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Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.
Xyrem® (sodium oxybate) is a central nervous system depressant that reduces excessive daytime sleepiness and cataplexy in patients with narcolepsy. Narcolepsy is a clinical syndrome of daytime sleepiness which can include hypnagogic hallucinations and sleep paralysis and can occur with or without cataplexy. Cataplexy is intermittent manifestation of rapid eye movement (REM) sleep physiology during wakefulness. The syndrome has a central nervous system origin.
The diagnosis of narcolepsy with cataplexy requires both of the following :
The diagnosis of narcolepsy without cataplexy requires both of the following:
Prior authorization is required for Xyrem Therapy.
Initiation of Xyrem Therapy
Initial authorization will be limited to a maximum of a 3-month supply if the clinical criteria and requirements below are met.
Xyrem will be approved when ALL of the following are met:
1. The patient is 16 years of age or older AND
2. ONE of the following:
a. The patient has a diagnosis of narcolepsy with cataplexy and the cataplexy has not responded to tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs) and/or venlafaxine OR
i. The patient’s excessive daytime sleepiness is unresponsive to modafinil and ONE of the following: amphetamine, methamphetamine, dextroamphetamine, methylphenidate OR
ii. The patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to modafinil or the stimulants listed above
3. The prescriber has documented that the patient is enrolled in the Xyrem REMS Program AND
4. The patient does not have any contraindications to therapy AND
5. The requested dose is at or below the FDA labeled maximum dose of 9 gm/night (540 mL/30 days)
Continuation of Xyrem Therapy
A continuation request must be submitted for subsequent authorization every 3 months. Subsequent authorizations will be approved for 3 months at a time if the following requirements are met:
1. The patient is evaluated by the prescribing physician no less frequently than every 3 months AND
2. Medical records are submitted that clearly document a reduction in frequency of cataplexy attacks associated with Xyrem therapy OR
3. Medical records are submitted clearly document a reduction in symptoms of excessive daytime sleepiness associated with Xyrem therapy.
POLICY EXCEPTIONSXyrem prior authorization is not required for Federal Employee Program (FEP) and State Health Plan members.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
01/01/2014: New policy added.
07/22/2015: Code Reference section updated for ICD-10.
08/15/2015: Policy description revised to provide additional clinical information regarding narcolepsy and cataplexy. Policy statement revised to state that prior authorization is required for this drug and that it will be limited to a maximum of a 3-month supply initially, with subsequent authorization required every 3 months. Added medications that the patient must try and fail before Xyrem therapy will be approved. Added coverage guidelines for continuation of Xyrem therapy. Sources section updated.
Xyrem® Prescribing Information
American Academy of Sleep Medicine: Practice Parameters for the Treatment of Narcolepsy and other Hypersomnias of Central Origin, 2007
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.