MHCP Enrolled Providers – Pharmacies
Fee-for-Service PA Criteria Sheet – Xyrem
(Revised October 2010)
Xyrem (sodium oxybate) [Jazz Pharmaceuticals]
FDA approved indication
Treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy.
Patient has been definitively diagnosed with cataplexy or excessive daytime sleepiness associated with narcolepsy
Is not taking other sedative-hypnotics
Xyrem will NOT be approved for fibromyalgia. Xyrem was reviewed by the FDA for fibromyalgia, and this indication was rejected in October of 2010.
Xyrem is available only through a central pharmacy that provides educational material to the prescriber and the patient explaining the risks and proper use of sodium oxybate, and the required prescription form. Once it is documented that the patient has read and/or understood the materials, the drug will be shipped to the patient. The Xyrem Success Program also recommends patient follow-up every 3 months. Physicians are expected to report all serious adverse events to the manufacturer.
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