REBYOTA (fecal microbiota, live-jslm)

REBYOTA (fecal microbiota, live-jslm)

Medical Administration – Rectal

Indications for Prior Authorization:

• Recurrent Clostridioides difficile infection (CDI) - 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.

Coverage Criteria:

For diagnosis of Clostridioides difficile infection (CDI):

• Dose does not exceed 150 mL provided as a single dose, AND

• Patient is 18 years of age or older, AND

• Prescribed by or in consultation with a gastroenterologist or infectious disease specialist, AND

• Diagnosis of recurrent clostridioides difficile infection (CDI) as defined by both of the following:

  • Presence of diarrhea defined as a passage of 3 or more loose bowel movements within a 24-hour period for 2 consecutive days

  • A positive stool test for C.difficile toxin or toxigenic C.difficile, AND

• Patient has a history of one or more recurrent episodes of CDI, AND

• Both of the following:

  • Patient has completed at least 10 consecutive days of antibiotic therapy between 24 to 72 hours prior to initiating Rebyota

  • Previous episode of CDI is under control (e.g., less than 3 unformed/loose [i.e., Bristol Stool Scale type 6-7] stools/day for 2 consecutive days)

Coverage Duration:

• Initial: 14 days

Authorization is not covered for the following:

The following conditions, and other uses of this drug for indications not listed in this policy, do not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

• REBYOTA is not indicated for treatment of CDI.

Additional Information:

• Administration

  • Prior to use, thaw REBYOTA completely by placing the carton in a refrigerator, 2°C to 8°C (36°F to 46°F), for approximately 24 hours.

  • DO NOT thaw using a heat source such as a microwave or hot water.

• Warnings

  • Because REBYOTA is manufactured from human fecal matter it may carry a risk of transmitting infectious agents. Any infection suspected by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Ferring Pharmaceuticals Inc.

  • REBYOTA is manufactured from human fecal matter and may contain food allergens. The potential for REBYOTA to cause adverse reactions due to food allergens is unknown.

Policy Updates:

• 05/16/2023  – New policy approved by P&T.

References:

• Rebyota Prescribing Information. Ferring Pharmaceuticals, Inc. Parsippany, NJ. November 2022.