ModifiedCentenePolicy CP.PMN.104

Clinical Policy: Tasimelteon (Hetlioz, Hetlioz LQ)

Defines medical necessity, prior authorization, and coverage criteria for tasimelteon (brand and generic) for Non-24-hour sleep-wake disorder and nighttime sleep disturbances in Smith-Magenis Syndrome for Centene lines of business.

Policy Summary

PayerCentene

PolicyClinical Policy: Tasimelteon (Hetlioz, Hetlioz LQ)

Policy CodePolicy CP.PMN.104

Change TypeStep therapy bypass for IL HIMgeneric preference for brand requestsquantity-limit clarification

Effective Date03.01.17

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing member meets all listed criteria, including diagnosis, prescriber specialty, age, prior therapy failures, blindness status for Non-24, and dose/quantity limits.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for Illinois HIM per IL HB 5395.

Applied redirection to generic tasimelteon for brand Hetlioz capsule requests across indications.

Added requirement that requests do not exceed health plan-approved quantity limit, if applicable.

2FDA-approved indications listed

20 mg/dayMax adult dose

12 monthsTypical approval duration

≥18

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Overrides when conflictingMedicaid precedence

Centene-developedPolicy ownership

Coverage Criteria

Non‑FDA approved indications that are not specifically addressed by this policy are not authorized for coverage unless the request includes sufficient documentation of efficacy and safety in accordance with applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or the member's evidence of coverage documents.

Coverage decisions and the administration of benefits are governed by the member's coverage documents and applicable legal/regulatory requirements. The Health Plan's determination of medical necessity, and any prior authorization requirements, are subject to all terms, conditions, exclusions, and limitations of the member's evidence of coverage, certificate of coverage, policy, or contract of insurance.

Use of tasimelteon for non‑FDA approved indications that lack sufficient supporting evidence or are not addressed by this policy is considered not authorized and may be denied unless the provider submits adequate documentation under the off‑label use policies referenced by the Health Plan.

Coding and Dosing

Product availability / NDCsNDC

NDCs not specified

Product availability listed: Hetlioz capsules 20 mg; Hetlioz LQ oral suspension 4 mg/mL (48 mL and 158 mL).

inv-08: Maximum daily dose — 20 mg/day

Maximum daily dose (adult capsules)20 mg per day; 1 capsule per day (maximum dose for Hetlioz and generic tasimelteon)

Administration timingGive once daily by mouth one hour before bedtime at the same time each night

Applies toHetlioz (brand) capsules and generic tasimelteon capsules for Non-24 and SMS indications as specified

inv-09: Hetlioz LQ pediatric dosing threshold — ≤ 28 kg: 0.7 mg/kg/day; > 28 kg: 20 mg/day

Hetlioz LQ pediatric dosing (≤28 kg)0.7 mg per kg per day (given orally once daily one hour before bedtime)

Hetlioz LQ dosing (>28 kg)20 mg per day (given orally once daily one hour before bedtime)

Age indicationHetlioz LQ indicated for pediatric patients 3 to 15 years of age

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Requests must include documentation that the member meets all listed criteria (diagnosis, prescriber specialty, age, prior therapies, dose/quantity limits, and any other applicable policy requirements).

Prior auth may be required for ramelteon per plan guidance.

Documentation Required

Required Supporting Documentation

Provider must submit supporting documentation such as office chart notes, sleep specialist consultation notes, visual status assessment (documentation of total blindness or inability to perceive light), prior therapy records (trial of melatonin and ramelteon unless contraindicated), and any relevant labs or clinical testing to demonstrate that the member meets all approval criteria.

Include documentation of prior failures or contraindications to melatonin and ramelteon when applicable.
For continuation requests, include evidence of positive response to therapy (e.g., increased nighttime sleep, decreased daytime naps, improved sleep quality).

Background

Tasimelteon is a melatonin receptor agonist approved by the FDA for Non‑24‑hour sleep‑wake disorder (Non‑24) in adults and for treatment of nighttime sleep disturbances in Smith‑Magenis Syndrome (SMS). Typical adult dosing for Hetlioz capsules is 20 mg once daily taken approximately one hour before bedtime; pediatric dosing for Hetlioz LQ is weight‑based. This clinical policy is intended to guide medical necessity determinations and does not replace provider clinical judgment.

Definitions

inv-20: Non-24-hour sleep-wake disorder (Non-24) — definition and key diagnostic requirements (total blindness/nonfunctioning retinas)

DefinitionA circadian rhythm sleep-wake disorder characterized by an inability to synchronize the endogenous circadian system to the 24-hour day

Key diagnostic requirementDiagnosis of non-24-hour sleep-wake disorder is required for coverage

Vision requirement for coverageMember must have total blindness (e.g., nonfunctioning retinas) and be unable to perceive light in both eyes

Age requirementIndication for Hetlioz/tasimelteon for Non-24 is for adults (age ≥ 18 years)

inv-21: Smith‑Magenis Syndrome (SMS) nighttime sleep disturbances — definition and genetic confirmation requirements

DefinitionNighttime sleep disturbances associated with Smith-Magenis Syndrome (SMS)

Policy Summary

PayerCentene

PolicyClinical Policy: Tasimelteon (Hetlioz, Hetlioz LQ)

Policy CodePolicy CP.PMN.104

Change TypeStep therapy bypass for IL HIMgeneric preference for brand requestsquantity-limit clarification

Effective Date03.01.17

Next Review DateN/A

SourceLink

On This Page

Billing Rule

Brand vs. Generic

Brand Hetlioz requests should be redirected to generic tasimelteon when available unless the provider documents a medical contraindication or clinically significant adverse events with generic therapy. Requests specifically seeking brand product without prior trial or justification may be denied or redirected.

Applies to both initial and continuation requests.
For pediatric Hetlioz LQ dosing rules, follow the policy dosing criteria; redirection to generic also applies where noted.

Denial Risk

Provider Responsibility and Denial Risk

Providers are expected to exercise professional medical judgment and remain responsible for the medical advice and treatment of members. Maintain and make available clinical documentation supporting the request and continued therapy; failure to supply adequate documentation may result in denial.

Coverage decisions remain subject to the member's benefit terms, exclusions, and limitations.
Requests for off‑label indications not addressed in this policy require sufficient documentation per off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53).

Step Therapy

Step Therapy and IL HIM Bypass

Step therapy: For Non‑24-Hour Sleep‑Wake Disorder, prior trial and failure of melatonin and ramelteon is required before approval of tasimelteon unless both are contraindicated or cause clinically significant adverse effects. Illinois HIM requests: step therapy requirements do not apply as of 1/1/2026 per IL HB 5395 (operational bypass applies).

Document trials of melatonin and ramelteon or documentation of contraindication/adverse events.
IL HIM: operational bypass applies — do not enforce step therapy for affected members per state law.

Genetic confirmation requirementDiagnosis of SMS must be confirmed by genetic testing (e.g., deletion 17p11.2 or RAI1 mutation)

Product and age matchingUse Hetlioz capsules for patients ≥ 16 years; use Hetlioz LQ for patients 3–15 years

inv-22: Health Plan — definition describing the plan that adopted this clinical policy and Centene relationship

Health Plan definitionA health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC or its affiliates

Policy purposeProvides guidance on medical necessity to assist coverage decisions and benefit administration

Coverage subject toAll terms, conditions, exclusions, and limitations of the member's coverage documents and applicable state/federal requirements