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

Initial criteria

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

Reauthorization criteria

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

Approval duration

BCBSIL: 12 months; others: 3 months initial, 12 months renewal