Hetlioz LQ — Blue Cross Blue Shield of Alabama

Initial criteria

• ONE of the following:
• • The requested agent is for Hetlioz capsules and ONE of the following:
• – BOTH of the following: the patient has a diagnosis of Non-24-hour sleep-wake disorder AND the patient is totally blind (i.e., no light perception)
• – OR BOTH of the following: the patient has a diagnosis of Smith-Magenis Syndrome (SMS) confirmed by the presence of ONE of the following genetic mutations: a heterozygous deletion of 17p11.2 OR a heterozygous pathogenic variant involving RAI1; AND the requested agent is being used to treat nighttime sleep disturbances associated with SMS
• • OR the requested agent is for Hetlioz suspension and BOTH of the following: the patient has a diagnosis of Smith-Magenis Syndrome (SMS) confirmed by the presence of ONE of the following genetic mutations: a heterozygous deletion of 17p11.2 OR a heterozygous pathogenic variant involving RAI1; AND the requested agent is being used to treat nighttime sleep disturbances associated with SMS
• • OR the patient has another FDA labeled indication for the requested agent and route of administration
• AND 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
• AND the prescriber is a specialist in the area of the patient’s diagnosis (e.g., sleep specialist, neurologist, psychiatrist) or has consulted with a specialist in the area of the patient’s diagnosis
• AND 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
• • AND the patient has had clinical benefit with the requested agent

Approval duration

12 months