DIACOMIT (stiripentol)

DIACOMIT (stiripentol)

SELF ADMINISTRATION- ORAL 

Indications for Prior Authorization:

• Treatment of seizures associated with Dravet syndrome (DS) in patients 2 years of age and older taking Clobazam and Valproic acid.  There are no clinical data to support the use of Diacomit as monotherapy in Dravet syndrome.

Patients must meet the following criteria for the indications(s) above:

• Dravet Syndrome:
  • Patient is 2 years of age or older, AND
  • Prescribed by or in consultation with a neurologist, AND
  • Diagnosis of Dravet syndrome confirmed by chart note documentation, AND
  • Patient has tried and failed Valproate, AND
  • The patient is concomitantly taking Clobazam OR the patient is unable to take Clobazam due to adverse events as determined by the prescribing physician (if unable to take with clobazam then the patient will be taking concomitantly with at least one other antiepileptic drug)
• Treatment-refractory seizures/epilepsy, including Lennox-Gastaut Syndrome:
  • Patient is 2 years of age or older, AND
  • Prescribed by or in consultation with a neurologist, AND
  • Diagnosis of seizures confirmed by chart note documentation, AND
  • Patient has tried at least two other antiepileptic drugs (e.g., valproic acid, lamotrigine, topiramate, clonazepam, Banzel, felbamate, clobazam, Fycompa, Sabril, levetiracetam, zonisamide, etc.)

Dosing:

• 50 mg/kg/day in 2 or 3 divided doses (maximum recommended total dosage is 3,000mg/day)

Approval:

• 1 year