tasimelteon capsule — Blue Cross Blue Shield of Illinois

Nighttime sleep disturbances associated with Smith-Magenis Syndrome (SMS) with confirmed 17p11.2 deletion or RAI1 pathogenic variant

Initial criteria

1. ONE of the following:
A. If requested agent is Hetlioz capsules, then ONE of the following:
1. Patient has BOTH: (A) diagnosis of Non-24-hour sleep-wake disorder AND (B) total blindness (no light perception) OR
2. BOTH: (A) diagnosis of Smith-Magenis Syndrome (SMS) confirmed by heterozygous deletion of 17p11.2 OR heterozygous pathogenic variant involving RAI1 AND (B) agent used to treat nighttime sleep disturbances associated with SMS
B. If requested agent is Hetlioz LQ suspension, then BOTH: (1) diagnosis of Smith-Magenis Syndrome (SMS) confirmed by heterozygous deletion of 17p11.2 OR heterozygous pathogenic variant involving RAI1 AND (2) agent used to treat nighttime sleep disturbances associated with SMS
C. Patient has another FDA labeled indication for the requested agent and route of administration OR
D. Patient has another indication supported in compendia for the requested agent and route of administration
2. If patient has FDA labeled indication, then ONE of the following:
A. Patient’s age is within FDA labeling for requested indication and agent OR
B. There is support for use of requested agent for patient’s age for requested indication
3. Prescriber is a specialist in area of diagnosis (e.g., sleep specialist, neurologist, psychiatrist) or has consulted with such specialist
4. Patient does NOT have any FDA labeled contraindications to requested agent

1. Patient previously approved for the requested agent through the plan’s Prior Authorization process
2. Patient has had clinical benefit with the requested agent
3. Prescriber is a specialist in the area of the patient’s diagnosis (e.g., sleep specialist, neurologist, psychiatrist) or has consulted with such specialist
4. Patient does NOT have any FDA labeled contraindications to the requested agent

12 months