CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Hetlioz (tasimelteon) for Non-24 and Smith-Magenis syndrome sleep disturbances

Defines coverage and prior authorization criteria for Hetlioz (tasimelteon) capsules and Hetlioz LQ oral suspension for treatment of Non-24-Hour Sleep-Wake Disorder and nighttime sleep disturbances in Smith-Magenis Syndrome (SMS), including required documentation, prescriber specialty, and authorization durations.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyHetlioz (tasimelteon) for Non-24 and Smith-Magenis syndrome sleep disturbances

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation: for Non-24, chart notes or test results confirming total blindness in both eyes and inability to perceive light; for SMS, documentation confirming Smith-Magenis syndrome and history of sleep disturbances.

POLICY UPDATE CHANGES

No material changes to clinical coverage or policy criteria.

2Covered Indications

1Required Prescriber Specialty

6-12Authorization Duration (months)

Coverage Summary

Hetlioz (tasimelteon) is covered with criteria for the FDA-approved indications: treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults and treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) (Hetlioz capsules for patients 16 years and older and Hetlioz LQ oral suspension for pediatric patients 3 to 15 years). All other indications are considered experimental/investigational and not medically necessary.

FDA-Approved Indications - Covered when ALL criteria met

The FDA-approved indications and compendial uses are covered provided all approval criteria are met and the member has no exclusions to therapy.

Covered Indications (one of)

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 patients 16 years and older; Hetlioz LQ oral suspension is indicated for pediatric patients 3 to 15 years of age.

Initial Therapy Criteria — Non-24-Hour Sleep-Wake Disorder

Criteria for Initial Approval - Non-24-Hour Sleep-Wake Disorder (authorization 6 or 12 months when criteria met)

Authorization may be granted when ALL of the following are met (separate 6-month and 12-month statements exist in document):

Non-24 initial approval

Diagnosis of total blindness: The member has a diagnosis of total blindness in both eyes (e.g., nonfunctioning retinas).
Unable to perceive light: The member is not able to perceive light in either eye.
Symptoms (6-month authorization): The member is experiencing difficulty initiating sleep, difficulty awakening in the morning, or excessive daytime sleepiness.
Authorization of 6 months may be granted when these criteria are met.
12-month authorization variant: The member is experiencing increased total nighttime sleep and/or decreased daytime nap duration.
Authorization of 12 months may be granted when this variant criterion is met.

Initial Therapy Criteria — Smith‑Magenis Syndrome (SMS)

Criteria for Initial Approval - Nighttime Sleep Disturbances in Smith-Magenis Syndrome (SMS)

Authorization may be granted when ALL of the following are met:

SMS initial approval

Confirmed diagnosis: The member has a confirmed clinical diagnosis of Smith-Magenis syndrome.
History of sleep disturbances: The member has a history of sleep disturbances.
For continuation, documentation must show improvement in quality of sleep (e.g., sleep efficiency, sleep onset and final sleep offset, or reduced waking after sleep onset). Authorization of 6 months may be granted when initial criteria are met; authorization of 12 months may be granted if the member experiences improvement in quality of sleep since starting therapy with Hetlioz.

Continuation Therapy Criteria

For prior authorization, submit documentation supporting the diagnosis: for Non-24 provide chart notes or test results confirming total blindness in both eyes and inability to perceive light; for SMS provide documentation confirming a clinical diagnosis of Smith-Magenis syndrome and history of sleep disturbances.

Continuation expectations: for SMS continuation, documentation must show improvement in quality of sleep (examples include improved sleep efficiency, changes in sleep onset and final sleep offset, or reduced waking after sleep onset).

Authorization durations for Non-24: 6-month authorization may be granted when criteria (total blindness, inability to perceive light, and symptoms such as difficulty initiating sleep, difficulty awakening, or excessive daytime sleepiness) are met; a 12-month authorization variant is available when criteria including increased total nighttime sleep and/or decreased daytime nap duration are met. For SMS, 6-month authorization may be granted for initial treatment and 12-month authorization may be granted if the member demonstrates improvement in quality of sleep since starting therapy.

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization review requires submission of documentation supporting the diagnosis: for Non-24, chart notes or test results confirming total blindness in both eyes and inability to perceive light; for Smith-Magenis syndrome (SMS), documentation confirming SMS and history of sleep disturbances. Authorization may be granted for 6 months when initial criteria are met, and 12-month authorizations are available when the longer-term criteria are satisfied (e.g., increased total nighttime sleep and/or decreased daytime nap duration for Non-24, or improvement in sleep quality for SMS).

Documentation Required

Required documentation elements

Required documentation: For Non-24, chart notes or test results confirming total blindness in both eyes and inability to perceive light, and documentation of symptoms such as difficulty initiating sleep, difficulty awakening in the morning, or excessive daytime sleepiness (or increased total nighttime sleep/decreased daytime naps for a 12-month authorization). For SMS, chart notes or test results confirming Smith-Magenis syndrome and a history of sleep disturbances; for continuation of SMS therapy, documentation of improved quality of sleep (for example improved sleep efficiency, sleep onset and final sleep offset, or reduced waking after sleep onset).

Documentation Required

Prescriber specialty requirement

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

Clinical Evidence & References

Evidence includes the Hetlioz package insert (January 2023) and the AASM 2015 clinical practice guideline referenced in the policy.

Supporting definition: Total blindness is defined as inability to perceive light in either eye or nonfunctioning retinas as documented in chart notes or test results.

Background

Hetlioz (tasimelteon) is indicated for Non-24-Hour Sleep-Wake Disorder in totally blind adults and for nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) (Hetlioz capsules for patients 16 years and older; Hetlioz LQ oral suspension for pediatric patients 3 to 15 years).

Other indications not listed as FDA-approved in this policy are considered experimental/investigational and not medically necessary.