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

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.

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

ref":

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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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.

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.