Daybue — Blue Cross Blue Shield of Kansas

Initial criteria

• 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 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
• • The prescriber has assessed baseline status (prior to therapy) of RTT symptoms (speech patterns, hand movements, gait, growth, muscle tone, seizures, breathing patterns, quality of sleep)
• The prescriber is a specialist in the area of the diagnosis (e.g., geneticist, neurologist, pediatrician) or has consulted with such specialist
• The patient has no FDA labeled contraindications to the requested agent

Reauthorization criteria

• The patient was 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 diagnosis (e.g., geneticist, neurologist, pediatrician) or has consulted with such specialist
• The patient has no FDA labeled contraindications to the requested agent

Approval duration

initial 3 months; renewal 12 months