Agents for Recurrent Clostridioides Difficile

POLICY NUMBER

L.5.01.604

Rebyota (fecal microbiota, live - jslm suspension)

Vowst (fecal microbiota spores, live-brpk capsule)

Please perform a formulary drug search on your patient’s Member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific Member’s benefit plan.

DESCRIPTION

Rebyota is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibiotic treatment for recurrent CDI.

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).

Related medical policies -

• Fecal Microbiota Transplantation

POLICY

Rebyota (fecal microbiota, live-jslm) and Vowst (fecal microbiota spores, live-brpk) are considered not medically necessary as there are other treatment options covered by the Plan for prevention of Clotridioides difficilie infection (CDI).

Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary.

POLICY EXCEPTIONS

State Health Plan (State and School Employees) Participants

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Member, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

POLICY HISTORY

05/01/2024: New policy added.

03/20/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated. Policy section updated to add that services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Sources updated.

SOURCE(S)

1. Clostridioides difficile infection in adults: Treatment and Prevention. UpToDate. Last updated January 27, 2025.

   https://www.uptodate.com/contents/clostridioides-difficile-infection-in-adults-treatment-and-prevention

2. Rebyota prescribing information. Ferring Pharmaceuticals Inc. December 2024. Last accessed February 2025.

3. Vowst prescribing information. Aimmune Therapeutics, Inc. June 2024. Last accessed February 2025.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Not Medically Necessary Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.