CurrentUnitedHealthcarePolicy N/A

Sleep Disorder Agents - Hetlioz (tasimelteon) coverage criteria

Prior authorization and clinical criteria for coverage of tasimelteon (Hetlioz) for Non-24-Hour Sleep-Wake Disorder and nighttime sleep disturbances in Smith‑Magenis Syndrome; applies to UnitedHealthcare pharmacy benefit submissions and providers requesting coverage.

Policy Summary

PayerUnitedHealthcare

PolicySleep Disorder Agents - Hetlioz (tasimelteon) coverage criteria

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit completed prior authorization form by fax to 866-940-7328 including member, provider, medical information, prior medication trials, and indication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2primary indications listed (N24SWD, SMS)

14 dayssleep logs/actigraphy min

3 monthssymptom duration min

866-940-7328fax for form

800-310-6826questions phone

Coverage Criteria

Coverage criteria (N24SWD and SMS)

Coverage considered when documentation meets indication-specific criteria and required documentation is provided.

Indication selection: Request specifies one of: Non-24-Hour Sleep-Wake Disorder (N24SWD) in adults OR nighttime sleep disturbances in Smith-Magenis Syndrome (SMS)

form item 2; see chunk 5

Specialist involvement: Prescribed by or in consultation with a psychiatrist, neurologist, or sleep specialist

form item 3; see chunk 5

N24SWD diagnostic criteria

N24SWD — symptom duration: Symptoms have persisted for at least 3 months>= 3 months

Policy Summary

PayerUnitedHealthcare

PolicySleep Disorder Agents - Hetlioz (tasimelteon) coverage criteria

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit completed prior authorization form by fax to 866-940-7328 including member, provider, medical information, prior medication trials, and indication.

SourceLink

On This Page

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N24SWD — objective documentation: Documentation of gradually shifting sleep-wake times demonstrated by daily sleep logs or actigraphy for at least 14 consecutive days>= 14 consecutive days

chunk 6 question 4

N24SWD — blindness query: Patient blind in both eyes without light perception (yes/no)

chunk 6 question 5

SMS diagnostic criteria

SMS — genetic confirmation: Confirmation by either: a heterozygous deletion of RAI1 on chromosome 17p11.2 OR presence of a pathogenic RAI1 variant on chromosome 17p11.2
chunk 7 question 6
SMS — sleep disturbance documentation: Documentation of sleep disturbances (e.g., frequent nocturnal arousals, early morning awakenings, daytime sleep attacks, inability to fall asleep)
chunk 7 question 7

Prior medication trials: Documentation of prior medication trials and reason for failure/intolerance; for SMS document failure/contraindication/intolerance to a beta-1 selective blocker (e.g., acebutolol) and an additional sleep-promoting medication where applicable

form item 8; see chunk 7

Continuation of therapy: If continuation, documentation of a positive clinical response from baseline (e.g., improved sleep quality, decreased nighttime awakening, increased sleep time, maintained or improved sleep intervals)

form item 1; see chunk 5

The prior authorization form requests diagnostic confirmation for Non-24-Hour Sleep-Wake Disorder (N24SWD) in adults. Relevant documentation includes symptom history showing symptoms persisting for at least 3 months, and objective demonstration of gradually shifting sleep–wake times by daily sleep logs or actigraphy for at least 14 consecutive days. The form also asks whether the patient is blind in both eyes without light perception, which is queried as part of the diagnostic assessment.

The form does not enumerate specific conditions as explicitly “not medically necessary.” However, approval depends on submission of the required documentation and meeting the indication-specific criteria. If the requested information (for example, chart notes, diagnostic testing for SMS, or sleep logs/actigraphy for N24SWD) is not provided or the diagnostic criteria are not met, the request may be denied.

