CurrentCignaPolicy N/A

Antiseizure Medications - Rufinamide Prior Authorization Policy

Defines Cigna's prior authorization requirements, coverage criteria, and medical necessity stance for rufinamide (Banzel) for Lennox-Gastaut syndrome and treatment-refractory seizures for affected members and prescribing providers.

Policy Summary

PayerCigna

PolicyAntiseizure Medications - Rufinamide Prior Authorization Policy

Policy CodePolicy N/A

Change TypeRevised

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization; initial therapy approvals require the patient to have tried or be concomitantly receiving at least two other antiseizure medications and prescription by or in consultation with a specialist.

SourceLink

POLICY UPDATE CHANGES

In initial therapy criteria, wording changed from 'tried and/or is concomitantly receiving at least two other antiseizure medications' to 'tried or is concomitantly receiving at least two other antiseizure medications' to remove redundancy.

Updated example list: Fycompa was changed to perampanel to reflect generic availability.

1 yearapproval duration for covered indications

≥1 yrminimum patient age for approval

>=2prior/concurrent ASM requirement

LGSprimary FDA indication referenced

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NMNuses outside listed indications

Coverage and Medical Necessity Criteria

Lennox‑Gastaut Syndrome

Covered when ONE of the following is met; approvals for 1 year

Lennox‑Gastaut coverage options: Approve for 1 year if the patient meets ONE of the following (A or B)

A) Initial Therapy: Initial therapy: approve if patient meets ALL of i, ii, iii

A.i Age: Patient is ≥ 1 year of age>=1 year

A.ii Prior/concurrent ASMs: Patient has tried or is concomitantly receiving at least two other antiseizure medications>=2 ASMs

Examples provided in policy (e.g., valproic acid, levetiracetam, perampanel, clobazam, topiramate, etc.)

A.iii Specialist: Medication is prescribed by or in consultation with a neurologist

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

Treatment‑Refractory Seizures/Epilepsy

Covered when ONE of the following is met; approvals for 1 year

Treatment‑refractory coverage options: Approve for 1 year if the patient meets ONE of the following (A or B)

A) Initial Therapy: Initial therapy: approve if patient meets ALL of i, ii, iii

A.i Age: Patient is ≥ 1 year of age>=1 year

A.ii Prior/concurrent ASMs: Patient has tried or is concomitantly receiving at least two other antiseizure medications>=2 ASMs

Rufinamide (Banzel) is considered not medically necessary for any uses not explicitly listed in this policy.

Any use of rufinamide beyond the specified indications for Lennox‑Gastaut syndrome and treatment‑refractory seizures/epilepsy as defined in this policy is not medically necessary.

Coding and Age Requirements

Drug referenceNDC | mixed

Banzel; rufinamide

Brand and generic drug referenced (no numeric codes listed in document)

inv-06: Minimum age — ≥ 1 year

Minimum age for approvalPatient is ≥ 1 year of age

Approval durationApprovals are provided for 1 year when criteria are met

Applicable indicationsApplies to Lennox‑Gastaut syndrome and treatment‑refractory seizures/epilepsy (per policy)

Provider Requirements, Prior Authorization, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for rufinamide. Approvals are provided for 1 year when criteria are met. Initial prescriptions must be by or in consultation with a physician who specializes in the condition being treated (e.g., neurologist).

Initial approval requires specialist prescription or consultation (neurologist).
Approvals duration: 1 year when criteria are met.

Step Therapy

Step Therapy Requirement — Prior/Concurrent Antiseizure Medications

Approval for initial therapy requires that the patient has tried or is concomitantly receiving at least two other antiseizure medications prior to or along with rufinamide. Examples of antiseizure medications include valproic acid, gabapentin, phenytoin, carbamazepine, oxcarbazepine, lacosamide, levetiracetam, zonisamide, perampanel, vigabatrin, lamotrigine, topiramate, clobazam, stiripentol (Diacomit), cannabidiol (Epidiolex), and felbamate.

Step requirement: tried or currently receiving ≥ 2 other antiseizure medications.

Background and Context

Rufinamide is FDA‑approved as adjunctive treatment for seizures associated with Lennox‑Gastaut syndrome in patients aged ≥ 1 year. It is used in clinical practice as adjunctive therapy for difficult‑to‑control epilepsies; treatment typically occurs in the context of multiple antiseizure medications, and prescriber assessment of response (for example, reduced seizure frequency, severity, or duration) guides ongoing therapy.

Key Definitions

inv-12: Lennox‑Gastaut syndrome definition — A severe epileptic and developmental encephalopathy beginning most often between ages 3–5 years, characterized by multiple seizure types and high morbidity/mortality; managed with multiple ASMs, ketogenic diet, and device/surgical options.

Core definitionA severe epileptic and developmental encephalopathy beginning most often between ages 3–5 years, characterized by multiple seizure types (commonly atonic and tonic seizures) and high morbidity/mortality; managed with multiple ASMs, ketogenic diet, and device/surgical options.

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

Common seizure typesMultiple seizure types, most commonly atonic and tonic seizures

Usual management approachesAntiseizure medications, dietary therapy (ketogenic diet), and device/surgical interventions (e.g., vagus nerve stimulation, corpus callostomy)

Policy Summary

PayerCigna

PolicyAntiseizure Medications - Rufinamide Prior Authorization Policy

Policy CodePolicy N/A

Change TypeRevised

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Examples provided in policy (e.g., valproic acid, levetiracetam, perampanel, clobazam, topiramate, etc.)

A.iii Specialist: Medication is prescribed by or in consultation with a neurologist

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

Examples list provided in policy.

Documentation Required

Prescriber and Clinical Documentation Requirements

Initial approval requires that rufinamide be prescribed by or in consultation with a physician who specializes in the condition being treated (for example, a neurologist). For continuation requests, documentation must indicate the patient is responding to therapy (e.g., reduced seizure severity, frequency, and/or duration) as determined by the prescriber.

Prescriber requirement: specialist (neurologist) for initial prescriptions.
Continuation documentation: evidence of clinical response (reduced seizure severity/frequency/duration).

Denial Risk

Denial Triggers / Not Medically Necessary Uses

Claims submitted for services that are not accompanied by covered diagnosis or procedure codes under the applicable coverage policy will be denied. Rufinamide is considered not medically necessary for any uses other than the FDA‑approved indication (Lennox‑Gastaut syndrome) or other uses specifically supported by the policy criteria; requests not meeting the listed criteria will be denied as not covered.

Claims lacking covered diagnosis/procedure codes will be denied.
Rufinamide is not medically necessary for any other uses outside the policy criteria.