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MP 5.01.112 Use of Sodium Oxybate (Xyrem®)

Medical Policy    

Section
Prescription Drug

Original Policy Date
05/2013

Last Review Status/Date
Created with literature search/5:2013

Issue
5:2013
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Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically. 


Description

Sodium oxybate (Xyrem ®) is a GABA analogue CNS depressant that is FDA-approved for narcolepsy with or without cataplexy.  The medication is not considered first-line therapy for these conditions and should not be used for treating other disorders.

 


Policy

 

Sodium oxybate may be considered medically necessary for the treatment of narcolepsy with or without cataplexy when ALL of the following criteria are met:

  • The patient must have a well-supported diagnosis of Narcolepsy with or without Cataplexy as confirmed by:
    • Symptoms of severe daytime sleepiness that interfere significantly with daily tasks AND
    • Significantly disrupted sleep as documented by a 4-week sleep log AND
    • An Epworth sleepiness scale score > 15 AND
    • A formal polysomnogram which rules out other causes of daytime sleepiness and shows:
      • The presence of multiple spontaneous awakenings
      • The presence of reduced sleep efficiency AND
    • A multiple sleep latency test performed the next morning
      • Valid only if the polysomnogram demonstrated at least 6 hours of sleep
      • Monitoring must include electroencephalography, electrooculography, mental or submental electromyography and electrocardiography
      • Recommendations to increase the validity of the test include stopping all stimulants and other psychoactive medications two weeks before testing and anti-depressants three weeks before testing.  Drugs of abuse should be ruled out by submitting a qualitative urine drug screen.
      • Sleep latency is documented for each nap session – repeated every two hours until 5 nap opportunities have been recorded and/or two or more sleep onset rapid eye movement periods (SOREM’s) have occurred.
      • All of the following criteria are necessary to diagnose narcolepsy
        • Decreased sleep latency (8 minutes or less averaged over the test period)
        • Naps include REM sleep
        • Presence of two or more SOREM’s AND
    • Other causes of sleep disorders have been ruled out or appropriately-treated including but not limited to:
      • Insufficient sleep opportunity and/or fragmented sleep
      • Sleep apnea (obstructive or central)
      • Periodic limb movements of sleep
      • Rapid eye movement (REM) sleep behavior disorder
      • Other medical and/or neurologic disorders
      • Substance abuse disorders
      • Medication use disorders
      • Psychiatric disorders - Psychological evaluation must be performed by a board-certified Psychologist or Psychiatrist with supporting clinical documentation submitted.  The purpose of this evaluation is to evaluate for psychiatric or behavioral factors which may contribute to the patient’s sleepiness.  Recommended treatments must be followed for a reasonable time frame with submitted documentation of the patient’s response AND
  • The patient must have previously tried and failed the following treatments.   Detailed, documented support of these interventions including patient response must be submitted.  “Treatment failure” must be supported by lack of significant improvement in the Epworth Sleepiness Scale, sleep log, and symptoms of narcolepsy/cataplexy that interfere significantly with daily tasks.
    • Regimented Non-Pharmacologic Therapy
      • A thorough medication and social history must be performed.
        • Prescription drugs must be evaluated for their potential contribution to the patient’s symptoms and adjusted/discontinued as appropriate.  This may include benzodiazepines, opiates, antipsychotics, stimulants, alpha-1 antagonists and others.
        • Patient must not be inappropriately using any substances including drugs of abuse, excessive alcohol and caffeine.  A qualitative urine drug screen is required as above AND
      • Behavioral interventions have been performed to improve sleep hygiene
        • These should be identified with an in-depth sleep-directed history and physical exam
        • Patient must have been recommended and complied with specific behavior modifications directed at improving sleep hygiene.  These measures and their impact must be clearly documented
        • Documentation of psychiatric recommendations and compliance with these recommendations must be provided as described above AND
      • Patient has failed to improve despite 2 months of optimized pharmacotherapy which must include
        • Use of a stimulant to reduce daytime sleepiness
          • All patients must have been treated for 2 months with modafinil or armodafinil
          • Other agents to decrease daytime sleepiness may also be tried but not in lieu of modafinil or armodafinil AND
      • Use of first-line night-time sleep aids which must include
        • At least one over-the-counter sleep aid such as Anti-histamines, Melatonin/melatonin agonists AND
        • At least one prescription sleep aid such as Sedating anti-depressants (eg. trazodone), Sedative hypnotics AND
  • Patient must be enrolled in the Xyrem success programhttp://www.xyrem.com/patient-success-program AND
  • Prescribing physician must be Board Certified in Sleep Medicine AND
  • Serial Epworth sleepiness scales and Sleep logs of at least 4 weeks must be performed and submitted minimally at the following intervals
    • Prior to initiation of any pharmacologic treatment
    • While receiving non-pharmacologic treatment and first-line pharmacologic treatment as described above
    • After having taken sodium oxybate for 4 weeks, if approved
    • Periodically while on continued sodium oxybate therapy in order to justify the ongoing use of this drug

The use of sodium oxybate for all other indications is considered investigational.

