CurrentUnitedHealthcarePolicy 2025 P 1416-3

Vowst (fecal microbiota spores) prior authorization

Defines UnitedHealthcare prior authorization criteria for Vowst (fecal microbiota spores, live-brpk) to prevent recurrent Clostridioides difficile infection in adults following antibacterial treatment. Applies to members whose benefits require prior authorization for this medication.

Policy Summary

PayerUnitedHealthcare

PolicyVowst (fecal microbiota spores) prior authorization

Policy CodePolicy 2025 P 1416-3

Change TypeAnnual review — non-material

Effective DateOct 1, 2025

Next Review Date

Key ActionSubmit prior authorization; Vowst will be approved only if all criteria are met (diagnosis of rCDI, age ≥18, completed antibiotic treatment 2–4 days prior to initiation).

SourceLink

POLICY UPDATE CHANGES

Updated reference and annual review with no changes to coverage criteria.

18+Age requirement (years)

2-4 daysAntibiotic-to-initiation

1 moAuthorization duration

3P&T approvals

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

Policy Summary

PayerUnitedHealthcare

PolicyVowst (fecal microbiota spores) prior authorization

Policy CodePolicy 2025 P 1416-3

Change TypeAnnual review — non-material

Effective DateOct 1, 2025

Next Review Date

Key ActionSubmit prior authorization; Vowst will be approved only if all criteria are met (diagnosis of rCDI, age ≥18, completed antibiotic treatment 2–4 days prior to initiation).

SourceLink

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Initial Authorization

Covered when ALL of the following are met

Primary authorization criteria: a. Diagnosis of recurrent Clostridioides difficile infection (rCDI)

Age requirement: b. Patient is 18 years of age or older>=18 years

Timing after antibiotics: c. Patient has completed antibiotic treatment for rCDI 2 to 4 days prior to initiating Vowst2-4 days

Intent of use: d. Vowst is used to prevent the recurrence of CDI

Authorization will be issued for 1 month.

Use of Vowst for indications other than prevention of recurrent Clostridioides difficile infection (CDI) is not supported by these criteria.

Coding and Patient Eligibility

ICD-10 diagnosis codesICD-10

No codes listed

Age

Age requirement>= 18 years

Source contextPolicy requires patient is 18 years of age or older for Vowst authorization

Applies toIndividuals eligible for prior authorization under UnitedHealthcare benefits

Antibiotic-to-initiation interval

Antibiotic-to-initiation interval2-4 days after completing antibiotic treatment

Policy requirementPatient must have completed antibiotic treatment for rCDI 2 to 4 days prior to initiating Vowst

Timing purposeEnsure Vowst is administered following completion of antibacterial therapy for recurrent CDI

Provider Actions and Prior Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization required. Vowst (fecal microbiota spores, live-brpk) will be approved only when ALL listed criteria are met.

Diagnosis: recurrent Clostridioides difficile infection (rCDI)
Age: ≥ 18 years
Timing: completed antibiotic treatment for rCDI 2–4 days prior to initiating Vowst
Indication: used to prevent recurrence of CDI
Authorization length: 1 month

Note

Program-level Automation May Apply

UnitedHealthcare may use automated approval or reauthorization based on prior claim and medication history, diagnosis codes (ICD-10), and claim logic; program automation varies by therapeutic class.

Automated approval/re-approval may be used
Decisions may rely on prior claims, medication history, and ICD-10 diagnosis codes
Use of automation varies by program/therapeutic class

Documentation Required

Documentation and Program Notes

Prior authorization/medical necessity requirements and supply limits may apply. State mandates, federal requirements, and the member's benefit plan may affect coverage. Other policies and utilization management programs may also apply.

Supply limits may be enforced
Prior Authorization and Medical Necessity requirements may apply
Coverage subject to state mandates, federal requirements, and member-specific benefit plan

Denial Risk

Denial Triggers

Denial is likely if required criteria are not met.

No diagnosis of recurrent Clostridioides difficile infection (rCDI)
Patient is < 18 years of age
Patient did not complete antibiotic treatment 2–4 days prior to initiating Vowst
Vowst not being used to prevent recurrence of CDI

Background

Vowst is indicated to prevent recurrence of Clostridioides difficile infection (CDI) in individuals 18 years and older following antibacterial treatment for recurrent CDI. Authorization will be granted only when ALL of the following are met: a. diagnosis of recurrent Clostridioides difficile infection (rCDI); b. patient is 18 years of age or older; and c. patient has completed antibiotic treatment for rCDI and initiates Vowst 2 to 4 days after completion of that antibiotic treatment. Authorization will be issued for 1 month.

Step Therapy / Automation Rules

Program feature	Details
Automated approval potential	UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic; use of automated approval and re-approval processes varies by program and/or therapeutic class.
Supply limits	Supply limits may be in place.
Prior authorization/medical necessity	Prior Authorization/Medical Necessity may be in place; prior approvals may be determined from claim/medication history and diagnosis codes.

OpenPayer

Vowst (fecal microbiota spores) prior authorization

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

Coding and Patient Eligibility

Provider Actions and Prior Authorization Process

Background

Definitions

Initial Therapy

Step Therapy / Automation Rules

Quantity Limits

Site of Care