WHA

WAKIX (pitolisant)

Self-Administration - oral tablet

 

Diagnosis considered for coverage:

 

  • Narcolepsy with Cataplexy (i.e., Narcolepsy Type 1): Indicated for the treatment of cataplexy in adult patients with narcolepsy.
  • Narcolepsy without Cataplexy (i.e., Narcolepsy Type 2): Indicated for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy.

 

Coverage Criteria:

 

For diagnosis of narcolepsy with cataplexy (i.e., Narcolepsy Type 1):

  • Diagnosis of narcolepsy as confirmed by sleep study (unless the prescriber provides justification confirming that a sleep study would not be feasible); AND
  • Symptoms of cataplexy are present; AND
  • Symptoms of excessive daytime sleepiness (e.g., irrepressible need to sleep or daytime lapses into sleep) are present; AND
  • Prescribed by or in consultation with one of the following:
    • Neurologist
    • Psychiatrist
    • Sleep Medicine Specialist

 

For diagnosis of narcolepsy without cataplexy (i.e., Narcolepsy Type 2):

  • Diagnosis of narcolepsy as confirmed by sleep study (unless the prescriber provides justification confirming that a sleep study would not be feasible); AND
  • Symptoms of cataplexy are absent; AND
  • Symptoms of excessive daytime sleepiness (e.g., irrepressible need to sleep or daytime lapses into sleep) are present; AND
  • Trial and failure, contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to BOTH of the following:
    • generic modafinil or generic armodafinil
    • Sunosi; AND
  • One of the following:
    • Trial and failure, contraindication, or intolerance to an amphetamine (e.g., amphetamine, dextroamphetamine) or methylphenidate-based stimulant
    • History of or potential for a substance use disorder; AND
  • Prescribed by or in consultation with one of the following:
    • Neurologist
    • Psychiatrist
    • Sleep Medicine Specialist

 

Reauthorization Criteria:

 

For diagnosis of narcolepsy with cataplexy (i.e., Narcolepsy Type 1):

  • One of the following
    • Documentation demonstrating a reduction in the frequency of cataplexy attacks associated with therapy.
    • Documentation demonstrating a reduction in symptoms of excessive daytime sleepiness associated with therapy.

 

For diagnosis of narcolepsy without cataplexy (i.e., Narcolepsy Type 2):

  • Documentation demonstrating a reduction in symptoms of excessive daytime sleepiness associated with therapy.

 

Dosing:

 

For NT1, NT2 (adults):

  • Week 1:  Initiate with a dosage of Wakix 8.9 mg (two 4.45 mg tablets) once daily
  • Week 2:  Increase dosage to Wakix 17.8 mg (one 17.8 mg tablet) once daily
  • Week 3:  May increase to the maximum recommended dosage of Wakix 35.6 mg (two 17.8 mg tablets) once daily

 

Coverage Duration:

 

  • Initial: 6 months
  • Reauthorization: 1 year

 

Authorization is not covered for the following:
  • The following conditions and other uses of this drug for indications not listed in this policy do not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.
    • Concomitant use of Wakix with sodium oxybate-based agents (Xyrem, Xywav, Lumryz), and/or solriamfetol (Sunosi).

 

Additional Information:
  • Narcolepsy is a chronic neurological disorder of hypersomnia and its associated symptoms are potentially debilitating. Narcolepsy is typically classified as type 1 (narcolepsy with cataplexy, NT1) or type 2 (narcolepsy without cataplexy, NT2)
  • Cataplexy is a sudden loss of muscle tone while a person is awake leads to weakness and a loss of voluntary muscle control.
  • Excessive daytime sleepiness (EDS) is present in all patients with narcolepsy. Other symptoms include cataplexy, hypnagogic hallucinations, and sleep paralysis; however, only about one-third of patients have all 4 symptoms.
    • Objective measures of EDS as assessed by sleep latency (ie, the time interval between attempting to fall asleep and the onset of sleep) measured using polysomnography (PSG) include the Maintenance of Wakefulness Test (MWT) and Multiple Sleep Latency Test (MSLT)
    • Subjective measures of EDS include Epworth Sleepiness Scale (ESS), Clinical Global Impression of Change (CGI-C), Clinical Global Impression of Improvement (CGI-I), and Patient Global Impression of Change (PGI-C)
  • Idiopathic hypersomnia (IH) is a rare sleep disorder that is characterized by chronic EDS and often difficulty waking up from nocturnal sleep or daytime naps. The condition is categorized as a central disorder of hypersomnolence. The pathophysiology of IH is not well understood, and diagnosis requires exclusion of other more common causes of excessive sleepiness.
    • International classification of Sleep Disorders (ICSD-3) diagnostic criteria for narcolepsy with cataplexy (narcolepsy type 1):
    • Daily periods of irrepressible need for sleep or daytime lapses into sleep (i.e., excessive daytime sleepiness) for at least 3 months.
    • Presence of one or both of the following: cataplexy and a mean sleep latency of less than or equal to 8 minutes and 2 or more sleep onset REM periods (SOREMPs) on a multiple sleep latency test (MSLT) performed using standard techniques (a SOREMP within 15 minutes of sleep onset on the preceding nocturnal polysomnogram may replace 1 of the SOREMPs on the MSLT); or cerebrospinal fluid (CSF) hypocretin-1 concentration is less than or equal to 110 pg/mL or less than one-third of the mean values obtained in normal subjects with the same standardized assay).
    • Exclusion of alternative causes of chronic daytime sleepiness by history, physical exam, and polysomnography. Other conditions that cause chronic daytime sleepiness include insufficient sleep, untreated sleep apnea, periodic limb movements of sleep, and idiopathic hypersomnia (chronic sleepiness but without SOREMPs or other evidence of abnormal REM sleep). In addition, the effects of sedating medications should be excluded.
  • ICSD-3 diagnostic criteria for narcolepsy without cataplexy (narcolepsy type 2):
    • Daily periods of irrepressible need for sleep or daytime lapses into sleep (i.e., excessive daytime sleepiness) for at least 3 months.
    • Cataplexy is absent
    • CSF hypocretin-1 levels, if measured, is greater than 110 pg/mL or greater than one-third of the mean values obtained in normal subjects with the same standardized assay)
    • A mean sleep latency of less than or equal to 8 minutes and 2 or more SOREMPs on a MSLT performed using standard techniques (a SOREMP within 15 minutes of sleep onset on the preceding nocturnal polysomnogram may replace 1 of the SOREMPs on the MSLT).
    • Exclusion of alternative causes of chronic daytime sleepiness by history, physical exam, and polysomnography. Other conditions that cause chronic daytime sleepiness include insufficient sleep, untreated sleep apnea, periodic limb movements of sleep, and idiopathic hypersomnia (chronic sleepiness but without SOREMPs or other evidence of abnormal REM sleep). In addition, the effects of sedating medications should be excluded.

 

Policy Updates:
  • 02/18/2020 – New policy approved by P&T.
  • 08/17/2021 – Update to criteria
  • 11/14/2023 – Remove requirement for antidepressants for NT1. Remove reference to dose, age, chart notes, and concomitant use from coverage criteria and manage these aspects through other policy sections (e.g., indication, dosing, etc.). (P&T 11/14/23)

 

References:
  1. Wakix Prescribing Information. Harmony Biosciences, LLC, Plymouth Meeting, PA. March 2021.
  2. Sateia MJ. International classification of sleep disorders - third edition: highlights and modifications. CHEST. 2014 Nov;146(5):1387-1394.

Last review date: November 14, 2023