Pharmacy Prior Authorization Criteria

Hetlioz, Hetlioz LQ (tasimelteon) - PA, NF

Indications for Prior Authorization

Hetlioz (tasimelteon) capsule

• For diagnosis of Non-24-Hour Sleep-Wake Disorder (Non-24)
  Indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in adults.

• For diagnosis of Smith-Magenis Syndrome (SMS)
  Indicated for the treatment of nighttime sleep disturbances in SMS in patients 16 years of age and older.

Hetlioz LQ (tasimelteon) suspension

• For diagnosis of Smith-Magenis Syndrome (SMS)
  Indicated for the treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in pediatric patients 3 to 15 years of age.

Criteria

Brand Hetlioz capsule, generic tasimelteon capsule

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Non-24-Hour Sleep-Wake Disorder (Non-24)

• Diagnosis of non-24-hour sleep-wake disorder (also known as free-running disorder, free-running or non-entrained type circadian rhythm sleep disorder, or hypernychthemeral syndrome) [2, 5-6, A]
AND
• Patient is totally blind (has no light perception) [2-8, B]
AND
• Trial and failure, contraindication, or intolerance to generic tasimelteon (Applies to Brand only)
AND
• Prescribed by or in consultation with one of the following:
• Specialist in sleep disorders
• Neurologist

Brand Hetlioz capsule, generic tasimelteon capsule

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Non-24-Hour Sleep-Wake Disorder (Non-24)

• Patient demonstrates positive clinical response to therapy

Brand Hetlioz capsule, generic tasimelteon capsule

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Smith-Magenis Syndrome (SMS)

• Diagnosis of Smith-Magenis Syndrome (SMS)
AND
• Patient is 16 years of age or older
AND
• Patient is experiencing nighttime sleep disturbances (i.e., difficulty falling asleep, frequent nighttime waking and early waking)
AND
• Trial and failure, contraindication, or intolerance to generic tasimelteon (Applies to Brand only)
AND
• Prescribed by or in consultation with one of the following:
• Specialist in sleep disorders
• Neurologist

Hetlioz LQ suspension

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Smith-Magenis Syndrome (SMS)

• Diagnosis of Smith-Magenis Syndrome (SMS)
AND
• Patient is 3 through 15 years of age
AND
• Patient is experiencing nighttime sleep disturbances (i.e., difficulty falling asleep, frequent nighttime waking and early waking)
AND
• Prescribed by or in consultation with one of the following:
• Specialist in sleep disorders
• Neurologist

Brand Hetlioz capsule, generic tasimelteon capsule, Hetlioz LQ suspension

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Smith-Magenis Syndrome (SMS)

• Patient demonstrates positive clinical response to therapy (i.e., improvement in nighttime total sleep time, improvement in nighttime sleep quality)

Hetlioz capsule

Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Non-24-Hour Sleep-Wake Disorder (Non-24)

• Submission of medical records (e.g., chart notes) confirming diagnosis of non-24-hour sleep-wake disorder (also known as free-running disorder, free-running or non-entrained type circadian rhythm sleep disorder, or hypernychthemeral syndrome) [2, 5-6, A]
AND
• Patient is totally blind (has no light perception) [2-8, B]
AND
• Submission of medical records (e.g., chart notes) confirming all of the following (Applies to Brand only):
• Patient has experienced intolerance (e.g., allergy to excipient) with generic tasimelteon
• Generic tasimelteon has not been effective
• Justification or rationale explaining how Brand Hetlioz capsule is expected to provide benefit when generic tasimelteon has not been shown to be effective despite having the same active ingredient
AND
• Prescribed by or in consultation with one of the following:
• Specialist in sleep disorders
• Neurologist

Hetlioz capsule

Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Smith-Magenis Syndrome (SMS)

• Submission of medical records (e.g., chart notes) confirming diagnosis of Smith-Magenis Syndrome (SMS)
AND
• Patient is 16 years of age or older
AND
• Submission of medical records (e.g., chart notes) confirming patient is experiencing nighttime sleep disturbances (i.e., difficulty falling asleep, frequent nighttime waking and early waking)
AND
• Submission of medical records (e.g., chart notes) confirming all of the following (Applies to Brand only):
• Patient has experienced intolerance (e.g., allergy to excipient) with generic tasimelteon
• Generic tasimelteon has not been effective
• Justification or rationale explaining how Brand Hetlioz capsule is expected to provide benefit when generic tasimelteon has not been shown to be effective despite having the same active ingredient
AND
• Prescribed by or in consultation with one of the following:
• Specialist in sleep disorders
• Neurologist

