CurrentCignaPolicy N/A

Tasimelteon Products

Defines Cigna prior authorization, coverage criteria, and exclusions for tasimelteon capsules (Hetlioz and generic) and states the payer stance that Hetlioz LQ is not recommended for approval for pediatric SMS due to insufficient evidence. Applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyTasimelteon Products (coverage criteria for tasimelteon capsules and related formulations)

Policy CodePolicy N/A

Change TypeTitle revisedHetlioz LQ removed from Non-24 criteria

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document total blindness, circadian testing or actigraphy/sleep logs, and a 6‑month trial of melatonin with inadequate response.

SourceLink

POLICY UPDATE CHANGES

Coverage Policy Title changed from 'Tasimelteon' to 'Tasimelteon Products'; Hetlioz LQ was removed from Non-24-Hour Sleep-Wake Disorder (Non-24) criteria.

Examples of medications and sleep-related disorders previously in 'Conditions Not Recommended for Approval' were moved into notes for clarity.

6 monthsinitial approval duration

1 yearcontinuing user approval

≥18minimum age

Totally blind

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Hetlioz LQ = experimentalpediatric SMS stance

Coverage Criteria for Tasimelteon Products

Tasimelteon capsules (Hetlioz, generic) — Non-24-Hour Sleep-Wake Disorder (FDA-approved)

Covered when ONE of the following is met:

Non-24 indication options

A. Initial Therapy
- i: Patient is ≥ 18 years of age≥ 18 years
- ii: Patient is totally blind with no perception of lightdocumented no light perception
  Documentation required
- iii
  - iii.a: Assessment of at least one physiologic circadian phase marker (examples: urinary melatonin, dim light melatonin onset in blood or saliva, core body temperature)
  - iii.b: If physiologic marker cannot be done, actigraphy for ≥ 1 week plus sleep logs recorded for ≥ 1 month
- iv: Patient has received at least 6 months of continuous daily melatonin therapy under the guidance of a physician who specializes in sleep disorders AND had inadequate efficacy with melatonin therapy≥ 6 months melatonin
  Documentation of inadequate efficacy required; examples include failure to achieve entrainment or meaningful increases in nighttime sleep/decreases in daytime sleep
- v: Medication is prescribed by or in consultation with a physician who specializes in the treatment of sleep disorders
- vi: Preferred product criteria is met for the product(s)
B. Currently Receiving Tasimelteon Capsules
- i: Patient is ≥ 18 years of age
- ii: Patient is totally blind with no perception of light
  Documentation required
- iii: Patient has received at least 6 months of continuous daily melatonin therapy under the guidance of a physician who specializes in sleep disorders AND had inadequate efficacy with melatonin therapy≥ 6 months melatonin
  Documentation of inadequate efficacy required
- iv: Patient has received at least 6 months of continuous daily tasimelteon capsules therapy under the guidance of a physician who specializes in sleep disorders

Authorization and prescriber: Prior authorization is required; tasimelteon capsules must be prescribed by or in consultation with a physician who specializes in the condition being treated; approvals are provided for specified durations (initial approval 6 months for new users; 1 year for patients currently receiving).

Employer and Individual/Family Plan brand-to-generic exception

Brand medical necessity for Hetlioz (employer/individual plans): Patient has tried the bioequivalent generic tasimelteon capsules and cannot take the generic due to a formulation difference in inactive ingredient(s) that would result in a significant allergy or serious adverse reaction; documentation may be required.

Tasimelteon products (tasimelteon capsules, Hetlioz, Hetlioz LQ) are not medically necessary when used for indications other than FDA‑approved Non‑24 in adults. Examples of uses considered not medically necessary include primary insomnia, where guideline-supported pharmacologic options exist and only limited data support tasimelteon; nighttime sleep disturbances in Smith‑Magenis Syndrome (SMS), for which efficacy data are underwhelming; concomitant use with ramelteon or other sedative‑hypnotic medications (e.g., benzodiazepines, nonbenzodiazepine hypnotics, chloral hydrate) because safety and efficacy in combination have not been established; and other sleep‑related disorders such as shift work disorder, jet lag, advanced/delayed sleep phase, and irregular sleep‑wake rhythm disorder.

