Subject: Hetlioz 2426-A SGM P2023
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HETLIOZ
(tasimelteon capsules)
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HETLIOZ LQ
(tasimelteon oral suspension)
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Policy:
I. 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
A. Non-24-Hour Sleep-Wake Disorder (Non-24):
Hetlioz capsules are indicated for the treatment of Non-24 in
adults.
B. Nighttime Sleep Disturbances in Smith-Magenis Syndrome
(SMS):
1. Hetlioz capsules are indicated for treatment of nighttime
sleep disturbances in SMS in patients 16 years of age and
older.
2. 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.
II. DOCUMENTATION
The following information is necessary to initiate the prior
authorization review:
A. For initial therapy, chart notes or test results to support one
of the following:
1. Total blindness in both eyes, OR
2. Smith-Magenis Syndrome.
B. For continuation of therapy, documentation to support one of
the following:
1. For Non-24-Hour Sleep-Wake Disorder, both of the
following:
i. Chart notes or test results confirming total blindness
in both eyes
ii. An increased total nighttime sleep and/or decreased
daytime nap duration, OR
2. For nighttime sleep disturbances in Smith-Magenis
syndrome:
i. Chart notes or test results confirming Smith-Magenis
Syndrome
ii. Improvement in quality of sleep such as
improvement in sleep efficiency, sleep onset and
final sleep offset, or waking after sleep onset.
III. 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.
IV. CRITERIA FOR INITIAL APPROVAL
A. Non-24-Hour Sleep-Wake Disorder
Authorization of 6 months may be granted for treatment of
Non-24-Hour Sleep-Wake Disorder when all of the following
criteria are met:
1. The member has a diagnosis of total blindness in both
eyes (e.g., nonfunctioning retinas).
2. The member is not able to perceive light in either eye.
3. The member is experiencing difficulty initiating sleep,
difficulty awakening in the morning, or excessive daytime
sleepiness.
B. Nighttime Sleep Disturbances in Smith-Magenis
Syndrome (SMS)
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:
1. The member has a confirmed clinical diagnosis of Smith-
Magenis syndrome.
2. The member has a history of sleep disturbances.
V. CONTINUATION OF THERAPY
A. Non-24-Hour Sleep-Wake Disorder
Authorization of 12 months may be granted for treatment of
Non-24-Hour Sleep-Wake Disorder when all of the following
criteria are met:
1. The member has a diagnosis of total blindness in both
eyes (e.g., nonfunctioning retinas).
2. The member is not able to perceive light in either eye.
3. The member is experiencing increased total nighttime
sleep and/or decreased daytime nap duration.
B. Nighttime Sleep Disturbances in Smith-Magenis
Syndrome (SMS)
Authorization of 12 months may be granted for the treatment
of nighttime sleep disturbances in Smith-Magenis syndrome
if the member experiences improvement in the quality of
sleep since starting therapy with Hetlioz.
Place of Service:
Outpatient
The above policy is based on the following references:
- Hetlioz [package insert]. Washington, D.C.: Vanda Pharmaceuticals, Inc.; January 2023.
- 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.
October 14, 2023
