CurrentUnitedHealthcarePolicy 2025 P 1118-14

CNS Depressants - Lumryz™ (sodium oxybate), sodium oxybate [Xyrem authorized generic (manufactured by Amneal)], sodium oxybate [Xyrem authorized generic (manufactured by Hikma)], Xyrem® (sodium oxybate), Xywav® (calcium, magnesium, potassium, and sodium oxybates)

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.

Policy Summary

PayerUnitedHealthcare

PolicyCNS Depressants - Lumryz™ (sodium oxybate), sodium oxybate [Xyrem authorized generic (manufactured by Amneal)], sodium oxybate [Xyrem authorized generic (manufactured by Hikma)], Xyrem® (sodium oxybate), Xywav® (calcium, magnesium, potassium, and sodium oxybates)

Policy CodePolicy 2025 P 1118-14

Change TypeRevisions/Annual review

Effective DateNov 16, 2025

Next Review Date

Key ActionObtain prior authorization and document diagnosis (sleep study unless prescriber justifies infeasibility); approvals issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

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).

3Drugs covered/managed

3Covered indications

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Authorization duration (months)

Coverage Summary & Scope

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).

Key policy details

PayerUnitedHealthcare

PolicyCNS Depressants - sodium oxybate products

Policy Number2025 P 1118-14

Effective date2025-11-16

Last review2025-09

Authorization duration12 months

Covered drugs count3

Covered indications count3

Clinical Criteria (Initial authorization and Reauthorization)

Narcolepsy with Cataplexy (Narcolepsy Type 1) - Initial Authorization

Covered when ALL of the following are met:

ALL of the following

Diagnosis of narcolepsy with cataplexy (Narcolepsy Type 1) as confirmed by sleep study
Prescriber may provide justification if sleep study is not feasible
Symptoms of excessive daytime sleepiness (including but not limited to daily periods of irrepressible need to sleep or daytime lapses into sleep) are present
Cataplexy is present

Narcolepsy with Cataplexy - Reauthorization

Covered when ANY of the following are met:

Codes in Scope

Relevant ICD-10 diagnoses referencedICD-10

No codes listed

Drugs in scopemixed

Lumryz	sodium oxybate (Avadel)
Xyrem	sodium oxybate (Jazz) and Xyrem authorized generics (Amneal, Hikma)
Xywav	calcium, magnesium, potassium, and sodium oxybates

Authorization & Documentation Requirements

Prior Authorization

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.

Documentation Required

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.

Documentation Required

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.

Background & Evidence

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).

Definitions

Narcolepsy Type 1Narcolepsy with cataplexy

Narcolepsy Type 2Narcolepsy without cataplexy

Policy Revision Timeline

12/2020added

Added Xywav to criteria; Added Xywav to criteria.

11/2021added

Added idiopathic hypersomnia indication for Xywav; Added criteria for idiopathic hypersomnia for Xywav due to labeling.

11/2023added

Added Lumryz to criteria; Lumryz inclusion noted; sodium oxybate (Amneal) and brand Xyrem typically excluded.

Policy Summary

PayerUnitedHealthcare

Policy CodePolicy 2025 P 1118-14

Change TypeRevisions/Annual review

Effective DateNov 16, 2025

Next Review Date

Key ActionObtain prior authorization and document diagnosis (sleep study unless prescriber justifies infeasibility); approvals issued for 12 months.

SourceLink

On This Page

ANY of the following

Cataplexy reduction: Reduction in frequency of cataplexy attacks associated with therapy
EDS reduction: Reduction in symptoms of excessive daytime sleepiness associated with therapy

Narcolepsy without Cataplexy (Narcolepsy Type 2) - Initial Authorization

Covered when ALL of the following are met:

ALL of the following

Diagnosis of narcolepsy without cataplexy (Narcolepsy Type 2) as confirmed by sleep study
Prescriber may provide justification if sleep study is not feasible
Cataplexy absent: Cataplexy is absent

Narcolepsy without Cataplexy - Reauthorization

Covered when ALL of the following are met:

EDS reduction: Reduction in symptoms of excessive daytime sleepiness associated with therapy

Idiopathic Hypersomnia (Xywav) - Initial Authorization

Covered when ALL of the following are met:

ALL of the following

Diagnosis of idiopathic hypersomnia
Symptoms of excessive daytime sleepiness (including but not limited to daily periods of irrepressible need to sleep or daytime lapses into sleep) are present

Idiopathic Hypersomnia (Xywav) - Reauthorization

Covered when ALL of the following are met:

EDS reduction: Reduction in symptoms of excessive daytime sleepiness associated with therapy

Documentation Required

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.

Billing Rule

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.

9/2024revisedLatest

Updated initial authorization duration to 12 months (noted 9/2024 update).