trofinetide oral soln 200 MG/ML — Blue Cross Blue Shield of Illinois

Initial criteria

• 1. ALL of the following:
• A. Diagnosis of classic/typical Rett syndrome (RTT)
• B. Disease-causing mutation in the MECP2 gene [chart notes required]
• C. If patient has an FDA labeled indication, then ONE of the following:
• A. Patient's age is within FDA labeling for the requested indication OR
• B. There is support for using the requested agent for the patient's age for the requested indication
• D. Patient's weight is ≥ 9 kg
• E. Prescriber has assessed baseline status (prior to therapy) of RTT symptoms (e.g., speech patterns, hand movements, gait, growth, muscle tone, seizures, breathing patterns, quality of sleep)
• 2. Prescriber is a specialist in the area of the patient’s diagnosis (e.g., geneticist, neurologist, pediatrician) or has consulted with a specialist
• 3. Patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• 1. Patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• 2. Patient has had clinical benefit with the requested agent
• 3. Prescriber is a specialist in the area of the patient’s diagnosis (e.g., geneticist, neurologist, pediatrician) or has consulted with a specialist
• 4. Patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months (BCBSIL); 3 months (other plans)