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201909-120734

2019

CVS Caremark

Self-Funded

Cardiac/ Circulatory Problems

Pharmacy/ Prescription Drugs

Medical necessity

Overturned

Case Summary

Diagnosis: Circadian Rhythm Sleep Disorder

Treatment: Hetlioz

The insurer denied the Hetlioz. The denial was reversed.

This is a young male patient with a diagnosis of Circadian Rhythm Sleep Disorder.

He has a history of attention deficit disorder (ADD), anxiety, mood disorder, asthma, chronic sinusitis, gynecomastia, and obstructive sleep apnea. It was noted that the patient had an attempted suicide by a Xanax overdose in early 2019, and had spent two weeks in a psychiatric facility for treatment. Light therapy was recommended for his sleep disorder diagnosis. The patient underwent a sleep study which revealed mild sleep apnea, periodic limb movements associated with restless leg syndrome, and mildly abnormal sleep architecture. He was evaluated by an Ear, Nose and Throat specialist. Continues Positive Airway Pressure (CPAP) treatment was recommended, however, it was not tolerated by the patient. It was reported that the patient was drinking a lot of caffeine energy drinks in attempt to stay awake and focus on school work; he was a senior in high school. The patient was started on Hetlioz. The patient reported major improvement in his sleep since he was started on the medication six months earlier.

Per UpToDate (2018), "Individuals with non-24-hour sleep-wake rhythm disorder (N24SWD) are unable to maintain appropriate alignment with the 24-hour environment, so each day their sleep-wake patterns shift (typically later) with respect to external time. N24SWD has previously been referred to as free-running disorder, non-entrained disorder, or hypernychthemeral syndrome¿ In sighted individuals with N24SWD, we suggest use of nightly melatonin as well as morning light therapy."

According to the current peer-reviewed medical literature, N24SWD occurs mostly in blind individuals, but may occur in patients with sight. Hetlioz is a melatonin receptor agonist indicated for the treatment of N24SWD. At this time, Hetlioz is the only drug to be approved by the US Food and Drug Administration (FDA) for the treatment of N24SWD. The patient is not blind. He has a diagnosis of Circadian Rhythm Sleep Disorder. The patient had other psychiatric diagnoses which may affect this disorder. The documentation indicated that the patient has utilized Ambien, light therapy and melatonin with no relief.

Based on the above, the medical necessity for Hetlioz is substantiated. The insurer's denial is reversed.

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