Fintepla®

Drug - Fintepla® (fenfluramine) [Zogenix, Inc.]

March 2021

Therapeutic area - Anticonvulsants

Initial approval criteria

Patient must be ≥ 2 years of age AND
Patient has been diagnosed with Dravet syndrome (DS) AND
Prescriber is a neurologist AND
Prescriber attests that patient has refractory epilepsy (patient has failed to become seizure-free with adequate trials of 2 antiepileptic drugs [AED]) AND
Patient has not been treated with a monoamine oxidase inhibitor (MAOI) within 14 days of starting fenfluramine AND
Patient will undergo echocardiogram to evaluate for valvular heart disease and pulmonary arterial hypertension prior to starting fenfluramine (Fintepla) therapy and every 6 months during therapy to evaluate risk versus benefit when used in patients with valvular hear disease or pulmonary arterial hypertension AND
Fenfluramine (Fintepla) will be added to background antiepileptic therapy
Initial approval is for 6 months

Patient continues to meet initial approval criteria listed above AND
Patient has documented disease response to treatment, as defined by decrease from baseline and stabilization of seizure frequency/severity AND
Patient has documented echocardiogram at baseline and every 6 months during therapy AND
Patient is absent of unacceptable toxicity from therapy. Examples of unacceptable toxicity (e.g., abnormal echocardiogram, significant weight loss, sedation) AND
Prescriber attests that when patient becomes stabilized on a given dose, reasonable efforts will be taken to ensure that all previously prescribed amounts, that have not been used but have not been expired, are used up before new prescriptions are issued in order to minimize waste
Renewal is for 12 months

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