Hetlioz LQ — Blue Cross Blue Shield of Texas

Non-24-hour sleep-wake disorder in totally blind patients

Initial criteria

ALL of the following:
1. ONE of the following:
A. If requested agent is Hetlioz capsules: ONE of the following: (1) Patient has BOTH: (A) diagnosis of Non-24-hour sleep-wake disorder AND (B) patient is totally blind (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) used to treat nighttime sleep disturbances associated with SMS.
B. If requested agent is Hetlioz LQ suspension: BOTH of the following: (1) diagnosis of Smith-Magenis Syndrome (SMS) confirmed by heterozygous deletion of 17p11.2 OR heterozygous pathogenic variant involving RAI1 AND (2) used to treat nighttime sleep disturbances associated with SMS.
C. Patient has another FDA labeled indication for the agent and route OR D. Patient has another compendia-supported indication for the agent and route.
2. If patient has an FDA labeled indication: ONE of the following: (A) Patient’s age is within FDA labeling for indication OR (B) There is support for agent use for the patient’s age for indication.
3. Prescriber is a specialist in the 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 the requested agent.

ALL of the following:
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 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 the requested agent.

12 months