CurrentCignaPolicy N/A

Antiseizure Medications - Clobazam Products Prior Authorization Policy

Defines prior authorization requirements and medical necessity criteria for clobazam products (Onfi tablets/suspension and Sympazan oral film) for FDA-approved indication (Lennox-Gastaut syndrome) and other supported uses (Dravet syndrome, treatment-refractory seizures) within Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyAntiseizure Medications - Clobazam Products Prior Authorization Policy

Policy CodePolicy N/A

Change TypeTerminology and drug list revisions

Effective Date

Next Review Date

Key ActionObtain prior authorization and ensure clobazam is prescribed by or in consultation with a neurologist; document prior/concomitant antiseizure therapies or response as specified.

SourceLink

POLICY UPDATE CHANGES

Policy name changed to Antiseizure Medications - Clobazam Prior Authorization Policy and references to antiepileptic medications changed to antiseizure medications.

Addition of Fintepla to the list of antiseizure medications that a patient has tried and/or is concomitantly receiving for Lennox-Gastaut Syndrome criteria.

Annual revisions noted with 'No criteria changes' on subsequent review dates.

3Covered Indications

1 yearApproval Duration

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Coverage Summary

Clobazam (Onfi, Sympazan, and generic formulations) is covered with prior authorization under Cigna-administered health benefit plans for Lennox-Gastaut syndrome (FDA-approved) and is supported for use in Dravet syndrome and treatment-refractory seizures based on available evidence. Initial coverage requires that the medication be prescribed by or in consultation with a neurologist/specialist and approvals are provided for 1 year.

Quick facts: Covered Indications: 3 (Lennox-Gastaut syndrome, Dravet syndrome, treatment-refractory seizures/epilepsy); Approval Duration: 1 year; Minimum Patient Age: ≥ 2 years.

Policy Summary

Covered Indications3

Approval Duration1 year

Minimum Patient Age≥ 2 years

Policy statusCURRENT

PayerCigna

Medical Necessity Criteria

Coding

Drugs covered by policyNDC|mixedCovered

Onfi	clobazam tablets and oral suspension (Lundbeck) - covered product
Sympazan	clobazam oral soluble film (Aquestive Therapeutics) - covered product
generic clobazam	generic formulations of clobazam - covered

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is recommended for prescription benefit coverage of clobazam. Initial approval requires the drug be prescribed by or in consultation with a physician who specializes in the condition being treated (neurologist).

Documentation Required

Documentation of prior antiseizure therapies or response

For initial therapy approvals, document prior and/or concomitant antiseizure medications as specified (for LGS: at least two other antiseizure medications or one of the listed agents such as lamotrigine, topiramate, rufinamide, felbamate, Fintepla, or Epidiolex). For continuation, document that the patient is responding to therapy (examples: reduced seizure severity, frequency, and/or duration from baseline).

Background

Background: All forms of clobazam are indicated as adjunctive therapy for seizures associated with Lennox-Gastaut syndrome in patients aged ≥ 2 years. Evidence and guideline statements support clobazam use in Dravet syndrome and as adjunctive therapy for refractory epilepsy.

Because evaluation, diagnosis, monitoring for adverse events, and assessment of long-term efficacy require specialized clinical skills, Cigna requires that initial prescriptions be written by or in consultation with a physician who specializes in the condition being treated (for example, a neurologist).

Supporting sources: FDA prescribing information for Onfi and Sympazan are cited as the primary labeling references for the approved LGS indication and age threshold.

Definitions

Definitions: Response to therapy — Reduced seizure severity, frequency, and/or duration from baseline (prior to initiation of clobazam) as determined by the prescriber.

Revision History

2023-11-15review

Annual revision: policy name changed from 'Antiepileptics - Clobazam Prior Authorization Policy' to 'Antiseizure Medications - Clobazam Prior Authorization Policy' and terminology updated throughout (references to antiepileptic medications changed to antiseizure medications). Added Fintepla to the list of antiseizure medications for Lennox-Gastaut syndrome; examples of other antiseizure medications were moved to a Note. (Material changes).

2024-11-13review

Annual revision: No criteria changes on review. (No material changes).

2025-10-15review