Hetlioz LQ — Blue Cross Blue Shield of Alabama
Non-24-Hour Sleep-Wake Disorder (Non-24 SWD) in adults
Initial criteria
- ONE of the following:
- If the requested agent is Hetlioz capsules, then ONE of the following:
- • The patient has BOTH of the following: - A diagnosis of Non-24-hour sleep-wake disorder AND - 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 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 If the requested agent is Hetlioz LQ suspension, then BOTH of the following: - The patient has a diagnosis of Smith-Magenis Syndrome (SMS) confirmed by 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
- OR • 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: • 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