Hetlioz LQ is considered experimental, investigational, or unproven for treatment of nighttime sleep disturbances in pediatric Smith‑Magenis Syndrome (ages 3–15 years) due to insufficient data demonstrating safety, efficacy, and improved health outcomes. Documentation and criteria will be updated if new published evidence becomes available; until then, approvals for this pediatric SMS indication are not supported.

Coding and Objective Data Requirements

No specific billing codesmixed

No codes listed

inv-06: Actigraphy duration

Actigraphy durationActigraphy performed for ≥ 1 week is acceptable to confirm Non-24 when physiologic circadian phase markers cannot be obtained.

ContextActigraphy is cited as an alternative diagnostic method alongside sleep logs when physiologic markers are not feasible.

DocumentationActigraphy results must be accompanied by sleep log evaluation for the specified durations to meet diagnostic confirmation.

inv-07: Sleep logs duration

Sleep logs durationSleep logs (sleep diaries) recorded for ≥ 1 month are required when using actigraphy in lieu of physiologic circadian markers.

Paired testingSleep logs must be evaluated together with actigraphy (actigraphy ≥ 1 week plus sleep logs ≥ 1 month) to confirm Non-24 if physiologic markers are not done.

Provider Actions, Documentation, and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization is required for coverage of tasimelteon capsules (Hetlioz, generic). Approvals: initial approvals for qualifying new users are for 6 months; approvals for patients currently receiving tasimelteon are for 1 year. Tasimelteon must be prescribed by or in consultation with a physician who specializes in the condition being treated (sleep disorders). All documentation must include patient-specific identifying information.

Initial approval duration: 6 months (1 month = 30 days)
Continuation (current users) approval duration: 1 year
Prescriber requirement: physician specializing in sleep disorders

Step Therapy

Provider/Step-Therapy Requirements

Patients must have a documented trial of at least 6 months of continuous melatonin therapy (6 consecutive months of daily treatment) under the guidance of a physician who specializes in the treatment of sleep disorders, with documentation that melatonin provided inadequate efficacy. For continuation therapy, patients must also have received at least 6 months of continuous tasimelteon if seeking continuation under the current-user pathway. Step-therapy expectations: providers should document prior melatonin use and outcomes before requesting tasimelteon.

Key Definitions

inv-14: Definition of Non-24-Hour Sleep-Wake Disorder (Non-24)

DefinitionNon-24-Hour Sleep-Wake Disorder is a chronic circadian rhythm disorder caused by misalignment of the endogenous body clock to the 24-hour day, disrupting the sleep–wake cycle.

High-risk populationPatients who are completely blind are particularly susceptible; up to one-half to three-quarters of totally blind patients may have Non-24.

Diagnostic markersDiagnosis can be confirmed by physiologic circadian phase markers (e.g., urinary melatonin, dim light melatonin onset in blood or saliva, or core body temperature) or, if not feasible, by actigraphy plus sleep logs.

inv-15: Definition of Smith-Magenis Syndrome (SMS)

DefinitionSmith-Magenis Syndrome (SMS) is a rare genetic disorder characterized by physical, neurobehavioral, and developmental features, with an estimated incidence of about 1 in 15,000 to 25,000 in the U.S.

