Fintepla — Blue Cross Blue Shield of Oklahoma

Initial criteria

• ONE of the following:
• A. BOTH of the following:
• 1. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed AND
• 2. The patient has an FDA labeled indication for the requested agent
• OR
• B. BOTH of the following:
• 1. ONE of the following:
• A. The patient has a diagnosis of Dravet syndrome (DS), AND ONE of the following:
• 1. The request is for a BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member OR
• 2. The patient is currently being treated with the requested agent and is currently stable on it [chart notes required] OR
• 3. The patient has tried and had an inadequate response to TWO generic antiseizure agents used in the treatment of DS (e.g., valproate, clobazam, topiramate) OR
• 4. The patient has tried one generic antiseizure agent and had intolerance or hypersensitivity to another such agent OR
• 5. The patient has intolerance or hypersensitivity to TWO generic antiseizure agents used in DS OR
• 6. The patient has an FDA labeled contraindication to ALL generic antiseizure agents used in DS OR
• 7. Two generic antiseizure agents used in DS were discontinued due to lack of efficacy, diminishing effects, or adverse events OR
• 8. Two generic antiseizure agents used in DS are clinically inappropriate based on clinical characteristics or would cause adherence barriers, worsen comorbidities, or reduce functional ability OR
• 9. Two generic antiseizure agents are not in the best interest of the patient based on medical necessity OR
• 10. Another prescription in the same pharmacologic class as two antiseizure agents used in DS was discontinued due to inefficacy or adverse event
• OR
• B. The patient has a diagnosis of Lennox-Gastaut syndrome (LGS), AND ONE of the following:
• 1. The request is for a BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member OR
• 2. The patient is currently being treated with and stable on the requested agent [chart notes required] OR
• 3. The patient has tried and had inadequate response to TWO generic antiseizure agents used in LGS (e.g., valproate, lamotrigine, rufinamide, topiramate, clobazam, felbamate) OR
• 4. Tried one generic antiseizure agent and had intolerance/hypersensitivity to another used in LGS OR
• 5. Has intolerance or hypersensitivity to TWO antiseizure agents used in LGS OR
• 6. Has FDA labeled contraindication to ALL antiseizure agents used in LGS OR
• 7. Two antiseizure agents used in LGS were discontinued due to lack of efficacy, diminished effect, or adverse event OR
• 8. Two antiseizure agents used in LGS expected to be ineffective based on patient characteristics or safety factors OR
• 9. Two antiseizure agents used in LGS not in patient’s best interest based on medical necessity OR
• 10. Another prescription in same pharmacologic class as two antiseizure agents used in LGS was discontinued due to inefficacy or adverse event
• C. The patient has another FDA labeled indication for the requested agent and route of administration
• 2. If the patient has an FDA labeled indication, then ONE of the following:
• A. The patient’s age is within labeling for the indication OR
• B. There is supporting evidence for use at that age
• AND if using for DS or LGS, requested agent will NOT be used as monotherapy
• An echocardiogram assessment will be performed before and during treatment for valvular heart disease and pulmonary arterial hypertension
• The prescriber is a specialist (e.g., neurologist) or has consulted one
• The patient has no FDA labeled contraindications
• Length of Approval: 12 months
• The requested agent will also be approved for specific plan member groups (e.g., BCBS NM Fully Insured, HIM, Ohio Fully Insured or HIM Shop) if:
• • No FDA labeled contraindications AND indication is rare disease AND one of the following:
• – Has another FDA labeled indication; OR
• – Has another indication supported in compendia; OR
• – Two peer-reviewed journal articles submitted supporting off-label use.
• Length of Approval: 12 months

Reauthorization criteria

• Patient previously approved for the agent through plan’s prior authorization process
• Patient has had clinical benefit with the requested agent
• If using for DS or LGS, the requested agent will NOT be used as monotherapy
• Echocardiogram assessment obtained during treatment
• Prescriber is a specialist in the area of diagnosis or has consulted one
• Patient has no FDA labeled contraindications
• Length of Approval: 12 months

Approval duration

12 months