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

Initial criteria

• Request for BCBS MT Fully Insured or MT HIM member:
• A. Patient is < 18 years old AND
• B. Patient does NOT have any FDA-labeled contraindications AND
• C. Patient has an indication supported by TWO articles from major peer-reviewed journals (e.g., JAMA, NEJM, Lancet) showing general safety and effectiveness (randomized, double-blind, placebo-controlled clinical trials; case studies not acceptable) AND
• D. Support for use in the patient’s age bracket in TWO peer-reviewed journal articles (infancy 0–<2 years, childhood 2–11 years, adolescence 12–17 years)
• OR
• Request for BCBS NM Fully Insured or NM HIM member:
• A. Patient does NOT have any FDA-labeled contraindications AND
• B. Requested indication is a rare disease AND
• C. ONE of the following:
• 1. Patient has another FDA-labeled indication for the agent and route OR
• 2. Patient has another indication supported in compendia for the agent and route OR
• 3. (For Ohio Fully Insured or HIM Shop member) ALL of the following:
• A. Member resides in Ohio AND
• B. Plan is Fully Insured or HIM Shop (SG) AND
• C. Patient does NOT have any FDA-labeled contraindications AND
• D. ONE of the following:
• 1. Patient has another FDA-labeled indication for the agent and route OR
• 2. Patient has another indication supported in compendia OR
• 3. Prescriber has submitted TWO articles from major peer-reviewed journals (e.g., JAMA, NEJM, Lancet) supporting the proposed use(s) as generally safe and effective (randomized, double-blind, placebo-controlled trials; case studies not acceptable)
• Acceptable non-oncology compendia: DrugDex level 1, 2A, 2B; AHFS-DI narrative supportive.
• Acceptable oncology compendia: NCCN 1 or 2A; AHFS-DI narrative supportive; DrugDex level 1, 2A, 2B; Clinical Pharmacology narrative supportive; Lexi-Drugs evidence level A; peer-reviewed literature.

Approval duration

1 course per 12 months