Zelsuvmi — Blue Cross Blue Shield of Texas

Initial criteria

• For BCBS NM Fully Insured or NM HIM member: 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
• For Ohio residents: 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. Accepted study designs may include randomized, double blind, placebo controlled clinical trials. Case studies are not acceptable. Non-oncology compendia allowed: DrugDex level 1, 2A or 2B, AHFS-DI (narrative text supportive). Oncology compendia allowed: NCCN 1 or 2A, AHFS-DI (narrative text supportive), DrugDex level 1, 2A, 2B, Clinical Pharmacology (narrative text supportive), LexiDrugs evidence level A, peer-reviewed medical literature.

Approval duration

12 months