CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Vowst (fecal microbiota spores, live-brpk) — prevention of recurrent C. difficile infection

Covers prior-authorization requirements and clinical criteria for Vowst to prevent recurrence of Clostridioides difficile infection (CDI) in members aged 18 and older; applies to benefit determinations when therapy is requested.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVowst (fecal microbiota spores, live-brpk) — prevention of recurrent C. difficile infection

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation showing recurrent CDI including two stool tests confirming C. difficile toxin or toxigenic C. difficile.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+minimum patient age for coverage

30 daysauthorization duration

>=3required CDI episodes

2confirmatory stool tests required

Coverage Criteria for Vowst (fecal microbiota spores, live-brpk)

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Prevention of recurrent CDI — coverage criteria

Covered when ALL of the following are met

Age requirement: Member is 18 years of age or older

Authorization and frequency: Authorization of 30 days for a one-time treatment may be grantedone-time, 30 days

Prior CDI episodes: Member has had three or more episodes of CDI within the past 12 months (including the most recent episode)>=3 episodes in 12 months

Recent episode clinical features: Recent episode includes at least 3 unformed stools per day for 2 consecutive days

Confirmatory stool testing: Two stool tests confirming the presence of C. difficile toxin or toxigenic C. difficile2 tests

Clinical response to antibiotics: An adequate clinical response (e.g., resolution of symptoms) following standard-of-care antibiotic therapy (e.g., vancomycin, fidaxomicin)

Requests for Vowst intended for treatment of active CDI (that is, as therapy for a current Clostridioides difficile infection rather than to prevent recurrence) are excluded and will be denied.

All other uses of Vowst beyond the approved indication to prevent recurrence of CDI are considered experimental/investigational and not medically necessary.

Product Codes and Testing Requirements

Product referencemixed

Reference 5922-A

Internal reference number for VOWST

Confirmatory stool testing

Required number of confirmatory stool testsTwo (2) stool tests confirming the presence of C. difficile toxin or toxigenic C. difficile

Acceptable supporting documentationMedical records, chart notes, and/or lab test results showing the two stool test results

Context within coverage criteriaStool testing is one of the required criteria for authorization for prevention of recurrent CDI

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization may be granted as a one-time, 30-day approval for prevention of recurrent Clostridioides difficile infection (CDI) when all applicable clinical criteria are met.

One-time 30-day authorization when criteria for prevention of recurrent CDI are satisfied.

Denial Risk

Excluded Indication

Requests for Vowst for treatment of an active CDI episode (rather than for prevention of recurrence) are excluded and will be denied.

Documentation Required

Required Documentation for Prior Authorization

Submit complete documentation to initiate prior authorization review. Include medical records, chart notes, and laboratory results that clearly support recurrent CDI and the requested use for prevention of recurrence.

Documentation of recurrent CDI and clinical course
Medical records and chart notes detailing prior episodes and treatments
Laboratory results including at least two stool tests confirming presence of C. difficile toxin or toxigenic C. difficile
Evidence of adequate clinical response (e.g., resolution of symptoms) to standard-of-care antibiotic therapy (e.g., vancomycin, fidaxomicin) for the most recent episode
Documentation that member is ≥18 years of age and has had ≥3 CDI episodes within the past 12 months, including the most recent episode
Documentation of stool frequency (e.g., ≥3 unformed stools per day for 2 consecutive days) as applicable

Background on Vowst and Indication

Vowst (fecal microbiota spores, live‑brpk) is indicated to prevent recurrence of Clostridioides difficile infection (CDI) in adults following antibacterial treatment for recurrent CDI. Coverage is intended for use in members aged 18 years and older to reduce the risk of further CDI episodes after an adequate clinical response to standard antibiotic therapy.

Definitions

Vowst — product definition and indication

Product name and descriptionVowst (fecal microbiota spores, live-brpk)

IndicationPrevent recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI

Minimum patient age for coverage18 years and older

Internal referenceReference number 5922-A

Recurrent CDI (rCDI) — policy definition

Definition of recurrent CDI (rCDI) used in this policyClinical scenario including three or more CDI episodes within the past 12 months (including the most recent episode)

Recent episode requirementsRecent episode must have at least 3 unformed stools per day for 2 consecutive days and a recent episode documented

Confirmation and responseRecent episode must be confirmed by two stool tests for C. difficile toxin or toxigenic C. difficile and show an adequate clinical response to standard-of-care antibiotics (e.g., vancomycin, fidaxomicin)