Epidiolex — Blue Cross Blue Shield of Montana

Initial criteria

• The patient has a diagnosis of seizures associated with ONE of the following: Lennox-Gastaut syndrome (LGS) OR Dravet syndrome (DS) OR Tuberous sclerosis complex (TSC)
• If the patient has an FDA labeled indication, then ONE of the following: (A) The patient’s age is within FDA labeling for the requested indication OR (B) There is support for using the requested agent for the patient’s age for the requested indication
• The requested agent will NOT be used as monotherapy for seizure management
• The patient’s medication history includes the use of an anticonvulsant in the past 90 days
• The prescriber submitted baseline liver transaminases and total bilirubin levels (medical records including lab results are required) upon initial review
• The prescriber will monitor the patient’s liver transaminases while the patient is on the requested agent
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist), or the prescriber has consulted with such a specialist
• The patient does NOT have any FDA labeled contraindications to the requested agent
• The requested quantity (dose) is within FDA labeled dosing for the requested indication
• OR coverage for BCBS NM Fully Insured or NM HIM members when ALL of the following are met: (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 coverage for members residing in Ohio with Fully Insured or HIM Shop (SG) plan when ALL of the following are met: (A) The patient does NOT have any FDA labeled contraindications to the requested agent AND (B) 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 peer-reviewed journal articles supporting the proposed use(s) as generally safe and effective (case studies not acceptable)

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s prior authorization process
• The patient has had clinical benefit with the requested agent
• The requested agent will NOT be used as monotherapy for seizure management
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist), or has consulted with such a specialist
• The patient does NOT have any FDA labeled contraindications to the requested agent
• The requested quantity (dose) is within FDA labeled dosing for the requested indication

Approval duration

12 months