Fecal Microbiota, Live - jslm (Rebyota™) Notification

• Fecal microbiota, live - jslm (Rebyota™) rectal suspension for administration by a healthcare professional

• For the prevention of recurrence of Clostridioides difficile infection (CDI) in patients 18 years of age and older, following antibiotic treatment for recurrent CDI 
• Limitation of use: Not indicated for treatment of CDI

The restricted product(s) may be considered medically necessary when the following criteria are met:

1. The patient is 18 years of age or older; AND
2. The patient has a diagnosis of recurrent Clostridioides difficile infection (CDI), as confirmed by BOTH of the following: 
   1. Passage of three or more loose stools within a 24-hour period for 2 consecutive days; AND 
   2. Positive stool test for Clostridioides difficile toxin or toxigenic Clostridioides difficile from a stool sample collected within the past 30 days [medical record documentation required]; AND
3. ONE of the following:
   1. The patient has had at least one CDI recurrence after a primary episode and has completed at least one round of standard-of-care oral antibiotic therapy for CDI; OR
   2. The patient has had at least two episodes of severe CDI resulting in hospitalization within the last year; AND
4. The patient has completed at least 10 consecutive days of antibiotic therapy for the current CDI; AND
5. The patient’s CDI is under control after completing antibiotic therapy, as defined by less than 3 unformed/loose stools per day (i.e., Bristol Stool Scale type 6-7) for 2 consecutive days; AND 
6. A minimum of 24 hours to a maximum of 72 hours have passed since the patient received the last dose of antibiotics for CDI; AND 
7. The patient will be receiving the requested agent to prevent recurrence of CDI; AND 
8. The patient has NOT had a previous fecal microbiota transplant.

Duration of Approval: 30 days (one-time approval for single dose)

All information referenced is from FDA package insert unless otherwise noted below.

 Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

January 2024: Criteria change: Added requirement that positive stool test for Clostridioides difficile toxin or toxigenic Clostridioides difficile must be within the past 30 days. Policy notification given 11/1/2023 for effective date 1/1/2024.

July 2023: Coding change: Added HCPCS code J1440 to dosing reference table effective 7/1/2023; deleted C9399, J3490, and J3590 termed 6/30/2023.

February 2023: Original medical policy criteria issued