WHA

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

  • Guideline ID
    GL-148293

  • Formulary
    EHB

  • Effective date
    Sep 1, 2024

  • P&T approval date
    Apr 8, 2014

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

  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.
  1. The International Classification of Sleep Disorders (an official publication of the American Academy of Sleep Medicine) defines non-24-hour sleep-wake disorder as a circadian rhythm sleep disorder characterized by complaints of insomnia or excessive sleepiness related to abnormal synchronization between the 24-hour light-dark cycle and the endogenous circadian rhythms of sleep and wake propensity, for a duration of 3 months. [2] Patients with non-24 experience a chronic steady pattern comprising 1- to 2-hour daily delays in sleep onset and wake times. As incremental phase delays in sleep occur, the complaint will consist of difficulty initiating sleep at night coupled with oversleeping into the daytime hours or inability to remain awake in the daytime. Therefore, over long periods of time, patients alternate between being symptomatic and asymptomatic, depending on the degree of synchrony between their internal biologic rhythm and the 24-hour world. [2] The condition is very rare in normally sighted people, but quite common in the totally blind who have no access to the entraining effects of the light-dark cycle. [3] Of the estimated 1.3 million legally blind individuals in the United States, approximately 130,000 have no light perception. Epidemiologic studies have found that as many as 70% of this totally blind sub-population suffer from non-24. [4] Non-24 is considered a chronic condition and markedly decreases the quality of life for patients. To varying extents, individuals with non-24 are unable to function in scheduled social activities or hold conventional jobs. [2, 4]
  2. Hetlioz was approved on the basis of two pivotal, randomized, double-masked, placebo-controlled, multicenter, parallel-group studies in totally blind patients with non-24-hour sleep-wake disorder. [1, 7] The Safety and Efficacy of Tasimelteon (SET) Trial [1,7] was conducted in 84 totally blind patients with non-24, aged 21-84 years. Subjects received either Hetlioz 20 mg or placebo, one hour prior to bedtime, at the same time every night for up to 6 months. The Randomized-withdrawal study of the Efficacy and Safety of Tasimelteon to treat non-24 (RESET) Trial [1,8] was conducted in 20 entrained totally blind patients with non-24, aged 28-70 years. Subjects were treated for approximately 12 weeks with Hetlioz 20 mg one hour prior to bedtime, at the same time every night. Patients in whom the calculated time of peak melatonin level (melatonin acrophase) occurred at approximately the same time of day (in contrast to the expected daily delay) during the run-in phase were randomized to receive placebo or continue treatment with Hetlioz 20 mg for 8 weeks.
  3. Given the wide range of available dosing regimens for melatonin, the variability in response time to treatment with tasimelteon and melatonin, and the need for consistent monitoring and evaluation of patients' sleep-related symptoms, tasimelteon must be prescribed by or in consultation with a specialist in sleep disorders. [3]
  • 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