FINTEPLA (fenfluramine)

FINTEPLA (fenfluramine)

SELF-ADMINISTRATION

Indications for Prior Authorization:

• Indicated for the treatment of seizures associated with Dravet syndrome in patients 2 years of age or older

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

• Initial Criteria:
  • Patient must be 2 years of age or older, AND
  • Diagnosis of seizures associated with Dravet syndrome documented in chart notes, AND
  • Must have documentation in chart notes of echocardiogram assessments to evaluate for valvular heart disease and pulmonary arterial hypertension prior to starting treatment, AND
  • Prescribed by or in consultation with a neurologist, AND
  • Patient has tried and failed both first-line therapies [e.g., valproate AND clobazam] (unless contraindicated), AND
  • Patient has tried and failed at least one-second line therapy (e.g., topiramate OR Stiripentol), OR
    • If first-line medications are contraindicated patient has tried and failed at least one of the second-line therapies
• Reauthorization criteria:
  • Documentation in chart notes of a positive clinical response to therapy

Additional Information:

• Fintepla’s REMs program requires periodic cardiac monitoring every 6 months while on therapy due to the risk of valvular heart disease and pulmonary arterial hypertension 

Dosing:

• Initial starting and maintenance dose: 0.1mg/kg twice daily
  • Can increase dose weekly based on efficacy and tolerability
• Maximum daily dose
  • If patient not on concomitant stiripentol (Diacomit): 0.35mg/kg twice daily or 26mg per day
  • If patient on concomitant stiripentol (Diacomit) plus clobazam: 0.2mg/kg twice daily or 17mg per day
• Not recommended to use in moderate or severe renal impairment
• Not recommended to use in hepatic impairment

Coverage Duration:

• Initial:
  • 1 year
• Reauthorization:
  • 1 year

Authorization is Not Covered for the Following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

Review History:

• November 17, 2020 - Original review

References:

• Fintepla Package Insert. Zogenix Inc. Emeryville, CA. June 2020.
• Wirrell EC. Treatment of Dravet Syndrome. Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques. Cambridge University Press; 2016; 43(S3): S13–S18.
• Cross J.H. Dravet Syndrome: Treatment Options and Management of Prolonged Seizures. Epilepsia. Wiley. January 6, 2020.
• Wirrell EC, Laux L, Donner E, et al. Optimizing the diagnosis and management of Dravet syndrome: recommendations from a North American consensus panel. Pediatr Neurol. 2017;68:18-34.e3. doi: 10.1016/j.pediatrneurol.2017.01.025.