Sodium oxybate — Blue Cross Blue Shield of Illinois
off-label indications when member resides in Ohio (Fully Insured or HIM Shop plan)
Initial criteria
- Member resides in Ohio AND plan is Fully Insured or HIM Shop (SG)
- Patient does NOT have any FDA labeled contraindication to the requested agent
- ONE of the following: (1) Patient has another FDA labeled indication for the requested agent and route of administration OR (2) Patient has another indication supported in compendia for the agent and route of administration OR (3) Two peer-reviewed journal articles supporting proposed use as generally safe and effective with accepted study design (randomized, double-blind, placebo-controlled). Case studies not acceptable. Non-oncology compendia allowed: DrugDex level 1/2A/2B, AHFS-DI supportive text. Oncology compendia allowed: NCCN 1/2A, AHFS-DI supportive text, DrugDex 1/2A/2B, Clinical Pharmacology supportive text, LexiDrugs level A, peer-reviewed medical literature
Approval duration
12 months