FMT Is Cost Effective for Any Recurrent Clostridioides Difficile Infection, Study Says - AJMC.com Managed Markets Network

Research found fecal microbiota transplantation (FMT) to be an optimal cost-effective treatment strategy for first and subsequent recurrent Clostridioides difficile infection (CDI), challenging current guidelines.

A study published in Clinical Infectious Diseases found that fecal microbiota transplantation (FMT) is an optimal cost-effective treatment for first recurrent Clostridioides difficile infection (CDI).

C difficile infection is the most common cause of health care–associated infection in adults in the United States and is the most common hospital-acquired intestinal infection worldwide.

FMT is known to be a highly effective and cost-effective treatment for second or subsequent recurrent CDI with a pooled success rate of 92%.

As CDI-attributable hospital length of stay and costs double with recurrent CDI episodes, researchers sought to understand FMT as a strategy to mitigate CDI recurrence earlier, reducing hospitalizations and cost.

Researchers from the University of Minnesota Medical School used mathematical modeling to understand the effectiveness and cost effectiveness of FMT in the treatment of CDI and first recurrent CDI.

A Markov model was used to estimate costs, effectiveness, and cost-effectiveness of different CDI treatment regimens recommended in the 2021 Infectious Disease Society of America (IDSA) guidelines for a simulated cohort of patients.

The expected cost and effectiveness of all 120 potential treatment strategies were evaluated.

The study found that FMT was cost effective for first and subsequent CDI recurrence 90% of the time given parameter uncertainty.

Researchers used a sensitivity analysis defining a prevention threshold that can be generalized across therapies. "At the current estimated cost of around $3,230, as long as the probability of cure of FMT is >69% then FMT is cost-effective for first recurrent CDI," wrote the authors.

CDI is often treated with antibiotics, including fidaxomicin for initial, non-severe CDI or vancomycin for severe CDI, followed by FMT for any recurrent CDI.

The study found that the most effective strategy was the use of fidaxomicin for non-severe initial CDI, vancomycin for severe CDI, FMT for first recurrence, and FMT for subsequent recurrences.

As this strategy had an incremental cost-effectiveness ratio of $27,135 per quality-adjusted life year (QALY) falling below the typical US willingness-to-pay threshold of $100,000 per QALY gained, the strategy was determined to be an optimal CDI treatment strategy from a cost-effectiveness standpoint.

By suggesting that FMT is a cost-effective strategy for recurrent CDI, these results challenge the current guideline recommendations to use FMT as a last resort for people with recurrent CDI.

This study did face limitations. Individuals at a particularly high risk of recurrence, such as individuals with inflammatory bowel disease or organ transplant, were not considered.

FMT is not an approved FDA therapy, and clinical implications regarding transmission of infectious agents were not included in the model as such implications are unclear.

Additionally, the model used assumed FMT is administered via colonoscopy.

However, the authors note that FMT via capsule likely has similar efficacy with a lower cost, which may make the evaluation of FMT for first recurrent CDI more favorable.

"FMT should be moved earlier in the treatment algorithm for CDI. Our model suggests it is effective and cost effective when used in patients after a single episode of recurrent CDI," Radha Rajasingham, MD, co-investigator and assistant professor of medicine at the edical school and an infectious disease physician at M Health Fairview, said in a statement.

Study authors recommend prospective research examining the role of FMT to prevent all recurrent CDI and as a primary prevention of CDI in high-risk individuals.

Research

Aby ES, Vaughn B, Enns EA, Rajasingham, R. Cost-effectiveness of fecal microbiota transplantation for first recurrent Clostridioides difficile infection. Clin Infect Dis. Published online March 11, 2022. doi:10.1093/cid/ciac207