Pharmacy Prior Authorization Criteria

Onfi (clobazam), Sympazan (clobazam)

Indications for Prior Authorization

Onfi (clobazam) tablets and oral suspension, Sympazan (clobazam) oral film

• For diagnosis of Lennox-Gastaut syndrome (LGS)
  Indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.

• For diagnosis of Refractory Seizures
  There is some clinical evidence to support the use in refractory seizures.

Criteria

Generic clobazam

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• All of the following:
• Diagnosis of seizures associated with Lennox-Gastaut syndrome (LGS)
AND
• Used as adjunctive therapy [A]
AND
• Patient is 2 years of age or older
AND
• Prescribed by or in consultation with a neurologist
OR
• All of the following: [4]
• Diagnosis of seizures associated with Dravet syndrome (DS)
AND
• Used in combination with Diacomit (stiripentol)
AND
• Both of the following:
• Patient is 6 months of age or older
• Patient weighs greater than or equal to 7 kg
AND
• Prescribed by or in consultation with a neurologist

Generic clobazam [off label]

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• All of the following: [B, 5-6]
• Diagnosis of refractory seizures (inadequate response to at least two antiepileptic drugs)
AND
• Used as adjunctive therapy
AND
• Prescribed by or in consultation with a neurologist

Brand Onfi

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• All of the following:
• Diagnosis of seizures associated with Lennox-Gastaut syndrome (LGS)
AND
• Used as adjunctive therapy [A]
AND
• Patient is 2 years of age or older
AND
• Prescribed by or in consultation with a neurologist
AND
• Trial and failure or intolerance to generic clobazam tablets or oral suspension
OR
• All of the following: [4]
• Diagnosis of seizures associated with Dravet syndrome (DS)
AND
• Used in combination with Diacomit (stiripentol)
AND
• Both of the following:
• Patient is 6 months of age or older
• Patient weighs greater than or equal to 7 kg
AND
• Prescribed by or in consultation with a neurologist
AND
• Trial and failure or intolerance to generic clobazam tablets or oral suspension

Brand Onfi [off label]

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• All of the following: [B, 5-6]
• Diagnosis of refractory seizures (inadequate response to at least two antiepileptic drugs)
AND
• Used as adjunctive therapy
AND
• Trial and failure or intolerance to generic clobazam tablets or oral suspension
AND
• Prescribed by or in consultation with a neurologist

Sympazan

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• All of the following:
• Diagnosis of seizures associated with Lennox-Gastaut syndrome (LGS)
AND
• Used as adjunctive therapy [A]
AND
• Patient is 2 years of age or older
AND
• Prescribed by or in consultation with a neurologist
AND
• One of the following:
• Trial and failure or intolerance to generic clobazam tablets or oral suspension
• For continuation of prior therapy
OR
• All of the following: [4]
• Diagnosis of seizures associated with Dravet syndrome (DS)
AND
• Used in combination with Diacomit (stiripentol)
AND
• Both of the following:
• Patient is 6 months of age or older
• Patient weighs greater than or equal to 7 kg
AND
• Prescribed by or in consultation with a neurologist
AND
• One of the following:
• Trial and failure or intolerance to generic clobazam tablets or oral suspension
• For continuation of prior therapy

Sympazan [off label]

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• All of the following: [B, 5-6]
• Diagnosis of refractory seizures (inadequate response to at least two antiepileptic drugs)
AND
• Used as adjunctive therapy
AND
• Prescribed by or in consultation with a neurologist
AND
• One of the following:
• Trial and failure or intolerance to generic clobazam tablets or oral suspension
• For continuation of prior therapy

Generic clobazam, Brand Onfi, or Sympazan

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy

P & T Revisions

2024-12-24, 2024-06-17, 2024-01-04, 2023-10-03, 2023-04-24, 2023-01-14, 2022-01-07, 2021-09-28, 2021-05-21, 2021-01-05, 2019-12-12, 2019-10-29

References

1. Onfi Prescribing Information. Lundbeck. Deerfield, IL. March 2024.
2. Ng Y-T, Conry JA, Drummond R, et al. Randomized, phase III study results of clobazam in Lennox-Gastaut syndrome. Neurology. 2011;77:1473-81.
3. Sympazan Prescribing Information. Aquestive Therapeutics. Warren, NJ. March 2023.
4. Diacomit Prescribing Information. Biocodex. Beauvais, France. June 2024.
5. Drislane, F. UptoDate. Refractory status epilepticus in adults. March 2023. Available at: https://www.uptodate.com/contents/refractory-status-epilepticus-in-adults?search=onfi&source=search_result&selectedTitle=3~17&usage_type=default&display_rank=3. Accessed April 18, 2023.
6. Epilepsy Foundation. Drug Resistant Epilepsy. Available at: https://www.epilepsy.com/treatment/medicines/drug-resistant-epilepsy. Accessed April 18, 2023.

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End Notes

1. Clobazam is approved for adjunctive therapy of LGS. In the pivotal trials, study participants were receiving from 1 to 3 concomitant antiepileptic drugs at stable doses for at least 4 weeks [1, 2]
2. Refractory status epilepticus is when seizures are not controlled after the administration of two antiseizure medications. [5]

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Revision History

• 2024-12-24: 2025 Annual Review - updated references
• 2024-06-17: Removal of COT for Brand Onfi
• 2024-01-04: Annual Review - No criteria changes
• 2023-10-03: Program update to standard reauthorization language. No changes to clinical intent
• 2023-04-24: Update guideline
• 2023-01-14: Annual review - update to age/weight requirements for Dravet Syndrome
• 2022-01-07: 2022 Annual Review
• 2021-09-28: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
• 2021-01-05: 2021 Annual Review. Removed reference to drug name from reauth criteria.
• 2019-12-12: 2020 Annual Review, no changes to criteria.
• 2019-10-29: Added step through generic for brand

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