CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Sodium Oxybate Products (Lumryz, Xywav, Sodium Oxybate) — Coverage Criteria

Policy governs coverage criteria, prescribing specialties, quantity limits, and authorization durations for sodium oxybate, Lumryz, and Xywav for members with narcolepsy or idiopathic hypersomnia.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySodium Oxybate Products (Lumryz, Xywav, Sodium Oxybate) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date12/2017

Next Review DateN/A

Key ActionObtain prior authorization; approval typically granted for 6 months when all specified clinical criteria and documentation are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsauthorization duration

>=7min age (narcolepsy)

>=18min age (IH)

18 ml/dayqty limit (solutions)

1 pkt/dayqty limit (Lumryz)

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Coverage Criteria for Sodium Oxybate Products

Initial Therapy — Authorization of 6 months may be granted when ALL of the following are met:

Authorization of 6 months may be granted when ALL of the following are met:

Universal initial requirements: 1. Documentation that the member is not being treated with sedative hypnotics that will be used concurrently with sodium oxybate; 2. Documentation that the member does not have a history of drug or alcohol abuse; 3. Member weighs at least 45 kgs if the requested drug is Lumryz; 4. Documentation that the member meets one of the indication-specific branches below.

Universal safety and product-specific weight requirement.

Indication-specific: Member meets criteria for ONE of the following: a) Cataplexy in narcolepsy (>=7 years); b) Excessive daytime sleepiness in narcolepsy without cataplexy (>=7 years); c) Idiopathic hypersomnia (>=18 years).

Choose one branch.

Cataplexy branch: a) The requested drug is being prescribed for the treatment of cataplexy in narcolepsy in a member 7 years of age or older; b) The diagnosis is confirmed by sleep lab evaluation; c) The member has a baseline history of at least 14 cataplexy attacks in a typical 2-week period; d) The member has experienced an inadequate treatment response, intolerance, or contraindication to at least two of the following agents from a different medication class: atomoxetine, fluoxetine, protriptyline, clomipramine, and/or venlafaxine.

Applies for members ≥7 years.

EDS in narcolepsy branch: a) The requested drug is being prescribed for the treatment of excessive daytime sleepiness in a member 7 years of age or older with narcolepsy without cataplexy; b) The diagnosis is confirmed by sleep lab evaluation; c) The member has experienced an inadequate treatment response, intolerance, or contraindication to at least one CNS stimulant (e.g., amphetamine, dextroamphetamine, methylphenidate); d) If the member is 18 years of age or older, the member experienced an inadequate treatment response or intolerance to at least one CNS wakefulness-promoting drug (e.g., modafinil, armodafinil) OR has a contraindication to both armodafinil and modafinil.

Applies for members ≥7 years; additional requirements for adults ≥18 years.

Idiopathic hypersomnia branch: a) The requested drug is being prescribed for the treatment of idiopathic hypersomnia in a member 18 years of age or older; b) Presence of daytime lapses into sleep or daily irrepressible need to sleep for at least 3 months; c) Insufficient sleep syndrome has been ruled out (preferably with at least a week of sleep log and wrist actigraphy); d) A multiple sleep latency test (MSLT) documents fewer than two SOREMPs or no SOREMPs if the REM latency on the preceding polysomnogram was ≤15 minutes; e) Presence of at least one of: mean sleep latency on MSLT ≤8 minutes OR total 24‑hour sleep time ≥660 minutes on 24‑hour PSG or wrist actigraphy averaged over ≥7 days; f) The member does not have cataplexy; g) Hypersomnolence/MSLT results are not better explained by another sleep disorder, medical/psychiatric disorder, or medication use; h) The member has experienced an inadequate treatment response, intolerance, or contraindication to at least one CNS stimulant; i) The member experienced an inadequate treatment response, intolerance, or has a contraindication to modafinil.

Applies for members ≥18 years.

