CurrentNeighborhood Health Plan of Rhode IslandPolicy 5922-A

Vowst (fecal microbiota spores, live-brpk)

Policy governs coverage and prior authorization criteria for Vowst (fecal microbiota spores, live-brpk) for prevention of recurrent Clostridioides difficile infection (rCDI) in adults, including documentation requirements, exclusions, and authorization duration.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVowst (fecal microbiota spores, live-brpk)

Policy CodePolicy 5922-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with medical records and stool test results confirming recurrent CDI and presence of C. difficile toxin or toxigenic C. difficile.

SourceLink

POLICY UPDATE CHANGES

No material changes

1FDA-approved indication covered

30dAuthorization duration (one-time)

>=3Required CDI episodes in 12 months

Coverage Summary

Coverage stance: covered_with_criteria — Vowst (fecal microbiota spores, live-brpk) is covered to prevent recurrence of Clostridioides difficile infection (CDI) in adults following antibacterial treatment for recurrent CDI when all policy criteria are met. It is not indicated for treatment of active CDI or for other experimental/investigational uses.

Coverage — Prevention of recurrence of Clostridioides difficile infection (CDI)

Authorization of 30 days for a one-time treatment may be granted when ALL of the following criteria are met:

ALL of the following

Member is 18 years of age and older>= 18 years
Reference: FDA indication
Member has had three or more episodes of CDI within the past 12 months (including the most recent episode)>= 3 episodes in past 12 months (including most recent)
Recent episode of recurrent CDI with all of the following
- At least 3 unformed stools per day for 2 consecutive days>= 3 unformed stools/day for 2 consecutive days
- Stool test confirming the presence of C.difficile toxin or toxigenic C. difficilestool test positive for C. difficile toxin or toxigenic C. difficile
  Documentation required: stool test result
- An adequate clinical response (e.g., resolution of symptoms) following standard of care antibiotic therapy (e.g., vancomycin, fidaxomicin)evidence of adequate clinical response to standard-of-care antibiotics
  Documentation required: clinical response after antibiotics

Authorization duration: 30 days for a one-time treatment

Exclusions / Not Covered

Exclusions / Not covered

Not covered when any of the following apply:

ANY of the following

Use of Vowst for the treatment of active CDI (Vowst is not indicated for treatment of CDI)
Vowst is not indicated for treatment of CDI
Any indication that is not FDA-approved or compendial for this drug (considered experimental/investigational and not medically necessary)
Non-FDA/compendial indications are experimental/investigational

Vowst is indicated only to prevent recurrence of CDI in adults 18 years and older following antibacterial treatment for recurrent CDI. It is not indicated for treatment of active CDI; use for active infection or non‑FDA/compendial indications is considered experimental/investigational and is not covered. See the Vowst package insert for prescribing details.

Provider Actions & Authorization

Prior Authorization

Prior authorization required

Submit prior authorization and include medical records/chart notes and lab test results documenting recurrent CDI. Include a stool test confirming the presence of C. difficile toxin or toxigenic C. difficile.

Documentation Required

Required documentation for approval

Provide evidence of an adequate clinical response to standard-of-care antibiotic therapy (e.g., vancomycin, fidaxomicin) and clinical details of the recent recurrent CDI, including stool frequency and a positive stool test.

Billing Rule

Authorization duration

Authorization is granted for 30 days for a one-time treatment to prevent recurrence of CDI when criteria are met.

Denial Risk

Denial if used for treatment of active CDI or non-compendial indications

Coverage will not be provided for Vowst when requested for treatment of active CDI or for any non-FDA-approved or non-compendial indications (considered experimental/investigational).

Key Clinical Thresholds

Age>= 18 years

Number of CDI episodes>= 3 episodes in past 12 months (including most recent)

Stool frequency>= 3 unformed stools/day for 2 consecutive days

Background & Clinical Evidence

Vowst (fecal microbiota spores, live-brpk) is indicated to prevent recurrence of CDI in adults following antibacterial treatment for recurrent CDI. The product contains fecal microbiota spores (live-brpk) intended to restore healthy gut microbiota and reduce the risk of recurrence. Its indication is limited to prevention of recurrence after antibacterial therapy and does not include treatment of active CDI or other non‑approved uses.

Vowst [package insert]. Seres Therapeutics Inc; June 2024.

Key Clinical Thresholds

Authorization duration (one-time)30 days

Required CDI episodes in 12 months>= 3

Indication age requirement>= 18 years