Currentmedical mutual - ohioPolicy N/A

Epidiolex (cannabidiol) coverage

Defines Medical Mutual - Ohio prior authorization and coverage criteria for Epidiolex for treatment of seizures in Dravet syndrome, Lennox-Gastaut syndrome, tuberous sclerosis complex, and certain treatment‑refractory epilepsies for members ≥ 1 year of age.

Policy Summary

Payermedical mutual - ohio

PolicyEpidiolex (cannabidiol) coverage

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateN/A

Next Review DateJul 17, 2025

Key ActionObtain prior authorization; initial prescriptions must be by or in consultation with a neurologist or specialist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥1minimum patient age for coverage

1 yrinitial approval duration

1 yrextended approval duration

3named indications

Recommended Authorization Criteria for Epidiolex

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LG initial or continuation

ALL of the following
- Patient is ≥ 1 year of ageage >=1 year
- ONE of
  - Patient has tried or is concomitantly receiving one antiepileptic drug used for Lennox-Gastaut Syndrome (examples: clobazam, clonazepam, felbamate, fenfluramine, lamotrigine, rufinamide, topiramate)
  - Patient has tried or is concomitantly receiving at least two other antiseizure medications (examples: valproic acid, levetiracetam, zonisamide, perampanel, vigabatrin)
- Medication is prescribed by or in consultation with a neurologist
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

LG note: Initial approvals are for 1 year; continuation approvals for currently receiving patients are for 1 year.

Dravet Syndrome

Covered when ONE of the following is met

Dravet initial or continuation

ALL of the following
- Patient is ≥ 1 year of ageage >=1 year
- ONE of
  - Patient has tried or is concomitantly receiving one antiepileptic drug used for Dravet Syndrome (examples: fenfluramine, stiripentol, clobazam)
  - Patient has tried or is concomitantly receiving at least two other antiseizure medications (examples: clonazepam, felbamate, lamotrigine, rufinamide, topiramate, valproic acid, levetiracetam, zonisamide)
- Medication is prescribed by or in consultation with a neurologist
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

Dravet note: Initial approvals are for 1 year; continuation approvals for currently receiving patients are for 1 year.

Tuberous Sclerosis Complex

Covered when ONE of the following is met

TSC initial or continuation

ALL of the following
- Patient is ≥ 1 year of ageage >=1 year
- Patient has tried or is concomitantly receiving at least two other antiseizure medications (examples: valproic acid, lamotrigine, topiramate, clonazepam, levetiracetam, zonisamide, rufinamide, felbamate, clobazam, perampanel, vigabatrin, everolimus)
- Medication is prescribed by or in consultation with a neurologist
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

TSC note: Initial approvals are for 1 year; continuation approvals for currently receiving patients are for 1 year.

Other Treatment‑Refractory Seizures/Epilepsy (select rare conditions)

Covered when ONE of the following is met

Other refractory seizure disorders

ALL of the following
- Patient is ≥ 1 year of ageage >=1 year
- Patient has tried or is concomitantly receiving at least two other antiseizure medications (examples: valproic acid, lamotrigine, topiramate, clonazepam, levetiracetam, zonisamide, rufinamide, felbamate, clobazam, perampanel, vigabatrin)
- Medication is prescribed by or in consultation with a neurologist
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

Other note: Initial approvals are for 1 year; continuation approvals for currently receiving patients are for 1 year.

Coding and Automation Triggers

Automation ICD-10 triggersICD-10

G40.83*	Dravet Syndrome (ICD-10 code prefix used in automation)
G40.81*	Lennox-Gastaut Syndrome (ICD-10 code prefix used in automation)

Prior antiseizure medication trials

Lookback period365-day prior medication history required to evaluate prior antiseizure medication trials

Required trials for Lennox-Gastaut initial therapyPatient must have tried or be concomitantly receiving one Lennox‑Gastaut antiseizure drug OR have tried at least two other antiseizure medications within the prior 365 days

Required trials for Dravet initial therapyPatient must have tried or be concomitantly receiving one Dravet antiseizure drug (examples: fenfluramine, stiripentol, clobazam) OR have tried at least two other antiseizure medications within the prior 365 days

Required trials for TSC and other refractory seizuresPatient must have tried or be concomitantly receiving at least two other antiseizure medications within the prior 365 days

Examples of antiseizure medicationsLennox‑Gastaut examples: clobazam, clonazepam, felbamate, fenfluramine, lamotrigine, rufinamide, topiramate; Other ASM examples: valproic acid, levetiracetam, zonisamide, perampanel, vigabatrin; Dravet examples: fenfluramine, stiripentol, clobazam

Required Provider Steps, Documentation, and Denial Risk

Prior Authorization

Prior Authorization Required; Specialist Involvement

Prior authorization required for initial therapy: initial approval requires the medication be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., neurologist). All initial approvals are for the initial approval duration noted in the policy; reauthorization generally requires documented response to therapy.

