Fecal Microbiota Capsules Improve CDI Access Through Specialty Pharmacy Integration

C. diff spore

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A recent quality improvement initiative at Henry Ford Health’s specialty pharmacy demonstrated that integrating oral fecal microbiota spore (FMS) capsules into the health system specialty pharmacy (HSSP) workflow enabled medication access in 56% of patients prescribed the therapy for prevention of recurrent Clostridioides difficile infection (CDI).

Between June 2023 and December 2024, 71 prescriptions for FMS were written for 50 unique adult patients with a median age of 65 years, predominantly insured through Medicare or Medicaid. Notably, 32% were immunocompromised, and 30% had underlying gastrointestinal conditions. The median number of CDI recurrences was 2. Among patients who obtained FMS, 71% received it through the HSSP, with 65% requiring only a single prior authorization. Median time to prior authorization approval was 8 days, and median time to dispensing was 15 days. Copayments varied widely, though 90% of patients paid less than $6.

Investigators identified opportunities to enhance the workflow, including formal infectious diseases pharmacist involvement and improved education for patients and providers on specialty drug processes. The study highlights the potential for specialty pharmacies to improve access to complex therapies like FMS and underscores the importance of integrated pharmacist roles to optimize transitions of care.

Similarly, another study presented at the 2025 MAD-ID meeting highlighted the consistent safety profile of Vowst (fecal microbiota spores) in adults with recurrent CDI, including those with significant comorbidities such as renal impairment, diabetes, cardiac disease, and immunocompromised states. This integrated analysis of two Phase 3 trials demonstrated favorable tolerability across high-risk patient populations, supporting Vowst’s use in routine clinical care.

You can listen to our in-depth interview with Dr. Dianne Nguyen, head of medical affairs at Nestlé Health Science, discussing these findings and their clinical implications: Vowst Maintains Consistent Safety Profile in rCDI Patients With Comorbidities

Reference

1.Boettcher S, Kenney R, Everson N, Kashat I, Soyad A, Tengler G, Ramesh M, Veve M. Early experience with oral fecal microbiota spores (Vowst) at a health system specialty pharmacy: process implementation and improvement. Abstract 75 OR FRS. MAD-ID Meeting. May 28–31, 2025. Orlando, FL.

2.Sims M, Stevens R, Nguyen D, Pullman J, Berenson C. Safety of fecal microbiota spores, live-brpk (formerly SER-109) in participants with recurrent Clostridioides difficile infection and comorbidities: an integrated analysis of Phase 3 trials. Abstract 108 E. MAD-ID Meeting. May 28–31, 2025. Orlando, FL.