CurrentColorado Rocky Mountain Health PlansPolicy N/A

Prior Authorization/Notification − Hetlioz (tasimelteon) and Hetlioz LQ

Prior authorization and notification requirements for tasimelteon (Hetlioz, Hetlioz LQ) for treatment of Non-24-Hour Sleep-Wake Disorder and nighttime sleep disturbances in Smith-Magenis Syndrome; applies to pharmacy benefit management for the payer's members.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPrior Authorization/Notification − Hetlioz (tasimelteon) and Hetlioz LQ

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization for Hetlioz or Hetlioz LQ; approvals are issued for up to 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

2covered indications listed

ages 3+pediatric range (Hetlioz LQ SMS)

2025 P 1130-13program id

Coverage Criteria for Tasimelteon (Hetlioz, Hetlioz LQ)

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Coverage criteria

Hetlioz or Hetlioz LQ will be approved based on one of the following criteria:

Approved indications: 1) Diagnosis of non-24-hour sleep-wake disorder OR 2) Diagnosis of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS)N/A

Authorization will be issued for 12 months.

Authorization duration: Authorization will be issued for 12 months.12 months

State mandates, federal requirements, and member-specific benefit plan coverage may impact coverage.

Coverage is subject to state mandates and the member's specific benefit plan. Other payer policies, utilization management programs, federal regulatory requirements, and supply limits or medical necessity determinations may also affect coverage determinations. These factors can modify how the criteria in this policy are applied and do not create additional guarantees of coverage.

Initial Therapy

Initial therapy

Initial approval criteria

Initial indication: Member has a diagnosis of non-24-hour sleep-wake disorder OR member has a diagnosis of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS).N/A

No additional clinical prerequisites or prior medication failures are specified in this document; authorization will be issued for 12 months.

Continuation and Re-authorization Criteria

Continuation therapy

Re-authorization and continuation

Re-authorization: Authorizations may be renewed for up to 12 months.12 months

Re-authorization may be based on prior claim/medication history, diagnosis codes, and/or automated claim logic; use of automated approval/re-approval varies by program and state mandates or member benefit plans may apply.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization/notification is required for Hetlioz (tasimelteon) and Hetlioz LQ; approvals are issued for up to 12 months when criteria are met.

Approved indications: diagnosis of non-24-hour sleep‑wake disorder OR nighttime sleep disturbances in Smith‑Magenis syndrome (SMS).
Authorizations may be granted for up to 12 months.

Step Therapy

No step therapy requirements are specified in this document.

Documentation Required

Supporting Documentation and Automated Review

Authorization and re-authorization may be based on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic; supplemental documentation may be requested. Supply limits and medical necessity rules may apply.

Automated approval/re-approval processes may be used.
Supplemental clinical documentation may be requested when automated review is insufficient.

Denial Risk

Denial Conditions

Claims for tasimelteon will be denied if the member does not have an appropriate diagnosis (e.g., lacks non-24‑hour sleep‑wake disorder or SMS nighttime sleep disturbances). State mandates and member-specific benefit plan coverage may further affect denial decisions.

Denial if diagnosis is not one of the approved indications.
Federal or state regulatory requirements and the member's specific benefit plan may also impact coverage.

Step therapy requirement	Policy statement
No step therapy required	No step therapy requirements are specified in this policy; prior authorization and other utilization management rules may still apply (see authorization rules).

Background

Tasimelteon is a melatonin receptor agonist indicated for treatment of Non-24-Hour Sleep-Wake Disorder in adults and for nighttime sleep disturbances in Smith-Magenis Syndrome (SMS). The policy covers both Hetlioz (tasimelteon) and the oral suspension formulation Hetlioz LQ where indicated. For SMS, product labeling distinguishes age ranges: Hetlioz is indicated for patients aged 16 years and older, while Hetlioz LQ is indicated for younger patients beginning at age 3.