685. Early Experience with a Simple Administration of a Novel Fecal Microbiome Replacement for Prevention of Recurrent Clostridioides difficile
Authors: Hengel Richard L , Krishnan Sujatha , Rosenberg Jonathan A , Ritter Timothy E , Baker Kathy A , Van Anglen Lucinda J , Guo Amy , Moosapanah Mielad , Yang Min , Garey Kevin W 
Published: November 2023

Abstract

Background
Fecal Microbiota, live-jslm (RBL) is a rectally administered, pre-packaged, live biotherapeutic approved in November 2022 for the prevention of recurrence of Clostridioides difficile infection (rCDI) in adults. As the first FDA-approved microbiota product, this new agent may pose challenges in administration, particularly with Infectious Disease (ID) or other specialties not typically providing rectally administered therapies. As part of an ongoing real-world study of RBL, the purpose of this study is to develop and report a simple protocol for the administration of RBL in clinical practice.

Methods
We reviewed electronic health records, administration records and internal databases for patients receiving RBL since February 2023. Records were reviewed for patient demographics, setting of care, time from order to treatment, logistics from order to administration and payor details.

Results
Six rCDI patients (73±14 years; female: 67%) have received RBL; 1 treated in an ID practice and the other 5 in GI practices. Following insurance approval and scheduling of the patient, RBL was ordered from the distributor and shipped to the practices in a 150mL pre-packaged frozen suspension. RBL was thawed for 24 hours and administered within 5 days. Average time from order to treatment was 18±5 days. Administration of RBL was performed by registered nurses or licensed vocational nurses. Reported RBL administration time was 5 minutes, with an additional 15 minutes for observation. Medicare (MCR) was the most common payor (71%) with traditional MCR (n=3), MCR Advantage (n=2), and one commercially insured. There have been no payor denials. Criteria for approval differed slightly between payors, but all required at least 1 prior episode of CDI. All plans required prior authorization except traditional MCR. Reimbursement was adequate for both the medication and instillation protocols.

Conclusion
Early experience with RBL administration found more treatment by GI than ID physician practices. Authorizations were granted as expected with the administration and visit surprisingly brief and simple. RBL holds promise as a feasible office-based therapy for prevention of rCDI.

Disclosures
Jonathan A. Rosenberg, MD, Aimmune: Advisor/Consultant|Ferring Pharmaceuticals: Advisor/Consultant Timothy E. Ritter, MD, Abbvie: Advisor/Consultant|Ardelyx: Advisor/Consultant|Arena: Advisor/Consultant|Boehringer Ingelheim: Advisor/Consultant|Bristol Myers Squibb/Celgene: Advisor/Consultant|Eli Lilly: Advisor/Consultant|Ferring: Advisor/Consultant|Ferring: Data Adjudication Committee|Genetech/Roche: Advisor/Consultant|Gilead: Advisor/Consultant|Intercept: Advisor/Consultant|Iterative Scopes: Expert Testimony|Iterative Scopes: Ownership Interest|Janssen: Advisor/Consultant|Nestle/Seres: Advisor/Consultant|Pfizer: Advisor/Consultant|Prometheus: Advisor/Consultant|Rebiotix: Data Adjudication Committee|Sanofi: Advisor/Consultant|Takeda Pharmaceuticals: Advisor/Consultant Lucinda J. Van Anglen, PharmD, ADMA Biologics, Inc.: Grant/Research Support|Ferring Pharmaceuticals: Grant/Research Support|Novartis: Grant/Research Support|Octapharma: Grant/Research Support|Paratek Pharmaceuticals: Grant/Research Support Amy Guo, PhD, Ferring Pharmaceuticals: Employee Mielad Moosapanah, PharmD, Ferring Pharmaceuticals: Employee Min Yang, MD, PhD, Analysis Group, Inc.: I am an employee of Analysis Group, Inc., which has received consulting fees from Ferring for the conduct of this study. Kevin W. Garey, PharmD, MS, Acurx: Grant/Research Support|Ferring: Advisor/Consultant|Paratek: Grant/Research Support