Diagnosis: Narcolepsy with Cataplexy.
Treatment: Xywav.

The health plan denied Xywav. The health plan's determination is overturned.

This is the case of a male patient who suffers from Narcolepsy with cataplexy. A Multiple Sleep Latency Test (MSLT) showed reduced mean sleep onset latency down to 4.28 minutes and 2 sleep onset rapid eye movement (REM).

At issue is the medical necessity for the requested medication, Xywav.

I overturn, in whole, the health plan's determination of medical necessity.

Yes. The requested health service/treatment of Xywav is medically necessary for this patient.

Narcolepsy is a serious, life-long, potentially disabling disorder. Symptoms are usually first noticed during the early teenage years. There is no known cure for narcolepsy and no completely adequate treatment is available.

Narcolepsy is a chronic neurological disorder caused by the brain's inability to regulate sleep-wake cycles normally. At various times throughout the day, people with narcolepsy experiences fleeting urges to sleep. If the urge becomes overwhelming, individuals will fall asleep for periods lasting from a few seconds to several minutes. In addition to excessive daytime sleepiness (EDS), three other major symptoms frequently characterize narcolepsy: cataplexy or the sudden loss of voluntary muscle tone; vivid hallucinations during sleep onset or upon awakening; and brief episodes of total paralysis at the beginning or end of sleep.

The MSLT is performed to evaluate the presence of pathological sleepiness and to confirm the diagnosis of Narcolepsy. These individuals are studied during 5 daytime naps taken 2 hours apart. The mean MSLT score is usually less than 8 minutes. Narcolepsy is excluded by the absence of sleep-onset REM (SOREM) periods on the 5-nap MSLT.

The review of the patient record revealed that the patient was referred to the sleep lab for evaluation of daytime sleepiness. The patient had MSLT that showed reduced mean sleep onset latency down to 4.28 minutes and 2 sleep onset REM confirming the diagnosis of Narcolepsy. The patient has also symptoms of cataplexy. The Xywav was approved for the treatment of Narcolepsy and cataplexy as in this patient case. The number of cataplexy episodes has no value in supporting the medical necessity of Xywav.