Xolremdi — Blue Cross Blue Shield of Montana
rare disease
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
Reauthorization criteria
- Same as initial reauthorization criteria apply per general renewal evaluation
Approval duration
12 months