CurrentmeridianPolicy MDN.CP.PMN.104

Tasimelteon (Hetlioz) therapy coverage

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Defines Medicaid coverage criteria, dosing, and authorization requirements for tasimelteon (Hetlioz and Hetlioz LQ) for non-24-hour sleep-wake disorder and nighttime sleep disturbances in Smith-Magenis Syndrome.

Policy Summary

Payermeridian

PolicyTasimelteon (Hetlioz) therapy coverage

Policy CodePolicy MDN.CP.PMN.104

Change TypeNo material change

Effective DateMar 1, 2024

Last ReviewJan 27, 2025

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) showing the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA-approved indications covered

12 mostandard approval duration (Medicaid)

20 mg/daymaximum Hetlioz adult dose

3-15 yrsHetlioz LQ pediatric range

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CurrentmeridianPolicy MDN.CP.PMN.104

Tasimelteon (Hetlioz) therapy coverage

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Policy Summary

Payermeridian

PolicyTasimelteon (Hetlioz) therapy coverage

Policy CodePolicy MDN.CP.PMN.104

Change TypeNo material change

Effective DateMar 1, 2024

Last ReviewJan 27, 2025

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) showing the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA-approved indications covered

12 mostandard approval duration (Medicaid)

20 mg/daymaximum Hetlioz adult dose

3-15 yrsHetlioz LQ pediatric range

Initial Approval — Non-24-Hour Sleep-Wake Disorder

Covered when ALL of the following are met

Non-24 initial criteria: 1. Diagnosis of non-24-hour sleep-wake disorder; 2. Request is for Hetlioz capsules; 3. Age ≥ 18 years; 4. Prescribed by or in consultation with a specialist in sleep disorders; 5. Member has total blindness (e.g., nonfunctioning retinas); 6. Member is unable to perceive light in both eyes; 7. If request is for brand Hetlioz capsules, member must use generic tasimelteon capsules unless contraindicated or clinically significant adverse events are experienced;dose ≤ 20 mg/day

Approval duration: Medicaid - 12 months

Initial Approval — Nighttime Sleep Disturbances in Smith-Magenis Syndrome (SMS)

Covered when ALL of the following are met

SMS initial criteria: 1. Diagnosis of Smith‑Magenis syndrome (SMS) with confirmation by genetic testing (e.g., deletion 17p11.2 or RAI1 mutation); 2. Prescribed by or in consultation with a specialist in sleep disorders; 3. One of the following: (a) request is for Hetlioz capsules and member is ≥ 16 years old; (b) request is for Hetlioz LQ and member is 3 to 15 years of age; 4. Request is for treatment of nighttime sleep disturbances; 5. If request is for brand Hetlioz capsules, member must use generic tasimelteon capsules unless contraindicated or clinically significant adverse events are experienced; 6. Dose does not exceed formulation-specific maximums (a. Hetlioz: 20 mg/day; b. Hetlioz LQ: 0.7 mg/kg/day if weight ≤ 28 kg, or 20 mg/day if weight > 28 kg).age and dosing per formulation

Approval duration: Medicaid - 12 months

Continued Therapy — All FDA-Approved Indications

Continued coverage when ALL of the following are met

Continued therapy criteria: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or has previously met initial approval criteria; (b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy (increase in nighttime sleep, decrease in daytime nap time, improvement in sleep quality); 3. If request is for a dose increase, the new dose does not exceed formulation-specific maximums (Hetlioz: 20 mg/day; Hetlioz LQ: 0.7 mg/kg/day if weight ≤ 28 kg or 20 mg/day if weight > 28 kg).response to therapy and dose limits

Approval duration: Medicaid - 12 months

Other Indications

If the requested use is not specified in initial or continued criteria

Other/label-change handling: 1. If the drug has had a label change within the last 6 months not yet reflected in this policy, follow the referenced formulary or non‑formulary policies for the relevant line of business as listed (see policy references); 2. If the requested use is not listed under section III (Diagnoses/Indications for which coverage is NOT authorized) and no recent label change applies, refer to the off‑label use policy for the relevant line of business (refer to the specified policy numbers).refer to specified policies

See CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53 as applicable.

Coverage is not authorized for non‑FDA approved indications that are not specifically addressed in this policy unless the request includes sufficient documentation of efficacy and safety per the applicable off‑label use policies (for example, CP.PMN.53 for Medicaid) or the member’s evidence of coverage documents. Providers requesting coverage for off‑label uses must submit clinical evidence and rationale consistent with the referenced off‑label policies.

For members enrolled in Medicaid, state Medicaid coverage provisions take precedence when they conflict with the provisions of this clinical policy; refer to the applicable state Medicaid manual for any differing coverage rules. For Health Insurance Marketplace members, this policy applies only when the prescribed agent is on the health plan’s approved formulary; non‑formulary requests must be reviewed under the formulary exception policy.

