CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Cmp_Rebyota_20250226 1

Defines coverage, clinical criteria, dosing, billing codes, and authorization limits for Rebyota for prevention of recurrent Clostridioides difficile infection (CDI) for Medicaid, Commercial, and Medicare-Medicaid Plan members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCmp_Rebyota_20250226 1

Policy CodePolicy N/A

Change Typeclarified

Effective DateDec 1, 2023

Next Review Date

Key ActionRequests must meet all listed clinical criteria and provide documentation (positive stool test within 30 days, evidence of ≥10-day antibiotic course, documentation of recurrences/hospitalizations, and that the current episode is controlled); coverage is limited to one-time administration and cannot be renewed.

SourceLink

POLICY UPDATE CHANGES

Policy reviewed in 9/2023, 01/2024, 02/2025 with Effective Date 12/01/2023.

1Authorized Treatments per Member

150 mLMaximum Dose

>=18Minimum Age (years)

30 daysMax interval for positive stool test prior to treatment

Coverage Summary & Medical Necessity

Coverage / Medical Necessity Criteria for Prevention of Recurrent CDI

Covered when ALL of the following are met:

ALL of the following

Member is 18 years of age and older>= 18 years
Medication is prescribed by or in consultation with an infectious disease specialist or gastroenterologist
Member has recurrent CDI infection with either of the following:
- Member has at least one recurrence after a primary episode and has completed at least 1 round of standard of care oral antibiotic therapy (e.g., metronidazole, fidaxomicin)At least 10 consecutive days of antibiotics required prior to Rebyota
- Member has had at least 2 episodes of severe CDI resulting in hospitalization within the past 12 months
Member has a positive stool test for the presence of C. difficile toxin or toxigenic C. difficile within 30 days prior to treatmentPositive within 30 days prior to treatment
Must be within 30 days prior to treatment
A single, one-time 150 mL dose will be administered rectally 24 to 72 hours after the last dose of at least 10 consecutive days of antibiotics for CDI treatment150 mL
Administration timing and antibiotic course length required
Current episode of CDI must be controlled (< 3 unformed/loose stools/day for 2 consecutive days)< 3 unformed/loose stools/day for 2 consecutive days
The request is not for the treatment of CDI
Policy covers prevention of recurrence, not treatment
MMP members who have previously received this medication within the past 365 days are not subject to Step Therapy Requirements365 days
Applies only to Medicare-Medicaid Plan members

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Not Covered / Investigational

Not Covered / Investigational:

Used at a dose or for a condition other than FDA-approved indication or other medically accepted indications per standard compendia

Neighborhood does not provide coverage for investigational uses

Authorization, Dosing Limits, and Provider Requirements

Length of Authorization

Authorization limits:

Coverage will be provided for a one (1) time treatment for one (1) month and may not be renewed1 month

Coverage cannot be renewed

Prior Authorization

Prior Authorization Required

Requests must meet ALL listed clinical criteria (age ≥18, specialist prescriber or consultation, recurrent CDI criteria, positive stool test within 30 days, timing after antibiotics, and controlled current episode). Coverage is limited to a single, one-time administration and authorization cannot be renewed.

Documentation Required

Required Clinical Documentation

Provide documentation of: a positive stool test for C. difficile toxin or toxigenic C. difficile within 30 days prior to treatment; evidence that the member completed at least a 10‑day course of antibiotics for the CDI episode; details of prior CDI recurrences or hospitalizations meeting the recurrent CDI criteria; and documentation that the current episode is controlled (< 3 unformed/loose stools per day for 2 consecutive days).

Positive stool test for C. difficile toxin or toxigenic C. difficile within 30 days prior to treatment
Evidence of at least a 10-day antibiotic course for CDI
Details of prior CDI recurrences or hospitalizations (per recurrent CDI criteria)
Documentation that current episode is controlled (< 3 unformed/loose stools/day for 2 consecutive days)

Billing Rule

Billing Units

Billing is based on milliliter units: 1 billable unit = 1 mL. Maximum billable units per authorized treatment = 150 units (150 mL). Affected HCPCS code: J1440 (Fecal microbiota, live - jslm, 1 ml).

Key Clinical Trial Results

70.6%Rebyota absence of CDI diarrhea at 8 weeks (vs placebo 57.5%)

13.1%Mean treatment effect vs placebo (95% CI 2.3–24.0)

65.5%Sustained clinical response at 6 months (Rebyota)

56.5%Sustained clinical response at 6 months (placebo) — difference not statistically significant

Rebyota is indicated to prevent recurrence of Clostridioides difficile infection (CDI) in adults following antibiotic treatment for recurrent CDI. Approval was supported by the PUNCH CD3 trial, which enrolled adults with recurrent or severe CDI and showed a higher treatment success at 8 weeks for Rebyota (70.6%) versus placebo (57.5%) with a mean treatment effect of 13.1% (95% CI: 2.3, 24.0).

Term	Definition
Billable unit	1 mL of Rebyota
Controlled episode	Less than 3 unformed/loose stools per day for 2 consecutive days

OpenPayer

Cmp_Rebyota_20250226 1

Coverage Summary & Medical Necessity

Authorization, Dosing Limits, and Provider Requirements

Applicable Billing Codes

Key Clinical Trial Results

Background & Definitions

Policy Revision History