Continuation Therapy — criteria for ongoing approval

Continuation Therapy: Authorization of 6 months may be granted when clinical documentation shows a decrease in daytime sleepiness for narcolepsy or idiopathic hypersomnia, or a decrease in cataplexy episodes for narcolepsy, compared to baseline (clinical notes provided to support treatment efficacy).

Must show treatment efficacy in submitted clinical documentation.

All indications other than the FDA‑approved indications listed for sodium oxybate products (including compendial or other non‑approved uses) are considered experimental/investigational and are not a covered benefit.

Dosing, Weight & Diagnostic Thresholds

inv-04: Weight for Lumryz — member weighs at least 45 kgs

Weight requirementMember weighs at least 45 kg when the requested drug is Lumryz.

ContextThis is a product-specific safety/usage requirement for Lumryz in the initial approval criteria.

Authorization impactMust be documented for initial 6-month approval; lack of documentation may preclude approval.

inv-05: Duration of symptoms for IH — at least 3 months

Minimum duration of symptomsDaytime lapses into sleep or irrepressible need to sleep for at least 3 months.

Role in diagnosisRequired to meet idiopathic hypersomnia initial approval branch for members 18 years or older.

DocumentationPreferably supported by sleep logs and wrist actigraphy to exclude insufficient sleep syndrome.

inv-06: Mean sleep latency on MSLT — less than or equal to 8 minutes

MSLT mean sleep latency thresholdMean sleep latency on MSLT of less than or equal to 8 minutes.

UseOne of the supportive criteria for idiopathic hypersomnia initial approval in adults (>=18 years).

MeasurementReported mean sleep latency from a standard multiple sleep latency test (MSLT).

inv-07: Total 24-hour sleep time threshold — greater than or equal to 660 minutes

24-hour sleep time thresholdTotal 24-hour sleep time greater than or equal to 660 minutes on 24-hour polysomnographic monitoring or wrist actigraphy.

ContextUsed as an alternative supportive objective measure for idiopathic hypersomnia diagnosis when averaged over at least 7 days of unrestricted sleep.

PrerequisiteChronic sleep deprivation should be corrected prior to measurement.

Prior Authorization, Documentation & Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization of up to 6 months may be granted when all specified clinical criteria are met and appropriate documentation is provided.

Approval duration: typically 6 months when criteria are met

Step Therapy

Required Prior Medication Trials / Step Therapy

Step therapy requirements apply prior to approval. For cataplexy, documentation must show inadequate response, intolerance, or contraindication to at least two agents from different medication classes (examples: atomoxetine, fluoxetine, protriptyline, clomipramine, venlafaxine). For excessive daytime sleepiness (EDS) in narcolepsy, documentation must show inadequate response, intolerance, or contraindication to at least one CNS stimulant (e.g., amphetamine, dextroamphetamine, methylphenidate); for adults (≥18 years) also inadequate response or contraindication to modafinil/armodafinil as specified.

Cataplexy: trial of ≥2 agents from different classes (atomoxetine, fluoxetine, protriptyline, clomipramine, venlafaxine)
EDS (narcolepsy): trial of ≥1 CNS stimulant (e.g., amphetamine, dextroamphetamine, methylphenidate)
Adults with EDS: trial of modafinil or armodafinil unless contraindicated

Documentation Required

Required Clinical Documentation

Provide clinical documentation that confirms the diagnosis and baseline symptom frequency where applicable. If prescribing for narcolepsy with cataplexy or narcolepsy with EDS, include sleep lab confirmation of the diagnosis. For cataplexy include baseline frequency (e.g., at least 14 cataplexy attacks in a typical 2-week period). For continuation requests, provide clinical notes demonstrating reduction in daytime sleepiness or reduction in cataplexy episodes from baseline.

