CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

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

Criteria and prior authorization requirements for coverage of tasimelteon (Hetlioz, Hetlioz LQ) for Non-24-Hour Sleep-Wake Disorder and nighttime sleep disturbances in Smith-Magenis Syndrome; applies to members of Neighborhood Health Plan of Rhode Island as implemented via CVS Caremark's policy framework.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

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

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with chart notes or test results supporting the diagnosis; authorization may be granted for 6 or 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial auth

12 monthscontinuation auth

2FDA indications

Coverage Criteria for Tasimelteon (Hetlioz)

Non-24 Initial Therapy (6 months)

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Non-24 Continuation (12 months)

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

Non-24 continuation: 1. Member has a diagnosis of total blindness in both eyes (e.g., nonfunctioning retinas). 2. Member is not able to perceive light in either eye. 3. Member is experiencing increased total nighttime sleep and/or decreased daytime nap duration.

Smith-Magenis Syndrome Initial Therapy (6 months)

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

SMS initial: 1. Member has a confirmed clinical diagnosis of Smith-Magenis syndrome. 2. Member has a history of sleep disturbances (increased total nighttime sleep and/or decreased daytime nap duration).

Smith-Magenis Syndrome Continuation (12 months)

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

SMS continuation: Member experiences improvement in the quality of sleep since starting therapy with the requested drug (e.g., improvement in sleep efficiency, sleep onset and final sleep offset, or reduced awakenings).

Provider Actions, Authorization, and Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for tasimelteon; authorization may be granted for 6 months or 12 months depending on which coverage criteria are met and when supporting documentation is provided.

Step Therapy

Prescriber specialty requirement

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 a psychiatrist.

Documentation Required

Required documentation for prior authorization

Submit chart notes or test results with the prior authorization: for initial requests, documentation supporting the specific indication (Non-24 or Smith-Magenis Syndrome); for continuation requests, documentation confirming total blindness for Non-24 or evidence of diagnosis and baseline plus improvement in sleep measures for SMS.

Initial requests: chart notes or test results supporting Non-24 or Smith-Magenis Syndrome.
Continuation requests (Non-24): chart notes or test results confirming total blindness in both eyes.
Continuation requests (SMS): chart notes or test results confirming SMS and showing improvement in sleep (e.g., sleep efficiency, sleep onset/final offset, or reduced awakenings).

Denial Risk

Non-covered indications

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

Denial Risk

Insufficient documentation may lead to denial

Prior authorization may be denied if required documentation (chart notes or test results) supporting the diagnosis or treatment response is not submitted.

Key Definitions

inv-13: Total blindness / not able to perceive light — definition and requirements

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

Functional requirementMember is not able to perceive light in either eye.

Associated clinical featuresDifficulty initiating sleep, difficulty awakening in the morning, or excessive daytime sleepiness (Non-24 presentation).

Documentation required for prior authorizationChart notes or test results confirming total blindness in both eyes for continuation requests; initial requests should include chart notes or test results supporting the Non-24 diagnosis.

inv-14: Clinical diagnosis of Smith-Magenis Syndrome — criteria and required documentation of history of sleep disturbances

DefinitionConfirmed clinical diagnosis of Smith-Magenis syndrome.

Required clinical historyHistory of sleep disturbances characterized by increased total nighttime sleep and/or decreased daytime nap duration.

Continuation requirementDocumentation of improvement in quality of sleep since starting therapy (e.g., improved sleep efficiency, sleep onset and final sleep offset, or reduced awakenings).

Documentation required for prior authorizationFor initial requests: chart notes or test results confirming Smith-Magenis Syndrome and sleep disturbance history; for continuation: chart notes demonstrating baseline and improvement in sleep measures.

Background

Non‑24‑Hour Sleep‑Wake Disorder is a circadian rhythm disorder that primarily affects individuals who are totally blind and unable to perceive light, because light perception is required to entrain the biological clock; without it, the sleep–wake cycle can free‑run and become desynchronized with the 24‑hour day. The policy applies tasimelteon therapy for this population when documentation confirms total blindness in both eyes (nonfunctioning retinas) and inability to perceive light and the member has symptoms such as difficulty initiating sleep, difficulty awakening, or excessive daytime sleepiness.