fecal microbiota spores, live-brpk — Blue Cross Blue Shield of Kansas

Initial criteria

• The requested agent will be used to prevent the recurrence of Clostridioides difficile infection (CDI) AND
• The patient has a diagnosis of recurrent CDI as defined by ALL of the following:
• • ≥ 3 episodes of CDI in a 12-month period AND
• • Positive C. difficile stool sample AND
• • CDI episode of diarrhea ≥ 3 unformed stools per day for at least 2 consecutive days AND
• The patient has completed a standard-of-care oral antibiotic regimen (e.g., vancomycin, fidaxomicin) for recurrent CDI at least 2–4 days before initiating treatment with the requested agent AND
• The patient has had an adequate clinical response to a standard-of-care oral antibiotic regimen (e.g., vancomycin, fidaxomicin), defined by < 3 unformed stools in 24 hours for ≥ 2 consecutive days AND
• The patient will NOT use the requested agent in combination with any antibiotic regimen for any indication AND
• If the patient has an FDA-approved indication, then ONE of the following:
• • The patient’s age is within FDA labeling for the requested indication OR
• • There is support for use of the requested agent for the patient’s age for the requested indication AND
• The prescriber is a specialist in infectious disease or gastroenterology or has consulted with such a specialist

Approval duration

12 months