CurrentUnitedHealthcarePolicy 2025 P 2021-19

CNS Depressants - Lumryz™ (sodium oblate), sodium oxybate [Xyrem authorized generic (manufactured by Amneal)], sodium oxybate [Xyrem authorized generic (manufactured by Hikma)], Xyrem® (sodium oxybate)

Policy defines prior authorization and medical necessity criteria for Lumryz, sodium oxybate authorized generics (Amneal, Hikma), brand Xyrem, and Xywav for narcolepsy with cataplexy (NT1), narcolepsy without cataplexy (NT2), and idiopathic hypersomnia (IH), including initial and reauthorization requirements, prescriber specialties, required diagnostic testing, prior therapy trials, and authorization duration.

Policy Summary

PayerUnitedHealthcare

PolicyCNS Depressants - Lumryz™ (sodium oblate), sodium oxybate [Xyrem authorized generic (manufactured by Amneal)], sodium oxybate [Xyrem authorized generic (manufactured by Hikma)], Xyrem® (sodium oxybate)

Policy CodePolicy 2025 P 2021-19

Change TypeAnnual review; references updated

Effective DateNov 16, 2025

Next Review Date

Key ActionSubmit required medical records (MSLT/PSG results, attestation, prior therapy trials, prescriber specialty) for prior authorization; approvals issued for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Effective date 11/16/2025; Annual review 9/2025 with updated references for Narcolepsy Type 2.

Policy notes that sodium oxybate (Amneal) and brand Xyrem are typically excluded from coverage.

3Covered indications (NT1, NT2, IH [Xywav only])

12Authorization duration (months)

≤8 / <8

MSLT mean sleep latency thresholds

2SOREMPs required for NT1/NT2

Coverage Summary

Scope: This policy (Program/Policy Number 2025 P 2021-19; effective 2025-11-16; last review 2025-09; status: CURRENT) defines prior authorization and medical necessity criteria for sodium oxybate products — Lumryz, sodium oxybate authorized generics (Amneal, Hikma), brand Xyrem, and Xywav — for treatment of narcolepsy with cataplexy (Narcolepsy Type 1), narcolepsy without cataplexy (Narcolepsy Type 2), and idiopathic hypersomnia (Xywav only).

Coverage stance: Covered with criteria — initial and reauthorization approvals require specified diagnostic documentation, prescriber specialty, prior therapy trials as applicable, and attestations; authorizations are issued for 12 months when criteria are met. High-level covered indications: NT1, NT2 for the listed sodium oxybate products, and IH (Xywav only) for Xywav. Key diagnostic thresholds referenced include mean sleep latency of ≤ 8 minutes for NT1/NT2 (and < 8 minutes for IH) and requirement of two or more SOREMPs for NT1/NT2 (with one SOREMP possibly from the prior PSG).

Threshold summary

Mean sleep latency (NT1/NT2)≤ 8 minutes

SOREMPs required (NT1/NT2)Two or more SOREMPs on MSLT (one may be replaced by a SOREMP on preceding nocturnal PSG)

Mean sleep latency (IH)< 8 minutes

SOREMPs for IHFewer than two SOREMPs on MSLT (or no SOREMPs if REM latency on prior PSG < 15 minutes)

Symptom durationDaily irrepressible need to sleep or daytime lapses into sleep for at least three months

Medical Necessity Criteria

Initial Authorization for Narcolepsy with Cataplexy (Narcolepsy Type 1)

Approved when ALL of the following are met:

ALL of the following

Submission of medical records (e.g., chart notes, laboratory values) documenting a diagnosis of narcolepsy with cataplexy (Narcolepsy Type 1)
Diagnostic features
- The patient has daily periods of irrepressible need to sleep or daytime lapses into sleep occurring for at least three months
- A mean sleep latency of ≤ 8 minutes and two or more sleep onset REM periods (SOREMPs) on an MSLT performed according to standard techniques following a normal overnight polysomnogramMSLT mean sleep latency ≤ 8 minutes; two or more SOREMPs

Not Covered / Typical Exclusions

Notes on exclusions/typical exclusionmixedNot Covered

Sodium oxybate [Xyrem authorized generic (manufactured by Amneal)] and brand Xyrem are typically excluded from coverage (policy note)

Policy note: sodium oxybate [Xyrem authorized generic (manufactured by Amneal)] and brand Xyrem are typically excluded from coverage. When coverage for these specific formulations is requested, the policy requires documentation of trial, failure, or intolerance to three alternative specified products (Lumryz; Hikma authorized generic; Xywav; Wakix) before approval — this three-product trial requirement does not apply when requesting Lumryz, the Hikma authorized generic, or Xywav.

