CurrentAdvanced HealthPolicy N/A

Fecal Microbiota Drug Use Criteria

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This policy governs prior authorization and coverage of Rebyota and Vowst to prevent recurrence of Clostridioides difficile infection in adults with recurrent CDI for Advanced Health members.

Policy Summary

PayerAdvanced Health

PolicyFecal Microbiota Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewFeb 12, 2025

Next Review DateN/A

Key ActionSubmit prior authorization requests for Rebyota or Vowst with documentation of recurrent CDI eligibility, required prior therapies, a positive stool test within 30 days, specialist involvement, and age 18 or older.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2+Required recurrent CDI recurrences

<3/dayControlled episode stool limit

30 daysPositive stool test window

18 yearsMinimum patient age

1 month

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CurrentAdvanced HealthPolicy N/A

Fecal Microbiota Drug Use Criteria

Customize your policy alerts

Sign up for all advancedhealth policy alerts

Know when advancedhealth releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

This policy governs prior authorization and coverage of Rebyota and Vowst to prevent recurrence of Clostridioides difficile infection in adults with recurrent CDI for Advanced Health members.

Policy Summary

PayerAdvanced Health

PolicyFecal Microbiota Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewFeb 12, 2025

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2+Required recurrent CDI recurrences

<3/dayControlled episode stool limit

30 daysPositive stool test window

18 yearsMinimum patient age

1 month

ExcludedVowst retreatment

Coverage Criteria

Initial Therapy Coverage Criteria

Initial therapy is covered when ALL of the following criteria are met:

ALL of the following

The patient has a confirmed diagnosis of recurrent Clostridioides difficile (C. difficile) infection (CDI) with a history of at least two recurrent episodes following the initial episode. Recurrent CDI requires resolution of symptoms while receiving appropriate therapy followed by reappearance of symptoms within 8 weeks after discontinuing treatment.
If not met, deny as not meeting criteria.
The current CDI episode is controlled, defined as fewer than 3 unformed or loose stools per day for 2 consecutive days.< 3 stools/day for 2 consecutive days
If not met, deny as not meeting criteria.
Both treatment categories are required
- The patient has previously been treated with vancomycin or fidaxomicin (Dificid) in the setting of CDI recurrence.
- ONE of the following
  - The patient has previously been treated with Zinplava (bezlotoxumab) in the setting of CDI recurrence.
  - The patient has previously undergone fecal microbiota transplantation (FMT) in the setting of CDI recurrence.
ONE of the following request pathways
- The request is not for Vowst.
- ALL of the following
  - The request is for Vowst.
  - The patient has experienced documented treatment failure with the first-line agents listed above and Rebyota.
    Treatment failure with both first-line treatment agents and Rebyota is required for Vowst.
A positive stool test for C. difficile has been documented within the last 30 days.≤ 30 days
If not met, deny as not meeting criteria.
The medication is prescribed by, or prescribed in consultation with, an infectious disease specialist or gastroenterologist.
If not met, deny as not meeting criteria.
The patient is 18 years of age or older.≥ 18 years
If not met, deny as not meeting criteria.
The request is not for retreatment with Vowst.
Retreatment with Vowst is not covered.
The request is within the coverage duration limit of 1 month, with no reauthorization unless otherwise specified.1 month
If met, approve for 1 month; if not met, deny as not meeting criteria.

Retreatment with Vowst is not covered.

Oral fecal microbiota capsules are not indicated for treatment of active Clostridioides difficile infection (CDI); they are indicated to prevent recurrence following antibacterial treatment for recurrent CDI in individuals 18 years of age and older.

Requests that do not meet all applicable criteria will be denied, including requests lacking a confirmed history of recurrent CDI with at least two recurrences, controlled current CDI, required prior treatment with vancomycin or fidaxomicin and Zinplava or fecal microbiota transplantation, documented treatment failure with the required agents and Rebyota when requesting Vowst, a positive C. difficile stool test within the preceding 30 days, prescribing or consultation by an infectious disease specialist or gastroenterologist, minimum age of 18 years, the non-retreatment requirement for Vowst, or the one-month coverage-duration limit.

Prior Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests for Rebyota and Vowst. Submit clinical documentation demonstrating the applicable recurrent CDI history, current episode control, prior therapies, testing, specialist involvement, age, and treatment-specific requirements.

Applies to both Rebyota and Vowst.
Include documentation supporting all applicable eligibility criteria before requesting authorization.

Step Therapy

Required Prior CDI Therapies

The patient must have received prior treatment for recurrent CDI with vancomycin or fidaxomicin (Dificid) and either Zinplava (bezlotoxumab) or fecal microbiota transplantation (FMT).

Required antibacterial therapy: vancomycin or fidaxomicin.
Required recurrence-prevention therapy: Zinplava or FMT.

Unsupported block type: documentation

Clinical Background

Fecal microbiota products are used to help prevent recurrence of Clostridioides difficile infection (CDI) in adults after antibacterial treatment for recurrent CDI. Fecal microbiota administration is thought to restore normal gut flora and thereby help prevent additional CDI episodes. The approved use is prevention of recurrence in individuals 18 years of age and older; these products are not intended to treat an active CDI episode.

Definitions and Indication

Recurrent CDI

DefinitionResolution of CDI symptoms while receiving appropriate therapy followed by reappearance of symptoms within 8 weeks after discontinuing treatment.

Controlled CDI Episode

DefinitionA current CDI episode with fewer than three unformed or loose stools per day for two consecutive days.

FDA-Approved Indication

IndicationPrevention of recurrence of Clostridioides difficile infection in individuals 18 years of age and older following antibacterial treatment for recurrent CDI.

