fenfluramine hcl — Blue Cross Blue Shield of Illinois

Initial criteria

• ONE of the following: (A) BOTH of the following: (1) Prescriber states patient has been treated with the requested agent within the past 90 days (samples not acceptable) AND is at risk if therapy is changed AND (2) Patient has an FDA labeled indication for the requested agent OR (B) BOTH of the following: (1) ONE of the following: (A) Patient has a diagnosis of Dravet syndrome (DS) AND ONE of the following: (1) Request is for specified BCBS IL or ASO member OR (2) Patient currently treated and stable on agent [chart notes required] OR (3) Patient has ONE of the following [chart notes required]: (A) Tried and had inadequate response to TWO generic antiseizure agents for DS (e.g., valproate, clobazam, topiramate) OR (B) Tried and had inadequate response to ONE generic antiseizure agent and intolerance or hypersensitivity to ONE generic antiseizure agent for DS OR (C) Intolerance or hypersensitivity to TWO generic antiseizure agents for DS OR (4) Patient has an FDA labeled contraindication to ALL generic antiseizure agents used for DS [chart notes required] OR (5) TWO generic antiseizure agents discontinued due to lack of efficacy/effectiveness/diminished effect/adverse event [chart notes required] OR (6) TWO generic antiseizure agents expected to be ineffective or cause barrier to care, worsen comorbid condition, decrease functional ability, cause adverse reaction or physical/mental harm [chart notes required] OR (7) TWO generic antiseizure agents not in best interest based on medical necessity [chart notes required] OR (8) Tried another prescription drug in same pharmacologic class/mechanism as TWO generic antiseizure agents used for DS and discontinued due to lack of efficacy/effectiveness/diminished effect/adverse event; OR (B) Patient has diagnosis of Lennox-Gastaut syndrome (LGS) AND ONE of the following: (1) Request is for specified BCBS IL or ASO member OR (2) Patient currently treated and stable on agent [chart notes required] OR (3) Patient has ONE of the following [chart notes required]: (A) Tried and had inadequate response to TWO generic antiseizure agents used for LGS (e.g., valproate, lamotrigine, rufinamide, topiramate, clobazam, felbamate) OR (B) Tried and had inadequate response to ONE generic antiseizure agent and intolerance/hypersensitivity to ONE generic antiseizure agent used for LGS OR (C) Intolerance/hypersensitivity to TWO generic antiseizure agents used for LGS OR (4) FDA labeled contraindication to ALL generic antiseizure agents used for LGS [chart notes required] OR (5) TWO generic antiseizure agents discontinued due to lack of efficacy/effectiveness/diminished effect/adverse event [chart notes required] OR (6) TWO generic antiseizure agents expected ineffective or cause barriers/adverse outcomes [chart notes required] OR (7) TWO generic antiseizure agents not in best interest based on medical necessity [chart notes required] OR (8) Tried another prescription drug with same pharmacologic class/mechanism as TWO generic antiseizure agents used in LGS and discontinued due to lack of efficacy/effectiveness/diminished effect/adverse event [chart notes required]; OR (C) Patient has another FDA labeled indication for the requested agent and route of administration
• If patient has FDA labeled indication, ONE of the following: (A) Patient's age is within FDA labeling for requested indication OR (B) There is support for using requested agent for patient's age and indication
• If patient has diagnosis of seizures associated with DS or LGS, Fintepla will NOT be used as monotherapy
• An echocardiogram assessment will be obtained before and during treatment to evaluate for valvular heart disease and pulmonary arterial hypertension
• Prescriber is a specialist in the pertinent area (e.g., neurologist) or has consulted with such specialist
• Patient does NOT have any FDA labeled contraindications to requested agent
• OR additional approval for rare or other indications: (1) For BCBS NM Fully Insured or NM HIM member when: (A) No FDA labeled contraindications AND (B) Indication is a rare disease AND (C) ONE of: (1) FDA labeled indication OR (2) Indication supported in compendia for requested route or (3) TWO peer-reviewed articles support safety/effectiveness OR (2) Member resides in Ohio, plan Fully Insured or HIM Shop (SG), no FDA contraindication, and same support criteria

Reauthorization criteria

• Patient previously approved for Fintepla through plan’s prior authorization process
• Patient has had clinical benefit with requested agent
• If used for DS or LGS seizure management, will NOT be used as monotherapy
• Echocardiogram assessment obtained during treatment to evaluate for valvular heart disease and pulmonary arterial hypertension
• Prescriber is a specialist in patient's diagnosis area (e.g., neurologist) or has consulted with one
• Patient has no FDA labeled contraindications to Fintepla

Approval duration

12 months