Subject: tasimelteon-Hetlioz-Hetlioz LQ SGM 2426-A P2025

Drug

HETLIOZ  (tasimelteon)

HETLIOZ LQ  (tasimelteon)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indications^1,2

Non-24-Hour Sleep-Wake Disorder (Non-24):

Hetlioz capsules are indicated for the treatment of Non-24 in adults.

Nighttime Sleep Disturbances in Smith-Magenis Syndrome (SMS):

• Hetlioz capsules are indicated for treatment of nighttime sleep disturbances in SMS in patients 16 years of age and older.
• Hetlioz LQ oral suspension is indicated for the treatment of nighttime sleep disturbances in SMS in pediatric patients 3 to 15 years of age.

All other indications are considered experimental/investigational and not medically necessary.

Documentation

Submission of the following information is necessary to initiate the prior authorization review:

For initial requests, chart notes or test results to support one of the following:

• Total blindness in both eyes for Non-24 Hour Sleep-Wake Disorder (Non-24)
• Smith-Magenis Syndrome.

For continuation requests, documentation to support one of the following:

• For Non-24-Hour Sleep-Wake Disorder, both of the following:
  • Chart notes or test results confirming total blindness in both eyes
  • An increased total nighttime sleep and/or decreased daytime nap duration
• For nighttime sleep disturbances in Smith-Magenis syndrome, both of the following:
  • Chart notes or test results confirming Smith-Magenis Syndrome
  • Improvement in quality of sleep such as improvement in sleep efficiency, sleep onset and final sleep offset, or waking after sleep onset.

Prescriber Specialties

This medication must be prescribed by or in consultation with a sleep specialist (e.g., neurologist experienced with sleep disorders, physician certified in sleep medicine) or psychiatrist.

Coverage Criteria

Non-24-Hour Sleep-Wake Disorder^1-3

Authorization of 6 months may be granted for treatment of Non-24-Hour Sleep-Wake Disorder when all of the following criteria are met:

• The member has a diagnosis of total blindness in both eyes (e.g., nonfunctioning retinas).
• The member is not able to perceive light in either eye.
• The member is experiencing difficulty initiating sleep, difficulty awakening in the morning, or excessive daytime sleepiness.

Nighttime Sleep Disturbances in Smith-Magenis Syndrome (SMS)¹

Authorization of 6 months may be granted for the treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) when all of the following criteria are met:

• The member has a confirmed clinical diagnosis of Smith-Magenis syndrome.
• The member has a history of sleep disturbances.

Continuation of Therapy

Non-24-Hour Sleep-Wake Disorder^1-3

Authorization of 12 months may be granted for treatment of Non-24-Hour Sleep-Wake Disorder when all of the following criteria are met:

• The member has a diagnosis of total blindness in both eyes (e.g., nonfunctioning retinas).
• The member is not able to perceive light in either eye.
• The member experiences increased total nighttime sleep and/or decreased daytime nap duration.

Nighttime Sleep Disturbances in Smith-Magenis Syndrome (SMS)¹

Authorization of 12 months may be granted for treatment of nighttime sleep disturbances in Smith-Magenis syndrome if the member experiences improvement in the quality of sleep since starting therapy with the requested drug.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Hetlioz [package insert]. Washington, D.C.: Vanda Pharmaceuticals Inc.; January 2023.
2. Tasimelteon [package insert]. Bridgewater, NJ: Amneal Pharmaceuticals LLC; January 2023.
3. Auger, Robert R, Burgess, Helen J, et al. Clinical Practice Guideline for the Treatment of Intrinsic Circadian Rhythm Sleep-Wake Disorders: Advanced Sleep-Wake Phase Disorder (ASWPD), Delayed Sleep-Wake Phase Disorder (DSWPD), Non-24-Hour Sleep-Wake Rhythm Disorder (N24SWD), and Irregular Sleep-Wake Rhythm Disorder (ISWRD). An Update for 2015: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2015 Oct;11(10):1199-236.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

June 07, 2025