Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Idiopathic Hypersomnia
Treatment: Xywav 0.5GM/ML Solution
The insurer denied: Xywav 0.5GM/ML Solution
The denial is overturned

The patient is an adult female who was reported to have been diagnosed with idiopathic hypersomnia with long sleep time (G47.11). The patient's provider is requesting the use of Xywav (oxybate salts) 0.5 g/mL (grams per milliliter) solution for treatment of the patient's symptoms related to idiopathic hypersomnia. The requested medication (Xywav) was noted to have been previously denied coverage by the health plan, as there was no indication that the patient had failed to respond to the preferred alternative, Xyrem (sodium oxybate) or had contraindications or adverse effects to the same. The diagnosis of idiopathic hypersomnia and previous trials of modafinil and armodafinil were noted to have been previously confirmed during the prior authorization process. The patient's provider is appealing the previous denial indicating that Xywav (oxybate salts) is the only medication that is approved by the Food and Drug Administration (FDA) for treatment of idiopathic hypersomnia. The proposed preferred alternative (Xyrem) was noted to be inappropriate as it is not approved for treatment of idiopathic hypersomnia.
A progress note indicates that the patient initially presented with excessive daytime sleepiness. She was reported to have been diagnosed with idiopathic hypersomnia based on multiple sleep latency test (MSLT). The provider indicated that the patient was initially treated with Nuvigil (armodafinil) 100 mg (milligrams) daily. The patient was reported to have been subsequently switched to Provigil (modafinil) 100 mg (milligrams) twice daily. The patient was noted to have partial benefit from modafinil. She was reported to have persistent improvement in sleepiness. The patient was reported to have been attending college and her symptoms were noted to have been interfering with her academic work. The patient was noted to have a medical history significant for asthma and psychogenic seizures. Clinical documentation from last year indicates that the patient continues to have excessive daytime sleepiness with scores on the Epworth sleepiness scale (ESS) in the range of 14-16. The 
patient was noted to have been treated with modafinil twice daily. 

The requested Xywav is medically necessary.

The patient is an adult female who was reported to have been diagnosed with idiopathic hypersomnia with long sleep time (G47.11). The diagnosis of idiopathic hypersomnia was noted to have been confirmed following a multiple sleep latency test (MSLT) as is the accepted standard of practice in sleep medicine. 
The underlying causes of idiopathic hypersomnia are not known, and therefore treatment is symptomatic (1-9). 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. There is significant evidence in current peer reviewed, evidence-based medical literature to indicate the safety and efficacy of Xywav (oxybate salts) for treatment of excessive daytime sleepiness associated with idiopathic hypersomnia (10).
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 alternative, Xyrem (sodium oxybate) or had contraindications or adverse effects to the same. However, Xyrem (sodium oxybate) is not currently approved by the Food and Drug Administration (FDA) or supported in medical literature or standard compendia for treatment of idiopathic hypersomnia. As the patient was noted to have previously failed trials of other wake promoting medications, the use of Xywav (oxybate salts) would be considered reasonable and appropriate in this patient. Therefore, the proposed treatment (Xywav 0.5 g/mL (grams per milliliter) solution) is medically necessary.