Subject: Epidiolex 2609-A SGM 2022

Drug

EPIDIOLEX  (cannabidiol)

Policy:

       I.  INDICATIONS

            The indications below including FDA-approved indications and
            compendial uses are considered a covered benefit provided
            that all the approval criteria are met and the member has no
            exclusions to the prescribed therapy.

            FDA-Approved Indications¹
            Epidiolex is indicated for the treatment of seizures associated
            with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous
            sclerosis complex in patients 1 year of age and older.

            All other indications are considered
            experimental/investigational and not medically necessary.

 

      II.  CRITERIA FOR INITIAL APPROVAL

            A.  Seizures associated with Lennox-Gastaut syndrome
                  or Dravet syndrome¹
                 Authorization of 12 months may be granted for treatment
                 of seizures associated with Lennox-Gastaut syndrome or
                 Dravet syndrome in members 1 year of age and older.

            B.  Seizures associated with Tuberous Sclerosis
                 Complex¹
                 Authorization of 12 months may be granted for treatment
                 of seizures associated with tuberous sclerosis complex in
                 members 1 year of age and older.

 

   III.   CONTINUATION OF THERAPY

            Authorization of 12 months may be granted for all members
            (including new members) who meet all of the following:
            1.  The member meets one of the following
                 a.  The member has seizures associated with Lennox-
                      Gastaut syndrome
                 b.  The member has seizures associated with Dravet
                      syndrome
                 c.  The member has seizures associated with tuberous
                      sclerosis complex
            2.  The member is at least 1 year of age
            3.  The member has achieved and maintained positive clinical
                 response as evidenced by reduction in frequency or
                 duration of seizures compared with seizure activity prior to
                 initiating Epidiolex.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Epidiolex [package insert]. Carlsbad, CA: Greenwich Biosciences, Inc.; February 2022.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

November 21, 2022