Prior Authorization and Provider Requirements

Prior Authorization

Prior authorization required with specialist involvement

Prior authorization requires documentation that the member meets all approval criteria described for the relevant indication; prescriber should be or consult a specialist in sleep disorders.

Submit evidence that all indication-specific criteria are met (diagnosis, age, formulation, blindness or genetic confirmation as applicable).
Prescriber must be a sleep disorders specialist or document consultation with one.

Note

Marketplace formulary requirement

For Health Insurance Marketplace members, this policy applies only when the prescribed agent is on the health plan approved formulary; non‑formulary requests must be reviewed under the formulary exception policy.

Verify the prescribed formulation is on the member's health plan formulary before submitting a PA.

Step Therapy

Generic substitution required before brand Hetlioz

If requesting brand Hetlioz capsules, the member must have used generic tasimelteon capsules first unless contraindicated or clinically significant adverse events occurred.

Document prior use of generic tasimelteon or document contraindication or intolerance to generic therapy when requesting brand Hetlioz.

Note

Documentation Required

Submit supporting clinical documentation with PA

Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria, including diagnosis, specialist consultation, and genetic test results for SMS where applicable.

For non-24: documentation of diagnosis, total blindness and inability to perceive light in both eyes, age, and specialist involvement.
For SMS: genetic testing confirming SMS (e.g., 17p11.2 deletion or RAI1 mutation) and age/formulation eligibility.
Include dosing information confirming dose does not exceed formulation-specific maximums.

Note

Coverage subject to plan documents and admin policies

Coverage decisions are subject to the member's coverage documents and applicable administrative policies and procedures; this policy is a guide to medical necessity and not a guarantee of payment.

Confirm benefits, exclusions, and limitations in the member's evidence of coverage or state Medicaid manual as applicable.

Denial Risk

Non‑24 requests must be for capsules and document total blindness

Requests for Hetlioz for non‑24 must be for the capsule formulation; absence of documentation showing total blindness or inability to perceive light in both eyes will not meet criteria.

Provide documentation that the member has total blindness (e.g., nonfunctioning retinas) and cannot perceive light in both eyes when requesting Hetlioz for non‑24.
Ensure the request is specifically for the capsule formulation for non‑24 patients.

Documentation Required

Genetic confirmation required for SMS requests

Requests for SMS must include genetic testing confirming Smith‑Magenis Syndrome (for example, 17p11.2 deletion or RAI1 mutation).

Attach genetic test results that confirm SMS when requesting therapy for nighttime sleep disturbances in SMS.

Note

State Medicaid provisions take precedence

When state Medicaid coverage provisions conflict with this clinical policy, state Medicaid coverage provisions take precedence; refer to the state Medicaid manual for specific coverage provisions.

For Medicaid members, check the state Medicaid manual and applicable state provisions before relying solely on this policy.

Definitions and References

inv-19: Non-24-hour sleep-wake disorder (non-24) — An intrinsic circadian rhythm sleep-wake disorder treated with tasimelteon in adults.

DefinitionAn intrinsic circadian rhythm sleep-wake disorder treated with tasimelteon in adults.

FDA-approved treatment formulationHetlioz (capsules) and generic tasimelteon for adults

Typical dosing20 mg PO once daily, one hour before bedtime

inv-20: Smith-Magenis Syndrome (SMS) nighttime sleep disturbances — Sleep disturbance associated with SMS; treatment with Hetlioz is indicated for patients ≥16 years and Hetlioz LQ for ages 3-15 with confi...

Condition descriptionNighttime sleep disturbances associated with Smith-Magenis Syndrome (SMS).

Age and formulation-specific indicationHetlioz indicated for patients ≥16 years; Hetlioz LQ indicated for pediatric patients 3 to 15 years

Requirement for genetic confirmationDiagnosis of SMS must be confirmed by genetic testing (e.g., 17p11.2 deletion or RAI1 mutation)

inv-21: Hetlioz Prescribing Information (Vanda Pharmaceuticals Inc.; January 2024)

Reference titleHetlioz Prescribing Information (Vanda Pharmaceuticals Inc.; January 2024)

Source availabilityAvailable at www.hetlioz.com; cited in Meridian policy references

Use in policyReferenced as the prescribing information supporting dosing and indications

Tasimelteon (Hetlioz) therapy coverage

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Tasimelteon (Hetlioz) therapy coverage

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Coverage Criteria for Tasimelteon (Hetlioz / Hetlioz LQ)

Dosing Limits and Product Information

Prior Authorization and Provider Requirements

Background and Drug Information

Definitions and References