Blue Cross Blue Shield - Iowa clobazam/rufinamide Coverage | OpenPayer

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Blue Cross Blue Shield - Iowa clobazam/rufinamide Coverage | OpenPayer

Initial — Banzel (rufinamide) for Lennox-Gastaut syndrome

Covered when ALL of the following are met

Banzel for LGS: a) Diagnosis of seizures associated with Lennox-Gastaut Syndrome; b) Patient is at least one year of age; c) Patient is taking another antiepileptic drug (AED) for the treatment of seizures associated with Lennox-Gastaut Syndrome.

Approval will be for 36 months

Initial — Banzel for treatment-resistant adult focal epilepsy

Covered when ALL of the following are met

Banzel for treatment-resistant focal epilepsy: a) Diagnosis of treatment-resistant focal seizures as defined by an inability to achieve sustained seizure freedom despite adequate trials of two tolerated and appropriately chosen and used AED schedules (whether as monotherapies or in combination); b) At least 18 years of age; c) Patient is taking another AED for the treatment of focal seizures.

Approval will be for 36 months

Initial — Onfi for Lennox-Gastaut syndrome

Covered when ALL of the following are met

Onfi for LGS: a) Diagnosis of seizures associated with Lennox-Gastaut Syndrome; b) Patient is at least 2 years of age; c) Patient is taking another AED for the treatment of Lennox-Gastaut Syndrome.

Approval will be for 36 months

Initial — Onfi for Dravet syndrome

Covered when ALL of the following are met

Onfi for Dravet syndrome: a) Diagnosis of seizures associated with Dravet syndrome; b) Patient is at least 2 years of age.

Initial — Onfi for drug-resistant partial-onset seizures

Covered when ALL of the following are met

Onfi for drug-resistant partial-onset seizures: a) Diagnosis of drug resistant partial-onset seizures associated with epilepsy as defined by an inability to achieve sustained seizure freedom despite adequate trials of two tolerated and appropriately chosen and used AED schedules (whether as monotherapies or in combination); b) Patient is at least 2 years of age.

Initial — Sympazan for Lennox-Gastaut syndrome (oral film limited-use)

Covered when ALL of the following are met

Sympazan for LGS: a) Diagnosis of seizures associated with Lennox-Gastaut Syndrome; b) Patient is at least 2 years of age; c) Patient is taking another AED for the treatment of Lennox-Gastaut Syndrome; d) Patient is unable to take both clobazam tablets and oral suspension due to an allergy, intolerance, or contraindication to the excipients.

Approval will be for 36 months

Initial — Sympazan for Dravet syndrome

Covered when ALL of the following are met

Sympazan for Dravet syndrome: a) Diagnosis of seizures associated with Dravet syndrome; b) Patient is at least 2 years of age; c) Patient is unable to take both clobazam tablets and oral suspension due to an allergy, intolerance, or contraindication to the excipients.

Initial — Sympazan for drug-resistant partial-onset seizures

Covered when ALL of the following are met

Sympazan for drug-resistant partial-onset seizures: a) Diagnosis of drug resistant partial-onset seizures associated with epilepsy as defined by an inability to achieve sustained seizure freedom despite adequate trials of two tolerated and appropriately chosen and used AED schedules (whether as monotherapies or in combination); b) Patient is at least 2 years of age; c) Patient is unable to take both clobazam tablets and oral suspension due to an allergy, intolerance, or contraindication to the excipients.

Approval will be for 36 months

Continuation therapy — All products

Covered when ALL of the following are met

Continuation: Member has achieved and maintained a positive clinical response with the requested medication as evidenced by reduction in frequency or duration of seizures.

Approval will be for 36 months

Note: Banzel (rufinamide) is contraindicated in patients with Familial Short QT Syndrome per the product labeling.

Note: Sympazan (clobazam oral film) is limited-use and is covered only when the patient is unable to take both clobazam tablets and oral suspension due to an allergy, intolerance, or contraindication to the excipients.

Not medically necessary: Brand and generic Banzel, Onfi, and Sympazan are considered not medically necessary for patients who do not meet the specific criteria set forth in this policy.

Prior Authorization, Documentation, and Step Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Banzel (rufinamide), Onfi (clobazam), and Sympazan (clobazam oral film). Approvals will be for 36 months. Quantity limits apply as specified for each formulation; submit documentation of prescribed quantity and intended duration with the prior authorization request.

Approval period: 36 months
Quantity limits: see drug-specific limits (Banzel, Onfi, Sympazan)

Step Therapy

Step / Failure Requirement for Refractory Epilepsy

For drug‑resistant (refractory) epilepsy, the prescriber must document failure of at least two tolerated, appropriately chosen, and adequately dosed antiepileptic drug (AED) regimens (may be monotherapy or combination) prior to approval for treatment‑resistant focal seizures or drug‑resistant partial‑onset seizures.

Failure of 62 AED regimens required for treatment‑resistant epilepsy indications
Applicable to adults (≥18 years) for treatment‑resistant focal epilepsy and ≥2 years for pediatric refractory indications where specified

Documentation Required

Required Clinical Documentation

Submit clinical documentation with the prior authorization request to demonstrate that all applicable criteria are met. Required documentation includes: diagnosis (Lennox‑Gastaut syndrome, Dravet syndrome, treatment‑resistant focal epilepsy, or drug‑resistant partial‑onset seizures), patient age, current and prior AED regimen history (including trials and reasons for failure/intolerance), and rationale if using Sympazan when tablets/suspension are not an option (e.g., allergy or intolerance to excipients). For continuation requests, provide evidence of maintained positive clinical response (reduction in seizure frequency or duration).

Diagnosis and patient age
List of current and prior AEDs with trial durations and outcomes
Clinical rationale for oral film use if tablets/suspension cannot be used
Evidence of clinical response for continuation requests

Denial Risk

Failure to Meet Criteria May Lead to Denial

Requests that do not meet the listed criteria (including missing documentation, failure to document required AED trials for refractory epilepsy, or lack of demonstrated clinical benefit for continuation) will be denied as not medically necessary.

Denial if required AED failure history (≥2 trials) is not documented for refractory indications
Denial if diagnosis, age, or concomitant AED use criteria are not met
Denial for continuation if no evidence of maintained clinical response