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Fintepla — Blue Cross Blue Shield of Texas

other FDA labeled indications

Initial criteria

  • ALL of the following:
  • 1. ONE of the following:
  • A. BOTH of the following:
  • 1. Prescriber states patient has been treated with requested agent (not samples) within past 90 days 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 diagnosis of Dravet syndrome (DS) AND ONE of:
  • 1. Request is for BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties OR
  • 2. Patient currently treated and stable on requested agent [chart notes required] OR
  • 3. Patient meets ONE of:
  • A. Tried and inadequate response to TWO generic antiseizure agents for DS (e.g., valproate, clobazam, topiramate) OR
  • B. Tried and inadequate response to ONE generic antiseizure agent and intolerance/hypersensitivity to ONE generic antiseizure agent (e.g., valproate, clobazam, topiramate) OR
  • C. Intolerance/hypersensitivity to TWO generic antiseizure agents (e.g., valproate, clobazam, topiramate) OR
  • 4. Patient has FDA labeled contraindication to ALL generic antiseizure agents for DS [chart notes required] OR
  • 5. TWO generic antiseizure agents discontinued due to lack of efficacy/effectiveness, diminished effect, or adverse event [chart notes required] OR
  • 6. TWO generic antiseizure agents expected to be ineffective or cause harm, adherence barriers, worsen comorbidities, decrease function, or cause adverse reaction [chart notes required] OR
  • 7. TWO generic antiseizure agents not in best interest based on medical necessity [chart notes required] OR
  • 8. Patient has tried another prescription in same class or mechanism as TWO generic antiseizure agents and discontinued for inefficacy/adverse effects [chart notes required] OR
  • B. Patient has diagnosis of Lennox-Gastaut syndrome (LGS) AND ONE of:
  • 1. Request is for BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties OR
  • 2. Patient currently treated and stable on requested agent [chart notes required] OR
  • 3. Patient meets ONE of:
  • A. Tried and inadequate response to TWO generic antiseizure agents for LGS (e.g., valproate, lamotrigine, rufinamide, topiramate, clobazam, felbamate) OR
  • B. Tried and inadequate response to ONE generic antiseizure agent and intolerance/hypersensitivity to ONE generic antiseizure agent for LGS (e.g., valproate, lamotrigine, rufinamide, topiramate, clobazam, felbamate) OR
  • C. Intolerance/hypersensitivity to TWO generic antiseizure agents for LGS (e.g., valproate, lamotrigine, rufinamide, topiramate, clobazam, felbamate) OR
  • 4. Patient has FDA labeled contraindication to ALL generic antiseizure agents for LGS [chart notes required] OR
  • 5. TWO generic antiseizure agents for LGS discontinued due to lack of efficacy/effectiveness, diminished effect, or adverse event [chart notes required] OR
  • 6. TWO generic antiseizure agents for LGS expected to be ineffective or cause harm, adherence barriers, worsen comorbidities, decrease function, or cause adverse reaction [chart notes required] OR
  • 7. TWO generic antiseizure agents for LGS not in best interest based on medical necessity [chart notes required] OR
  • 8. Patient tried another prescription in same class or mechanism as TWO generic antiseizure agents and discontinued for inefficacy/adverse effects [chart notes required] OR
  • C. Patient has another FDA labeled indication for requested agent and route of administration AND
  • 2. If patient has FDA labeled indication: ONE of the following:
  • A. Age within FDA labeling for requested indication OR
  • B. Support for using agent for patient's age for indication AND
  • 2. If indication is DS or LGS, agent NOT used as monotherapy for seizure management AND
  • 3. Echocardiogram assessment obtained before and during treatment to evaluate for valvular heart disease and pulmonary arterial hypertension AND
  • 4. Prescriber is a specialist in area of diagnosis (e.g., neurologist) or has consulted with one AND
  • 5. Patient has no FDA labeled contraindications to requested agent
  • Alternate approvals:
  • 1. For BCBS NM Fully Insured or NM HIM members: ALL of:
  • A. No FDA labeled contraindications AND
  • B. Requested indication is a rare disease AND
  • C. ONE of:
  • 1. Patient has another FDA labeled indication and route OR
  • 2. Patient has another indication supported in compendia for requested agent and route OR
  • 2. For Ohio residents (Fully Insured or HIM Shop): ALL of:
  • A. No FDA labeled contraindications AND
  • B. ONE of:
  • 1. Another FDA labeled indication and route OR
  • 2. Another indication supported in compendia OR
  • 3. Prescriber submits TWO peer-reviewed journal articles supporting proposed use with acceptable study designs

Reauthorization criteria

  • ALL of the following:
  • 1. Patient previously approved through PA process AND
  • 2. Patient has had clinical benefit with requested agent AND
  • 3. If used for DS or LGS seizure management, NOT used as monotherapy AND
  • 4. Echocardiogram assessment obtained during treatment to evaluate for valvular heart disease and pulmonary arterial hypertension AND
  • 5. Prescriber is a specialist in area of diagnosis or has consulted with one AND
  • 6. Patient has no FDA labeled contraindications

Approval duration

12 months