CurrentCignaPolicy IP0428

Tasimelteon (Hetlioz, Hetlioz LQ) for Non-24-Hour Sleep-Wake Disorder

Medical necessity and coverage policy for tasimelteon products (Hetlioz, Hetlioz LQ, and generic tasimelteon) primarily addressing treatment of Non-24-Hour Sleep-Wake Disorder in adults who are totally blind; includes preferred product guidance, authorization durations, reauthorization criteria, and conditions considered not covered.

Policy Summary

PayerCigna

PolicyTasimelteon (Hetlioz, Hetlioz LQ) for Non-24-Hour Sleep-Wake Disorder

Policy CodePolicy IP0428

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and document a trial of bioequivalent generic tasimelteon capsules (or contraindication) and confirm diagnosis with physiologic marker or ≥1 month sleep logs.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+minimum age for Non-24 coverage

Totally blindrequired visual status for Non-24 coverage

6 monthsrequired trial of melatonin prior to tasimelteon

up to 6 moinitial authorization duration

up to 12 mo

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Coverage and Medical Necessity Criteria

Initial Therapy

Covered when ALL of the following are met:

Non-24 initial coverage criteria: A. Age 18 years of age or older; B. Documented diagnosis of non-24 hour sleep-wake disorder confirmed by ONE of: (i) assessment of at least ONE physiologic circadian phase marker (e.g., urinary melatonin, dim light melatonin onset in blood or saliva, core body temperature) OR (ii) if physiologic marker cannot be done, evaluation of sleep logs recorded for at least 1 month; C. Documentation that the individual is totally blind with no perception of light; D. Documentation of BOTH: (i) at least 6 months of continuous daily melatonin therapy under the guidance of a physician who specializes in the treatment of sleep disorders AND (ii) inadequate efficacy with melatonin therapy (examples include lack of entrainment or no clinically meaningful increases in nighttime sleep or decreases in daytime sleep); E. Medication is prescribed by, or in consultation with, a neurologist or physician who specializes in the treatment of sleep disorders; F. Preferred product criteria met (documented trial of bioequivalent generic tasimelteon capsules unless unable to take due to formulation difference causing significant allergy or serious adverse reaction).see text

Requires all listed criteria to be met

Continuation Therapy / Reauthorization

Continuation is covered when ALL of the following are met:

Reauthorization criteria: Medical necessity criteria from Initial Therapy continue to be met AND there is documentation of beneficial clinical response to tasimelteon.see text

Beneficial response must be documented

Tasimelteon use is limited to the indications and clinical circumstances described in this policy. Of particular importance for coverage decisions are concomitant-therapy risks and the strength of evidence for alternative indications. The safety and efficacy of combining Hetlioz (tasimelteon) with other melatonin receptor agonists (for example, ramelteon) have not been studied and concurrent use is suspected to increase additive central nervous system effects such as somnolence and may increase risk in hepatic impairment; therefore concomitant use with ramelteon is not supported by available data. [[chunk 7]]

There are no data to support the safety or efficacy of using tasimelteon together with sedative-hypnotic medications or other insomnia treatments (for example, benzodiazepines, nonbenzodiazepine hypnotics, chloral hydrate), and these combinations were excluded from clinical trials. Potential additive adverse effects and lack of evidence mean concomitant therapy with these agents is not considered acceptable for coverage. [[chunk 8]]

For indications beyond Non-24 and the limited FDA-labeled Smith-Magenis Syndrome (SMS) uses, evidence is insufficient. Existing data are limited or underwhelming for primary insomnia and nighttime sleep disturbances in SMS, and larger or confirmatory studies are needed to establish safety and efficacy before such uses can be considered clinically supported. [[chunk 7]]

Any use of tasimelteon that is not expressly described as medically necessary in this policy is considered experimental, investigational, or unproven and therefore not medically necessary. This includes, but is not limited to, treatment of primary insomnia and other sleep disorders where evidence is lacking. [[chunk 7]]

