TOPLINE

In a short-term cost analysis from the perspective of a US health insurer, fecal microbiota, live-jslm (RBL) was cost-effective compared with standard antibiotic therapy after a first recurrence of Clostridioides difficile infection (CDI), and starting treatment early with either RBL or fecal microbiota spores, live-brpk (VOS) offered better economic value than delaying treatment. At the second recurrence, VOS remained cost-effective relative to standard of care (SoC), whereas RBL no longer did.

METHODOLOGY

• Although FDA-approved microbiota-based therapies help prevent recurrent CDI, the optimal timing of their use and the economic impact of early vs delayed initiation remain uncertain, prompting researchers to conduct a cost-effectiveness analysis from a US payer perspective.
• The cost analysis, based on clinical trial data, compared FDA-approved microbiota therapies (RBL and VOS) with SoC antibiotics at recurrence, directly assessing RBL after the first recurrence and both therapies after the second, and examined whether starting treatment at the first recurrence offered better value than delaying treatment until later recurrences.
• A decision-tree model followed up patients from their first or second CDI recurrence — tracking recovery, subsequent recurrence, surgery, or death — through up to the fourth episode. Costs and outcomes were estimated by the model over less than 1 year, based on clinical trial follow-up durations, and each CDI episode was assumed to last about 2 weeks.
• The model included patients aged 18 years or older who experienced at least one recurrent CDI after an initial episode, had active symptomatic and laboratory-confirmed infection, and received SoC antibiotic treatment with vancomycin or fidaxomicin.
• The primary health outcome was quality-adjusted life-years (QALYs), estimated by combining how long and how well patients lived across different health states (active recurrent CDI, no CDI, colectomy, and postcolectomy states); costs included the prices of the drugs themselves (VOS, RBL, and antibiotics) plus related medical care.

TAKEAWAY

• When RBL was initiated after the first CDI recurrence, it was associated with more QALYs than SoC alone (0.4251 vs 0.2482), yielding an incremental cost-effectiveness ratio (ICER) of $25,415 per QALY gained. RBL use after the second recurrence yielded an ICER of $171,496 per QALY gained, exceeding the commonly applied willingness-to-pay threshold of $150,000.
• VOS treatment after the second CDI recurrence resulted in more QALYs than SoC alone (0.4172 vs 0.3785) at a higher cost ($38,103 vs $36,019), yielding an ICER of $53,983 per QALY gained.
• Early initiation of VOS after the first CDI recurrence was associated with more QALYs than initiation after the second recurrence (0.4471 vs 0.3463) at a higher cost ($23,241 vs $20,493), yielding an ICER of $27,239 per QALY gained. Likewise, early initiation of RBL after the first CDI recurrence was more cost-effective than initiation after the second recurrence, yielding an ICER of $26,704 per QALY gained.
• In an exploratory indirect comparison, VOS was associated with more QALYs than RBL after the first recurrence (0.4471 vs 0.4251) but at a greater cost ($23,241 vs $20,499), yielding an ICER of $124,636 per QALY gained. In the second-recurrence analysis, VOS provided a slightly greater health benefit than RBL at a higher cost, yielding an ICER of about $137,350 per QALY, which was above $100,000 but below $150,000.

IN PRACTICE

“This short-term focus better reflects real-world clinical decision-making, in which recurrence risk is concentrated rather than averaged over extended follow-up. In that context, our results suggest that stepwise escalation strategies that defer microbiota restoration may be economically inefficient as they allow accumulation of recurrence-related costs and quality-of-life loss that accrue early in the rCDI [recurrent C difficile infection] disease course,” the authors of the study wrote.

SOURCE

The study was led by Parul Berry, MBBS, Mayo Clinic, Rochester, Minnesota. It was published online in The American Journal of Gastroenterology.

LIMITATIONS

The study excluded indirect costs such as productivity losses or caregiver burden. Comparisons between VOS and RBL were based on data from separate clinical trial programs. The model’s short-term time horizon may have underestimated the long-term benefits of preventing recurrence.

DISCLOSURES

The study did not receive any financial support. Two authors disclosed receiving research grants and consulting fees from various biotechnology and pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.