Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Idiopathic hypersomnia.
Treatment: Xywav (oxybate salts) 0.5 grams per milliliter (g/mL) solution.
The insurer denied: Xywav (oxybate salts) 0.5 grams per milliliter (g/mL) solution.
The denial is overturned.

The patient is an adult female who was reported to have been diagnosed with idiopathic hypersomnia (G47.11). The patient's provider is requesting the use of the nonformulary medication, Xywav (oxybate salts) 0.5 grams per milliliter (g/mL) solution for treatment of the patient's symptoms including excessive daytime sleepiness related to idiopathic hypersomnia. The requested medication (Xywav) was noted to have been previously denied as there was no indication that the patient had failed to respond to the preferred formulary alternative, Xyrem (sodium oxybate) or had contraindications or adverse effects to the same. An appeal letter provided by the treating provider states that Xywav (oxybate salts) is the only Food and Drug Administration (FDA) approved agent for idiopathic hypersomnia. The provider indicates that Xyrem (sodium oxylate) is not currently approved by the Food and Drug Administration for idiopathic hypersomnia.
The patient was noted to have been seen for a clinical encounter 3 months ago. She was noted to have presented with excessive daytime sleepiness. The patient was reported to have a history of insomnia while in school. She was reported to have been previously diagnosed with bipolar disorder. The patient was reported to have a history of rhabdomyolysis and acute renal failure. She was reported to have developed significant excessive daytime sleepiness following the episode. The patient was reported to have had a home sleep study which indicated mild sleep apnea with an apnea hypopnea index (AHI) of ten per hour. The patient was reported to have had a multiple sleep latency test (MSLT) performed recently which indicated a mean sleep latency of 2.5 minutes with no sleep onset rapid eye movement periods. She was reported to have some symptoms consistent with sleep paralysis and sleep related to hallucinations. The provider indicated that the patient also appears to have symptoms of cataplexy. The provider was noted to have indicated that the patient's clinical picture is consistent with a diagnosis of idiopathic hypersomnia. The patient was reported to have been treated with modafinil 400 milligrams daily. The provider recommended starting Xywav 
(oxybate salts). A pharmacy paid claims report from 2 years ago and forward indicates that the patient was treated with psychotropic medications including pregabalin, duloxetine, citalopram, alprazolam, amitriptyline, topiramate, aripiprazole, modafinil, and fluoxetine.

The proposed treatment (Xywav) is medically necessary.

The patient's provider is requesting the use of the nonformulary medication, Xywav (oxybate salts) 0.5 grams per milliliter solution for treatment of the patient's symptoms including excessive daytime sleepiness related to idiopathic hypersomnia. There are no medications approved by the Food and Drug Administration (FDA) for treatment of idiopathic hypersomnia other than Xywav (oxybate salts), a medication that consolidates nighttime sleep. Xyrem (sodium oxybate) is not currently approved by the Food and Drug Administration for treatment of idiopathic hypersomnia. Other accepted treatment options for idiopathic hypersomnia among sleep medicine specialists 
include stimulant and non-stimulant wake promoting agents to address excessive daytime sleepiness including modafinil, armodafinil, methylphenidates, and amphetamines (1-6). However, the patient was noted to have been previously treated with high doses of modafinil with persistent excessive daytime sleepiness. Therefore, the proposed treatment (Xywav) would be considered appropriate and medically necessary in this patient.