Coding

Product Names / Covered Agents (subject to criteria above)mixedCovered

	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)
	Wakix (pitolisant) - listed for prior trial requirement
	Sunosi (solriamfetol) - listed for prior trial requirement

Provider Actions & Authorization Details

Prior Authorization

Prior authorization required

Initial and reauthorization requests must include submission of medical records (e.g., chart notes, laboratory values) documenting the diagnosis, MSLT and/or overnight polysomnogram results, physician attestation, any required prior therapy trials, and the prescriber specialty. If all criteria are met, a prior authorization will be issued for 12 months.

Documentation Required

Required diagnostic documentation

Submit medical records (chart notes, lab values) documenting MSLT results including mean sleep latency and number of SOREMPs, and an overnight polysomnogram when applicable. Include a physician attestation that other causes of sleepiness have been ruled out or treated.

Background, Evidence & Definitions

Background: Lumryz, Xyrem (sodium oxybate) and Xywav are central nervous system depressants indicated for treatment of excessive daytime sleepiness (EDS) or cataplexy in narcolepsy; Xywav is also indicated for idiopathic hypersomnia in adults. These products are controlled substances and are available only through a REMS program with restricted distribution that requires patient and prescriber education, documentation that the patient has read/understood REMS materials (drug shipped thereafter), and recommended follow-up (every 3 months).

Evidence and references: Primary references cited in the policy include the package inserts for Xyrem, Xywav, Lumryz, and authorized generic sodium oxybate products, and the American Academy of Sleep Medicine 2021 clinical practice guideline (Maski et al., 2021). The reference list in the policy specifically names Xyrem [package insert], Xywav [package insert], Lumryz [package insert], sodium oxybate authorized generic package inserts, and the AASM guideline and classification references.

Term	Definition
SOREMP	Sleep onset REM period occurring within 15 minutes of sleep onset
MSLT	Multiple Sleep Latency Test; used to measure mean sleep latency and detect SOREMPs

Revision History

2025-11-16effective_dateLatest

Policy effective date set to 11/16/2025 (Program Number 2025 P 2021-19).

2025-09revision_note

Annual review (9/2025) with updated references.

2024-09revision_note

Annual review (9/2024) updated initial authorizations to 12 months and updated references.

Policy Summary

PayerUnitedHealthcare

Policy CodePolicy 2025 P 2021-19

Change TypeAnnual review; references updated

Effective DateNov 16, 2025

Next Review Date

Key ActionSubmit required medical records (MSLT/PSG results, attestation, prior therapy trials, prescriber specialty) for prior authorization; approvals issued for 12 months when criteria are met.

SourceLink

On This Page

Physician attestation

Patient has experienced cataplexy defined as more than one episode of sudden loss of muscle tone with retained consciousness
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 other sleep disorders)

Prescribed by a Neurologist, Psychiatrist, Pulmonologist, or Sleep Medicine Specialist

Additional requirement for Xyrem (brand) and Amneal authorized generic

Select three from
- Lumryz
- sodium oxybate [Xyrem authorized generic (manufactured by Hikma)]
- Xywav
- Wakix

Reauthorization for Narcolepsy with Cataplexy

Continuation approved when ONE of the following is met:

ANY of the following

Documentation demonstrating a reduction in frequency of cataplexy attacks associated with therapy
Documentation demonstrating reduction in symptoms of excessive daytime sleepiness associated with therapy

Initial Authorization for Narcolepsy without Cataplexy (Narcolepsy Type 2)

Approved when ALL of the following are met:

