Subject: Specialty Quantity Limit Epidiolex 2611-H P2023

Drug

EPIDIOLEX  (cannabidiol)

Policy:

      I.  PROGRAM DESCRIPTION

          The standard limit is designed to allow a quantity sufficient for
          the most common uses of the medication. If the member’s plan
          allows a quantity limit exception review for the requested
          medication, coverage of an additional quantity may be provided
          up to the exception limit with prior authorization.


    II.  COVERED QUANTITIES

Medication	Standard Limit	Exception   Limit*	FDA-recommended dosing
Epidiolex   100 mg/mL   oral solution	800 mL   per 30 days	1500 mL   per 30 days	Seizures Associated with Lennox-Gastaut Syndrome or Dravet Syndrome   •  Initial dose: 2.5 mg/kg twice      daily. After one week,      increase to a maintenance      dose of 5 mg/kg twice daily.      Increase in weekly      increments of 2.5 mg/kg      twice daily.   •  Maximum dose: 10 mg/kg      twice daily. Seizures Associated with Tuberous Sclerosis Complex   •  Initial dose: 2.5 mg/kg twice      daily. Increase to a      maintenance dose of 12.5      mg/kg twice daily. Increase      in weekly increments of 2.5      mg/kg twice daily. Dose adjustment   •  With a strong inducer of      CYP3A4 or CYP2C19: Dose      increase of Epidiolex may be      considered based on clinical      response and tolerability.

*Coverage up to the exception limit may be provided with prior authorization via the Specialty Post Limit Quantity Exception Criteria for approval.

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 15, 2023