Daybue (trofinetide) — Blue Cross Blue Shield of Alabama

Initial criteria

• ONE of the following:
• • The requested agent is eligible for continuation of therapy AND ONE of the following:
•   – The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
•   – 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
• OR ALL of the following:
• • The patient has a diagnosis of classic/typical Rett syndrome (RTT)
• • The patient has a disease-causing mutation in the MECP2 gene
• • If the patient has an FDA labeled indication, then ONE of the following:
•   – The patient's age is within FDA labeling for the requested indication for the requested agent OR
•   – There is support for using the requested agent for the patient's age for the requested indication
• • The patient's weight is 9 kg or greater
• • 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)
• • The prescriber is a specialist in the area of the patient’s diagnosis (e.g., geneticist, neurologist, pediatrician) or has consulted with such a specialist
• • The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

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

Approval duration

initial 3 months; renewal 12 months