CurrentMedical Mutual - OhioPolicy N/A

Narcolepsy Products Prior Authorization Policy

Defines prior authorization requirements for Wakix, sodium oxybate products (Xyrem, Xywav, Lumryz) for narcolepsy and related indications; applies to pharmacy benefit coverage decisions for members under Medical Mutual - Ohio.

Policy Summary

PayerMedical Mutual - Ohio

PolicyNarcolepsy Products Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAnnual review (no material changes)

Effective DateN/A

Next Review DateAug 21, 2025

Key ActionObtain prior authorization and ensure initial prescribing is by or in consultation with a sleep specialist or neurologist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4impacted drugs listed

3mo / 1yrapproval durations

≥6–≥18age range

Sleep studydiagnostic testing required

Coverage Criteria for Narcolepsy Products

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Concomitant use of sodium oxybate products is not recommended. Specifically, Lumryz, sodium oxybate oral solution (Xyrem), and Xywav should not be used together or alternated because they contain the same active moiety (oxybate) and have not been studied in combination. Additionally, use of any oxybate product in combination with Wakix (pitolisant) or Sunosi (solriamfetol) is not recommended due to lack of published evidence evaluating such combinations and potential safety concerns related to combining a CNS depressant with other wake-promoting agents.

Impacted Drugs, Age Criteria, and Codes

Impacted drugsNDC

Wakix	pitolisant tablets
Xyrem	sodium oxybate oral solution
Xywav	calcium, magnesium, potassium, and sodium oxybates oral solution
Lumryz	sodium oxybate extended-release oral suspension

Impacted drugs (alternate listing)mixed

Wakix	pitolisant tablets - Harmony
Xyrem	sodium oxybate oral solution - Jazz, generic
Xywav	calcium, magnesium, potassium, and sodium oxybates oral solution - Jazz
Lumryz	sodium oxybate extended-release oral suspension - Avadel

Minimum age by product/indication

Wakix (pitolisant)>= 6 years for EDS and cataplexy (per Wakix criteria)

Lumryz (sodium oxybate ER)>= 7 years for narcolepsy indications (EDS and cataplexy)

Xyrem (sodium oxybate oral solution)>= 7 years for narcolepsy indications (EDS and cataplexy)

Xywav (calcium/magnesium/potassium/sodium oxybates)>= 7 years for narcolepsy indications; >= 18 years for idiopathic hypersomnia

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for the listed narcolepsy products prior to pharmacy benefit coverage. Initial approvals require the drug be prescribed by or in consultation with a physician who specializes in the condition being treated. All approvals for initial therapy are provided for the initial approval duration noted in the policy; reauthorization requires documented response to therapy when continuation is allowed.

Affected products: Wakix (pitolisant), Xyrem (sodium oxybate), Xywav (mixed-cation oxybate), Lumryz (sodium oxybate ER).
Prescriber requirement: prescribed by or in consultation with a sleep disorder specialist, neurologist, pulmonologist, or psychiatrist as specified per criteria.

Step Therapy

Step-Therapy / Multiple-Step Requirements

Step-therapy and multiple-step requirements apply and vary by product and indication. For EDS and cataplexy criteria, trials of modafinil or armodafinil, or trials of CNS stimulants (e.g., methylphenidate, dexmethylphenidate, dextroamphetamine) are required per the specific product/age/indication rules. For some adult EDS criteria additional prior trials may include Lumryz, Sunosi, and Wakix or documented contraindications/intolerance to those agents.

Examples: adults may need trials of two agents from CNS stimulant/modafinil/armodafinil; pediatric criteria may require one trial depending on age and indication.
For idiopathic hypersomnia (Xywav) the patient must have tried at least one of modafinil, armodafinil, or methylphenidate.

Documentation Required

Documentation May Be Requested

The Company may request additional documentation to support medical necessity as part of its coverage determination.

Documentation may include patient medical records, polysomnography and multiple sleep latency test (MSLT) results, and provider credentials.
Be prepared to supply requested records promptly to avoid delays or adverse coverage determinations.

Denial Risk

Denial Risk for Insufficient Criteria or Documentation

The Company may deny reimbursement when coverage criteria are not met or documentation is insufficient.

Denial reasons include: drug or service not medically necessary, investigational or experimental, not within the member's benefits, or inappropriate/excessive billing patterns.
Ensure submitted documentation demonstrates medical necessity and meets the policy's diagnostic and prior-trial requirements to reduce denial risk.

Background and Clinical Context

Wakix (pitolisant) is a non‑controlled histamine‑3 (H3) receptor antagonist/inverse agonist indicated for treatment of excessive daytime sleepiness (EDS) and for reduction of cataplexy in narcolepsy. Sodium oxybate products (Xyrem, Xywav, Lumryz) are formulations of oxybate, a CNS depressant indicated for EDS and cataplexy in narcolepsy (age thresholds vary by product), and Xywav additionally has an indication for idiopathic hypersomnia in adults. Diagnosis confirmation for these disorders commonly requires polysomnography and multiple sleep latency testing, and prior authorization is required for these agents with initiation by or in consultation with a sleep specialist or neurologist per the policy.

Key Definitions

EDS (Excessive Daytime Sleepiness) — definition and covered products

DefinitionExcessive daytime sleepiness (EDS) associated with narcolepsy: daytime sleepiness in patients with narcolepsy confirmed by polysomnography and multiple sleep latency testing (MSLT); covered products include wakefulness‑promoting agents (e.g., Wakix) and sodium oxybate preparations for treatment as specified by age and prior therapy.

Required diagnostic evaluationPolysomnography and multiple sleep latency test (MSLT) are required to confirm narcolepsy/EDS in covered criteria.

Covered product classesNon‑controlled wakefulness‑promoting agent (pitolisant/Wakix) and sodium oxybate products (Xyrem, Xywav, Lumryz).

Prescribing requirementMedication must be prescribed by or in consultation with a sleep disorder specialist, neurologist, pulmonologist, or psychiatrist as specified in product criteria.

Wakix (pitolisant) — description and indications

Drug descriptionWakix (pitolisant) — an antagonist/inverse agonist of the histamine‑3 (H3) receptor; the only wakefulness‑promoting agent in this policy that is not a controlled substance.

IndicationsIndicated for excessive daytime sleepiness (EDS) in adults and pediatric patients >= 6 years with narcolepsy; indicated for cataplexy in adults with narcolepsy.

Prescribing contextUse covered when prescribed by or in consultation with a sleep specialist physician or neurologist and when diagnostic criteria (polysomnography/MSLT and confirmed narcolepsy) are met.

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