Prior Authorization : Services Requiring Prior Authorization

Hetlioz and Hetlioz LQ

Hetlioz and Hetlioz LQ require clinical PA.

PA requests for Hetlioz or Hetlioz LQ must be completed, signed, and dated by the prescriber. PA requests for Hetlioz or Hetlioz LQ must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form. Clinical documentation supporting the use of Hetlioz or Hetlioz LQ must be submitted with the PA request.

The PA form must be sent to the pharmacy where the prescription will be filled. The prescriber may send the PA form to the pharmacy, or the member may carry the PA form with the prescription to the pharmacy. The pharmacy provider will use the completed PA form to submit a PA request to ForwardHealth. Prescribers should not submit the PA form to ForwardHealth.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for Hetlioz or Hetlioz LQ may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

For information about general ForwardHealth PA policy for drugs that require PA approval, prescribers and pharmacy providers may refer to the Standard Pharmacy Policy for Covered and Noncovered Drugs topic. Providers may also refer to this topic for information about what may not be considered criteria to support the need for a drug.

Conditions for Which PA Requests for Use of Hetlioz and Hetlioz LQ Will Be Considered for Review

PA requests for Hetlioz or Hetlioz LQ will only be approved for use to treat the following identified clinical conditions:

• Non-24 (Hetlioz PA requests only)
• Nighttime sleep disturbances in SMS (Hetlioz and Hetlioz LQ PA requests)

Clinical Criteria for Hetlioz for Members With Non-24-Hour Sleep-Wake Disorder

Clinical criteria that must be documented for approval of a PA request for Hetlioz for members with Non-24 are all of the following:

• The member's age is consistent with the FDA-approved product labeling for Hetlioz.
• The member has Non-24.
• One of the following is true:
  • The member is totally blind (no light perception in either eye).
  • The member is sighted (has light perception in either eye), and the following documentation has been submitted:
    • The member has a history of insomnia, excessive daytime sleepiness, or both that alternates with time periods of being asymptomatic as the member rotates between alignment and misalignment with the environmental light-dark schedule.
    • The member's symptoms have been present for at least three months.
    • The member's daily sleep logs and actigraphy (for at least 14 days) have been submitted and demonstrate a gradual daily drift (typically later) in rest-activity patterns.
    • The member's symptoms are not better explained by another current sleep, medical, neurologic, mental, or substance abuse disorder or medication use.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Hetlioz. The supporting clinical information and the medical records must document the following:

• The member's medical condition being treated
• Details regarding previous medication use
• The member's current treatment plan

If the clinical criteria for Hetlioz are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for Hetlioz may be approved for up to 365 days. Renewal PA requests for members who have Non-24 must include supporting clinical information and copies of the member's current medical records demonstrating that the member had a significant increase in nighttime total sleep time or a decrease in daytime nap duration compared to the member's baseline prior to the initiation of Hetlioz.

Note: All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Clinical Criteria for Hetlioz and Hetlioz LQ for Members With Nighttime Sleep Disturbances in Smith-Magenis Syndrome

Clinical criteria that must be documented for approval of a PA request for Hetlioz or Hetlioz LQ for members with nighttime sleep disturbances in SMS are all of the following:

• The member's age is consistent with the FDA-approved product labeling for the drug requested.
• The member has nighttime sleep disturbances.
• The member has SMS.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Hetlioz or Hetlioz LQ. The supporting clinical information and the medical records must document the following:

• The member's medical condition being treated
• Details regarding previous medication use
• The member's current treatment plan

If the clinical criteria for Hetlioz or Hetlioz LQ are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for Hetlioz or Hetlioz LQ may be approved for up to 365 days. Renewal PA requests for members who have nighttime sleep disturbances in SMS must include supporting clinical information and copies of the member's current medical records demonstrating that the member had a significant improvement in nighttime sleep quality compared to the member's baseline prior to the initiation of Hetlioz or Hetlioz LQ.

Note: All renewal PA requests require the member to be adherent with the prescribed treatment regimen.