Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Narcolepsy Type 2
Treatment: Xyrem
The insurer denied: Xyrem
The denial is overturned

The patient is an adult female who was reported to have been diagnosed with narcolepsy without cataplexy (G47.419). The patient's provider is requesting the use of Xyrem (sodium oxybate) 0.5 grams per milliliter (g/mL) solution for treatment of the patient's symptoms including excessive daytime sleepiness related to narcolepsy without cataplexy. The requested medication (Xyrem) was noted to have been previously denied due to lack of medical records showing a diagnosis of narcolepsy without cataplexy including daily irrepressible need to sleep for at least three months and results from diagnostic polysomnogram (PSG) and multiple sleep latency test (MSLT) showing a mean sleep latency of less than or equal to eight minutes with at least two sleep onset rapid eye movement periods. In addition, there was no indication that other causes of sleepiness were ruled out including obstructive sleep apnea, insufficient sleep syndrome, shiftwork disorder, effects of substances or medications, sleep phase disorder or other sleep disorders.

The patient's provider is appealing the previous denial indicating that there is significant variability with multiple sleep latency test (MSLT) in patients with narcolepsy without cataplexy and idiopathic hypersomnia. The patient's provider included medical literature indicating poor test-retest reliability of a multiple sleep latency test (MSLT). Additional clinical information provided indicates that the patient had previously failed a trial of armodafinil. A pharmacy claims history indicated that the patient was treated with psychotropic medications including alprazolam, buspirone, citalopram, lamotrigine and Vyvanse (lisdexamfetamine). An appeal letter provided by the treating provider indicates that the patient was diagnosed with narcolepsy without cataplexy following a diagnostic polysomnogram and multiple sleep latency test. The provider indicates that the multiple sleep latency test was noted to have indicated a mean sleep latency of 10.8 minutes with two sleep onset rapid eye movement periods. The patient was reported to have failed a trial of modafinil/armodafinil due to increased anxiety. The patient was noted to have been seen for a clinical encounter. The provider indicated that the patient has a long history of sleep difficulties including initiating and maintaining sleep. She was noted to have been treated with Xyrem (sodium oxybate), Vyvanse (lisdexamfetamine), lamotrigine, alprazolam and buspirone. The patient's provider was noted to have recommended increasing the dosage of Xyrem and continuing the other medications. The patient was noted to have had a diagnostic polysomnogram (PSG) performed which indicated an overall apnea hypopnea index (AHI) of two per hour with an oxygen saturation nadir of 92%. The subsequent multiple sleep latency test performed was noted to have indicated a mean sleep latency of 10.8 minutes with two sleep onset rapid eye movement periods.

The proposed treatment (Xyrem) was found to be medically necessary and appropriate in this patient.

Xyrem (sodium oxybate) is a central nervous system depressant that is indicated for treatment of narcolepsy with and without cataplexy. There is significant evidence in current peer reviewed, evidence-based medical literature for the safety and efficacy of oxybate salts including Xyrem (sodium oxybate) for treatment of excessive daytime sleepiness associated with narcolepsy (8-15). The patient was noted to have previously failed trials of other wake promoting medications including armodafinil due to intolerance. She was also noted to have been treated with Vyvanse (lisdexamfetamine), which was noted to have been ineffective in controlling the patient's excessive daytime sleepiness. Therefore, the proposed treatment (Xyrem) was found to be medically necessary and appropriate for this patient.