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Hetlioz LQ — Blue Cross Blue Shield of Alabama

nighttime sleep disturbances associated with Smith-Magenis Syndrome (SMS)

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