CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Sodium oxybate (Xyrem, Lumryz) for narcolepsy (EDS and cataplexy) — Coverage Criteria

Covers FDA‑approved use of sodium oxybate for treatment of cataplexy or excessive daytime sleepiness (EDS) in patients aged 7 years and older with narcolepsy; applies to members of Neighborhood Health Plan of Rhode Island following payer criteria and prior authorization. Other uses are considered experimental/investigational and not covered.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySodium oxybate (Xyrem, Lumryz) for narcolepsy (EDS and cataplexy) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization with sleep lab documentation and required prior‑therapy or contraindication information; authorization may be granted for up to 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

7minimum covered patient age

12 moauthorization duration

1+prior CNS stimulant trial

FDA‑approved onlyOther indications

Coverage Criteria for Sodium Oxybate (Narcolepsy)

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Initial EDS therapy

Authorization of 12 months may be granted when ALL of the following are met:

EDS initial criteria: 1) Diagnosis of narcolepsy confirmed by a sleep lab evaluation; 2) Member is 7 years of age or older; 3) For members 7 to <18 years: experienced inadequate response or intolerance to at least one central nervous system (CNS) stimulant (e.g., amphetamine, dextroamphetamine, methylphenidate); 4) For members ≥18 years: one of the following - contraindication to at least one CNS stimulant OR experienced inadequate response or intolerance to modafinil or armodafinil OR contraindication to both modafinil and armodafinil.age and prior therapy requirements

Documentation of sleep lab evaluation and prior medication trials or clinical reasons to avoid therapy required

Initial cataplexy therapy

Authorization of 12 months may be granted when ALL of the following are met:

Cataplexy initial criteria: 1) Member is 7 years of age or older; 2) Diagnosis of narcolepsy confirmed by a sleep lab evaluation.age ≥7 and diagnostic confirmation

Prescriber specialty and documentation of sleep lab evaluation required

Continuation therapy

Authorization of 12 months may be granted for continued treatment when the following is met:

Continuation criteria: Member has demonstrated beneficial response to therapy: for EDS a decrease in daytime sleepiness from baseline; for cataplexy a decrease in cataplexy episodes from baseline.documented clinical improvement

Chart notes or medical record documentation supporting clinical benefit required

Requests for sodium oxybate for indications other than treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy are considered experimental/investigational and are not covered. This policy limits coverage to the FDA‑approved and compendial uses specified in the Indications section.

Use of sodium oxybate for any non‑FDA or non‑compendial indication (that is, indications not listed in the Indications section) is considered not medically necessary and will not be authorized.

Prior Authorization, Documentation, and Step Therapy Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization up to 12 months may be granted when the listed clinical criteria and documentation are provided for the requested indication.

Authorization duration: up to 12 months
Applicable indications: treatment of cataplexy or excessive daytime sleepiness (EDS) in patients ≥7 years with narcolepsy

Step Therapy

Step Therapy / Prior Trials

Step therapy / prior trials required for EDS: for adults, documentation of inadequate response or intolerance to modafinil or armodafinil, or contraindication to both, is required; alternatively, inadequate response or intolerance to at least one CNS stimulant (eg, amphetamine, dextroamphetamine, methylphenidate) or contraindication to a CNS stimulant may satisfy requirements where specified. Per regulatory behavioral health guidance, step therapy restrictions may vary.

Adults (≥18 years): inadequate response or intolerance to modafinil or armodafinil, or contraindication to both; OR inadequate response or intolerance to at least one CNS stimulant, or contraindication to a CNS stimulant
Pediatrics (≥7 to <18 years): documentation of inadequate response or intolerance to at least one CNS stimulant (eg, amphetamine, dextroamphetamine, methylphenidate) or documented contraindication to a CNS stimulant when required
Note: Step therapy rules may vary by regulatory behavioral health requirements

Documentation Required

Required Documentation for Initial and Continuation Requests

Required documentation for initial and continuation requests must be submitted to initiate prior authorization review.

Initial requests: sleep lab evaluation confirming diagnosis of narcolepsy; chart notes/medical records or claims history documenting prior medications tried and responses, or clinical rationale for avoiding specific therapies
Continuation requests: chart notes or medical records demonstrating beneficial response from baseline — for EDS, decreased daytime sleepiness; for cataplexy, decreased cataplexy episodes
Documentation must include age confirmation (≥7 years) and any contraindications cited

Documentation Required

Prescriber Specialty Requirement

Prescription must be written by or in consultation with an appropriate specialist experienced in managing sleep disorders.

Prescriber must be a sleep specialist, neurologist experienced with sleep disorders, or a physician certified in sleep medicine
If prescribed in consultation, include documentation of the consult

Denial Risk

Non-covered Indications

Requests for indications other than treatment of cataplexy or EDS in patients ≥7 years with narcolepsy are considered experimental/investigational and are not covered.

Only FDA-approved and compendial uses listed (cataplexy or EDS in narcolepsy ≥7 years) are covered when criteria met
All other indications: experimental/investigational — not medically necessary

Denial Risk

Insufficient Diagnostic or Trial Documentation — Denial Risk

Insufficient diagnostic or trial documentation may result in denial of the request.

Missing sleep lab confirmation of narcolepsy
Lack of chart notes/medical records or claims history supporting prior therapy trials or contraindications
Absence of documentation demonstrating clinical benefit for continuation requests

Clinical Definitions and Diagnostic Requirements

inv-15: Beneficial response — Definitions for response in EDS and cataplexy (decrease from baseline)

Beneficial response — EDSDocumented decrease in daytime sleepiness from baseline as shown in chart notes or medical records

Beneficial response — CataplexyDocumented decrease in cataplexy episodes from baseline as shown in chart notes or medical records

Documentation sourceChart notes, medical records, or claims history demonstrating clinical improvement

inv-16: Sleep lab evaluation — Objective diagnostic testing confirming narcolepsy required for initial request

Sleep lab confirmation requiredObjective diagnostic testing confirming narcolepsy (documentation from a sleep laboratory) is required for initial requests

Applies to both EDS and cataplexy initial requestsInitial authorization for treatment of EDS or cataplexy requires sleep lab evaluation confirming narcolepsy

Submission guidanceProvide documentation of the sleep lab evaluation with the initial prior authorization request (alongside chart notes/medication history)

OpenPayer

Sodium oxybate (Xyrem, Lumryz) for narcolepsy (EDS and cataplexy) — Coverage Criteria

Coverage Criteria for Sodium Oxybate (Narcolepsy)

Drug Products, Codes, and Authorization Length

Prior Authorization, Documentation, and Step Therapy Requirements

Clinical Definitions and Diagnostic Requirements

Background on Sodium Oxybate

Xyrem	sodium oxybate (brand)
Lumryz	sodium oxybate (brand)