Subject: Specialty Quantity Limit Epidiolex 2611-H P2024
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
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Medication
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Standard Limit
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Exception Limit*
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FDA-recommended dosing
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Epidiolex (cannabidiol) 100 mg/mL oral solution
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800 mL per 30 days
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1500 mL per 30 days
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Seizures Associated with Lennox-Gastaut Syndrome or
Dravet Syndrome
• Initial dose: 2.5 mg/kg twice daily (5 mg/kg/day).
After one week, increase to a maintenance dose of 5
mg/kg twice daily (10 mg/kg/day).
• May increase in weekly increments of 2.5 mg/kg
twice daily (5 mg/kg/day) to a maximum
maintenance dose of 10 mg/kg twice daily (20
mg/kg/day). If more rapid titration is warranted, the
dosage may be increased no more frequently than
every other day.
Seizures Associated with Tuberous Sclerosis Complex
• Initial dose: 2.5 mg/kg twice daily (5 mg/kg/day).
Increase to a maintenance dose of 12.5 mg/kg twice
daily (25 mg/kg/day) in weekly increments of 2.5
mg/kg twice daily (5 mg/kg/day). If more rapid
titration is warranted, the dosage may be increased
no more frequently than every other day.
Dose adjustment
• With a strong inducer of CYP3A4 or CYP2C19:
Dose increase of Epidiolex may be considered
based on clinical response and tolerability.
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*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:
- Epidiolex [package insert]. Palo Alto, CA: Jazz Pharmaceuticals, Inc.; March 2024.
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 30, 2024
