CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Vowst (fecal microbiota, live-jslm) — Prevention of Recurrent Clostridioides difficile Infection (coverage criteria)

Covers criteria for one-time authorization of Vowst to prevent recurrence of Clostridioides difficile infection (rCDI) in adults when prescribing and documentation requirements are met; applies to Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVowst (fecal microbiota, live-jslm) — Prevention of rCDI (coverage criteria)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateDec 1, 2023

Next Review DateN/A

Key ActionSubmit prior authorization for a one-time 30-day course with documentation of age ≥18, prescriber specialty consult, prior appropriate antibiotic therapy, stool test confirmation, and timing 2–4 days after antibiotics.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

30 daysauthorization duration

one-timeauthorized treatment course frequency

12 capsquantity limit

4 caps x3ddose regimen

≥18age requirement

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Coverage Criteria for Vowst (fecal microbiota, live-jslm)

Initial authorization criteria

Covered when ALL of the following are met

Age: Member is 18 years of age and older>=18 years

Prescriber: Medication is prescribed by or in consultation with an infectious disease specialist or gastroenterologist

Recurrent CDI documentation: Documentation that the member has recurrent CDI infection with either: (1) at least one recurrence after a primary episode and completed at least 1 round of standard-of-care oral antibiotic therapy (e.g., metronidazole, fidaxomicin) OR (2) at least 2 episodes of severe CDI resulting in hospitalization within the past 12 months

Current episode confirmation and timing: Stool test confirming presence of C. difficile toxin or toxigenic C. difficile; treatment initiation with Vowst will occur 2–4 days after the last dose of at least 10 consecutive days of antibiotics for CDI; current episode controlled with <3 unformed/loose stools/day for 2 consecutive days2-4 days after antibiotics; <3 stools/day x2 days

Coverage will not be provided for members requesting Vowst for the treatment of active Clostridioides difficile infection (CDI). This use is explicitly excluded from coverage.

All indications for Vowst beyond the FDA-approved prevention of recurrent CDI are considered experimental/investigational and not medically necessary. Vowst is not indicated for the treatment of CDI.

Coding and Dosing

Codes referencedmixed

NDC or CPT not listed

No explicit procedure, diagnosis, or NDC codes provided in document.

Dose regimen

Dose regimen4 capsules orally once daily for 3 consecutive days; take each 4‑capsule dose on an empty stomach prior to the first meal of the day.

Quantity limit12 capsules per 30 days (one treatment course).

Pre-dose preparationDrink 296 mL (10 oz) of magnesium citrate the day before and at least 8 hours before the first dose; alternatives used in studies for impaired renal function included 250 mL polyethylene glycol electrolyte solution (GoLYTELY).

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for a one-time 30-day authorization for prevention of recurrent CDI (rCDI). Quantity limit: 12 capsules per 30 days.

Authorization = one-time, 30 days
Quantity limit = 12 capsules per 30 days

Denial Risk

Exclusion and Renewal

Requests for Vowst to treat active CDI are excluded and will be denied. Coverage for this therapy cannot be renewed; only a single one-time authorization may be granted for prevention of rCDI.

Treatment of active CDI — not covered
No renewal permitted

Definitions

Recurrent CDI — definition and requirements

Definition of recurrent CDI (rCDI)Recurrent CDI refers to Clostridioides difficile infection occurring after a prior episode; Vowst is indicated to prevent recurrence in individuals 18 years and older following antibacterial treatment for rCDI.

Required documentation of recurrenceDocumentation must show prior antibacterial treatment for CDI and confirmation of the current episode with stool testing demonstrating C. difficile toxin or toxigenic C. difficile.

Timing relative to antibioticsVowst should be initiated 2–4 days after completion of at least 10 consecutive days of antibacterial therapy for the CDI episode being prevented.

Age requirementMember must be 18 years of age or older.

Background

Vowst (fecal microbiota, live-jslm) is an FDA-approved microbiota-based live biotherapeutic indicated to prevent recurrence of Clostridioides difficile infection (rCDI) in adults following antibacterial treatment for rCDI. It is not indicated for treatment of active CDI, and uses outside the approved prevention of rCDI are considered experimental/investigational and not medically necessary.

Documentation Required

Antibiotic Therapy Prerequisite and Clinical Requirements

Member must have completed at least one round (≥10 consecutive days) of standard-of-care oral antibiotic therapy for CDI prior to initiation of Vowst. Treatment with Vowst should begin 2–4 days after the last dose of that antibiotic course. Vowst is indicated for prevention of recurrence only when the current episode is controlled (fewer than 3 unformed/loose stools per day for 2 consecutive days) and stool testing confirms presence of C. difficile toxin or toxigenic C. difficile.

Completed ≥10 consecutive days of oral antibiotic therapy for CDI (e.g., metronidazole, fidaxomicin)
Initiate Vowst 2–4 days after last antibiotic dose
Current episode controlled: <3 unformed/loose stools/day for 2 consecutive days
Stool test confirming C. difficile toxin or toxigenic C. difficile