Initial Therapy

Initial coverage requires all applicable clinical criteria to be met:

Initial drug authorization

Recurrent CDI history: The patient has a confirmed diagnosis of recurrent Clostridioides difficile infection with an initial episode and at least two recurrences. Recurrent CDI is defined as resolution of CDI symptoms while on appropriate therapy followed by reappearance of symptoms within 8 weeks of discontinuing treatment.Initial episode plus at least 2 recurrences
Controlled current episode: The current episode of CDI is controlled.Fewer than 3 unformed or loose stools per day for 2 consecutive days
Required prior therapies

Required Prior Treatment

Step	Required prior treatment	Product-specific requirement
1	Before coverage, the patient must have received vancomycin or fidaxomicin and either Zinplava or fecal microbiota transplantation for CDI recurrence.	For Vowst, documented treatment failure with the required prior agents and Rebyota is also required.

Coverage Duration

Rebyota or Vowst

Coverage duration1 month of coverage with no reauthorization unless otherwise specified.

Policy Summary

PayerAdvanced Health

PolicyFecal Microbiota Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewFeb 12, 2025

Next Review DateN/A

SourceLink

On This Page

Documentation Required

Confirm Current Episode Control

Document that the current CDI episode is controlled before requesting treatment: stool frequency must be fewer than three unformed or loose stools per day for two consecutive days.

Controlled episode: <3 unformed or loose stools per day.
The threshold must be met for two consecutive days.

Documentation Required

Document Prior Therapy and Treatment Failure

Submit treatment history showing prior use of the required CDI antibacterial and recurrence-prevention therapies. For Vowst, also document treatment failure with those agents and with Rebyota.

Document vancomycin or fidaxomicin treatment.
Document Zinplava or FMT treatment.
For Vowst, document treatment failure with the required prior agents and Rebyota.

Documentation Required

Recent Positive Stool Test Required

A positive C. difficile stool test obtained within the previous 30 days must be documented in the request.

Test must be positive for C. difficile.
Specimen/test date must be within 30 days before the request.

Documentation Required

Specialist and Age Verification

The medication must be prescribed by, or used in consultation with, an infectious disease specialist or gastroenterologist, and the patient must be at least 18 years old.

Verify infectious disease specialist or gastroenterologist prescribing or consultation.
Verify patient age is 18 years or older.

Denial Risk

Insufficient Recurrent CDI History

Deny the request when documentation does not establish the initial CDI episode and at least two recurrences, or when the record otherwise fails to support the required recurrent CDI history.

Insufficient documentation of the initial episode is a denial condition.
Fewer than two documented recurrences is a denial condition.
The record must show symptom resolution followed by recurrence within 8 weeks when applicable.

Denial Risk

Current Infection Not Controlled

Deny the request when the current CDI episode is not controlled. The controlled-episode requirement is not met when stool frequency is three or more unformed or loose stools per day or is not fewer than three per day for two consecutive days.

Denial condition: ≥3 unformed or loose stools per day.
Denial condition: failure to document fewer than three unformed or loose stools per day for two consecutive days.

Denial Risk

Required Prior Treatment Not Completed

Deny when the patient has not completed the required prior CDI treatment sequence, including the required antibacterial therapy and Zinplava or FMT.

Required antibacterial therapy must include vancomycin or fidaxomicin.
Required recurrence-prevention therapy must include Zinplava or FMT.
Missing either component does not meet criteria.

Denial Risk

Vowst Treatment-Failure Requirement

Vowst requires documented treatment failure with the required prior agents in criterion 3 and with Rebyota before authorization can proceed.

Document failure with vancomycin or fidaxomicin and with Zinplava or FMT.
Also document treatment failure with Rebyota.
Without documented failure of the required prior agents and Rebyota, deny the Vowst request.

Denial Risk

Complete Clinical Eligibility Documentation

Missing or inadequate clinical eligibility documentation creates a denial risk. The request must include recent positive stool testing, specialist prescribing or consultation, patient age, and the other required recurrent CDI and treatment history.

Positive C. difficile stool test within the previous 30 days.
Infectious disease specialist or gastroenterologist prescribing or consultation.
Patient age of at least 18 years.
Complete documentation of recurrence history, episode control, prior treatment, and—when requesting Vowst—treatment failure.

Denial Risk

Retreatment and Duration Limits

Retreatment with Vowst is not covered. If the request is not for retreatment, coverage is limited to one month with no reauthorization unless otherwise specified; requests outside that duration should be denied.

Vowst retreatment: not covered.
Standard approved duration: one month.
No reauthorization unless otherwise specified.
Requests exceeding the one-month duration without an applicable exception do not meet criteria.

Antibacterial therapy: Treatment with vancomycin or fidaxomicin has been completed.

ONE of

Zinplava: Treatment with Zinplava has been completed.
Fecal microbiota transplantation has been completed.

Product-specific requirement

Rebyota: The request is for Rebyota.
Vowst: The request is for Vowst, and documented treatment failure has occurred with the required prior agents and with Rebyota.

Recent positive test: A positive stool test for C. difficile is documented.Within the last 30 days

Specialist consultation: The medication is prescribed by, or in consultation with, an infectious disease specialist or gastroenterologist.

Adult patient: The patient is 18 years of age or older.18 years or older

Retreatment exclusion: The request is not for retreatment with Vowst.

Retreatment with Vowst is not covered.

Coverage duration: The request is within the coverage duration limit; if approved, coverage is for 1 month.1 month with no reauthorization unless otherwise specified