Sleep lab evaluation confirming diagnosis for narcolepsy indications
Baseline cataplexy frequency (≥14 attacks per 2-week period) for cataplexy indication
For continuation: documentation of clinical improvement from baseline

Denial Risk

Non‑FDA Indications May Be Denied

Requests for uses not included in FDA‑approved indications (including indications other than narcolepsy [cataplexy or EDS] and idiopathic hypersomnia for Xywav) are considered experimental/investigational and may be denied.

All indications other than FDA‑approved uses are considered experimental/investigational and are not a covered benefit

Denial Risk

Concurrent Sedative Use or Substance Abuse — Denial Risk

Concurrent use of sedative-hypnotics or a history of drug or alcohol abuse may preclude approval. Documentation must show the member is not being treated with sedative hypnotics that will be used concurrently with sodium oxybate and that there is no history of drug or alcohol abuse.

Member must not be treated with concurrent sedative-hypnotics
No history of drug or alcohol abuse

Documentation Required

Idiopathic Hypersomnia Diagnostic Documentation

For idiopathic hypersomnia (IH) requests (adults ≥18 years), include specific diagnostic documentation: daytime lapses into sleep or irrepressible need to sleep for ≥3 months; exclusion of insufficient sleep syndrome (preferably via ≥1 week sleep log with wrist actigraphy showing lack of improvement after increased time in bed); MSLT showing <2 SOREMPs (or no SOREMPs if REM latency on preceding PSG ≤15 minutes); and at least one of: mean MSLT latency ≤8 minutes OR total 24‑hour sleep time ≥660 minutes on 24‑hour polysomnography or wrist actigraphy averaged over ≥7 days. Also document lack of cataplexy, exclusion of other causes, and prior inadequate response/intolerance/contraindication to at least one CNS stimulant and to modafinil (or documentation of contraindication).

Daytime lapses/irrepressible sleep ≥3 months
Rule out insufficient sleep syndrome (sleep log + wrist actigraphy)
MSLT: <2 SOREMPs (or none if PSG REM latency ≤15 min)
At least one: mean MSLT ≤8 min OR 24‑hour total sleep time ≥660 minutes (24‑hr PSG or wrist actigraphy averaged ≥7 days)
No cataplexy; exclude other causes; prior trial of ≥1 CNS stimulant and inadequate response/intolerance/contraindication to modafinil

Key Definitions and Baseline Requirements

inv-15: Idiopathic hypersomnia (IH) — definition and diagnostic features (>=3 months daytime sleepiness etc.)

DefinitionIdiopathic hypersomnia (IH) is a disorder characterized by excessive daytime sleepiness with daytime lapses into sleep or an irrepressible need to sleep for at least 3 months.

Diagnostic testingMSLT must document fewer than two SOREMPs (or no SOREMPs if preceding PSG REM latency <= 15 minutes); supportive findings include mean MSLT latency <= 8 minutes or total 24-hour sleep time >= 660 minutes.

ExclusionsInsufficient sleep syndrome must be ruled out, preferably with sleep logs and wrist actigraphy; hypersomnolence must not be better explained by another disorder or medication.

Age requirementApplies for initial approval in members 18 years of age or older.

inv-16: Cataplexy baseline requirement — baseline history of at least 14 cataplexy attacks in a typical 2-week period required for approval

Cataplexy baseline requirementBaseline history of at least 14 cataplexy attacks in a typical 2-week period is required for approval when treating cataplexy.

Diagnosis confirmationCataplexy branch also requires diagnosis confirmed by sleep lab evaluation.

Prior treatment requirementMember must have had inadequate response, intolerance, or contraindication to at least two specified agents from different classes (atomoxetine, fluoxetine, protriptyline, clomipramine, venlafaxine).

OpenPayer

Sodium Oxybate Products (Lumryz, Xywav, Sodium Oxybate) — Coverage Criteria

Coverage Criteria for Sodium Oxybate Products

Dosing, Weight & Diagnostic Thresholds

Prior Authorization, Documentation & Step Therapy

Background on Sodium Oxybate Products

Key Definitions and Baseline Requirements