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    Xywav™

    Drug - Xywav™ (calcium, magnesium, potassium, and sodium oxybates solution) [Jazz Pharmaceuticals Inc.]

    March 2021

    Therapeutic Area - Narcolepsy

    Initial approval criteria

    • Patient must be ≥ 7 years of age AND
    • Patient has a diagnosis of narcolepsy (as defined in the below criteria) AND
    • Patient and provider are enrolled in and compliant with Xywav and Xyrem REMS program AND
    • Patient must not be receiving treatment with sedative hypnotic agents (e.g., zolpidem, eszopiclone, zaleplon, benzodiazepines, barbiturates, etc.) AND
    • Patient must not drink alcohol when using Xywav AND
    • Patient must not have succinic semialdehyde dehydrogenase deficiency AND
    • Patient was evaluated for history of drug abuse AND
    • Prescriber will monitor for signs of misuse or abuse of sodium oxybate (a.k.a. gamma-hydroxybutyrate [GHB]) including, but not limited to, the following: use of increasingly large doses, increased frequency of use, drug-seeking behavior, feigned cataplexy, etc. AND
    • Patient has daily periods of irrepressible need to sleep or daytime lapses into sleep occurring for ≥ 3 months AND
    • Patient has a documented inadequate response, contraindication, or intolerance to sodium oxybate or Xyrem AND
    • Patient has one of the following:
      • Cataplexy (e.g., sudden loss of some or all muscle tone in which consciousness is maintained) with narcolepsy AND
        • Baseline frequency of attacks is documented in patient’s record AND
        • A mean sleep latency of ≤ 8 minutes AND ≥ 2 sleep onset REM sleep periods (SOREMPs) are found on a mean sleep latency test (MSLT) performed according to 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, measured by immunoreactivity, is either ≤ 110 pg/mL OR 1/3 of mean values obtained in normal subjects with the same standardized assay OR
      • Excessive daytime sleepiness (EDS) with narcolepsy AND
        • Baseline daytime sleepiness as measured by a validated scale (e.g., Epworth Sleepiness Scale, Stanford Sleepiness Scale, Karolinska Sleepiness Scale, Cleveland Adolescent Sleepiness Questionnaire, or a Visual Analog Scale) AND
        • A mean sleep latency of < 8 minutes AND ≥ 2 sleep onset REM periods (SOREMPs) are found on a mean sleep latency test (MSLT) performed according to standard techniques (A SOREMP [within 15 minutes of sleep onset] on the preceding nocturnal polysomnogram may replace one of the SOREMPs on the MSLT) AND
        • Either CSF hypocretin-1 concentration has not been measured OR the CSF hypocretin-1 concentration measured by immunoreactivity is either > 110 pg/mL or > 1/3 of mean values obtained in normal subjects with the same standardized assay AND
        • The hypersomnolence and/or MSLT findings are not better explained by other causes such as insufficient sleep, obstructive sleep apnea, delayed sleep phase disorder, or the effect of medication or substances or their withdrawal AND
        • Patient has a documented inadequate response, contraindication, or intolerance to monotherapy with a wakefulness promoting agent (e.g., modafinil, armodafinil, etc.)
    • Initial approval is for 3 months

    Renewal criteria

    • Patient must continue to meet above criteria AND
    • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include severe depression or suicidality, parasomnias, life-threatening respiratory depression, parasomnias, behavior/psychiatric adverse reactions, severe impaired cognitive function, or motor function, etc. AND
    • Nightly dose does not exceed 9 g AND
    • For Excessive Daytime Sleepiness: Response to therapy with a reduction in excessive daytime sleepiness from pre-treatment baseline as measured by a validated scale (e.g., Epworth Sleepiness Scale, Stanford Sleepiness Scale, Karolinska Sleepiness Scale, Cleveland Adolescent Sleepiness Questionnaire, or a Visual Analog Scale) AND
    • For Cataplexy - reduced frequency of cataplexy attacks from pre-treatment baseline
    • Renewal approval is for 3 months

    Quantity limits

    • 540 mL (3 bottles) per 30 days (based on a maximum 9 g/18 mL per night)

    Questions?

    MHCP Provider Call Center 651-431-2700 or 800-366-5411

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