Coding and Diagnostic Evidence

Diagnosis codes (form field)ICD-10

ICD-10 CODE

Placeholder field on form for the patient's diagnosis ICD-10 code

inv-05: Sleep logs/actigraphy duration — at least 14 consecutive days

Required durationSleep logs or actigraphy for at least 14 consecutive days

Acceptable methodsDaily sleep logs or actigraphy documenting gradually shifting sleep-wake times

PurposeDemonstrate shifting sleep-wake pattern to support diagnosis of N24SWD

inv-06: Symptom duration for N24SWD — at least 3 months

Required symptom durationSymptoms have persisted for at least 3 months

Associated findingHistory of insomnia or excessive daytime sleepiness alternating with asymptomatic episodes may be present

Assessment contextUsed with sleep logs/actigraphy documentation to establish N24SWD diagnosis

Definitions

inv-12: Non-24-Hour Sleep-Wake Disorder (N24SWD) documentation — symptom duration and sleep logs/actigraphy requirements

Symptom duration requirementSymptoms persisting for at least 3 months

Objective documentationDaily sleep logs or actigraphy documenting gradually shifting sleep-wake times for at least 14 consecutive days

Additional queryForm asks whether patient is blind in both eyes without light perception (relevant to N24SWD)

inv-13: Smith-Magenis Syndrome (SMS) diagnostic confirmation — genetic confirmation (RAI1 deletion/variant)

Diagnostic confirmationHeterozygous deletion of RAI1 on chromosome 17p11.2

Alternative genetic confirmationPresence of a pathogenic variant involving RAI1 on chromosome 17p11.2

Clinical documentationPlus documentation of sleep disturbances (eg frequent nocturnal arousals, early morning awakenings, daytime sleep attacks, inability to fall asleep)

Provider Actions & Submission Requirements

Prior Authorization

Prior authorization form and submission

Please complete and submit the required prior authorization form in full. Incomplete forms or missing attachments may delay review or result in denial/return of the request.

Fax completed form to: 866-940-7328
Questions: call 800-310-6826
Allow at least 24 hours for review

Step Therapy

Previous medication trials / preferred alternatives

Document prior medication trials including medication name, strength, directions, dates of therapy, and reason for failure or discontinuation. If requesting a non-preferred agent, explain why preferred medications are not appropriate for this patient and reference the patient or payer PDL for preferred alternatives.

Section D – list prior medication trials with: Medication Name; Strength; Directions; Dates of Therapy; Reason for failure/discontinuation
Section E – provide explanation why preferred medications would not meet the patient’s needs and reference the PDL for alternatives

Documentation Required

Required documentation

Submit all required documentation with the request. Failure to include the items below may lead to a denial or a request for additional information.

Chart notes documenting diagnosis, baseline status, and response to therapy
For Smith-Magenis Syndrome (SMS): diagnostic testing and documentation of sleep disturbance
For Non-24-Hour Sleep-Wake Disorder (N24SWD): sleep logs or actigraphy if applicable
Prescriber signature, prescriber specialty, and date

Denial Risk

Missing required documentation

Missing required documentation will delay processing and may result in denial or return of the request. Ensure every item listed under "Required documentation" and the completed prior authorization form (Sections D and E) are included at time of submission.

Omitted chart notes, sleep logs/actigraphy, or diagnostic testing for SMS/N24SWD may lead to denial
Omitted prescriber signature/specialty/date will lead to return of request

Background

Tasimelteon (Hetlioz) is requested for two indication sets captured on the form: Non-24-Hour Sleep-Wake Disorder (N24SWD) in adults and nighttime sleep disturbances in Smith‑Magenis Syndrome (SMS). For N24SWD the form requires documentation of symptom duration (≥ 3 months) and objective daily sleep logs or actigraphy for ≥ 14 consecutive days. For SMS the form requires genetic confirmation (heterozygous deletion of RAI1 or a pathogenic RAI1 variant) and documentation of sleep disturbances. Requests must include required materials with the submission (chart notes; for SMS: diagnostic testing and documentation of sleep disturbance; for N24SWD: sleep logs or actigraphy if applicable) and a prescriber signature, specialty, and date.

Provider Contact & Submission Details

inv-07: Submission contact details (fax and phone) surfaced as quick-reference

Fax for prior authorization form866-940-7328

Phone for questions800-310-6826

Submission instructionComplete entire form and fax; allow at least 24 hours for review

Revision History

policy_form_updateLatest

Prior authorization form for Hetlioz (tasimelteon) documents coverage criteria and required submission details including fax (866-940-7328) and contact number (800-310-6826).