PA applies to new starts only.
Fintepla will be approved when ALL of the following are met:
- BOTH of the following:
- The patient has a diagnosis of seizures associated with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS) AND
- The patient is within the FDA labeled age for the requested medication AND
- ONE of the following:
- There is evidence of a claim that the patient is currently being treated with the requested medication within the past 180 days OR
- The prescriber states the patient is currently being treated with the requested medication OR
- ALL of the following:
- An echocardiogram assessment will be obtained before and during treatment with the requested medication, to evaluate for valvular heart disease and pulmonary arterial hypertension AND
- The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
- The patient does NOT have any FDA labeled contraindications to the requested medication AND
- ONE of the following:
- The requested quantity (dose) does NOT exceed the program quantity limit OR
- BOTH of the following:
- The requested quantity (dose) is greater than the program quantity limit AND
- The prescriber has provided information in support of therapy with a higher dose for the requested indication
Length of Approval: 12 months
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