Clinical Experience with Oral Fecal Microbiota Spores (Vowst®) in a Health System Specialty Pharmacy.

PURPOSE: To describe clinical experience and patient outcomes with orally administered fecal microbiota spore (FMS) capsules, live-brpk, for prevention of recurrent Clostridioides difficile infection (rCDI) after workflow implementation into a local health-system specialty pharmacy (HSSP) model. SUMMARY: rCDI carries substantial morbidity, and the approval of orally administered FMS capsules introduced a novel prevention option with new challenges in medication access, prior authorization, and cost. To meet this need, an HSSP workflow was adapted to support acquisition of FMS for adults receiving a prescription order. Over the period from June 1, 2023, through December 31, 2024, a total of 72 FMS prescriptions were generated for 50 patients, of which 29 (58%) ultimately obtained the medication. Patients reflected a real-world population, the median (IQR) age was 70 (55-79) years, 55% were men, the median (IQR) number of previous CDI episodes (including the proximal episode) was 2 (1-3), and 25% were immunocompromised. Among patients who received FMS, rCDI occurred in 2 (7%) patients at eight weeks. Of the 21 prescriptions obtained through the HSSP, 62% required a single prior authorization (PA) attempt, and the median (IQR) time to dispensing from prescription generation was 16 (12-20) days. Copayments ranged from $0 to >$2,500, with most patients (18, 86%) receiving FMS for less than $6. CONCLUSION: Implementation of an adapted HSSP FMS medication workflow resulted in medication access for more than half of patients and offers a practical, adaptable model for integrating high-cost microbiome therapies into specialty pharmacy practice.