fecal microbiota spores, live-brpk capsules — Blue Cross Blue Shield of New Mexico

Initial criteria

• ALL of the following must be met:
• 1. Requested agent will be used to prevent the recurrence of Clostridioides difficile infection (CDI) AND
• 2. Patient has diagnosis of recurrent CDI defined by ALL of the following:
• A. ≥ 3 episodes of CDI in a 12-month period AND
• B. Positive C. difficile stool sample AND
• C. CDI episode of diarrhea ≥ 3 unformed stools per day for ≥ 2 consecutive days AND
• 3. 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
• 4. 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
• 5. Patient will NOT use the requested agent in combination with any antibiotic regimen for any indication AND
• 6. If patient has an FDA-approved indication, then ONE of the following:
• A. Patient’s age is within FDA labeling for the requested indication OR
• B. There is support for use in the patient’s age for the requested indication AND
• 7. Prescriber is a specialist in infectious disease or gastroenterology, or has consulted with a specialist AND
• 8. Patient does NOT have any FDA-labeled contraindications to the requested agent

Approval duration

1 course per 12 months