CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tasimelteon (Hetlioz / Hetlioz LQ) — coverage criteria for Non-24 and Smith‑Magenis Syndrome

Policy governs prior authorization, coverage criteria, and documentation requirements for tasimelteon (Hetlioz / Hetlioz LQ) for Non-24‑Hour Sleep‑Wake Disorder and nighttime sleep disturbances in Smith‑Magenis Syndrome for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTasimelteon (Hetlioz / Hetlioz LQ) — coverage criteria for Non-24 and Smith‑Magenis Syndrome

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionInclude chart notes or test results confirming total blindness for Non‑24 or documentation confirming Smith‑Magenis Syndrome with all prior authorization requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial authorization duration

12 monthscontinuation authorization duration

2FDA‑approved indications

16+ / 3-15age splits (formulations)

Coverage and Medical Necessity Criteria

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inv-01: Initial — Non-24

Authorization of 6 months may be granted when ALL of the following are met:

Non-24 initial: 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.

Initial requests require chart notes or test results confirming total blindness in both eyes.

inv-02: Initial — Smith-Magenis Syndrome

Authorization of 6 months may be granted when ALL of the following are met:

SMS initial: 1. The member has a confirmed clinical diagnosis of Smith-Magenis syndrome. 2. The member has a history of sleep disturbances.

Initial requests require chart notes or test results confirming Smith-Magenis Syndrome.

inv-03: Continuation — Non-24

Authorization of 12 months may be granted when ALL of the following are met:

Non-24 continuation: 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.

Continuation requests must include documentation confirming total blindness and evidence of increased nighttime sleep and/or decreased daytime naps.

inv-04: Continuation — Smith-Magenis Syndrome

Authorization of 12 months may be granted when ALL of the following are met:

SMS continuation: The member experiences improvement in the quality of sleep since starting therapy with the requested drug.

Continuation requests must include documentation of clinical improvement in sleep (e.g., sleep efficiency, onset/offset, or reduced awakenings).

Coverage for tasimelteon (Hetlioz / Hetlioz LQ) is limited to the FDA-approved indications listed below. All other indications are considered experimental/investigational and not medically necessary.

Uses of tasimelteon outside the FDA-approved indications — Non-24-Hour Sleep-Wake Disorder (Non-24) in adults and nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) (capsules for ≥16 years; oral suspension for 3–15 years) — are considered not medically necessary and experimental/investigational.

Authorization Durations, Documentation & Prescriber Requirements

Prior Authorization

Initial authorization: duration & criteria

Authorization of 6 months may be granted for initial treatment when criteria below are met. Submit chart notes or test results to support the diagnosis (total blindness in both eyes for Non-24 OR Smith-Magenis Syndrome).

Initial authorization duration: 6 months
Initial criteria for Non-24: diagnosis of total blindness in both eyes; unable to perceive light; difficulty initiating sleep, difficulty awakening, or excessive daytime sleepiness
Initial criteria for SMS: confirmed clinical diagnosis of Smith-Magenis syndrome and history of sleep disturbances
Required documentation for initial requests: chart notes or test results confirming diagnosis

Prior Authorization

Continuation authorization: duration & criteria

Authorization of 12 months may be granted for continuation when criteria below are met. Provide documentation demonstrating clinical benefit since initiation of therapy.

Continuation authorization duration: 12 months
Continuation criteria for Non-24: chart notes or test results confirming total blindness in both eyes AND increased total nighttime sleep and/or decreased daytime nap duration
Continuation criteria for SMS: chart notes confirming Smith-Magenis Syndrome AND documented improvement in quality of sleep (eg, sleep efficiency, sleep onset/final offset, or reduced awakenings)
Required documentation for continuation requests: clinical notes or test results showing diagnosis confirmation and objective or documented improvement

Documentation Required

Provider action: documentation & prescriber requirements

Providers must submit supporting documentation with requests and ensure prescriber specialty requirements are met. Requests without adequate documentation or for non‑covered indications will be denied.

For initial requests: chart notes or test results to support total blindness in both eyes for Non-24 OR Smith-Magenis Syndrome
For continuation requests: documentation as above plus evidence of clinical improvement (see continuation criteria)
Non‑covered indications: any use not FDA‑approved or compendial (all other indications considered experimental/not medically necessary)
Prescriber requirement: must be prescribed by or in consultation with a sleep specialist (eg, neurologist with sleep experience or physician certified in sleep medicine) or psychiatrist

Documentation Required

Required documentation for initial and continuation requests

Submission of documentation is necessary to initiate prior authorization review. Include relevant chart notes, test results, and objective measures of sleep improvement when applicable.

Initial requests: chart notes or test results confirming total blindness in both eyes for Non-24 OR confirming Smith-Magenis Syndrome
Continuation requests: for Non-24, chart notes confirming total blindness AND evidence of increased total nighttime sleep and/or decreased daytime nap duration; for SMS, chart notes confirming diagnosis AND improvement in sleep quality (eg, sleep efficiency, onset/offset, reduced awakenings)

Note

Prescriber specialty requirement

This medication must be prescribed by or in consultation with an appropriate specialist. Ensure specialty documentation or consultation notes are included with the request.

Prescriber specialty: sleep specialist (eg, neurologist experienced with sleep disorders, physician certified in sleep medicine) or psychiatrist
Include consultation notes if prescriber is not a sleep specialist

Denial Risk

Non-covered indications

Requests for indications other than Non-24 or nighttime sleep disturbances in Smith-Magenis Syndrome are considered experimental and not medically necessary and will be denied.

Non-covered indications: any use not described under FDA‑approved indications (Non-24 in adults; nighttime sleep disturbances in SMS for specified age groups)
Denial risk: requests outside these indications are experimental/investigational and not covered

Key Definitions

Non-24-Hour Sleep-Wake Disorder (Non-24) — definition and required documentation

DefinitionA circadian rhythm disorder primarily affecting totally blind individuals who cannot perceive light; manifests as inability to entrain the sleep-wake cycle to the 24-hour day.

Coverage requirement — diagnosisTotal blindness in both eyes (e.g., nonfunctioning retinas).

Coverage requirement — light perceptionMember is not able to perceive light in either eye.

Coverage requirement — symptomsMember is experiencing difficulty initiating sleep, difficulty awakening in the morning, or excessive daytime sleepiness.

Required documentationInitial requests must include chart notes or test results confirming total blindness in both eyes.

Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) — definition and required documentation

DefinitionNighttime sleep disturbances associated with Smith-Magenis Syndrome (SMS).

Coverage requirement — diagnosisConfirmed clinical diagnosis of Smith-Magenis syndrome.

Coverage requirement — historyMember has a history of sleep disturbances.

Required documentationInitial requests must include chart notes or test results confirming Smith-Magenis Syndrome.

Age/formulation notesHetlioz capsules: indicated for SMS patients ≥16 years; Hetlioz LQ oral suspension: indicated for SMS patients 3–15 years (per FDA labeling).

brand: Hetlioz (tasimelteon)	Hetlioz capsules indicated for Non-24 in adults and SMS nighttime disturbances in patients 16 years and older
brand: Hetlioz LQ (tasimelteon oral suspension)	Hetlioz LQ oral suspension indicated for SMS nighttime disturbances in pediatric patients 3 to 15 years of age

OpenPayer

Tasimelteon (Hetlioz / Hetlioz LQ) — coverage criteria for Non-24 and Smith‑Magenis Syndrome

Coverage and Medical Necessity Criteria

Covered Products and Codes

Authorization Durations, Documentation & Prescriber Requirements

Drug and Indication Background

Key Definitions