ALL of the following

Submission of medical records (e.g., chart notes, lab values) documenting a diagnosis of narcolepsy without cataplexy (Narcolepsy Type 2)
Diagnostic features
- The patient has daily periods of irrepressible need to sleep or daytime lapses into sleep occurring for at least three months
- A mean sleep latency of ≤ 8 minutes and two or more SOREMPs on an MSLT performed according to standard techniques following a normal overnight polysomnogramMSLT mean sleep latency ≤ 8 minutes; two or more SOREMPs
Physician attestation: 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)
History of failure/contraindication/intolerance
- Stimulant trial (one required)
  - Amphetamine based stimulant (e.g., amphetamine, dextroamphetamine)
  - Methylphenidate based stimulant
- Wake-promoting agent trial (one required)
  - modafanil (Provigil)
  - armodafanil (Nuvigil)
- Sunosi (solriamfetol)
Prescribed by a Neurologist, Psychiatrist, Pulmonologist, or Sleep Medicine Specialist
Additional requirement for Xyrem (brand) and Amneal authorized generic
- Select three from
  - Lumryz
  - sodium oxybate [Xyrem authorized generic (manufactured by Hikma)]
  - Xywav
  - Wakix

Reauthorization for Narcolepsy without Cataplexy (Narcolepsy Type 2)

Continuation approved when the following is met:

Documentation demonstrating reduction in symptoms of excessive daytime sleepiness associated with therapy

Initial Authorization for Idiopathic Hypersomnia (IH) - Xywav only

Xywav approved when ALL of the following are met:

ALL of the following

Submission of medical records (e.g., chart notes, lab values) documenting a diagnosis of idiopathic hypersomnia
Diagnostic features
- The patient has daily periods of irrepressible need to sleep or daytime lapses into sleep occurring for at least three months
- A mean sleep latency of < 8 minutes and fewer than two REM periods (SOREMPs) on an MSLT performed according to standard techniques following a normal overnight polysomnogram, or no SOREMPs if the REM sleep latency on the preceding polysomnogram was < 15 minutesMSLT mean sleep latency < 8 minutes; fewer than two SOREMPs (or none if REM latency on prior PSG < 15 minutes)
Physician attestation that 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)
History of failure/contraindication/intolerance
- Stimulant trial (one required)
  - Amphetamine based stimulant (e.g., amphetamine, dextroamphetamine)
  - Methylphenidate based stimulant
- Wake-promoting agent trial (one required)
  - modafanil (Provigil)
  - armodafanil (Nuvigil)
Prescribed by a Neurologist, Psychiatrist, Pulmonologist, or Sleep Medicine Specialist

Reauthorization for Idiopathic Hypersomnia (Xywav)

Continuation approved when the following is met:

Documentation demonstrating reduction in symptoms of excessive daytime sleepiness associated with therapy

Documentation Required

Physician specialty requirement

Prescriptions must be written by a Neurologist, Psychiatrist, Pulmonologist, or Sleep Medicine Specialist.

Prior Authorization

Prior trial requirements for certain products

For brand Xyrem and the Amneal authorized generic, the request must document a trial, failure, or intolerance to three of the following: Lumryz; the Hikma authorized generic; Xywav; or Wakix prior to approval.

Denial Risk

Denial risk if diagnostic criteria not met

Claims may be denied when diagnostic or documentation requirements are not met. Common reasons include MSLT/PSG results that do not meet mean sleep latency or SOREMP thresholds, other causes of sleepiness not ruled out or treated, missing required prior trials, or absence of required prescriber specialty documentation.

MSLT/PSG thresholds (mean sleep latency and SOREMP count) not met
Other causes of sleepiness not ruled out or treated
Required prior therapy trials not documented
Prescriber is not an approved specialist (Neurologist, Psychiatrist, Pulmonologist, Sleep Medicine Specialist)

Billing Rule

Authorization duration

Authorizations (initial and reauthorization) are issued for 12 months when the coverage criteria are met.

Documentation Required

REMS and restricted distribution

These agents are available only through a REMS program with restricted distribution. Document patient enrollment and that the patient has read and/or understood REMS educational materials as required for shipment. The REMS program also recommends patient follow-up every 3 months.

ongoingclarification

Policy notes that sodium oxybate (manufactured by Amneal) and brand Xyrem are typically excluded from coverage.