Fecal Microbiota Therapy Potentially Cost-effective at Preventing Recurrent CDI

A fecal microbiota–based therapy for recurrent Clostridioides difficile infection (rCDI) is cost-effective, according to a new analysis, due to its ability to prevent health care costs associated with treating infection recurrences.

The analysis concerns Rebyota (fecal microbiota-live jslm; FMBL), a therapy manufactured from stool samples from prescreened donors. The therapy is part of a wave of new research into the therapeutic potential of fecal microbiota transplants (FMTs), with the theory behind such products being that by using fecal matter from people with healthy gut microbiomes, the product can help restore the recipient’s gut flora to prevent further infections.

Last November,¹ Rebyota became the first fecal microbiota product approved by the FDA. Peter Marks, MD, PhD, who directs the agency’s Center for Biologics Evaluation and Research, called the approval an “important milestone” in the battle against CDI.

An analysis of clinical trial data suggested that FMBL was 70.6% successful at preventing CDI recurrences within 8 weeks compared with a success rate of 57.5% in the placebo group.²

The new poster was presented at AMCP 2023 in San Antonio, with the study investigators noting that as many as 35% of people who experience CDI will experience rCDI. Those who experience a recurrence have a 65% chance of additional recurrences, they added.

The investigators developed a model to estimate the budget impact of using FMBL over 1 to 3 years, which they then compared with the standard of care, which is antibiotic therapy without a preventive element.

To estimate the potential costs associated with rCDI treatment, they used previously published data related to hospitalizations, stool tests, colectomies, and ileostomy reversal. They then estimated that FMBL would have a 5% market share in its first year and increase to 20% market share by its third year.

Using an estimate that 468 people from a health plan of 1 million members would experience CDI recurrence each year, and using a price of $9000 per course of FMBL therapy, the investigators found FMBL would ultimately lower the costs to the health plan by an average of $0.0039 per member per month (PMPM) and by $8.30 per treated member per month (PTMPM). Over years 1 to 3, they estimated that the plan would save $139,865. As expected, the model showed that using FMBL would lead to higher initial drug costs but that those costs would be offset over time by lower medical costs associated with rCDI.

When the investigators refined their data to look only at the estimated 164 patients in the model who would be experiencing their first recurrence, they found plans could garner even greater cost savings by using FMBL rather than the standard of care. The plan would save $0.0139 PMPM and $84.78 on a PTMPM basis.

Overall, the plan would save $500,022 over 1 to 3 years, the authors found.

Such data points could be an important factor as health plans consider which therapies to add to their formularies. Rebyota is manufactured by Ferring Pharmaceuticals, which funded the study.

Reference

1. FDA approves first fecal microbiota product. News release. FDA. November 30, 2022. Accessed April 10, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-first-fecal-microbiota-product

2. Lodise T, Guo A, Yang M, et al. Budget impact analysis of Rebyota (fecal microbiota, live-jslm [FMBL]) for preventing recurrent Clostridioides difficile infection in the US. Poster presented at: AMCP 2023; March 21-24, 2023; San Antonio, TX. Accessed April 10, 2022.