CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Epidiolex (cannabidiol) — coverage criteria for seizures

Policy governs coverage criteria for Epidiolex (cannabidiol) for treatment of seizures in Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex for members covered under Rhode Island Medicaid.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEpidiolex (cannabidiol) — coverage criteria for seizures

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date2/2019

Next Review DateN/A

Key ActionObtain prior authorization and document age, specialist consultation, prior AED trial, required clinical assessments (EEG/MRI/genetic testing) to support approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearminimum patient age

6 monthsinitial auth duration

12 monthscontinuation auth

600 mL/30dquantity limit

LGS/Dravet/TSCcovered indications

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Initial Authorization — LGS or Dravet

Covered when ALL of the following are met

Initial LGS/Dravet Criteria: A. Member is one year of age or older; B. Medication must be prescribed by or in consultation with a neurologist; C. Member has a documented inadequate response to prior therapy with at least one anti-epileptic drug (examples listed in policy); D. Epidiolex will be used in combination with one or more anti-epileptic drugs; E. Documentation that member has received clinical assessments including: (1) EEG, MRI, or SCN1A gene mutation confirmed by genetic testing; (2) age at seizure onset, seizure types, and frequency of episodes; (3) review of risk factors, other causes of seizures, family history, and developmental history.

Authorization of 6 months may be granted.

Initial Authorization — Tuberous Sclerosis Complex

Covered when ALL of the following are met

Initial TSC Criteria: A. Member has a documented diagnosis of tuberous sclerosis complex (TSC); B. Member is one year of age or older.

Authorization of 6 months may be granted.

Continuation of Therapy

Covered when ALL of the following are met

Continuation Criteria: A. For Lennox-Gastaut syndrome or Dravet syndrome: documentation of EEG, MRI, or SCN1A gene mutation confirmed by genetic testing has been submitted; OR B. For tuberous sclerosis complex: documentation that member continues to meet the initial authorization criteria; AND C. Documentation that member has achieved and maintained a positive clinical response to Epidiolex as evidenced by reduction in frequency or duration of seizures.

Authorization of 12 months may be granted.

Use of Epidiolex for any indication other than seizures associated with Lennox‑Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex is considered experimental/investigational and is not covered under this policy.

Use of Epidiolex for indications other than seizures associated with Lennox‑Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC) is not medically necessary and will not be authorized.

Prior authorization, documentation, and provider responsibilities

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial authorizations may be granted for up to 6 months when the clinical criteria are met.

Initial authorization duration: up to 6 months
Prescriber requirement: must be prescribed by or in consultation with a neurologist

Step Therapy

Step Therapy / Prior AED Trial

Member must have a documented inadequate response to at least one prior antiepileptic drug (AED) before initiating therapy for Lennox‑Gastaut syndrome or Dravet syndrome. Examples of AEDs include: Lennox‑Gastaut — clobazam, felbamate, lamotrigine, levetiracetam, topiramate, rufinamide, valproate; Dravet — clobazam, levetiracetam, stiripentol, topiramate, valproate.

Step therapy requirement: documented trial and inadequate response to ≥1 AED prior to approval
Examples of prior AEDs by condition provided in policy text

Documentation Required

Prior and Concomitant Therapy Documentation

Documentation must include evidence of prior therapies and any concomitant antiepileptic medications. Approval requires that Epidiolex will be used in combination with one or more AEDs and that prior trial details (drug name, dose, duration, and reason for failure) are provided.

Concomitant therapy: confirmation that Epidiolex is being used with ≥1 other AED
Prior therapy documentation: name of AED(s), dosing, duration of trial, and reason for inadequate response or intolerance

Documentation Required

Required Clinical Documentation

Required clinical documentation must be submitted with the prior authorization request. For LGS or Dravet syndrome provide EEG, MRI, or SCN1A genetic testing results, age at seizure onset, seizure types and frequency, review of risk factors/other causes, family and developmental history. For TSC provide documentation of diagnosis and that the member meets initial criteria.

EEG, MRI, or SCN1A genetic test results (as applicable)
Seizure history: age at onset, seizure types, frequency/duration
Clinical review: risk factors, comorbid conditions, medications, family and developmental history
TSC: documentation of Tuberous sclerosis complex diagnosis

Documentation Required

Continuation Documentation / Renewal Criteria

For continuation/renewal, authorization may be granted for up to 12 months when documentation shows maintained clinical benefit. Submit evidence of reduction in seizure frequency or duration and confirm ongoing documentation (EEG/MRI/SCN1A for LGS/Dravet or continued fulfillment of initial criteria for TSC).

Continuation authorization duration: up to 12 months
Renewal requirements: evidence of maintained clinical response (reduction in seizure frequency or duration)
Ongoing documentation: EEG, MRI, or SCN1A results for LGS/Dravet; confirmation that TSC members continue to meet initial criteria

Denial Risk

Non‑FDA Indications

Uses of Epidiolex outside of the FDA‑approved indications (LGS, Dravet, TSC) are considered experimental/investigational and not medically necessary.

Non‑FDA indications are not covered

Definitions and key terms

inv-15: FDA-Approved Indications — seizures associated with LGS, Dravet, TSC in patients ≥1 year

Covered indications (FDA-approved)Seizures associated with Lennox-Gastaut syndrome (LGS)

Covered indications (FDA-approved)Seizures associated with Dravet syndrome

Covered indications (FDA-approved)Seizures associated with tuberous sclerosis complex (TSC)

Minimum patient age1 year of age and older

inv-16: Inadequate response to prior therapy — definition / examples of prior antiepileptic drug failure

DefinitionDocumented failure to achieve adequate seizure control with at least one prior anti-epileptic drug appropriate to the syndrome.

Examples for Lennox-Gastaut syndromeclobazam; felbamate; lamotrigine; levetiracetam; topiramate; rufinamide; valproate

Examples for Dravet syndromeclobazam; levetiracetam; stiripentol; topiramate; valproate

Documentation requirementRecord medication trial(s) and inadequate response prior to authorization for LGS or Dravet.

OpenPayer

Epidiolex (cannabidiol) — coverage criteria for seizures

Coverage criteria for Epidiolex (cannabidiol)

Product coding and limits

Prior authorization, documentation, and provider responsibilities

Background on Epidiolex and clinical context

Definitions and key terms