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tasimelteon — Blue Cross Blue Shield of New Mexico

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

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. The patient has a diagnosis of Non-24-hour sleep-wake disorder AND B. The patient is totally blind (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 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 AND
  • The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

  • 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
  • 2. The patient has had clinical benefit with the requested agent
  • 3. The prescriber is a specialist in the area of the patient’s diagnosis or has consulted with one
  • 4. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months