CurrentCignaPolicy N/A

Antiseizure Medications - Clobazam Products Prior Authorization Policy

Prior authorization policy for clobazam products (Onfi tablets/suspension and Sympazan oral film) governing coverage when used for FDA-approved indications (Lennox-Gastaut syndrome, Dravet syndrome) and treatment-refractory seizures/epilepsy; includes prescriber specialty, prior-therapy and response requirements and duration of approval.

Policy Summary

PayerCigna

PolicyAntiseizure Medications - Clobazam Products Prior Authorization Policy

Policy CodePolicy N/A

Change TypeName/terminology update; Fintepla added; editorial

Effective Date

Next Review Date

Key ActionObtain prior authorization for clobazam products; initial approval requires prescription by or consultation with a neurologist and approvals are provided for 1 year.

POLICY UPDATE CHANGES

Policy name changed from 'Antiepileptics - Clobazam Prior Authorization Policy' to 'Antiseizure Medications - Clobazam Prior Authorization Policy' and terminology changed from 'antiepileptic' to 'antiseizure'.

Fintepla (fenfluramine oral solution) was added to the list of 'one of the following' antiseizure medications for Lennox-Gastaut Syndrome prior-therapy requirement.

Examples of other antiseizure medications were moved into a Note.

3Covered Indications

1 yearApproval Duration

≥2Minimum Age for Coverage

Scope: Prior authorization policy for clobazam products (Onfi tablets/suspension and Sympazan oral film) governing coverage when used for FDA‑approved indications (Lennox‑Gastaut syndrome, Dravet syndrome) and treatment‑refractory seizures/epilepsy; includes prescriber specialty, prior‑therapy and response requirements and duration of approval. Coverage stance: covered_with_criteria. Minimum age for coverage: ≥ 2 years. Approval duration when criteria met: 1 year.

Coverage summary - Clobazam prior authorization

Covered IndicationsLennox-Gastaut syndrome (FDA-approved), Dravet syndrome (supportive evidence), Treatment‑refractory seizures/epilepsy (supportive evidence)

Approval Duration1 year

Minimum Age for Coverage≥ 2 years

Policy StatusCURRENT

SubjectClobazam (Onfi, Sympazan) prior authorization

Medical Necessity Criteria

FDA-Approved Indication - Lennox-Gastaut Syndrome

Approve for 1 year if the patient meets ONE of the following (A or B): Note: Initial approval requires clobazam to be prescribed by or in consultation with a neurologist; approvals provided for 1 year.

ANY of the following

A) Initial Therapy
- Patient is ≥ 2 years of age
- Patient has tried and/or is concomitantly receiving ONE of the following (a or b)
  - a: At least two other antiseizure medications (examples include valproic acid, levetiracetam, zonisamide, perampanel (Fycompa), vigabatrin, others)
    Examples listed in policy
  - b: One of lamotrigine, topiramate, rufinamide, felbamate, fenfluramine (Fintepla), or cannabidiol oral solution (Epidiolex)
    Fintepla added as acceptable option
- Clobazam is prescribed by or in consultation with a neurologist
  Prescriber specialty required
B) Patient is Currently Receiving Clobazam: Patient is responding to therapy, as determined by the prescriber
Examples: reduced seizure severity, frequency, and/or duration from baseline

Other Uses with Supportive Evidence - Dravet Syndrome

ANY of the following

A) Initial Therapy
- Patient is ≥ 2 years of age
- Clobazam is prescribed by or in consultation with a neurologist
  Prescriber specialty required
B) Patient is Currently Receiving Clobazam: Patient is responding to therapy, as determined by the prescriber
Examples: reduced seizure severity, frequency, and/or duration from baseline

Other Uses with Supportive Evidence - Treatment-Refractory Seizures/Epilepsy

ANY of the following

A) Initial Therapy
- Patient is ≥ 2 years of age
- Patient has tried and/or is concomitantly receiving at least two other antiseizure medications (examples include valproic acid, lamotrigine, topiramate, clonazepam, levetiracetam, zonisamide, rufinamide, felbamate)
  Examples listed in policy
- Clobazam is prescribed by or in consultation with a neurologist
  Prescriber specialty required

Responding to therapy is defined as reduced seizure severity, frequency, and/or duration from baseline (prior to initiation of clobazam), as determined by the prescriber. The prescriber must document that the patient is responding to therapy in the medical record (required for patients currently receiving clobazam).

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is recommended/required for clobazam products; initial approval requires clobazam to be prescribed by or in consultation with a physician who specializes in the condition (neurologist). Approvals provided for 1 year.

Onfi
Sympazan
Approval duration: 1 year

Documentation Required

Documentation of treatment response

For patients currently receiving clobazam, the prescriber must determine and document that the patient is responding to therapy. Examples of response include reduced seizure severity, frequency, and/or duration from baseline (prior to initiation of clobazam).

Definition: Responding to therapy = reduced seizure severity, frequency, and/or duration from baseline, as determined by the prescriber
Examples: reduced seizure severity; reduced seizure frequency; reduced seizure duration

Background & Evidence

Background: All forms of clobazam are indicated as adjunctive therapy for seizures associated with Lennox‑Gastaut syndrome (LGS) in patients ≥ 2 years of age; there is supportive evidence for use in Dravet syndrome and treatment‑refractory epilepsy. LGS and Dravet are severe epileptic encephalopathies that often begin in early childhood, are frequently refractory to treatment, and commonly require multiple antiseizure medications, dietary therapy, device/surgical options, and specialty neurologic management. Because of the specialized evaluation and monitoring required, initial approval requires clobazam to be prescribed by or in consultation with a physician who specializes in the condition (neurologist).

Source	Summary/Reference
Guideline (AAN/AES 2018)	AAN/AES 2018 practice guideline update: clobazam is probably effective as add-on therapy for Lennox-Gastaut syndrome and possibly effective as add-on therapy for treatment‑resistant adult focal epilepsy (Practice guideline summary referenced in policy).
Prescribing Information (Onfi, Sympazan) March 2024	Onfi and Sympazan prescribing information (March 2024) — clobazam indicated as adjunctive treatment for seizures associated with Lennox‑Gastaut syndrome in patients ≥ 2 years; referenced in policy prescribing information list.

Revision History

2024-11-13RevisionLatest

Annual revision: Policy name changed from 'Antiepileptics - Clobazam Prior Authorization Policy' to 'Antiseizure Medications - Clobazam Prior Authorization Policy' and terminology changed from 'antiepileptic' to 'antiseizure'.

2024-11-13RevisionLatest

Material change — Fintepla (fenfluramine oral solution) was added to the list of 'one of the following' antiseizure medications for Lennox-Gastaut Syndrome prior-therapy requirement.

2024-11-13RevisionLatest

Editorial/organizational change: Examples of other antiseizure medications were moved into a Note.

OpenPayer

Antiseizure Medications - Clobazam Products Prior Authorization Policy

Coverage Summary

Medical Necessity Criteria

Coding

Provider Actions

Background & Evidence

Revision History

Onfi	clobazam tablets and oral suspension (Lundbeck, generic)
Sympazan	clobazam oral soluble film (Aquestive Therapeutics)