Fintepla - NC Standard

Restricted Product(s)

• Fintepla® (fenfluramine) oral solution

FDA Approved Use

• For the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years of age and older.

Criteria for Approval of Restricted Product(s)

Initial Coverage

1. The patient is currently taking the requested medication for seizure control and is stable on therapy; AND 
   1. The patient will utilize the generic formulation of this product (if available); OR 
2. The patient is 2 years of age or older; AND 
3. The patient has been diagnosed with Dravet syndrome or Lennox-Gastaut syndrome (medical record documentation required); AND 
4. The patient has tried and failed or has a clinical intolerance/contraindication to two other anticonvulsive agents (e.g., valproic acid, clobazam, topiramate, etc); AND 
5. The patient is being managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., neurologist); AND 
6. The prescribed dose and quantity are appropriate based on intended use and FDA labeling; AND 
7. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   
   Duration of Approval: 180 days (6 months)

Continuation Coverage

1. The patient has been previously approved for Fintepla with Blue Cross and Blue Shield of North Carolina (Blue Cross NC) or would have met initial criteria for approval upon the start of therapy; AND 
2. The patient has experienced clinical benefit since initiation of therapy (e.g., reduction in seizure frequency) (medical record documentation required).
   
   Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

January 2023: Criteria Change: Decreased initial duration of approval. Added step therapy through other anticonvulsive agents. Added the patient is 2 years of age or older. For initial criteria added the prescribed dose and quantity are appropriate based on intended use and FDA labeling and required patient be managed by or in consultation with a specialist. Added continuation criteria.
April 2022: Criteria update to include expanded indication of Lennox-Gastaut syndrome. Updated duration of approval to 365 days.
July 2020: Original utilization management criteria issued.