Budget Impact Analysis of REBYOTA™ (Fecal Microbiota, Live-jslm [FMBL]) for Preventing Recurrent Clostridioides difficile Infection in the US

Abstract

Introduction: Patients with Clostridioides difficile infection (CDI) often experience recurrences (rCDI), which are associated with high morbidity, mortality, and healthcare expenditures. REBYOTA TM (fecal microbiota, live-jslm [FMBL]) is a microbiota-based live biotherapeutic approved for the prevention of rCDI following antibiotic treatment for rCDI. We quantified the budget impact of FMBL during the first 3 years following introduction from a thirdparty US payer perspective. Methods: A decision-tree model was used to estimate the budget impact of one-course FMBL by comparing costs under the scenario with FMBL to the scenario without FMBL (standard of care) in patients with one or more (C 1) recurrences after a primary episode of CDI and had completed C 1 round of antibiotic treatments. Drug costs, rCDI-related medical costs, and budget impact over 1-3 years were estimated in 2022 US dollars. One-way sensitivity analyses were performed. Results: For an insurance plan with a population size of 1,000,000, 468 patients per year were estimated to have C 1 rCDI. The budget impact of one-course FMBL at $9000/course was cost-saving at an» average of -$0.0039 on a permember-per-month (PMPM) basis, an average of -$8.30 on a per-treated-member-per-month (PTMPM) basis, and a total of -$139,865 on a plan level assuming 5%, 15%, and 20% of patients receive FMBL over 1-3 years, respectively. The scenario with FMBL entry was associated with higher drug costs

Prescription Microbiome Therapeutic for Recurrent Clostridioides difficile Infection: Fecal Microbiota Live-jslm

“…The treatment was deemed to be cost-effective across sensitivity analyses (25). A similar budget impact analysis demonstrated cost savings for payers (26).…”

Microbiota-Based Live Biotherapeutic Products for Clostridioides Difficile Infection- The Devil is in the Details

“… 45 , 136 Budget impact analysis of potential cost savings for new LBPs is already being published. 137 Similar analyses advocating for bezlotoxumab have been performed and yet pharmacy budgets have not been increased to account for inpatient use and payors continue to impede prescribing it without prior authorization. 138 , 139 Whether an increased number of therapeutic options for rCDI will influence the costs of existing agents on the market remains to be seen.…”

Therapeutic Approach Targeting Gut Microbiome in Gastrointestinal Infectious Diseases

“…An FMT product, "Rebyota", is currently available for recurrent CDI treatment and has been approved by the Food and Drug Administration (FDA) in 2022 [86]. Rebyota is also expected to reduce medical expenses for recurrent CDI patients [87].…”