CurrentNeighborhood Health Plan of Rhode IslandPolicy 2426-A

Hetlioz (tasimelteon) coverage for Non-24 and Smith-Magenis Syndrome

Defines prior authorization, documentation, prescriber specialty, initial and continuation approval criteria for Hetlioz (tasimelteon) for Non-24-Hour Sleep-Wake Disorder and nighttime sleep disturbances in Smith-Magenis Syndrome for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyHetlioz (tasimelteon) coverage for Non-24 and Smith-Magenis Syndrome

Policy CodePolicy 2426-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit chart notes or test results confirming total blindness in both eyes or a diagnosis of Smith-Magenis Syndrome.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial approval

12 monthscontinuation approval

2FDA-approved indications

specialistrequired prescriber

Coverage Criteria

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial Therapy — Non-24

Covered when ALL of the following are met for initial approval (Non-24):

Non-24 Initial Approval: The member has a diagnosis of total blindness in both eyes (e.g., nonfunctioning retinas).

chunk 6

Non-24 Initial Approval: The member is not able to perceive light in either eye.

chunk 6

Non-24 Initial Approval: The member is experiencing difficulty initiating sleep, difficulty awakening in the morning, or excessive daytime sleepiness.

chunk 6

Initial Therapy — Smith-Magenis Syndrome

Covered when ALL of the following are met for initial approval (SMS):

SMS Initial Approval: The member has a confirmed clinical diagnosis of Smith-Magenis syndrome.

chunk 7

SMS Initial Approval: The member has a history of sleep disturbances.

chunk 7

Continuation Therapy — Non-24

Covered when ALL of the following are met for continuation approval (Non-24):

Non-24 Continuation Approval: The member has a diagnosis of total blindness in both eyes (e.g., nonfunctioning retinas).

chunk 8

Non-24 Continuation Approval: The member is not able to perceive light in either eye.

chunk 8

Non-24 Continuation Approval: The member is experiencing increased total nighttime sleep and/or decreased daytime nap duration.

chunk 8

Continuation Therapy — Smith-Magenis Syndrome

Covered when ALL of the following are met for continuation approval (SMS):

SMS Continuation Approval: The member has a confirmed clinical diagnosis of Smith-Magenis syndrome and experiences improvement in the quality of sleep since starting therapy with Hetlioz.

chunk 9

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial approvals may be granted for up to 6 months; continuation/renewal approvals may be granted for up to 12 months when documentation supports clinical benefit.

Initial approval: 6 months
Continuation/renewal approval: 12 months

Note

Provider Actions

Providers should submit a completed prior authorization request per payer procedures.

Documentation Required

Required Documentation for Prior Authorization

For initial therapy, submit chart notes or test results confirming one of the following: total blindness in both eyes OR Smith‑Magenis syndrome. For continuation of therapy, submit documentation showing clinical benefit: for Non‑24, documentation confirming total blindness plus increased total nighttime sleep and/or decreased daytime naps; for SMS, documentation confirming SMS plus improvement in sleep quality (for example, sleep efficiency, sleep onset/offset, or reduced awakenings).

Initial therapy: chart notes or test results confirming total blindness in both eyes OR Smith‑Magenis Syndrome
Continuation therapy (Non‑24): chart notes/test results confirming total blindness AND evidence of increased total nighttime sleep and/or decreased daytime nap duration
Continuation therapy (SMS): chart notes/test results confirming Smith‑Magenis Syndrome AND evidence of improvement in sleep quality (e.g., sleep efficiency, sleep onset/offset, reduced awakenings)

Denial Risk

Non‑Covered Indications

Requests for indications other than the FDA‑approved uses listed (Non‑24 and nighttime sleep disturbances in Smith‑Magenis Syndrome) are considered experimental/investigational and not medically necessary and will be denied.

Non‑covered: any indication other than treatment of Non‑24 in adults and nighttime sleep disturbances in SMS (per age-appropriate formulations)

Definitions

Total blindness in both eyes / Non-24 eligibility — diagnostic requirements

Required diagnosisTotal blindness in both eyes (e.g., nonfunctioning retinas).

Light perceptionMember is not able to perceive light in either eye.

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

Smith-Magenis Syndrome (SMS) eligibility — diagnosis and product notes

Confirmed diagnosisConfirmed clinical diagnosis of Smith-Magenis syndrome is required.

Sleep historyMember must have a history of sleep disturbances.

Product age notesHetlioz capsules indicated for patients 16 years and older; Hetlioz LQ oral suspension indicated for pediatric patients 3–15 years.

Background

Tasimelteon (Hetlioz) is a circadian rhythm–modulating agent that is FDA‑approved for two specific indications: treatment of Non‑24‑Hour Sleep‑Wake Disorder (Non‑24) in adults and treatment of nighttime sleep disturbances in Smith‑Magenis Syndrome (SMS). Hetlioz is available as capsules for adults and as an LQ oral suspension for pediatric patients with SMS aged 3 to 15 years. Per the FDA‑approved labeling, all other uses are considered experimental/investigational and not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyHetlioz (tasimelteon) coverage for Non-24 and Smith-Magenis Syndrome

Policy CodePolicy 2426-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit chart notes or test results confirming total blindness in both eyes or a diagnosis of Smith-Magenis Syndrome.

SourceLink

On This Page

OpenPayer

Hetlioz (tasimelteon) coverage for Non-24 and Smith-Magenis Syndrome

Coverage Criteria

Provider Actions and Requirements

Coding

Definitions

Background

Revision History