Hetlioz — Blue Cross Blue Shield of Kansas

Initial criteria

• ONE of the following:
• A. If the requested agent is Hetlioz capsules, then ONE of the following:
• 1. The patient has BOTH of the following: A. A diagnosis of Non-24-hour sleep-wake disorder AND B. Is totally blind (i.e., no light perception) OR
• 2. BOTH of the following: A. The patient has a diagnosis of Smith-Magenis Syndrome (SMS) confirmed by ONE of the following genetic mutations: 1. A heterozygous deletion of 17p11.2 OR 2. A heterozygous pathogenic variant involving RAI1 AND B. The requested agent is being used to treat nighttime sleep disturbances associated with SMS OR
• B. If the requested agent is Hetlioz LQ suspension, then BOTH of the following: 1. The patient has a diagnosis of Smith-Magenis Syndrome (SMS) confirmed by ONE of the following genetic mutations: A. A heterozygous deletion of 17p11.2 OR B. A heterozygous pathogenic variant involving RAI1 AND 2. The requested agent is being used to treat nighttime sleep disturbances associated with SMS OR
• C. The patient has another FDA labeled indication for the requested agent and route of administration OR
• D. The patient has another indication that is supported in compendia for the requested agent and route of administration AND
• 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 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