 


Policy Guidelines

 

If approved, initial authorization will be given for a maximum of 4 weeks. The following requirements must be met if continued sodium oxybate treatment is requested beyond that period 

  • All of the above initial requirements must have been met
  • An Epworth sleepiness scale reduction of at least 30% and a post-treatment sleep log showing significant improvement must be documented as a result of sodium oxybate treatment
  • A face-to-face evaluation with the prescribing provider must have occurred
  • Clinical documents must support a significant improvement in the ability to perform daily activities and rationale for continuing the medication must be provided.
  • No more than 56 total doses per 4 week period (2 doses a night) will be prescribed for any reason.

References:

 

  1. Overeem S, van Nues SJ, van der Zande WL, et al. The clinical features of cataplexy: a questionnaire study in narcolepsy patients with and without hypocretin-1 deficiency. Sleep Med 2011; 12:12.

  2. Chokroverty S. Sleep apnea in narcolepsy. Sleep 1986; 9:250.

  3. Schenck CH, Mahowald MW. Motor dyscontrol in narcolepsy: rapid-eye-movement (REM) sleep without atonia and REM sleep behavior disorder. Ann Neurol 1992; 32:3.

  4. Dauvilliers Y, Pennestri MH, Petit D, et al. Periodic leg movements during sleep and wakefulness in narcolepsy. J Sleep Res 2007; 16:333.

  5. Cipolli C, Franceschini C, Mattarozzi K, et al. Overnight distribution and motor characteristics of REM sleep behaviour disorder episodes in patients with narcolepsy-cataplexy. Sleep Med 2011; 12:635.

  6. Plazzi G, Ferri R, Antelmi E, et al. Restless legs syndrome is frequent in narcolepsy with cataplexy patients. Sleep 2010; 33:689.

  7. Jara CO, Popp R, Zulley J, et al. Determinants of depressive symptoms in narcoleptic patients with and without cataplexy. J Nerv Ment Dis 2011; 199:329.

  8. Dimitrova A, Fronczek R, Van der Ploeg J, et al. Reward-seeking behavior in human narcolepsy. J Clin Sleep Med 2011; 7:293.

  9. Carskadon MA, Dement WC, Mitler MM, et al. Guidelines for the multiple sleep latency test (MSLT): a standard measure of sleepiness. Sleep 1986; 9:519.

  10. Moscovitch A, Partinen M, Guilleminault C. The positive diagnosis of narcolepsy and narcolepsy's borderland. Neurology 1993; 43:55.

  11. Mitler MM, Van den Hoed J, Carskadon MA, et al. REM sleep episodes during the Multple Sleep Latency Test in narcoleptic patients. Electroencephalogr Clin Neurophysiol 1979; 46:479.

  12. Richardson GS, Carskadon MA, Flagg W, et al. Excessive daytime sleepiness in man: multiple sleep latency measurement in narcoleptic and control subjects. Electroencephalogr Clin Neurophysiol 1978; 45:621.

  13. Dauvilliers Y, Gosselin A, Paquet J, et al. Effect of age on MSLT results in patients with narcolepsy-cataplexy. Neurology 2004; 62:46.

  14. Chervin RD, Aldrich MS. Sleep onset REM periods during multiple sleep latency tests in patients evaluated for sleep apnea. Am J Respir Crit Care Med 2000; 161:426.

  15. Mignot E, Lin L, Finn L, et al. Correlates of sleep-onset REM periods during the Multiple Sleep Latency Test in community adults. Brain 2006; 129:1609.

  16. Randomized trial of modafinil for the treatment of pathological somnolence in narcolepsy. US Modafinil in Narcolepsy Multicenter Study Group. Ann Neurol 1998; 43:88.

  17. Randomized trial of modafinil as a treatment for the excessive daytime somnolence of narcolepsy: US Modafinil in Narcolepsy Multicenter Study Group. Neurology 2000; 54:1166.

  18. Vignatelli L, D'Alessandro R, Candelise L. Antidepressant drugs for narcolepsy. Cochrane Database Syst Rev 2005; :CD003724.

  19. Tunnicliff G, Raess BU. Gamma-Hydroxybutyrate (orphan medical). Curr Opin Investig Drugs 2002; 3:278.

  20. A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy. Sleep 2003; 26:31.

  21. Mamelak M, Black J, Montplaisir J, Ristanovic R. A pilot study on the effects of sodium oxybate on sleep architecture and daytime alertness in narcolepsy. Sleep 2004; 27:1327.

  22. Alshaikh MK, Tricco AC, Tashkandi M, et al. Sodium oxybate for narcolepsy with cataplexy: systematic review and meta-analysis. J Clin Sleep Med 2012; 8:451.


Policy History

Date Action Reason
05/14/13 Add to Prescription section New policy