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
- 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
- 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
- Hetlioz Prescribing Information. Vanda Pharmaceuticals, Inc. Washington D.C. December 2020.
- International Classification of Sleep Disorders. 3rd ed. Darien, IL: American academy of sleep medicine; 2014.
- 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.
- Vanda Pharmaceuticals, Inc. About Non-24. Available at: http://www.non-24.com/about-non-24.php. Accessed September 27, 2017.
- 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.
- 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.
- 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.
- 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.
- 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.
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
HEALTHY LIVING