Specific exclusions include: nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) when clinical efficacy data are insufficient or underwhelming; concomitant therapy with ramelteon due to unstudied safety and potential additive adverse effects; concomitant use with sedative-hypnotic medications or other insomnia agents (e.g., benzodiazepines, nonbenzodiazepine hypnotics, chloral hydrate); and other sleep-related disorders such as shift work disorder, jet lag, advanced or delayed sleep phase disorders, and irregular sleep-wake rhythm disorder. [[chunk 7]][[chunk 8]]

Because trials of Hetlioz excluded medications that could interfere with circadian rhythm assessment and because published studies for many alternative indications are limited in size or scope, these uses remain unproven and are not covered under this policy. [[chunk 7]][[chunk 8]]

Provider Requirements and Prior Authorization

Prior Authorization

Provider Requirements and Prior Authorization

Prior authorization may be required for Hetlioz (tasimelteon). Coverage is limited to the FDA‑approved indication of Non‑24‑Hour Sleep‑Wake Disorder (Non‑24) in totally blind individuals; use for other indications is considered experimental, investigational, or unproven and is not covered.

Coverage for Hetlioz requires documentation of a diagnosis of Non‑24 confirmed by ONE of: assessment of at least one physiologic circadian phase marker (e.g., urinary melatonin measurement, dim light melatonin onset in blood or saliva, or core body temperature) OR sleep logs recorded for at least 1 month when physiologic markers cannot be assessed.
Documentation must include that the individual is totally blind with no perception of light and that medication is prescribed by or in consultation with a neurologist or a physician who specializes in sleep disorders.
Documentation must show prior therapy with melatonin: at least 6 consecutive months of continuous daily melatonin therapy under the guidance of a sleep specialist, with inadequate efficacy (no entrainment or no clinically meaningful improvement in nighttime or daytime sleep).
Preferred product requirement: a documented trial of bioequivalent generic tasimelteon capsules is required prior to coverage of the branded Hetlioz unless the member cannot take the generic due to a formulation difference in inactive ingredients that would cause a significant allergy or serious adverse reaction.
Receipt of samples does not satisfy trial requirements.

Key Definitions

Non-24-Hour Sleep-Wake Disorder (Non-24) — definition and key diagnostic features

DefinitionA chronic circadian rhythm disorder caused by misalignment of the endogenous master body clock to the 24-hour day that disrupts the sleep–wake cycle.

Population most affectedCommon in totally blind individuals; as many as one-half to three-quarters of totally blind patients may have Non-24 (estimated 65,000–95,000 Americans).

Diagnostic methodsDiagnosis can be confirmed by assessment of at least one physiologic circadian phase marker (e.g., urinary melatonin, dim light melatonin onset in blood or saliva, or core body temperature) or, when physiologic markers are not available, by actigraphy or sleep logs/diaries recorded for at least 1 month.

Pathophysiology noteFrequently due to failure of light to reach the suprachiasmatic nuclei, leading to endogenous clock misalignment.

Clinical impactProduces disrupted sleep–wake cycles with variable timing of sleep and daytime sleepiness; diagnosis and monitoring may use objective circadian markers or activity monitoring (actigraphy).

Background and Clinical Context

Non-24-Hour Sleep-Wake Disorder (Non-24) is a chronic circadian rhythm disorder caused by misalignment of the endogenous master clock to the 24-hour day and occurs most commonly in individuals who are totally blind. The disorder is characterized by a recurrent pattern of circadian desynchrony leading to cyclic insomnia and daytime sleepiness as the endogenous rhythm free-runs relative to the external 24‑hour environment. Diagnosis may be established by assessment of physiologic circadian phase markers (for example, dim light melatonin onset, urinary melatonin, or core body temperature), actigraphy, or prospective sleep logs. [[chunk 10]]

Tasimelteon is a melatonin receptor agonist indicated for treatment of Non-24 in adults and has been evaluated specifically in this population. Clinical trials excluded concurrent medications that could interfere with circadian rhythm assessment, and the agent’s use is focused on entraining circadian rhythms in totally blind patients who have failed or had inadequate response to an adequate trial of melatonin. The targeted population and diagnostic requirements underlie the policy’s coverage criteria. [[chunk 9]][[chunk 10]]