Hetlioz (tasimelteon) — Point32Health
nighttime sleep disturbances in Smith-Magenis Syndrome (SMS)
Initial criteria
- For management of Non-24 sleep-wake disorder: Documentation the patient is totally blind (has no light perception)
- For management of Non-24 sleep-wake disorder: Documented diagnosis of Non-24 sleep-wake disorder
- For management of Non-24 sleep-wake disorder: Patient age ≥ 18 years
- For management of Non-24 sleep-wake disorder: Prescribed by a specialist in sleep disorders
- For management of Non-24 sleep-wake disorder: Trial and failure, inadequate response, intolerance, or contraindication to a trial of timed over-the-counter melatonin
- For management of Smith-Magenis syndrome: Documented diagnosis of nighttime sleep disturbances in Smith-Magenis Syndrome
- For management of Smith-Magenis syndrome: Patient age ≥ 16 years
- For management of Smith-Magenis syndrome: Prescribed by a specialist in sleep disorders
Reauthorization criteria
- Documented diagnosis of Non-24 sleep-wake disorder or Smith-Magenis Syndrome
- Documentation the patient is totally blind (has no light perception) if used for Non-24 sleep-wake disorder
- Prescribed by or in consultation with a specialist in sleep disorders
- Documentation of continued positive clinical response to therapy
Approval duration
initial 4 months; reauth 12 months