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Fintepla — Medical Mutual

Dravet Syndrome (Severe Myoclonic Epilepsy in Infancy)

Initial criteria

  • Patient is age ≥ 2 years; AND
  • Patient has a diagnosis of Dravet Syndrome (Severe Myoclonic Epilepsy in Infancy) or Lennox-Gastaut Syndrome (LGS); AND
  • Fintepla is prescribed by or in consultation with a neurologist or a provider who specializes in the treatment of Dravet Syndrome or Lennox-Gastaut Syndrome (LGS); AND
  • Fintepla will not be used concomitantly or within 14 days of the administration of an MAOI; AND
  • Patient has undergone an echocardiogram prior to initiating therapy with Fintepla; AND
  • Patient meets one of the following: a) Valvular heart disease AND pulmonary arterial hypertension were not observed on ECHO; OR b) Valvular heart disease and/or PAH is observed on ECHO and the prescriber attests that the benefits of therapy with Fintepla outweigh the risks; AND
  • If the diagnosis is Dravet Syndrome: Patient has been inadequately controlled on at least ONE antiepileptic drug (AED) or other antiseizure treatment including vagal nerve stimulation or a ketogenic diet; AND
  • If the diagnosis is LGS: Patient has been inadequately controlled on at least ONE antiepileptic drug (AED), with or without vagal nerve stimulation and/or ketogenic diet

Reauthorization criteria

  • Patient has been using Fintepla for at least 6 months (patients who have been using Fintepla for less than 6 months should refer to initial therapy criteria); AND
  • Patient has had a beneficial response to therapy per the prescriber (e.g. reduced seizure severity, frequency, and/or duration); AND
  • Patient has a diagnosis of Dravet Syndrome (Severe Myoclonic Epilepsy in Infancy) or Lennox-Gastaut Syndrome (LGS); AND
  • Fintepla is prescribed by or in consultation with a neurologist or a provider who specializes in the treatment of Dravet Syndrome or Lennox-Gastaut Syndrome (LGS); AND
  • Patient has undergone a follow-up echocardiogram after at least 6 months of therapy of Fintepla and the ECHO was performed within the past 6 months; AND
  • Patient meets one of the following: a) Valvular heart disease AND pulmonary arterial hypertension were not observed on ECHO; OR b) Valvular heart disease and/or PAH is observed on ECHO and the prescriber attests that the benefits of continuing therapy with Fintepla outweigh the risks

Approval duration

6 months initial, 6 months reauth