Pharmacy Prior Authorization Criteria

Banzel (rufinamide)

Indications for Prior Authorization

Banzel (rufinamide) tablets and oral suspension

• For diagnosis of Lennox-Gastaut Syndrome (LGS)
  Indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults.

Criteria

Brand Banzel

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of seizures associated with Lennox-Gaustaut Syndrome (LGS)
AND
• Used as adjunctive therapy
AND
• Patient is 1 year of age or older
AND
• One of the following:
• Trial of and inadequate response to, contraindication, or intolerance to ONE generic formulary anticonvulsant (e.g., topiramate, lamotrigine, valproate)
• For continuation of prior therapy if the patient is established on Brand Banzel
AND
• Prescribed by or in consultation with a neurologist

generic rufinamide

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of seizures associated with Lennox-Gaustaut Syndrome (LGS)
AND
• Used as adjunctive therapy
AND
• Patient is 1 year of age or older
AND
• One of the following:
• Trial of and inadequate response to, contraindication, or intolerance to ONE generic formulary anticonvulsant (e.g., topiramate, lamotrigine, valproate) other than generic rufinamide
• For continuation of prior therapy if the patient is established on generic rufinamide
AND
• Prescribed by or in consultation with a neurologist

Brand Banzel, generic rufinamide

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy

P & T Revisions

2024-05-31, 2023-09-13, 2023-05-25, 2022-06-02, 2021-07-08, 2021-06-21, 2021-06-21, 2021-05-20, 2020-12-01, 2020-05-05, 2019-07-30

References

1. Banzel Prescribing Information. Eisai Inc. Woodcliff, NJ. April 2020.

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Revision History

• 2024-05-31: Annual Review - No criteria changes
• 2023-09-13: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-05-25: Annual Review - no criteria changes
• 2022-06-02: Annual review - addition of age criteria
• 2021-07-08: Added generic rufinamide tablets as target, mirrors criteria for generic rufinamide suspension.
• 2021-06-21: 2021 Annual Review, no changes to criteria.
• 2021-06-21: Updated CoT verbiage for generic rufinamide suspension, no change to clinical criteria
• 2021-05-20: Addition of EHB formulary to guideline, no changes to criteria
• 2020-12-01: Added criteria for new generic suspension; updated original criteria to allow for either t/f requirements or continuation of therapy.
• 2020-05-05: Annual Review. No changes.
• 2019-07-30: updated approval duration due to system update

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