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UnitedHealthcare prior authorization criteria for sodium oxybate products (Lumryz, Xyrem authorized generics, Xywav) for treatment of narcolepsy (with and without cataplexy) and idiopathic hypersomnia (Xywav). Defines initial and reauthorization clinical criteria and authorization durations; notes REMS/restricted distribution and exclusions.
Updated initial authorization duration to 12 months (noted 9/2024 update).
Added Lumryz to criteria (11/2023).
Added Xywav and idiopathic hypersomnia indication (12/2020 and 11/2021).
Scope: UnitedHealthcare prior authorization criteria for sodium oxybate products (Lumryz, Xyrem authorized generics, Xywav) for treatment of narcolepsy (with and without cataplexy) and idiopathic hypersomnia (Xywav). Coverage stance: Covered with criteria. Policy number: 2025 P 1118-14. Subject: Sodium oxybate products (Lumryz, Xyrem, Xywav) prior authorization.
Authorization duration: initial and reauthorization approvals are issued for 12 months.
Covered indications (from policy stats and criteria): narcolepsy with cataplexy (Narcolepsy Type 1), narcolepsy without cataplexy (Narcolepsy Type 2), and idiopathic hypersomnia (Xywav).
Narcolepsy with Cataplexy (Narcolepsy Type 1) - Initial Authorization
Covered when ALL of the following are met:
ALL of the following
Prescriber may provide justification if sleep study is not feasible
Narcolepsy with Cataplexy - Reauthorization
Covered when ANY of the following are met:
ANY of the following
Narcolepsy without Cataplexy (Narcolepsy Type 2) - Initial Authorization
Covered when ALL of the following are met:
ALL of the following
Prescriber may provide justification if sleep study is not feasible
Narcolepsy without Cataplexy - Reauthorization
Covered when ALL of the following are met:
Idiopathic Hypersomnia (Xywav) - Initial Authorization
Covered when ALL of the following are met:
ALL of the following
Idiopathic Hypersomnia (Xywav) - Reauthorization
Covered when ALL of the following are met:
| No codes listed |
| Lumryz | sodium oxybate (Avadel) |
| Xyrem | sodium oxybate (Jazz) and Xyrem authorized generics (Amneal, Hikma) |
| Xywav | calcium, magnesium, potassium, and sodium oxybates |
Prior authorization required
Prior authorization/notification is required for Lumryz, Xyrem (including authorized generics) and Xywav. Initial approvals and reauthorizations are issued for 12 months.
Sleep study documentation
Diagnosis must be confirmed by a sleep study for initial authorization; the prescriber may provide justification if a sleep study is not feasible.
Clinical benefit documentation for reauthorization
For reauthorization, documentation must demonstrate clinical benefit: either a reduction in the frequency of cataplexy attacks or a reduction in symptoms of excessive daytime sleepiness, as applicable to the indication.
REMS and restricted distribution
These products are available only through a REMS with restricted distribution. Prescribers and patients must participate in the REMS program; documentation that the patient has read and/or understood REMS materials may be required. The REMS program recommends manufacturer follow-up every 3 months.
Coverage exceptions and exclusions noted
Sodium oxybate (Xyrem authorized generic manufactured by Amneal) and brand Xyrem are typically excluded from coverage; state mandates and member-specific benefits may override these exclusions.
Background: Lumryz, Xyrem (sodium oxybate) and Xywav are central nervous system depressants indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in patients with narcolepsy; Xywav is also indicated for idiopathic hypersomnia in adults.
These agents are controlled substances and available only through a REMS program with restricted distribution. The REMS provides educational materials to prescribers and patients, requires documentation that the patient has read/understood materials before shipment, and the program recommends patient follow-up every 3 months. Prescribers are expected to report serious adverse events to the manufacturer.
Evidence sources cited in the policy include package inserts for Xyrem (2025), Xywav (2023), Lumryz (2024), and authorized generics (Amneal 2023, Hikma 2023), and the American Academy of Sleep Medicine guideline (2021).
Added Xywav to criteria; Added Xywav to criteria.
Added idiopathic hypersomnia indication for Xywav; Added criteria for idiopathic hypersomnia for Xywav due to labeling.
Added Lumryz to criteria; Lumryz inclusion noted; sodium oxybate (Amneal) and brand Xyrem typically excluded.
Updated initial authorization duration to 12 months (noted 9/2024 update).