SUNOSI (solriamfetol)

SUNOSI (solriamfetol)

Self-Administration - oral tablet

Diagnosis considered for coverage:

• Narcolepsy: Indicated to improve wakefulness in adults patients with excessive daytime sleepiness associated with narcolepsy.
• Obstructive sleep apnea (OSA): Indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with obstructive sleep apnea (OSA).
  • Limitations of use: Sunosi is not indicated to treat the underlying airway obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure [CPAP]) for at least one month prior to initiating Sunosi for excessive daytime sleepiness. Modalities to treat the underlying airway obstruction should be continued during treatment with Sunosi. Sunosi is not a substitute for these modalities.

Coverage Criteria:

For diagnosis of narcolepsy:

• Diagnosis of narcolepsy as confirmed by sleep study (unless the prescriber provides justification confirming that a sleep study would not be feasible); AND
• Trial and failure, contraindication, or intolerance to one of the following:
  • generic modafinil (Provigil)
  • generic armodafinil (Nuvigil); 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

For diagnosis of obstructive sleep apnea (OSA):

• Diagnosis of OSA is defined by one of the following:
  • Fifteen (15) or more obstructive respiratory events per hour of sleep confirmed by a sleep study (unless the prescriber provides justification confirming that a sleep study would not be feasible)
  • Both of the following:
    • Five (5) or more obstructive respiratory events per hour of sleep confirmed by a sleep study (unless the prescriber provides justification confirming that a sleep study would not be feasible)
    • One of the following signs and symptoms are present:
      • Daytime sleepiness
      • Nonrestorative sleep
      • Fatigue
      • Insomnia
      • Waking up with breath holding, gasping, or choking
      • Habitual snoring noted by a bed partner or other observer
      • Observed apnea
  • Both of the following:
    • Standard treatment(s) for the underlying obstruction (e.g., with continuous positive airway pressure [CPAP], bi-level positive airway pressure [BiPAP]) have been used for one month or longer
    • Patient is fully compliant with ongoing treatment(s) for the underlying airway obstruction; AND
• Trial and failure, contraindication, or intolerance to one of the following:
  • generic modafinil (Provigil)
  • generic armodafinil (Nuvigil)

Reauthorization Criteria:

For diagnosis of narcolepsy:

• Documentation of positive clinical response to therapy.

For diagnosis of OSA:

• Documentation of positive clinical response to therapy; AND
• Patient continues to be fully compliant with ongoing treatment(s) for the underlying airway obstruction (e.g., CPAP, BiPAP)

Dosing:

• For narcolepsy (adults):
  • Administer once daily upon awakening.
  • Starting dose for patients with narcolepsy: 75 mg once daily.
    • Dose may be increased at intervals of at least 3 days.
  • Maximum dose is 150 mg once daily.
• For OSA (adults):
  • Administer once daily upon awakening.
  • Starting dose for patients with OSA: 37.5 mg once daily.
    • Dose may be increased at intervals of at least 3 days.
  • Maximum dose is 150 mg 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 solriamfetol (Sunosi) with sodium oxybate-based agents (Xyrem, Xywav, Lumryz), and/or Wakix (pitolisant).

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)
• 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.
• Sunosi is contraindicated in patients receiving concomitant treatment with monoamine oxidase inhibitors (MAOI) or within 14 days after discontinuation of MAOI because of the risk of hypertensive reaction.

Policy Updates:

• 10/15/2019 – New policy approved by P&T.
• 11/14/2023 – Remove requirement for specialist consultation. Update requirement for diagnosis of narcolepsy and OSA using a sleep study. 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.). Add reauthorization requirements for narcolepsy and OSA. Update coverage duration for initial authorization to 6 months. (P&T 11/14/2023)

References:

1. Sunosi Prescribing Information. Jazz Pharmaceuticals, Inc. Palo Alto, CA. October 2021.
2. Sateia MJ. International classification of sleep disorders - third edition: highlights and modifications. CHEST. 2014 Nov;146(5):1387-1394.