Wakix (pitolisant) — United Healthcare

Initial criteria

• Submission of medical records documenting a diagnosis of narcolepsy with cataplexy (Narcolepsy Type 1) with both of the following: (a) patient has daily periods of irrepressible need to sleep or daytime lapses into sleep occurring for at least 3 months AND (b) mean sleep latency ≤ 8 minutes and two or more sleep onset REM periods (SOREMPs) found on a MSLT performed according to standard techniques following a normal overnight polysomnogram; a SOREMP within 15 minutes of sleep onset on the preceding polysomnogram may replace one on the MSLT.
• Physician attestation to both of the following: (a) patient has experienced cataplexy defined as more than one episode of sudden loss of muscle tone with retained consciousness AND (b) other causes of sleepiness have been ruled out or treated (including but not limited to obstructive sleep apnea, insufficient sleep syndrome, shift work, the effects of substances or medications or their withdrawal, sleep phase disorder, or other sleep disorders).
• Prescribed by or in consultation with a neurologist, psychiatrist, pulmonologist, or sleep medicine specialist.

Reauthorization criteria

• Reduction in frequency of cataplexy attacks associated with therapy OR reduction in symptoms of excessive daytime sleepiness associated with therapy.

Approval duration

12 months