Background

Non‑24‑Hour Sleep‑Wake Disorder (Non‑24) is a chronic circadian rhythm disorder caused by misalignment of the endogenous circadian clock with the 24‑hour day, commonly occurring in individuals who are totally blind. Diagnosis relies on demonstration of a non‑entrained circadian rhythm using physiologic circadian phase markers (for example, dim light melatonin onset measured in saliva or blood, urinary melatonin metabolites, or core body temperature) or, when physiologic testing is not feasible, objective activity monitoring plus sleep logs. The policy specifies actigraphy for ≥ 1 week plus sleep logs for ≥ 1 month as the alternative diagnostic approach when physiologic markers cannot be obtained. In clinical context, Non‑24 produces recurrent and variable periods of insomnia and daytime sleepiness as the internal rhythm drifts relative to the 24‑hour day, and management decisions (including use of tasimelteon) are made in the setting of this circadian misalignment and its functional impact.

Policy Summary

PayerCigna

PolicyTasimelteon Products (coverage criteria for tasimelteon capsules and related formulations)

Policy CodePolicy N/A

Change TypeTitle revisedHetlioz LQ removed from Non-24 criteria

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document total blindness, circadian testing or actigraphy/sleep logs, and a 6‑month trial of melatonin with inadequate response.

SourceLink

On This Page

≥ 6 months tasimelteon

iv.b: Patient has achieved adequate results with tasimelteon capsules therapy

Documentation required; examples include entrainment or clinically meaningful increases in nighttime sleep/decreases in daytime sleep

v: Medication is prescribed by or in consultation with a physician who specializes in the treatment of sleep disorders

vi: Preferred product criteria is met for the product(s)

PurposeSleep logs provide complementary longitudinal sleep–wake pattern data to support diagnosis and prior authorization decisions.

inv-08: Required prior melatonin therapy duration

Required melatonin therapy durationPatient must have received at least 6 months continuous daily melatonin therapy under a sleep specialist with documented inadequate efficacy before initial approval of tasimelteon.

Definition of continuousContinuous therapy is defined as 6 consecutive months of daily treatment.

DocumentationChart documentation from the treating sleep specialist confirming the 6-month melatonin trial and inadequate response is required for prior authorization.

Minimum melatonin trial: ≥ 6 months continuous daily therapy under a sleep specialist
Evidence of inadequate efficacy with melatonin required
For current tasimelteon users: ≥ 6 months continuous tasimelteon therapy to qualify for 1-year continuation

Documentation Required

Documentation is required to support the diagnosis and medical necessity. Required documentation must be included with the prior authorization request and may include chart notes, sleep specialist evaluation, actigraphy and sleep logs, physiologic circadian marker results, and other patient-specific evidence. All documentation must include patient identifiers.

Documentation confirming total blindness with no light perception (explicit statement in chart)
Diagnosis confirmation by at least one physiologic circadian phase marker (e.g., dim light melatonin onset, urinary melatonin, core body temperature) OR actigraphy ≥ 1 week plus sleep logs ≥ 1 month if circadian marker testing is not feasible
Evidence of ≥ 6 months continuous melatonin therapy and documentation of inadequate efficacy
For current tasimelteon users: documentation of ≥ 6 months continuous tasimelteon and evidence of adequate response when applicable
Chart notes, laboratory/test results, claims records, and other patient-specific records as applicable

Billing Rule

Billing and Denial Conditions

Claims submitted without a covered diagnosis, required supporting documentation, or applicable procedure/coding will be denied. Ensure prior authorization is obtained where required and that the claim includes the documented diagnosis (Non-24) and supporting evidence; unsupported or incomplete claims risk denial.

Claims lacking documentation of total blindness or missing circadian confirmation (physiologic marker or actigraphy + sleep logs) will be denied
Claims without evidence of the required ≥ 6 months melatonin trial and documentation of inadequate efficacy will be denied
Claims for uses not meeting covered indications (see Conditions Not Covered) will be denied

Sleep disturbances in SMS begin early (as early as one year of age) and include shortened sleep cycles, multiple nighttime awakenings, early morning arousal, and increased daytime sleepiness.

Etiology and impactMost cases involve deletion or mutation of the RAI1 gene; circadian melatonin secretion instability contributes to sleep problems and associated behavioral issues.