Initial prescriptions must be by or in consultation with a specialist (neurologist) for conditions listed (Lennox-Gastaut, Dravet, tuberous sclerosis complex, treatment-refractory seizures, etc.)
Reauthorization requires documentation of response to therapy (reduced seizure frequency, severity, and/or duration) unless otherwise specified

Step Therapy

Step Therapy / Prior ASM Trials

Step therapy / prior antiseizure medication (ASM) trials are required per indication before approval of initial therapy unless the patient is currently receiving Epidiolex and demonstrating benefit. Examples of required trials include using one AED specific to the syndrome or at least two other antiseizure medications as noted in the criteria.

Lennox-Gastaut: try or be concomitantly receiving one AED used for LGS OR have tried/concomitantly receive at least two other antiseizure medications
Dravet Syndrome: try or be concomitantly receiving one AED used for Dravet OR have tried/concomitantly receive at least two other antiseizure medications
Tuberous Sclerosis Complex and other treatment-refractory seizures: tried or be concomitantly receiving at least two other antiseizure medications
Examples of AEDs and other antiseizure medications are listed in the policy (e.g., clobazam, clonazepam, felbamate, fenfluramine, lamotrigine, rufinamide, topiramate, valproic acid, levetiracetam, zonisamide, perampanel, vigabatrin, everolimus where applicable)

Documentation Required

Documentation Requests

Documentation may be requested to support medical necessity; provide records promptly when asked.

The Company may request patient records, test results, and/or credentials of the provider ordering or performing the service
Additional documentation supporting medical necessity must be made available upon request to the Company

Denial Risk

Denial Conditions

Denial conditions — the Company may deny reimbursement when the drug or services are not medically necessary, are investigational/experimental, outside the member's benefit scope, or when inappropriate/excessive billing or practice patterns are found.

Denial may occur if the drug provided or services performed were not medically necessary
Denial may occur if use is investigational or experimental
Denial may occur if the request is not within the scope of benefits afforded to the member
Denial may occur for patterns of billing or other practices found to be inappropriate or excessive

Clinical Context

Epidiolex (cannabidiol) is indicated and recommended for use in specific severe, often treatment‑resistant pediatric and adult epilepsy syndromes. The policy identifies three primary labeled or well‑supported indications: Dravet syndrome, Lennox‑Gastaut syndrome, and seizures associated with tuberous sclerosis complex (TSC), as well as certain select treatment‑refractory seizure disorders supported by the literature. These conditions are characterized by early onset, multiple seizure types, and frequent refractoriness to standard antiseizure medications, which is why prior trials or concomitant use of other antiseizure medications and specialist involvement are required for initial approval. Initial and continuation approvals are granted for 1 year when the patient meets the age and prior‑therapy requirements and the prescriber documents a clinical response or meets initial trial criteria.

Key Condition Definitions

Dravet syndrome

DefinitionA rare genetic epileptic encephalopathy with onset in the first year of life characterized by frequent and/or prolonged seizures and multiple seizure types (myoclonic, tonic‑clonic, absence, atypical absence, atonic, focal, status epilepticus)

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

Clinical course and treatmentSeizures are often refractory; two or more antiseizure medications are frequently required with goals to stop prolonged convulsions, reduce seizure frequency, and minimize side effects

Lennox‑Gastaut syndrome

DefinitionA severe epileptic and developmental encephalopathy, most often beginning between ages 3 and 5, characterized by multiple seizure types (commonly atonic and tonic) and high treatment resistance

Common seizure typesAtonic (sudden loss of muscle tone) and tonic seizures are common; multiple seizure types occur

Treatment considerationsManagement includes antiseizure medications, dietary therapy (ketogenic diet), and device/surgery (vagus nerve stimulation, corpus callosotomy); many patients remain treatment‑resistant

Tuberous sclerosis complex (TSC)

DefinitionA genetic disorder causing benign tumors in the brain and other organs; associated with seizures, intellectual disability, autism, behavioral problems, skin abnormalities, and kidney disease

Seizure prevalence and controlMost individuals with TSC experience seizures at some point and seizures can be difficult to control

Antiseizure medication requirement for coverageInitial therapy criteria require the patient to have tried or be concomitantly receiving at least two other antiseizure medications

Policy Summary

Payermedical mutual - ohio

PolicyEpidiolex (cannabidiol) coverage

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateN/A

Next Review DateJul 17, 2025

Key ActionObtain prior authorization; initial prescriptions must be by or in consultation with a neurologist or specialist.

SourceLink

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