Xolremdi — Blue Cross Blue Shield of Montana

FDA labeled indication

Initial criteria

1. For BCBS NM Fully Insured or NM HIM member: ALL of the following:
A. The patient does NOT have any FDA labeled contraindications to the requested agent AND
B. The requested indication is a rare disease AND
C. ONE of the following:
1. The patient has another FDA labeled indication for the requested agent and route of administration OR
2. The patient has another indication that is supported in compendia for the requested agent and route of administration
OR
2. ALL of the following:
A. The member resides in Ohio AND
B. The plan is Fully Insured or HIM Shop (SG) AND
C. The patient does NOT have any FDA labeled contraindications to the requested agent AND
D. ONE of the following:
1. The patient has another FDA labeled indication for the requested agent and route of administration OR
2. The patient has another indication that is supported in compendia for the requested agent and route of administration OR
3. The prescriber has submitted TWO articles from major peer-reviewed professional medical journals (e.g., JAMA, NEJM, Lancet) supporting the proposed use(s) as generally safe and effective. Case studies are not acceptable [journal articles required]
Non-oncology compendia allowed: DrugDex level 1, 2A, or 2B, AHFS-DI (narrative must be supportive)
Oncology compendia allowed: NCCN 1 or 2A, AHFS-DI (narrative must be supportive), DrugDex level 1, 2A, or 2B, Clinical Pharmacology (supportive narrative), LexiDrugs evidence level A, or peer-reviewed medical literature

12 months