Publish Date:

10/23/2023

Last Review Date:

09/11/2023

Overview

Coding

References

Clinical Criteria

Document History

Overview

This document addresses the use of Rebyota (fecal microbiota, live – jslm), approved by the Food and Drug Administration (FDA) for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibiotic treatment for recurrent CDI. Rebyota is administered as a single dose rectal enema within 24 to 72 hours after completion of antibiotic therapy. Rebyota is not indicated for treatment of CDI.

The Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA) published a 2021 focused update to their 2017 CDI management guidelines. Recommendations for the treatment of an initial episode of CDI in adults include Dificid as the preferred option with oral vancomycin as an alternative. Recommendations for CDI first recurrence include Dificid in a standard or extended-pulse regimen as the preferred option with standard or tapered/pulsed vancomycin as an alternative. For individuals with a recurrent CDI episode within the last 6 months, IDSA/SHEA recommends using Zinplava with standard of care antibiotics. Recommendations for CDI second or subsequent recurrence include Dificid in a standard or extended-pulse regimen, tapered/pulsed vancomycin, vancomycin followed by Xifaxan, or fecal microbiota transplant.

Clinical Criteria

When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose.

Rebyota (fecal microbiota, live – jslm)

Requests for Rebyota (fecal microbiota, live – jslm) may be approved if the following criteria are met:

1. Individual is 18 years of age or older; AND
2. Individual is requesting Rebyota for prevention of recurrence of Clostridiodes difficile infection; AND
3. Individual has had at least three episodes of Clostridiodes difficile infection (initial episode and two recurrences) treated with antibiotic therapy (including Dificid, metronidazole or oral vancomycin) (IDSA/SHEA 2021); AND
4. Current episode of Clostridiodes difficile infection has been verified with a positive stool test for Clostridiodes difficile toxin; AND
5. Rebyota will be administered within 24 to 72 hours of completing antibiotic treatment for the current Clostridiodes difficile infection episode.

Requests for Rebyota (fecal microbiota, live – jslm) may not be approved for the following:

• Treatment of Clostridiodes difficile infection; OR
• Use in combination with Vowst or Zinplava during the same Clostridiodes difficile infection episode; OR
• May not be approved when the above criteria are not met and for all other indications.

Approval Duration: One dose

Quantity Limits

Rebyota (fecal microbiota, live – jslm) Quantity Limit

• 1

Drug Limit

Rebyota (fecal microbiota, live – jslm) 150 mL rectal suspension

• One 150 mL dose, one time

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

HCPCS

J1440

ICD-10 Diagnosis

A04.71

Document History

Revised: 9/11/2023