HETLIOZ/HETLIOZ LQ (tasimelton) 

Self Administration - Oral

Indications for Prior Authorization:
  • Hetlioz capsule
    • Non-24-Hour Sleep-Wake Disorder (N24SWD) - Indicated for the treatment of N24SWD.
    • Smith-Magenis Syndrome (SMS) - Indicated for the treatment of nighttime sleep disturbances in SMS in patients 16 years of age and older.
  • Hetlioz LQ suspension
    • Smith-Magenis Syndrome (SMS) - Indicated for the treatment of nighttime sleep disturbances in SMS in pediatric patients 3 to 15 years of age.
Coverage Criteria:

For treatment of Non-24-Hour Sleep-Wake Disorder (N24SWD) (also known as non-24, free-running disorder, free-running or non-entrained type circadian rhythm sleep disorder, or hypernychthemeral syndrome):

  • Dose does not exceed 20 mg capsule once daily; AND
  • Patient is 18 years of age or older; AND
  • Prescribed by or in consultation with a specialist in sleep disorders; AND
  • Patient is totally blind and has no light perception; AND
  • Medical record confirms the patient has an inability to maintain a stable sleep-wake pattern synchronized to a 24-hour schedule; AND
  • Medical record confirms symptoms of insomnia are causing functional impairment (i.e., excessive daytime drowsiness, reduced daytime activity, etc.).

For treatment of Smith-Magenis Syndrome (SMS):

  • One of the following:
    • For patient is 3 to 15 years of age: Dose of suspension does not exceed 0.7 mg/kg once daily for patients weighing 28 kg (61.7 lbs) or less OR 20 mg once daily for patients weighing more than 28 kg; OR
    • For patients aged 16 years of age and older: dose does not exceed 20 mg capsule once daily; AND
  • Prescribed by or in consultation with a specialist in sleep disorders; AND
  • Medical record confirms a clinical diagnosis of SMS; AND
  • Patient is experiencing nighttime sleep disturbances (i.e., difficulty falling asleep, frequent nighttime waking, early waking, etc.).
Reauthorization Criteria:

For continued treatment of N24SWD or SMS (Hetlioz or Hetlioz LQ):

  • Dose does not exceed FDA label maximum; AND
  • Documentation of positive clinical response to therapy (i.e., improvement in nighttime total sleep time compared to baseline, improvement in nighttime sleep quality).
Coverage Duration:
  • Initial: up to 6 months
  • Reauthorization: up to 12 months
Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:
  • Hetlioz or Hetlioz LQ should be taken 1 hour prior to bedtime at the same time daily.
  • The International Classification of Sleep Disorders defines N24SWD 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.
  • Individuals with N24SWD are unable to maintain appropriate alignment with the 24-hour environment, so each day their sleep-wake patterns shift (typically later) with respect to external time.
  • Due to the cyclical nature of the N24SWD, some affected persons will tend to feel normal for periods of days to weeks when their body’s rhythm is synchronized with the rhythm of society around them.
  • SMS is a genetic disorder resulting from chromosome 17p11.2 microdeletions and is characterized by numerous congenital anomalies and intellectual disabilities.
  • SMS results in an inversion of the typical secretion of melatonin and altered regulation of circadian gene expression, which results in frequent nocturnal arousals, early morning awakenings, and daytime sleep attacks. Sleep problems in patients with SMS typically present in infancy and persist throughout adulthood. Administration of melatonin in the morning may be helpful, although the mechanism for this paradoxical effect is unclear.
  • SMS is characterized by brachycephaly, midface hypoplasia, prognathism, hoarse voice, speech delay with or without hearing loss, psychomotor and growth retardation, cutaneous features, and behavior problems.
  • In the clinical trial, although improvement in the amount of sleep obtained on the 50% of nights with least sleep favored Hetlioz, the difference compared with placebo was not statistically significant. However, there was a statistically significant improvement in the 50% worst nights’ sleep quality with Hetlioz compared to placebo. With the small sample size, there remains uncertainty about the clinical effects in children with SMS.
Policy Updates:
  • 08/17/2021 – Updated criteria created for existing drug with new oral suspension formulation; approved by P&T.
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: http://sleepfoundation.org/non-24/facts_prevalence.html. Accessed September 27, 2017.
  • 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.

 

 

 

Last review date: August 17, 2021