Subject: Vowst SGM 5922-A P2025

Drug

VOWST  ((fecal microbiota spores, live-brpk))

Policy:

Indication

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-approved Indication¹

Vowst is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).

Limitations of Use¹

Vowst is not indicated for the treatment of CDI.

All other indications are considered experimental/investigational and not medically necessary.

Documentation

Submission of the following information is necessary to initiate the prior authorization review:

• Medical records, chart notes, and/or lab test results documenting the following:
  • Recurrent CDI
  • Stool test confirming the presence of C.difficile toxin or toxigenic C. difficile

Exclusions

Coverage will not be provided for members requesting Vowst for the treatment of CDI.

Coverage Criteria

Prevention of recurrence of Clostridioides difficile infection (CDI)¹

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

• Member is 18 years of age and older
• Member has had three or more episodes of CDI within the past 12 months (including the most recent episode).
• Member has a recent episode of recurrent CDI with all of the following:
  • At least 3 unformed stools per day for 2 consecutive days
  • Stool test confirming the presence of C.difficile toxin or toxigenic C. difficile
  • An adequate clinical response (e.g., resolution of symptoms) following standard of care antibiotic therapy (e.g., vancomycin, fidaxomicin).

Place of Service:

Outpatient

The above policy is based on the following references:

1. Vowst [package insert]. Cambridge, MA: Seres Therapeutics Inc; June 2024.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

April 20, 2025