CurrentUnitedHealthcarePolicy N/A

Hetlioz (tasimelteon) prior authorization for sleep disorders

Form and criteria governing prior authorization requests for Hetlioz (tasimelteon) for Non-24-Hour Sleep-Wake Disorder in adults and nighttime sleep disturbances in Smith-Magenis Syndrome; affects prescribers and UnitedHealthcare pharmacy reviewers.

Policy Summary

PayerUnitedHealthcare

PolicyHetlioz (tasimelteon) prior authorization for sleep disorders

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionFax a completed prior authorization form to 866-940-7328 (questions to 800-310-6826) including member, provider, diagnosis, prior medication trials, and indication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2indications listed on form

14days of required actigraphy or sleep logs for NZSWD documentation

3required supporting documents enumerated

866-940-7328fax number to submit the form

800-310-6826phone number for questions

Policy Summary

PayerUnitedHealthcare

PolicyHetlioz (tasimelteon) prior authorization for sleep disorders

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionFax a completed prior authorization form to 866-940-7328 (questions to 800-310-6826) including member, provider, diagnosis, prior medication trials, and indication.

SourceLink

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Initial authorization criteria

Covered when ALL of the following are met

Indication and prescriber: Request is for Hetlioz for either Non-24-Hour Sleep-Wake Disorder in adults or nighttime sleep disturbances in Smith-Magenis Syndrome, and it is prescribed by or in consultation with a psychiatrist, neurologist, or sleep specialist.

NZ4SWD diagnostic requirements: For NZ4SWD: history of insomnia or excessive daytime sleepiness alternating with asymptomatic episodes AND symptoms have persisted for at least 3 months AND documentation of gradually shifting sleep-wake times demonstrated by daily sleep logs or actigraphy for at least 14 consecutive days AND patient is blind in both eyes without light perception.

SMS diagnostic requirements: For SMS: diagnosis of nighttime sleep disturbances in Smith-Magenis Syndrome (as indicated on the form) with documentation of sleep disturbances (e.g., frequent nocturnal arousals, early morning awakenings, daytime sleep attacks, inability to fall asleep) AND history of failure, contraindication, or intolerance to listed agents as documented on the prior authorization form.

Patients who do not meet the listed diagnostic confirmation or documentation requirements are not eligible for approval until the missing items are provided. For Non-24-Hour Sleep-Wake Disorder (NZ4SWD), this includes absence of documented symptoms for at least 3 months, or lack of objective evidence of gradually shifting sleep-wake times demonstrated by daily sleep logs or actigraphy for at least 14 consecutive days, or failure to indicate bilateral blindness without light perception. For Smith-Magenis Syndrome (SMS), this includes lack of genetic confirmation (heterozygous deletion of RAI1 on chromosome 17p11.2 or a pathogenic RAI1 variant) or missing documentation of the characteristic sleep disturbances and prior trial/ intolerance information for specified agents.

Requests missing required documentation will not be supportable as medically necessary. Required items that must accompany the prior authorization include: chart notes; for SMS, diagnostic testing and documentation of the reported sleep disturbance; for NZ4SWD, sleep logs or actigraphy (when applicable); and the prescriber’s signature, specialty, and date. Omitting any of these items may delay review or result in denial.

Prior Authorization Submission and Provider Responsibilities

Prior Authorization

Prior Authorization Required

Prior Authorization Submission Requirements: Complete the entire prior authorization form and fax to 866-940-7328. Allow at least 24 hours for review. For questions, call 800-310-6826. The form collects member, provider, diagnosis, and therapy details; complete all pages to avoid a delay in decision.

Fax completed form to 866-940-7328
Questions: call 800-310-6826
Allow ≥ 24 hours for review
Form collects member, provider, diagnosis, prior therapy and dates

Step Therapy

Prior Medication Trials / Step Therapy

Prior Medication Trials / Step Therapy Evidence: Document prior medication trials in Section D (previous medication trials) and include reason for failure or discontinuation for each therapy. For SMS, indicate history of failure, contraindication, or intolerance to listed agents (e.g., a beta-1 selective blocker, ramelteon, clonidine, trazodone, diphenhydramine) and specify medications tried.

List medication name, strength, directions, dates of therapy and reason for discontinuation in Section D
For SMS: document prior trials or contraindications to specified sleep-promoting agents and beta-1 selective blockers
Refer to the patient's PDL for preferred alternatives

Documentation Required

Documentation Required with Request

Required Supporting Documentation: Include all required clinical documentation with the request. Missing documentation may delay review or result in denial.

Chart notes (required with every request)
Prescriber signature, prescriber specialty, and date
For Smith-Magenis Syndrome (SMS): diagnostic testing confirming genetic diagnosis and documentation of sleep disturbances (e.g., frequent nocturnal arousals, early morning awakenings, daytime sleep attacks, inability to fall asleep)
For Non-24-Hour Sleep-Wake Disorder (NZ4SWD): sleep logs or actigraphy data when applicable

Denial Risk

Missing Documentation — Risk of Delay or Denial

Missing Required Supporting Documentation: Highlight items commonly omitted that will delay or prevent authorization.

Absent chart notes or insufficient clinical notes detailing symptom history and prior therapies
Missing diagnostic confirmation for SMS (genetic testing showing RAI1 deletion or pathogenic variant)
No documentation of sleep disturbance severity or frequency for SMS
Omitted sleep logs or actigraphy for NZ4SWD
Missing prescriber signature, specialty, or date

Clinical Definitions

Smith-Magenis Syndrome (SMS) — diagnostic confirmation and sleep disturbance documentation

Genetic confirmationDiagnosis confirmed by heterozygous deletion of RAI1 on chromosome 17p11.2 or presence of a pathogenic RAI1 variant

Documented sleep disturbancesDocumentation of sleep disturbances such as frequent nocturnal arousals, early morning awakenings, daytime sleep attacks, or inability to fall asleep

Prior treatment historyHistory of failure, contraindication, or intolerance to listed agents (e.g., a beta-1 selective blocker like acebutolol or additional sleep-promoting medications such as ramelteon, clonidine, trazodone, diphenhydramine) must be documented

OpenPayer

Hetlioz (tasimelteon) prior authorization for sleep disorders

Coverage Criteria for Hetlioz (tasimelteon)

Key Definitions and Coding-related Requirements

Prior Authorization Submission and Provider Responsibilities

Clinical Definitions

Background