CurrentCignaPolicy N/A

Ip_0410_Coveragepositioncriteria_Cannabidiol

Defines Cigna prior authorization and medical necessity criteria for coverage of Epidiolex (cannabidiol oral solution) for FDA‑approved indications (Dravet syndrome, Lennox‑Gastaut syndrome, tuberous sclerosis complex) and certain treatment‑refractory rare epilepsies; includes duration of approval, prescriber requirements, and noncovered uses.

Policy Summary

PayerCigna

PolicyIp_0410_Coveragepositioncriteria_Cannabidiol

Policy CodePolicy N/A

Change TypeRevised / Added / Clarified

Effective Date

Next Review Date

Key ActionObtain prior authorization and document specialist involvement, patient age, prior or concomitant antiseizure medications (or clinical response for continuations).

SourceLink

POLICY UPDATE CHANGES

Policy title changed from 'Cannabidiol' to 'Antiseizure Medications - Epidiolex' and Dravet criterion expanded to allow treatment if patient has tried or is concomitantly receiving Fintepla, Diacomit, or clobazam.

Focal epilepsy was added to the list of specific rare conditions covered under Treatment‑Refractory Seizures/Epilepsy.

Examples of other antiseizure medications updated (e.g., Banzel updated to rufinamide; Fycompa updated to perampanel) to reflect generic availability.

3FDA‑approved indications covered

1Approval duration (years)

≥1

Minimum patient age (years)

2Required other ASMs tried/concomitant

Coverage Summary

Scope: This policy defines Cigna prior authorization and medical necessity criteria for coverage of Epidiolex (cannabidiol oral solution) for FDA‑approved indications — Dravet syndrome, Lennox‑Gastaut syndrome, and tuberous sclerosis complex — and for certain treatment‑refractory rare epilepsies per the policy Note. Coverage requires prior authorization and specialist involvement and approvals are provided for 1 year.

Coverage stance: Covered with criteria. For FDA‑approved indications, initial approval requires the patient to be ≥1 year of age and to have tried or be concomitantly receiving at least two other antiseizure medications (or meet the specific alternative option for Dravet), with the medication prescribed by or in consultation with a neurologist; continued therapy may be approved if the prescriber documents response. The policy also provides 1‑year approvals for certain treatment‑refractory rare epilepsies when the same age, ASM, and specialist criteria are met.

FDA indications covered (explicit): Dravet syndrome, Lennox‑Gastaut syndrome, and Tuberous Sclerosis Complex (all FDA‑approved for patients ≥1 year).

Approval duration and age minimum: Approvals are for 1 year and the minimum patient age across covered indications is ≥1 year.

Additional coverage: Certain treatment‑refractory rare epilepsies (listed in the policy Note) are covered with supportive evidence from expanded access and cohort studies and with the same age/ASM/specialist requirements as above.

Quick Facts

FDA‑approved indications covered3

Approval duration (years)1

Minimum patient age (years)>=1

Required other ASMs tried/concomitant2

Medical Necessity Criteria

Prior Authorization and General Requirement

Prior Authorization is required; initial approval requires prescription by or in consultation with a specialist (neurologist) and approvals provided for duration noted in each indication.

ALL of the following

Prior Authorization is required for benefit coverage of Epidiolex.
Initial approval requires Epidiolex to be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., neurologist).

Dravet Syndrome (FDA‑approved)

Approve for 1 year if the patient meets ONE of the following (A or B):

ANY of the following

A) Initial Therapy

Conditions Not Covered

Epidiolex for any other use is considered not medically necessary.

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is required for any Epidiolex benefit coverage; initial approval requires prescription by or consultation with a specialist (neurologist).

Documentation Required

Documentation of prior ASMs or current response

For initial therapy: document patient age (≥1 year), evidence the patient has tried or is concomitantly receiving at least two other antiseizure medications (examples listed in policy) or has tried/is concomitantly receiving one of Fintepla (fenfluramine), Diacomit (stiripentol), or clobazam, and that the medication is prescribed by or in consultation with a neurologist. For continuation therapy: document clinical response to Epidiolex (e.g., reduced seizure severity, frequency, and/or duration) as determined by the prescriber.

Coding

No procedure or billing codes specified in policy bodymixed

No codes listed

Background & Evidence

Background: Epidiolex (cannabidiol oral solution) is FDA‑indicated for seizures associated with Dravet syndrome, Lennox‑Gastaut syndrome, and tuberous sclerosis complex in patients ≥1 year of age. Prior authorization is required and initial prescribing should be by or in consultation with a specialist (e.g., neurologist).