Hetlioz LQ suspension

Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Smith-Magenis Syndrome (SMS)

• Submission of medical records (e.g., chart notes) confirming diagnosis of Smith-Magenis Syndrome (SMS)
AND
• Patient is 3 through 15 years of age
AND
• Submission of medical records (e.g., chart notes) confirming patient is experiencing nighttime sleep disturbances (i.e., difficulty falling asleep, frequent nighttime waking and early waking)
AND
• Prescribed by or in consultation with one of the following:
• Specialist in sleep disorders
• Neurologist

P & T Revisions

2024-06-07, 2023-10-03, 2023-06-19, 2023-01-21, 2022-06-16, 2021-08-05, 2021-06-17, 2021-05-25, 2021-03-22, 2021-02-05, 2020-08-25, 2019-09-05

References

1. Hetlioz Prescribing Information. Vanda Pharmaceuticals, Inc. Washington D.C. December 2020.
2. International Classification of Sleep Disorders. 3rd ed. Darien, IL: American academy of sleep medicine; 2014.
3. Sack RL, Auckley D, Auger RR, et al. Circadian rhythm sleep disorders: Part II, advanced sleep phase disorder, delayed sleep phase disorder, free-running disorder, and irregular sleep-wake rhythm. Sleep 2007;30(11):1484-1501.
4. Vanda Pharmaceuticals, Inc. About Non-24. Available at: http://www.non-24.com/about-non-24.php. Accessed September 27, 2017.
5. National Sleep Foundation. Non-24-hour Sleep Wake Disorder Facts and Prevalence. Available at: https://www.sleepfoundation.org/non-24-sleep-wake-disorder/treatment-care. May 13, 2022. Accessed June 16, 2022.
6. Circadian Sleep Disorders Network. Non-24-Hour Sleep-Wake Disorder Questions and Answers. Available at: http://www.circadiansleepdisorders.org/docs/N24-QandA.php. Accessed September 27, 2017.
7. Lockley SW, Dressman MA, Xiao C, et al. Tasimelteon treatment entrains the circadian clock and demonstrates a clinically meaningful benefit in totally blind individuals with non-24-hour circadian rhythms [Poster abstract no. FP26-6]. 95th Annual Meeting of the Endocrine Society; 15-18 Jun 2013; San Francisco, CA.
8. Lockley SW, Dressman MA, Xiao C, Licamele L, Polymeropoulos MH. RESET study demonstrates that tasimelteon maintains entrainment of melatonin and cortisol in totally blind individuals with non-24-hour circadian rhythms [Poster abstract no. SUN-137]. 95th Annual Meeting of the Endocrine Society; 15-18 Jun 2013; San Francisco, CA.
9. National Organization for Rare Disorders. Non-24-Hour Sleep-Wake Disorder Available at: https://rarediseases.org/rare-diseases/non-24-hour-sleep-wake-disorder/Accessed June 16, 2022.

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Revision History

• 2024-06-07: 2024 Annual Review
• 2023-10-03: Program update to standard reauthorization language. No changes to clinical intent
• 2023-06-19: 2023 Annual Review.
• 2023-01-21: update guideline
• 2022-06-16: 2022 Annual Review.
• 2021-08-05: 2021 Annual Review
• 2021-06-17: Added neurologist as an additional specialist option for Smith-Magenis Syndrome criteria for both Hetlioz and Hetlioz LQ.
• 2021-05-25: Addition of EHB formulary. No changes to criteria
• 2021-03-22: updated guideline to add GPI for Hetlioz LQ (GPI 60250070001820)as it has launched. Criteria was approved at Feb P&T, no criteria changes with GPI addition.
• 2021-02-05: updated guideline for expanded indication for Hetlioz capsule and new criteria for new Hetlioz LQ formulation.
• 2020-08-25: 2020 Annual Review: updated references only
• 2019-09-05: Guideline updated

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