Xywav — United Healthcare
Narcolepsy without cataplexy (Narcolepsy Type 2)
Preferred products
- Lumryz
- sodium oxybate [Xyrem authorized generic (manufactured by Hikma)]
- Xywav
- Wakix
Initial criteria
- Submission of medical records documenting diagnosis of narcolepsy without cataplexy with BOTH:
- - Patient has daily periods of irrepressible need to sleep or daytime lapses into sleep for ≥3 months
- - Mean sleep latency ≤8 minutes and ≥2 SOREMPs on MSLT (per standard techniques after normal overnight polysomnogram), or 1 SOREMP on MSLT plus SOREMP on preceding nocturnal PSG
- Physician attestation that other causes of sleepiness ruled out or treated (e.g., obstructive sleep apnea, insufficient sleep, shift work, substances/medications, sleep phase disorder, other sleep disorders)
- History of failure, contraindication, or intolerance of ALL:
- - One of: amphetamine-based stimulant (e.g., amphetamine, dextroamphetamine) OR methylphenidate-based stimulant
- - One of: modafanil (Provigil) OR armodafanil (Nuvigil)
- - Sunosi
- Prescribed by Neurologist OR Psychiatrist OR Pulmonologist OR Sleep Medicine Specialist
- For sodium oxybate [Xyrem authorized generic (Amneal)] and Xyrem: trial, failure or intolerance to THREE of: Lumryz, sodium oxybate [Xyrem authorized generic (Hikma)], Xywav, Wakix
Reauthorization criteria
- Documentation demonstrating reduction in symptoms of excessive daytime sleepiness
Approval duration
Initial: 3 months; Reauth: 12 months