CurrentUnitedHealthcarePolicy N/A

Hetlioz (tasimelteon) and Hetlioz LQ prior authorization

Form captures prescriber and beneficiary information and documents medical necessity criteria for initiating or reauthorizing Hetlioz (tasimelteon) or Hetlioz LQ for Non-24 sleep-wake disorder or nighttime sleep disturbances in Smith-Magenis Syndrome; intended for providers requesting coverage. Affects beneficiaries and prescribing providers interacting with UnitedHealthcare pharmacy prior authorization.

Policy Summary

PayerUnitedHealthcare

PolicyHetlioz (tasimelteon) and Hetlioz LQ prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete the Hetlioz/Hetlioz LQ questionnaire and document prior trials of ≥2 other sleep medications plus objective improvement evidence for reauthorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12questionnaire items

>=18adult minimum age

3 monthsinitial continuous use

2prior medication trials

Coverage criteria for Hetlioz (tasimelteon) and Hetlioz LQ

Policy Summary

PayerUnitedHealthcare

PolicyHetlioz (tasimelteon) and Hetlioz LQ prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete the Hetlioz/Hetlioz LQ questionnaire and document prior trials of ≥2 other sleep medications plus objective improvement evidence for reauthorization.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

inv-01: Initial Authorization — Covered when ALL of the following are met for an initial request

Covered when ALL of the following are met for an initial request:

Initial Authorization Criteria: 1) Beneficiary meets age criterion per product (Hetlioz: >=18 years; Hetlioz LQ: 3-15 years). 2) Documented diagnosis of Non-24 sleep-wake disorder or nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) as applicable. 3) Diagnostic confirmation for Non-24 by at least one physiologic circadian phase marker OR, if such assessment cannot be done, by actigraphy performed for >=1 week plus sleep logs recorded for >=1 month. 4) Provider documents insufficient response or intolerance to at least two (2) other medications for sleep (can be OTC or prescription). 5) Medication is prescribed by or in consultation with a physician who specializes in the treatment of sleep disorders.see node text

All items must be documented on the form.

inv-02: Reauthorization — Reauthorization covered when ALL of the following are met

Reauthorization covered when ALL of the following are met:

Reauthorization Criteria: 1) Beneficiary used Hetlioz/Hetlioz LQ continuously without gaps in treatment for the initial approval period of three (3) months. 2) An objective evaluation of the beneficiary's sleep quality is included showing improvement in overall sleep quality while taking Hetlioz/Hetlioz LQ (documentation of improvement must accompany the reauthorization). 3) Prescriber signature and required documentation accompany the request.3 months continuous use

Documentation of improvement and prescriber signature are mandatory.

For reauthorization, the form requires evidence of both continued use and clinical benefit. Specifically, the beneficiary must have used Hetlioz/Hetlioz LQ continuously without gaps for the initial 3‑month approval period, and the provider must include an objective evaluation showing improvement in overall sleep quality. Reauthorization requests that lack documentation of continuous use during the first 3 months or that do not include objective improvement documentation may be denied; the prescriber’s signature is also mandatory.

Initial therapy coverage conditions

inv-13: Initial Therapy — Initial therapy coverage conditions (use nested ALL/ANY logic as in form)

Initial therapy coverage conditions:

Initial therapy: 1) Age appropriate for the product (Hetlioz: >=18 years; Hetlioz LQ: 3-15 years). 2) Documented diagnosis applicable to the product (Non-24 sleep-wake disorder for Hetlioz; nighttime sleep disturbances in SMS for Hetlioz LQ). 3) Diagnostic confirmation for Non-24 by at least one physiologic circadian phase marker OR, if not feasible, actigraphy >=1 week plus sleep logs >=1 month. 4) Failure or intolerance to >=2 other sleep medications (OTC or prescription). 5) Medication prescribed by or in consultation with a sleep specialist.

Provider specialty/consultation should be documented on the form.

Reauthorization and continuation requirements

inv-14: Reauthorization / Continuation — Reauthorization requirements for continued coverage

Reauthorization requirements for continued coverage:

Continuation therapy: Continuous use without gaps for the initial 3-month approval period PLUS objective documentation of improvement in overall sleep quality while taking Hetlioz/Hetlioz LQ must be provided. Prescriber signature and accompanying documentation are required.3 months

Lack of documentation of improvement or continuous use may result in denial.

