.1007/s12325-023-02505-1. Epub 2023 Apr 24.

Cost-Effectiveness Analysis of REBYOTA™ (Fecal Microbiota, Live-jslm [FMBL]) Versus Standard of Care for the Prevention of Recurrent Clostridioides difficile Infection in the USA

Thomas Lodise  1 , Amy Guo  2 , Min Yang  3 , Erin E Cook  3 , Wei Song  3 , Danni Yang  3 , Qingyuan Wang  4 , Angela Zhao  3 , Markian Bochan  5
Affiliations

Cost-Effectiveness Analysis of REBYOTA™ (Fecal Microbiota, Live-jslm [FMBL]) Versus Standard of Care for the Prevention of Recurrent Clostridioides difficile Infection in the USA

Thomas Lodise et al. Adv Ther. 2023 Jun.

Abstract

Introduction: Recurrent Clostridioides difficile infection (rCDI) is common and associated with considerable clinical and economic consequences. REBYOTA™ (fecal microbiota, live-jslm [FMBL]) is a microbiota-based live biotherapeutic approved for the prevention of rCDI following antibiotic treatment for rCDI. We sought to evaluate cost-effectiveness of FMBL compared to standard of care (SOC) from a US third-party payer perspective among patients with one or more (≥ 1) recurrences.

Methods: A Markov model with a lifetime time horizon was developed. The model population included adult patients who had ≥ 1 recurrence after a primary CDI episode and had completed ≥ 1 round of antibiotics, or had ≥ 2 severe CDI episodes resulting in hospitalization within the last year. The model consisted of six health states with an 8-week model cycle: rCDI, absence of CDI after recurrence, colectomy, ileostomy, ileostomy reversal, and death. Drug costs and rCDI-related medical costs were estimated in 2022 US dollars and discounted at 3% annually. Deterministic sensitivity analyses were performed.

Results: Compared to SOC, FMBL at $9000/course resulted in an incremental cost-effectiveness ratio (ICER) of $18,727 per quality-adjusted life year (QALY) gained. The incremental cost was $5336 (FMBL $79,236, SOC $73,900) and the incremental effectiveness was 0.285 QALYs (FMBL 10.346, SOC 10.061). The cumulative drug acquisition and administration costs for the FMBL and SOC arms were $24,245 and $16,876, while rCDI-related medical costs for FMBL and SOC were $54,991 and $57,024, respectively. The ICER in the subgroup of patients at first recurrence was $13,727 per QALY gained. FMBL remained cost-effective across all sensitivity analyses.

Conclusions: FMBL was found to be cost-effective compared to SOC for the prevention of rCDI with more benefits among patients at first recurrence, with an ICER far below the payer ICER threshold of $100,000. Patients treated with FMBL experienced higher total QALYs and reduced healthcare resource utilization, including reduced hospitalizations.

Keywords: Cost-effectiveness analysis; Economic modeling; FMBL; Live fecal microbiota; REBYOTA; Recurrent Clostridioides difficile infection.

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Conflict of interest statement

Authors have a conflict of interest. Amy Guo is an employee of Ferring Pharmaceuticals, Inc. Min Yang, Erin Cook, Wei Song, Danni Yang, Qingyuan Wang, and Angela Zhao are employees of Analysis Group, which received funding from Ferring Pharmaceuticals, Inc. to conduct this study. Thomas Lodise and Markian Bochan received consulting fees from Ferring Pharmaceuticals, Inc. related to the submitted work.

Figures

Fig. 1
Fig. 1
Model schematic. CDI C. difficile infection, rCDI recurrent C. difficile infection
Fig. 2
Fig. 2
Tornado diagram based on DSA/scenario analyses among patients with one or more rCDI. formula image Decrease in input value; formula image Increase in input value. CI confidence interval, CDI C. difficile infection, DSA deterministic sensitivity analyses, FMBL fecal microbiota, live-jslm, ICER incremental cost-effectiveness ratio, QALY quality-adjusted life year, rCDI recurrent C. difficile infection, SOC standard of care
See this image and copyright information in PMC

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