Xywav (calcium, magnesium, potassium, and sodium oxybates) — CareFirst (Caremark)

Initial criteria

• Diagnosis confirmed by all of the following:
• Presence of daytime lapses into sleep or daily irrepressible periods of need to sleep for ≥ 3 months
• Insufficient sleep syndrome ruled out (e.g., lack of improvement after adequate trial of increased time in bed, verified by ≥1 week sleep log with wrist actigraphy)
• Multiple sleep latency test (MSLT) documents fewer than two SOREMPs or no SOREMPs if REM latency on preceding polysomnography ≤ 15 minutes
• Presence of at least one of the following: mean sleep latency on MSLT ≤ 8 minutes OR total 24-hour sleep time ≥ 660 minutes on 24-hour polysomnographic monitoring after correcting chronic sleep deprivation or by wrist actigraphy with sleep log over ≥ 7 days of unrestricted sleep
• Member does not have cataplexy
• Hypersomnolence or MSLT results not better explained by another sleep disorder, other medical or psychiatric disorder, or use or withdrawal of drugs/medications
• Medication must be prescribed by or in consultation with a sleep specialist (e.g., neurologist experienced with sleep disorders, physician certified in sleep medicine)

Reauthorization criteria

• Beneficial response to treatment as demonstrated by a decrease in daytime sleepiness from baseline

Approval duration

12 months