Policy Applies to:

 

• Commercial plans
• Healthcare Reform plans

 

Drugs Addressed in this Policy

 

• Xyrem (sodium oxybate)

 

FDA-Approved Indications

 

• Indicated for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy

 

Medically Accepted Indications

 

• Fibromyalgia
• Breathing-related sleep disorder (e.g. obstructive sleep apnea)

  

Background:

Xyrem (sodium oxybate) is a central nervous system depressant that has been shown in clinical studies to reduce excessive daytime sleepiness and cataplexy in patients with narcolepsy. However, the precise mechanism by which sodium oxybate produces an effect on cataplexy is unknown.

• Sodium oxybate is GHB, a known drug of abuse. Abuse has been associated with some important central nervous system (CNS) adverse events (including death). Even at recommended doses, use has been associated with confusion, depression and other neuropsychiatric events. Reports of respiratory depression occurred in clinical trials. Almost all of the patients who received sodium oxybate during clinical trials were receiving CNS stimulants. Xyrem is available through the Xyrem Success Program^®.
• Sodium oxybate is also being studied for use in chronic insomnia (from a variety of sources including PTSD, in patients with schizophrenia, and chronic fatigue syndrome), fibromyalgia, Parkinson’s disease, and obstructive sleep apnea.

 

Initial Approval Criteria: 

 

When a benefit, sodium oxybate may be approved when the following criteria are met (A. B., C. plus if the member does not have cataplexy D.):

 

A.    The member has a diagnosis of narcolepsy (ICD-9 347.00, 347.01; ICD-10 G47.411, G47.419).

 

B.    The member meets one of the following (1. through 3.):

 

1.     The member has a documented hypocretin-1 deficiency defined as one of the following (a. or b.):

a.     Cerebrospinal fluid hypocretin-1 < 110 pg/mL.

b.    Cerebrospinal fluid hypocretin-1 < one-third of the normal value based on laboratory reference range.

 

2.     The prescriber provides a multiple sleep latency test (MSLT) substantiating both of the following (a. and b.):

a.     Mean sleep latency < 8 minutes.

b.    At least two sleep-onset rapid eye movement periods (SOREMPs).

 

3.     The prescriber provides polysomnography and a multiple sleep latency test (MSLT) substantiating all of the following (a., b., or c.):

a.     Multiple sleep latency test (MSLT) demonstrating a mean sleep latency < 8 minutes.

b.    Multiple sleep latency test (MSLT) demonstrating one sleep-onset rapid eye movement period (SOREMP).

c.     Polysomnography demonstrating at least one sleep-onset rapid eye movement period (SOREMP).

 

C.    Documentation of baseline data of excessive daytime sleepiness (EDS) via the Epworth Sleepiness Scale (ESS) or Maintenance of Wakefulness Test (MWT) and baseline number of cataplexy episodes if diagnosed with narcolepsy with cataplexy

 

D.    If the member does not have narcolepsy with cataplexy, the member must also meet the following (1. AND 2. OR 3.):

 

1.     Documented treatment failure, intolerance, or contraindication to the wakefulness drug, generic modafinil

AND

2.     Documented treatment failure, intolerance, or contraindication to one preferred/formulary CNS stimulant (e.g. amphetamine salt combo, methylphenidate).

OR

3.     Evidence of trials for wakefulness or stimulant medications deemed as clinically inappropriately (e.g. cardiovascular disease, drug misuse concerns)  

 

Reauthorization Approval Criteria

 

Upon reauthorization, the member should meet the following (1 OR 2.):

1. Decrease in cataplexy episodes with narcolepsy compared to baseline
2. Decrease in daytime sleepiness with narcolepsy as proven by improvement on the Epworth       Sleepiness Scale (ESS) or Maintenance of Wakefulness Test (MWT) compared to baseline

 

 

For Commercial and Healthcare Reform members, use of sodium oxybate for disease states outside of its FDA-approved indication should be denied based on the lack of clinical data to support its effectiveness and safety in other conditions.

 

For members with a closed formulary, a non-formulary product will only be approved if the member meets the criteria for a formulary exception in addition to the criteria outlined within this policy.

 

 

For Commercial and Healthcare Reform members enrolled in a West Virginia Plan, an exception to the step therapy within this policy may be made base on Policy J-513 – West Virginia – Step Therapy Override Exception – Commercial and Healthcare Reform.

 

Authorization Duration

 

• Commercial and Healthcare Reform plans: If approved, up to a one year authorization may be granted.

 

References:

1. Xyrem^® (sodium oxybate) prescribing information. Jazz Pharmaceuticals, Inc. Palo Alto, CA. April 2015.
2. Sodium oxybate.  Clinical Pharmacology. Tampa, FL: Gold Standard 2012. Updated May 12, 2015.
3. Sodium oxybate. DRUGDEX system. New York: Thomson Reuters 2012.  Updated  November 9, 2015.
4. McEvoy GK,ed. AHFS: Drug Information. Bethesda, MD: American Society of Health-System Pharmacists: 2015. 2734-2736.
5. Scammel TE. Clinical features and diagnosis of narcolepsy. In: UpToDate, Eichler, AF (Ed), UpToDate, Waltham, MA, 2013. Last modified October 2, 2015..
6. Morgenthaler T, Kapur V, Brown T, et al. Standards of Practice Committee of the AASM. Practice parameters for the treatment of narcolepsy and other hypersomnias of central orgin. SLEEP 2007;30(12):1705-1711.
7. Sateia MJ. International Classification of Sleep Disorders-Third Edition Contemporary Reviews in Sleep Medicine. American Academy of Sleep Medicine. International classification of sleep disorders, 3rd Edition: Diagnostic and coding manual. Darien, IL: American Academy of Sleep Medicine; 2014CHEST 2014; 146(5):1387-1394
8. Mignot, E, Lammers GJ, Ripley, B, et al. The role of cerebrospinal fluid hypocretin measurement in the diagnosis of narcolepsy and other hypersomnias. Arch Neurol. 2002; 59(10):1553-1562.
9. Division of Sleep Medicine at Harvard Medical School. Narcolepsy testing. http://healthysleep.med.hardvard.edu/narcolepsy/diagnosing-narcolepsy/narcolepsy-testing. July 22, 2013. Accessed March 7, 2017.

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