Provider actions, documentation, and administrative requirements

Prior Authorization

Prior authorization required

Prior authorization is required for Hetlioz / Hetlioz LQ. The completed questionnaire must document beneficiary age and diagnosis criteria, and include diagnostic confirmation as indicated (physiologic circadian phase marker or actigraphy plus sleep logs).

Complete beneficiary identifying information (name, DOB, ID#).
Complete prescriber information (NPI, contact name, phone, fax).
Drug details: name, strength, quantity per 30 days, and requested length of therapy (initial or re-authorization interval).
Hetlioz-specific diagnostic confirmation: either assessment of a physiologic circadian phase marker (e.g., urinary melatonin, dim light melatonin onset, core body temperature) OR actigraphy for ≥1 week plus sleep logs for ≥1 month when physiologic markers cannot be performed.

Prior Authorization

Prior medication trials required

Document prior medication trials: the questionnaire must confirm insufficient response or intolerance to at least two other sleep medications (which may include over-the-counter or prescription agents).

Question 9 on the form: record trials/intolerance of ≥2 other sleep medications.

Documentation Required

Reauthorization documentation required

Reauthorization requires documentation of continuous use and objective evidence of improvement in sleep quality. Submit objective evaluation data with the reauthorization request.

Confirm continuous use of Hetlioz/Hetlioz LQ without gaps during the initial 3-month approval period (Question 11).
Include an objective evaluation of sleep quality demonstrating overall improvement while taking the medication (Question 12).
Attach supporting documentation (e.g., validated sleep questionnaires, actigraphy summaries, sleep logs, clinician assessment).

Denial Risk

Denial risk for incomplete documentation

Lack of required documentation (age/diagnosis confirmation, prior medication trials, continuous use, or objective improvement) may result in denial of the prior authorization. Prescriber signature is mandatory on the form.

Missing prescriber signature or missing objective improvement data risks denial.
Ensure all questionnaire items (Questions 1–12 as applicable) are completed and supporting documentation is attached.

Diagnostic definitions and confirmation criteria

Diagnostic confirmation of Non-24

Required diagnostic confirmation for Non-24Confirmed by assessment of at least one physiologic circadian phase marker (e.g., urinary melatonin levels, dim light melatonin onset measured in blood or saliva, or core body temperature)

Alternative confirmation methodIf physiologic marker assessment cannot be done, diagnosis must be confirmed by actigraphy performed for >=1 week plus sleep logs recorded for >=1 month

Applicable diagnosis question on formForm asks whether beneficiary has a documented diagnosis of Non-24 sleep-wake disorder

Prior Medication Trial	Documented on Form
Insufficient response or intolerance to at least two (2) other medications for sleep (OTC or prescription)	Yes / No (question 9 on the form)
Prescriber specialty or consultation regarding sleep disorder	Yes / No (question 10 on the form)

Quantity per 30 days and allowable therapy durations

Quantity limits (per 30 days)

Quantity per 30 daysAs specified on the form under 'Quantity Per 30 Days'

Form field locationDrug Information section item 10 requests 'Quantity Per 30 Days'

Provider must supplyCompleted beneficiary/prescriber drug details including quantity per 30 days must be provided on the form

Length of therapy options

Initial length of therapy optionsUp to 30 days; up to 60 days; up to 90 days

Reauthorization length optionsUp to 30 days; up to 60 days; up to 90 days; up to 120 days; up to 180 days

Form field location for lengthDrug Information section item 11 lists initial and re-authorization length checkboxes

Background and purpose of the form

The Hetlioz/Hetlioz LQ prior authorization questionnaire is the required form to evaluate medical necessity for these therapies. It captures beneficiary age and diagnosis (Non‑24 or SMS), the method used to confirm Non‑24 (physiologic circadian phase marker or, if not feasible, actigraphy ≥1 week plus sleep logs ≥1 month), prior medication trial history, and reauthorization evidence of continuous use and objective improvement. Providers must complete the relevant Hetlioz (questions 1–6) or Hetlioz LQ (questions 7–8) sections and include the reauthorization items (questions 11–12) when applicable; prescriber signature is required.

OpenPayer