Evidence: In addition to randomized trials supporting the FDA indications, supportive evidence for use in other treatment‑resistant epilepsies comes from an expanded access program and cohort analyses (the expanded access review included 840 patients and demonstrated reduced seizure frequency across diagnoses).

Supplemental: Other antiseizure medications can be used as comparators or concomitant therapies; examples are provided in the policy definitions.

Source	Summary
Expanded access program	840 patients included; reduced seizure frequency observed (Szaflarski et al. 2023)

Definitions

Other antiseizure medications (examples): valproic acid, topiramate, clonazepam, levetiracetam, zonisamide, lamotrigine, rufinamide, felbamate, clobazam, perampanel, vigabatrin, everolimus.

Revision History

5/1/2024revised

Policy title changed from 'Cannabidiol' to 'Antiseizure Medications - Epidiolex'; Dravet criterion expanded to allow treatment if patient has failure, contraindication or intolerance to, or is concomitantly receiving Fintepla, Diacomit, or clobazam; removed requirement of contraindication/intolerance for Lennox-Gastaut, Tuberous Sclerosis Complex, and Treatment-Refractory Seizures/Epilepsy that previously required failure/contraindication/intolerance to all alternative formulary anti-epileptic medications.

5/15/2025added

Treatment-Refractory Seizures/Epilepsy (specific rare conditions) expanded to include focal epilepsy among the list of covered specific rare conditions.

5/1/2026revised

Policy Summary

PayerCigna

PolicyIp_0410_Coveragepositioncriteria_Cannabidiol

Policy CodePolicy N/A

Change TypeRevised / Added / Clarified

Effective Date

Next Review Date

Key ActionObtain prior authorization and document specialist involvement, patient age, prior or concomitant antiseizure medications (or clinical response for continuations).

SourceLink

On This Page

Patient is ≥ 1 year of age

ONE of

Patient has tried or is concomitantly receiving at least two other antiseizure medications
Patient has tried or is concomitantly receiving one of Fintepla (fenfluramine oral solution), Diacomit (stiripentol), or clobazam

The medication is prescribed by or in consultation with a neurologist

B) Patient is Currently Receiving Epidiolex

Patient is currently receiving Epidiolex and is responding to therapy (e.g., reduced seizure severity, frequency, and/or duration) as determined by the prescriber

Lennox‑Gastaut Syndrome (FDA‑approved)

Approve for 1 year if the patient meets ONE of the following (A or B):

ANY of the following

A) Initial Therapy
- Patient is ≥ 1 year of age
- Patient has tried or is concomitantly receiving at least two other antiseizure medications
- The medication is prescribed by or in consultation with a neurologist
B) Patient is Currently Receiving Epidiolex
- Patient is currently receiving Epidiolex and is responding to therapy (e.g., reduced seizure severity, frequency, and/or duration) as determined by the prescriber

Tuberous Sclerosis Complex (FDA‑approved)

Approve for 1 year if the patient meets ONE of the following (A or B):

ANY of the following

A) Initial Therapy
- Patient is ≥ 1 year of age
- Patient has tried or is concomitantly receiving at least two other antiseizure medications
- The medication is prescribed by or in consultation with a neurologist
B) Patient is Currently Receiving Epidiolex
- Patient is currently receiving Epidiolex and is responding to therapy (e.g., reduced seizure severity, frequency, and/or duration) as determined by the prescriber

Treatment‑Refractory Seizures/Epilepsy (Specific Rare Conditions) - Supportive Evidence

Approve for 1 year if the patient meets ONE of the following (A or B). Note lists included conditions.

ANY of the following

A) Initial Therapy
- Patient is ≥ 1 year of age
- Patient has tried or is concomitantly receiving at least two other antiseizure medications
- The medication is prescribed by or in consultation with a neurologist
B) Patient is Currently Receiving Epidiolex
- Patient is currently receiving Epidiolex and is responding to therapy (e.g., reduced seizure severity, frequency, and/or duration) as determined by the prescriber

Note: Specific rare 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.

Standardized language across indications replacing 'failure, contraindication or intolerance, or is concomitantly receiving' with 'tried or is concomitantly receiving at least two other antiseizure medications' (Dravet, Lennox-Gastaut, Tuberous Sclerosis Complex, Treatment-Refractory Seizures). Example drug updates: Banzel updated to rufinamide and Fycompa updated to perampanel to reflect generic availability. Specific rare conditions list was relocated to a Note.

annual (multiple dates listed)clarified

Examples of other antiseizure medications updated (e.g., Banzel → rufinamide; Fycompa → perampanel) and generic availability reflected; multiple annual revision entries recorded in revision history (dates include 5/1/2024; 5/15/2025; 5/1/2026).