CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Sodium Oxybate (Xyrem, Lumryz) — Coverage Criteria for Narcolepsy-related Cataplexy and Excessive Daytime Sleepiness

Covers prior authorization and medical necessity criteria for sodium oxybate (Xyrem, Lumryz) for treatment of narcolepsy-related cataplexy and excessive daytime sleepiness in members when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySodium Oxybate (Xyrem, Lumryz) — Coverage Criteria for Narcolepsy-related Cataplexy and Excessive Daytime Sleepiness

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with sleep lab confirmation and required documentation to request up to a 12-month authorization when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period when criteria met

>= 7 yrsminimum age for covered indications

>= 3/weekcataplexy baseline required

sleep lab requireddiagnosis confirmation

Coverage Criteria for Sodium Oxybate

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Initial therapy — EDS with narcolepsy

Authorization of 12 months may be granted for treatment of excessive daytime sleepiness (EDS) with narcolepsy when ALL of the following criteria are met:

EDS Initial Criteria: Diagnosis of narcolepsy is confirmed by a sleep lab evaluation

Age-specific prior treatment requirements: For members 7-17: inadequate response or intolerance to at least one CNS stimulant (e.g., amphetamine, dextroamphetamine, methylphenidate) OR contraindication to at least one CNS stimulant; For members >=18: inadequate response or intolerance to modafinil or armodafinil OR contraindication to both modafinil and armodafinil

Examples of CNS stimulants: amphetamine, dextroamphetamine, methylphenidate

Initial therapy — Cataplexy with narcolepsy

Authorization of 12 months may be granted for treatment of cataplexy with narcolepsy when ALL of the following criteria are met:

Cataplexy Initial Criteria: Member is >= 7 years of age

Cataplexy Initial Criteria: Diagnosis of narcolepsy is confirmed by a sleep lab evaluation

Cataplexy Initial Criteria: Member has a baseline history of at least 3 cataplexy attacks per week>= 3/week

Continuation therapy — Demonstrated benefit

Continuation therapy — EDS and Cataplexy

Continuation EDS: Chart notes or medical record documentation supporting a beneficial response to therapy as demonstrated by a decrease in daytime sleepiness from baseline

12-month authorization possible

Continuation Cataplexy: Chart notes or medical record documentation supporting a beneficial response to therapy as demonstrated by a decrease in cataplexy episodes from baseline

12-month authorization possible

Sodium oxybate coverage is limited to the two FDA‑approved narcolepsy indications: cataplexy and excessive daytime sleepiness (EDS) in members 7 years and older. Use for any other indication is considered experimental/investigational and is not covered. Prior authorization requirements and clinical documentation must support these specific indications to be eligible for benefit approval.

Use of sodium oxybate for indications other than treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy is not medically necessary. Requests for non‑FDA or non‑compendial uses should be denied as experimental/investigational per the policy.

Key Coding & Thresholds

inv-06: Cataplexy attack frequency threshold for initial authorization

Initial authorization threshold>= 3 cataplexy attacks per week for baseline history

Authorization durationUp to 12 months when criteria met

DocumentationDiagnosis of narcolepsy must be confirmed by a sleep lab evaluation

inv-07: Minimum age requirement for covered indications

Minimum age for coverage>= 7 years

Applicable indicationsCataplexy and excessive daytime sleepiness (EDS) in narcolepsy

Non‑covered usesAll indications other than the two narcolepsy indications are experimental/investigational and not medically necessary

inv-14: Cataplexy baseline requirement — documented history >= 3 attacks/week

Baseline cataplexy requirementDocumented history of at least 3 cataplexy attacks per week

Confirmation neededDiagnosis of narcolepsy must be confirmed by a sleep lab evaluation

Authorization durationUp to 12 months when criteria met

inv-13: Drug definition — sodium oxybate (Xyrem, Lumryz)

Generic namesodium oxybate

Brand namesXyrem, Lumryz

IndicationsTreatment of cataplexy and excessive daytime sleepiness in patients 7 years and older with narcolepsy

Provider Requirements, Documentation, and Operational Notes

Prior Authorization

Prior authorization duration and general requirement

Authorization may be granted for up to 12 months when criteria are met for either excessive daytime sleepiness (EDS) or cataplexy related to narcolepsy. Ensure prior authorization includes the required clinical documentation described below.

Duration: 12 months when medical necessity criteria are met
Applies to initial and continuation requests meeting the specific diagnostic and response criteria

Step Therapy

Step therapy note

Per regulatory guidance for behavioral health, step therapy restrictions may vary by plan and benefit design. Verify member-specific step therapy requirements prior to submitting a prior authorization request; do not assume uniform step edits across behavioral health medications.

Step therapy rules may differ by behavioral health benefit and state/regulatory requirements
Confirm any plan-specific step edits or exceptions before prescribing or requesting authorization

Documentation Required

Required documentation

Submit the following documentation to initiate prior authorization review. For initial requests include sleep lab evaluation results and prior medication history; for continuation requests include chart notes documenting beneficial response.

Initial requests: sleep lab evaluation documenting narcolepsy diagnosis
Initial requests: chart notes, medical record documentation, or claims history supporting prior medications tried and response, or clinical rationale for avoiding therapy
Continuation requests: chart notes documenting beneficial response — decreased daytime sleepiness (EDS) from baseline for EDS indications, or decreased cataplexy episodes from baseline for cataplexy indications

Denial Risk

Non‑covered indications

Uses 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 not medically necessary.

Non‑covered: any indication outside FDA‑approved narcolepsy indications (EDS or cataplexy in ≥7-year-olds)

Definitions

inv-13: Sodium oxybate — marketed as Xyrem and Lumryz

Marketed asXyrem and Lumryz (generic name: sodium oxybate)

All dosage forms includedBoth brand and generic and all dosage forms and strengths unless otherwise stated

Reference contextListed in products referenced by this document

inv-14: Cataplexy baseline requirement restated

Required baseline frequencyAt least 3 cataplexy attacks per week documented in history

Related requirementDiagnosis of narcolepsy must be confirmed by a sleep lab evaluation

ScopeApplies to initial authorization for cataplexy indication