Diagnosis: hypersomnia
Treatment: Modafinil
The insurer denied Modafinil.

The health plan's determination is overturned.

The patient is a woman diagnosed with idiopathic (primary) hypersomnia and mild obstructive sleep apnea. The patient has excessive daytime sleepiness. Treatment with modafinil is the subject of this review. The drug was denied by the plan as off-label.

Modafinil is medically necessary for treatment excessive daytime sleepiness due to idiopathic hypersomnia and mild obstructive sleep apnea.
The effectiveness of modafinil has been demonstrated in two randomized trials in a total of 104 patients with idiopathic hypersomnia without long sleep time. In both trials, patients treated with modafinil (200 mg daily given once in the morning or as two divided doses) had improved Epworth Sleepiness Scale (ESS) and clinical global impression rating scores compared with placebo. Mean sleep latency on the maintenance of wakefulness test (MWT) improved by approximately five minutes with treatment. Headache and gastrointestinal distress were the most common. The utility of modafinil was also illustrated by a multicenter cross-sectional study of 104 patients with idiopathic hypersomnia and 126 patients with narcolepsy, all treated with modafinil. In the subset of 63 idiopathic hypersomnia patients who completed the ESS before and after treatment, the mean improvement in the ESS score was 2.6 points, which was similar to that observed in narcolepsy patients.
Of note, Modafiinl is also on-label for treatment of excessive daytime sleepiness due to obstructive sleep apnea.

The health plan's determination is overturned.