CurrentCignaPolicy N/A

Antiseizure Medications - Epidiolex Prior Authorization Policy

Defines Cigna's prior authorization requirements and medical necessity criteria for coverage of Epidiolex (cannabidiol oral solution) for seizure disorders in patients ≥ 1 year of age, including FDA‑approved indications and selected treatment‑refractory rare epilepsies; applies to health benefit plans administered by Cigna companies.

Policy Summary

PayerCigna

PolicyAntiseizure Medications - Epidiolex Prior Authorization Policy

Policy CodePolicy N/A

Change TypeClarified terminologyprior expansion retained

Effective DateN/A

Next Review DateFeb 5, 2025

Key ActionObtain prior authorization and document neurologist involvement plus prior or concomitant trials of at least two other antiseizure medications for initial approvals.

SourceLink

POLICY UPDATE CHANGES

Policy name changed from 'Antiepileptics - Epidiolex Prior Authorization Policy' to 'Antiseizure Medications - Epidiolex Prior Authorization Policy' and references to antiepileptic medications were changed to antiseizure medications.

Expanded list of treatment‑refractory seizures/epilepsy to include focal epilepsy in prior revision history.

≥1minimum patient age for covered indications

1 yrapproval duration (initial and renewals)

3FDA‑approved indications listed

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required other ASMs for initial therapy

Coverage Criteria for Epidiolex (cannabidiol)

Dravet Syndrome

Covered when ONE of the following for Dravet syndrome is met

Dravet syndrome - initial or continuing: A) Initial Therapy: Approve for 1 year if ALL of the following are met: (i) patient is >= 1 year of age; AND (ii) patient meets ONE of: (a) patient has tried or is concomitantly receiving at least two other antiseizure medications; OR (b) patient has tried or is concomitantly receiving one of Fintepla, Diacomit, or clobazam; AND (iii) the medication is prescribed by or in consultation with a neurologist; OR B) Patient is Currently Receiving Epidiolex: Approve for 1 year if the patient is responding to therapy (e.g., reduced seizure severity, frequency, and/or duration) as determined by the prescriber.see text

Examples of other antiseizure medications include valproic acid, topiramate, clonazepam, levetiracetam, zonisamide.

Lennox‑Gastaut Syndrome

Covered when ONE of the following for Lennox‑Gastaut syndrome is met

Lennox-Gastaut syndrome - initial or continuing: A) Initial Therapy: Approve for 1 year if ALL of the following are met: (i) patient is >= 1 year of age; AND (ii) patient has tried or is concomitantly receiving at least two other antiseizure medications; AND (iii) the medication is prescribed by or in consultation with a neurologist; OR B) Patient is Currently Receiving Epidiolex: Approve for 1 year if the patient is responding to therapy (e.g., reduced seizure severity, frequency, and/or duration) as determined by the prescriber.see text

Examples of other antiseizure medications include lamotrigine, topiramate, Banzel, felbamate, clobazam, valproic acid, levetiracetam, zonisamide, Fycompa, vigabatrin.

Tuberous Sclerosis Complex

Covered when ONE of the following for tuberous sclerosis complex is met

Tuberous sclerosis complex - initial or continuing: A) Initial Therapy: Approve for 1 year if ALL of the following are met: (i) patient is >= 1 year of age; AND (ii) patient has tried or is concomitantly receiving at least two other antiseizure medications; AND (iii) the medication is prescribed by or in consultation with a neurologist; OR B) Patient is Currently Receiving Epidiolex: Approve for 1 year if the patient is responding to therapy (e.g., reduced seizure severity, frequency, and/or duration) as determined by the prescriber.see text

Examples of other antiseizure medications include valproic acid, lamotrigine, topiramate, clonazepam, levetiracetam, zonisamide, Banzel, felbamate, clobazam, Fycompa, vigabatrin, everolimus.

Treatment‑Refractory Seizures/Epilepsy (specified rare conditions)

Covered when ONE of the following for specified treatment‑refractory seizures/epilepsy is met

Treatment-Refractory Seizures/Epilepsy - initial or continuing: A) Initial Therapy: Approve for 1 year if ALL of the following are met: (i) patient is >= 1 year of age; AND (ii) patient has tried or is concomitantly receiving at least two other antiseizure medications; AND (iii) the medication is prescribed by or in consultation with a neurologist; OR B) Patient is Currently Receiving Epidiolex: Approve for 1 year if the patient is responding to therapy (e.g., reduced seizure severity, frequency, and/or duration) as determined by the prescriber.see text

Specified conditions include CDKL5 deficiency disorder; Dup15q, Aicardi, or Doose syndromes; febrile infection-related epilepsy syndromes; focal epilepsy; Sturge-Weber syndrome; lissencephaly; cortical malformation/dysplasia; and epilepsy with myoclonic absences. Examples of other antiseizure medications include valproic acid, lamotrigine, topiramate, clonazepam, levetiracetam, zonisamide, Banzel, felbamate, clobazam, Fycompa, vigabatrin.

Epidiolex (cannabidiol oral solution) is covered only for the specific indications and treatment‑refractory seizure conditions described in this policy. Requests for uses not listed in this policy are considered experimental, investigational, or unproven and may be denied. This policy will be updated as new published data become available.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Epidiolex. Approvals are provided for 1 year when criteria are met for FDA‑approved indications (Dravet syndrome, Lennox‑Gastaut syndrome, tuberous sclerosis complex) or selected treatment‑refractory seizure/epilepsy conditions. Initial approvals require prescription by or consultation with a specialist in the treated condition (typically a neurologist).

