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

Abstract

Introduction: Recurrent Clostridioides difficile infection (rCDI) is common and associated with considerable clinical and economic consequences. REBYOTA TM (fecal microbiota, livejslm [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 (C 1) recurrences. Methods: A Markov model with a lifetime time horizon was developed. The model population included adult patients who had C 1 recurrence after a primary CDI episode and had completed C 1 round of antibiotics, or had C 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.

Efficacy of Fecal Microbiota (REBYOTA) in Recurrent Clostridium difficile Infections: A Systematic Review and Meta-Analysis

“…Various studies have demonstrated the costeffectiveness and impact on quality of life of RBX2660 (REBYOTA). A study consisting of adult patients with ≥ 1 recurrence after a primary CDI and who had completed ≥ 1 round of antibiotics or had ≥ 2 severe CDI concluded that RBX2660 (REBYOTA) was cost-effective across all sensitivity analyses compared to the standard of care in preventing recurrent CDI [22]. Furthermore, other studies have demonstrated that treatment of recurrent CDI with RBX2660 (REBYOTA) improved patients' quality of life.…”

“…It must be administered as a rectal suspension and shipped frozen to pharmacies in a ready-to-administer enema bag. Furthermore, RBX2660 (REBYOTA) costs around $9500 per course in 2023, which may be a barrier, but economic analysis suggested that it is cost-effective compared to the standard of care [22]. RBX2660 (REBYOTA) significantly reduces recurrent CDI, but the cost may be a barrier to access and limit its use in the general population.…”

The intestinal microbiota as an ally in the treatment of Alzheimer’s disease

“…Furthermore, the Federal Drug Administration (FDA) recently approved the rectal administration of a probiotic suspension to prevent recurrent C. difficile infection. The technique is also more cost-effective when compared to traditional treatment (i.e., prolonged use of antibiotics, without subsequent administration of the probiotic suspension; Lodise et al, 2023;Walter and Shanahan, 2023).…”