Cost-Effectiveness of Microbiota Restoration Therapies for Recurrent Clostridioides difficile Infection

Area of Science:

• Health Economics
• Infectious Diseases
• Microbiome Therapeutics

Background:

• Recurrent Clostridioides difficile infection (rCDI) presents significant morbidity and healthcare costs.
• FDA-approved microbiota-based therapies, fecal microbiota spores, live-brpk (VOS) and fecal microbiota, live-jslm (RBL), can reduce rCDI recurrence.
• The optimal timing and cost-effectiveness of integrating these therapies into rCDI treatment pathways require evaluation.

Purpose of the Study:

• To conduct a U.S. payer-perspective cost-effectiveness analysis of microbiota-based therapies for rCDI.
• To compare the cost-effectiveness of VOS and RBL initiated after the first or second recurrence versus standard-of-care (SoC).
• To evaluate the impact of early versus delayed initiation of microbiota-based therapies on health outcomes and costs.

Main Methods:

• Decision-tree modeling adhering to CHEERS 2022 guidelines.
• Inclusion of adult patients with rCDI after their first or second recurrence.
• Effectiveness data sourced from pivotal trials (ECOSPOR III/IV for VOS, PUNCH CD3/CD3-OLS for RBL) and literature for SoC comparators.
• Analysis of costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) using a $150,000/QALY willingness-to-pay threshold.

Main Results:

• After the first recurrence, RBL was cost-effective versus SoC ($25,415/QALY).
• Early initiation of both VOS ($27,239/QALY) and RBL ($26,704/QALY) was favorable compared to delayed use.
• After the second recurrence, VOS remained cost-effective ($53,983/QALY), while RBL exceeded the willingness-to-pay threshold ($171,496/QALY).
• Exploratory cross-trial comparisons indicated threshold-sensitive cost-effectiveness between VOS and RBL.

Conclusions:

• Earlier initiation of microbiota-based therapies after the first CDI recurrence improves health benefits and is cost-effective.
• These findings support the earlier integration of VOS and RBL into rCDI treatment strategies.
• Direct comparisons between VOS and RBL are exploratory and require further real-world or head-to-head data.