Approval duration: 1 year when criteria met
Applies to: FDA‑approved indications and specified treatment‑refractory conditions

Step Therapy

Required Antiseizure Medication Trials

Initial therapy generally requires that the patient has tried or is concurrently receiving at least two other antiseizure medications. An alternative pathway allows trial or concomitant use of one of the specified agents (e.g., clobazam, Fintepla, Diacomit) in some indications — see indication-specific criteria.

Required antiseizure medication trials: ≥ 2 other antiseizure medications for initial therapy

Definitions

Dravet syndrome — definition

DefinitionA rare genetic epileptic encephalopathy beginning in the first year of life with multiple seizure types (myoclonic, tonic-clonic, absence, atypical absence, atonic, focal aware or impaired awareness) and frequent or prolonged refractory seizures.

Typical age of onsetSeizures generally begin in the first year of life.

Seizure characteristicsMultiple seizure types common; seizures are often refractory to medications and may be prolonged or lead to status epilepticus.

Treatment implicationsTreatment often requires two or more antiseizure medications; goals include stopping prolonged convulsions, reducing seizure frequency, and minimizing side effects.

Lennox‑Gastaut syndrome — definition

Definition

Background

Epidiolex is a pharmaceutical formulation of cannabidiol that is FDA‑approved for the treatment of seizures associated with certain rare epilepsy syndromes in patients aged ≥ 1 year. The product is used as an adjunctive antiseizure medication for conditions that are frequently treatment‑resistant and may require multiple concomitant antiseizure therapies.

Revision History and Policy Changes

2025-02-05annual revisionLatest

Policy reviewed; administrative terminology updated — policy name changed from 'Antiepileptics - Epidiolex Prior Authorization Policy' to 'Antiseizure Medications - Epidiolex Prior Authorization Policy' and references changed from antiepileptic to antiseizure medications.

2024-02-07annual revision

Policy reviewed; no clinical criteria changes reported in this revision.

2023-02-15annual revision

Policy Summary

PayerCigna

PolicyAntiseizure Medications - Epidiolex Prior Authorization Policy

Policy CodePolicy N/A

Change TypeClarified terminologyprior expansion retained

Effective DateN/A

Next Review DateFeb 5, 2025

Key ActionObtain prior authorization and document neurologist involvement plus prior or concomitant trials of at least two other antiseizure medications for initial approvals.

SourceLink

On This Page

Alternative: trial or concomitant use of one of Fintepla, Diacomit, or clobazam where specified

Examples of qualifying antiseizure medications are listed in the full criteria (e.g., valproic acid, topiramate, levetiracetam, clobazam, zonisamide, lamotrigine, Fycompa, vigabatrin)

Documentation Required

Required Prescriber and Supporting Documentation

Initial approval requires that Epidiolex be prescribed by or in consultation with a specialist (neurologist or other clinician specialized in the treated condition). Supporting documentation must demonstrate patient age eligibility (≥ 1 year) and either prior/concomitant antiseizure medication use or that the patient is currently responding to Epidiolex for continuation requests.

Prescriber requirement: prescribed by or in consultation with a neurologist or specialist
Documentation required: patient age (≥ 1 year), prior or concurrent antiseizure medication trials (as specified), or evidence of clinical response for patients already receiving therapy (reduced seizure frequency, severity, and/or duration)
For treatment‑refractory indications, document the specific rare condition being treated (e.g., CDKL5 deficiency disorder, Dup15q, Aicardi, Doose, Sturge‑Weber, lissencephaly, cortical malformation/dysplasia, epilepsy with myoclonic absences)

Denial Risk

Non‑Covered Uses

Requests for uses other than the listed FDA‑approved indications or the specified treatment‑refractory seizure/epilepsy conditions are considered experimental, investigational, or unproven and are not covered.

Non‑covered: any other use not enumerated in the policy
The policy will be updated as new published data become available

A severe epileptic and developmental encephalopathy characterized by multiple seizure types (especially atonic and tonic) and high morbidity and mortality.

Typical age of onsetMost often begins between ages 3 and 5 years.

Seizure characteristicsAffected children experience several different seizure types, commonly atonic and tonic seizures; the disorder is often resistant to many therapies.

Treatment approachesManagement may include antiseizure medications, dietary therapy (ketogenic diet), and device/surgical interventions (vagus nerve stimulation, corpus callosotomy).

Tuberous sclerosis complex (TSC) — definition

DefinitionA rare genetic disease causing benign (non-cancerous) tumors in the brain and other organs; associated with seizures, developmental impairment, autism, behavioral problems, and organ involvement (kidneys, heart, eyes, lungs, skin).

Seizure prevalence and controlSeizures affect most individuals with tuberous sclerosis complex at some point and can be difficult to control.

Clinical manifestationsMay include impaired intellectual development, autism spectrum features, behavioral problems, skin abnormalities, and kidney disease.

PathologyCharacterized by growth of benign tumors (hamartomas) in multiple organs due to genetic mutations.

Policy reviewed; no clinical criteria changes reported in this revision.

2024-02-07prior expansion note

Prior revision expanded the list of treatment‑refractory seizures/epilepsy to include focal epilepsy.