Subject: Epidiolex 2609-A SGM P2023

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 Indications
          Epidiolex is indicated for the treatment of seizures associated
          with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or
          tuberous sclerosis complex (TSC) 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 syndrome
               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 Complex
               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 continuation of
          treatment in members (including new members) 1 year of age
          or older requesting reauthorization for an indication listed in
          Section II when the member has achieved or maintained a
          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]. Palo Alto, CA: Jazz Pharmaceuticals, Inc.; January 2023.

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.

October 14, 2023