CurrentMass General Brigham Health PlanPolicy N/A

Epidiolex (cannabidiol) Effective 01/01/2024

Pharmacy prior authorization and quantity limit policy for Epidiolex (cannabidiol) covering indications (Dravet syndrome, Lennox-Gastaut syndrome, tuberous sclerosis complex) including initial and continuation criteria, prescriber requirements, and quantity limits for Mass General Brigham Health Plan / MassHealth UPPL.

Policy Summary

PayerMass General Brigham Health Plan

PolicyEpidiolex (cannabidiol) Effective 01/01/2024

Policy CodePolicy N/A

Change TypeRevised / Added (historical and 2024 age update)

Effective DateJan 1, 2024

Next Review Date

Key ActionPrior authorization required for Epidiolex; specialty-designated medications must be filled at a contracted specialty pharmacy; contact phone/fax provided for PA submission.

SourceLink

POLICY UPDATE CHANGES

Age per FDA approved indications updated effective 1/1/2024.

Program Type set to Prior Authorization and Quantity Limit added effective 10/01/2020 (historical).

Tuberous sclerosis complex indication and criteria added (effective 2/1/21).

3Covered Indications

600 mL/30dQuantity Limit

3 moInitial Approval

12 moReauth Duration

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Coverage Summary

Epidiolex (cannabidiol) is covered with criteria for seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex. Coverage requires prior authorization and is subject to a quantity limit of 600 mL per 30 days. Epidiolex is designated as a specialty medication and must be filled at a contracted specialty pharmacy. Policy changes effective 2024-01-01.

Quick Facts

Covered Indications3 (Lennox-Gastaut syndrome, Dravet syndrome, tuberous sclerosis complex)

Quantity Limit600 mL per 30 days (Epidiolex 100 mg/mL)

Initial Approval Duration3 months

Reauthorization Duration12 months

Age Minimum>= 1 year (criteria use >=1 year for Dravet, LGS and TSC; overview notes FDA language of >=2 years for LGS/DS)

Initial Therapy Criteria

General Authorization Conditions

Authorization may be granted for members new to the plan who are currently receiving treatment OR when all of the following are met:

ANY of the following

ALL of the following
- Member new to the plan and currently receiving treatment with Epidiolex (excludes product obtained as samples or via manufacturer's patient assistance programs)
- Documentation has been submitted to support the request
- Member meets the specific indication criteria (Dravet syndrome, Lennox-Gastaut syndrome, or tuberous sclerosis complex) as detailed below

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Continuation Therapy Criteria

Continuation of Therapy (Reauthorization)

Reauthorization may be approved when ALL of the following are provided:

ALL of the following

Physician assessment documenting a decrease in the number of seizures

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Initial approvals are granted for 3 months. Reauthorizations are approved for 12 months when continuation criteria are met, with physician assessment documenting a decrease in the number of seizures.

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for Epidiolex. Specialty-designated medications must be filled at a contracted specialty pharmacy. Phone and fax are provided for PA submission: Phone: 877-519-1908; Fax: 855-540-3693.

Documentation Required

Prescriber specialty / neurology consultation

Prescriber must be a neurologist or provide documentation of a recent neurology consultation for initial authorization.

Documentation Required

Prior therapy documentation

Documentation must show inadequate response, intolerance, or contraindication to the required number of listed anticonvulsant agents per indication (at least 2 agents for Dravet and Lennox-Gastaut; carbamazepine or oxcarbazepine for TSC). See the policy for the specific agent lists by indication.

Applicable Codes

Product / StrengthmixedCovered

Epidiolex 100 mg/mL

Oral solution - quantity limit: 600 mL per 30 days

Clinical Evidence & References

Key supporting evidence includes randomized and interventional trials and the FDA prescribing information: Devinsky et al., N Engl J Med 2017; Devinsky et al., Lancet Neurol 2016; and the Epidiolex prescribing information. These references support the indicated uses for treatment-resistant seizures in the named syndromes.

Background

Epidiolex is indicated for treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome (per overview, ages as specified) and for seizures associated with tuberous sclerosis complex. The policy implements prior authorization and a quantity limit of 600 mL per 30 days, designates the product as specialty (must be filled at a contracted specialty pharmacy), and applies within the Mass General Brigham Health Plan / MassHealth UPPL pharmacy PA scope. Effective date in the policy is 01/01/2024.

Adjunctive therapy: Use of Epidiolex in addition to other anticonvulsant treatments.

Revision History

2024-01-01revisedLatest

Age per FDA approved indications updated effective 1/1/2024

2020-10-01revised

Program Type set to Prior Authorization and Quantity Limit added effective 10/01/2020

2021-02-01added

Tuberous sclerosis complex indication and criteria added (effective 2/1/21)

Policy Summary

PayerMass General Brigham Health Plan

PolicyEpidiolex (cannabidiol) Effective 01/01/2024

Policy CodePolicy N/A

Change TypeRevised / Added (historical and 2024 age update)

Effective DateJan 1, 2024

Next Review Date

Key ActionPrior authorization required for Epidiolex; specialty-designated medications must be filled at a contracted specialty pharmacy; contact phone/fax provided for PA submission.

SourceLink

On This Page

Dravet Syndrome - Initial Authorization

Covered when ALL of the following are met:

ALL of the following

Member is at least 1 years old
Medication will be used as adjunctive therapy
Prescriber is a neurologist or documentation provided of recent neurology consultation
ALL of the following
- Anticonvulsant agent list (for inadequate response/intolerance/contraindication)
  - Clobazam
  - Clonazepam
  - Ethosuximide
  - Levetiracetam
  - Phenobarbital
  - Stiripentol
  - Topiramate
  - Valproic acid
  - Zonisamide

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Lennox-Gastaut Syndrome - Initial Authorization

Covered when ALL of the following are met:

ALL of the following

Member is at least 1 years old
Medication will be used as adjunctive therapy
Prescriber is a neurologist or documentation provided of recent neurology consultation
ALL of the following
- Anticonvulsant agent list (for inadequate response/intolerance/contraindication)
  - Clobazam
  - Felbamate
  - Lamotrigine
  - Topiramate
  - Valproic acid

ref":

Tuberous Sclerosis Complex (TSC) - Initial Authorization

Covered when ALL of the following are met:

ALL of the following

Member is at least 1 year old
Member has a diagnosis of seizures associated with TSC confirmed by genetic testing showing a mutation in either the TSC1 or TSC2 gene
Prescriber is a neurologist or documentation provided of recent neurology consultation
Member has had an inadequate response, intolerance, or has a contraindication with carbamazepine or oxcarbazepine

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Prior Authorization

Initial approval duration

Initial approvals will be granted for 3 months.

Prior Authorization

Reauthorization duration

Reauthorizations will be approved for 12 months when continuation criteria are met (physician assessment documenting a decrease in seizures).

Billing Rule

Quantity limit

Epidiolex 100 mg/mL is limited to 600 mL per 30 days. This product is specialty-designated and must be filled at a contracted specialty pharmacy.