CurrentMass General Brigham Health PlanPolicy N/A

Sodium oxybate, oxybate salts, and pitolisant for narcolepsy and idiopathic hypersomnia — Prior Authorization and Coverage Criteria

Defines prior authorization, quantity limits, approval criteria, and reauthorization requirements for Lumryz, Xyrem, Xywav, and Wakix for treatment of narcolepsy-related excessive daytime sleepiness, cataplexy, and Xywav for idiopathic hypersomnia for Mass General Brigham Health Plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicySodium oxybate, oxybate salts, and pitolisant for narcolepsy and idiopathic hypersomnia — Prior Authorization and Coverage Criteria

Policy CodePolicy N/A

Change TypeMaterial updates to step therapy and age indications

Effective DateApr 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization through the pharmacy benefit and document required prior trials (CNS stimulant, wakefulness agents, Sunosi and Wakix where applicable) and sleep‑lab confirmation.

SourceLink

POLICY UPDATE CHANGES

Requires step through with Sunosi for members 18 and older with excessive daytime sleepiness in narcolepsy.

Specified that the requirement to try Wakix prior to Xyrem or Xywav for cataplexy applies to members 18 years and older.

Added FDA-approved age indications for Lumryz, Xyrem, Xywav, and Wakix, including Lumryz approvable age of 7 years and Wakix age updates.

Added coverage criteria for idiopathic hypersomnia for Xywav.

12 monthsApproval duration

540 mLXyrem/Xywav QL

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Coverage Criteria

Excessive Daytime Sleepiness Associated with Narcolepsy

Authorization may be granted when ALL the following criteria are met:

EDS in narcolepsy - diagnosis and confirmation: Member has a diagnosis of excessive daytime sleepiness in narcolepsy; diagnosis is confirmed by sleep lab evaluation.

Age and product applicability: Member meets ONE of the following product age requirements: a) Lumryz, Sodium Oxybate, Xyrem: age >= 7 years; b) Wakix: age >= 6 years.

Prior therapy - stimulants: Member has had inadequate response, intolerance, or contraindication to at least one CNS stimulant (e.g., amphetamine, dextroamphetamine, methylphenidate).

Adult (>=18 years) additional steps: For members 18 years of age or older BOTH must be met: a) inadequate response, intolerance, or contraindication to at least one CNS wakefulness-promoting drug (e.g., modafinil, armodafinil); AND b) inadequate response, intolerance, or contraindication to Sunosi.

Applies to EDS approvals for adults per policy update.

Product-specific sequencing: Lumryz, Sodium Oxybate and Xyrem: member has had inadequate response, intolerance, or contraindication to Wakix.

Cataplexy in Narcolepsy

Authorization may be granted when ALL the following are met:

Cataplexy - diagnosis and confirmation: Member has a diagnosis of cataplexy in narcolepsy; diagnosis is confirmed by sleep lab evaluation.

Age applicability for cataplexy: Member meets ONE of the following: a) Lumryz, Sodium Oxybate and Xyrem: age >= 7 years; b) Wakix: age >= 18 years.

Prior therapy - stimulants: Member has had inadequate response, intolerance, or contraindication to at least one CNS stimulant (e.g., amphetamine, dextroamphetamine, methylphenidate).

Adult (>=18 years) additional steps: For members 18 years of age or older BOTH must be met: a) inadequate response, intolerance, or contraindication to at least one CNS wakefulness-promoting drug (e.g., modafinil, armodafinil); AND b) for Lumryz, Sodium Oxybate and Xyrem: inadequate response, intolerance, or contraindication to Wakix.

Idiopathic Hypersomnia

Authorization for Xywav may be granted when ALL the following are met:

Idiopathic Hypersomnia - diagnosis and confirmation: Member has a diagnosis of idiopathic hypersomnia; diagnosis is confirmed by sleep lab evaluation; member is 18 years of age or older.

Prior therapy - stimulants: Member has had inadequate response, intolerance, or contraindication to at least one CNS stimulant (e.g., amphetamine, dextroamphetamine, methylphenidate).

Prior therapy - wakefulness agents: Member has had inadequate response, intolerance, or contraindication to at least one CNS wakefulness-promoting drug (e.g., modafinil, armodafinil).

Continuation Therapy

Reauthorization requires physician documentation of continuation of therapy and positive response, as evidenced by:

Evidence of benefit: For EDS or cataplexy in narcolepsy: documented decreased daytime sleepiness or a decrease in cataplexy episodes; For Xywav in idiopathic hypersomnia: documented decrease in daytime sleepiness from baseline.

Documentation of prior trials and diagnosis: Physician documentation includes prior trials/intolerance/contraindications to required medications (CNS stimulants, wakefulness-promoting agents, Sunosi, Wakix where applicable) and sleep lab confirmation of the diagnosis.

Approval duration and quantity limits: Initial approvals and reauthorizations are granted for 12 months; applicable product quantity limits apply (e.g., Xyrem/Xywav 540 mL/30 days; Lumryz 30 tablets/30 days; Wakix 60 tablets/30 days).

An authorization review exception may be considered for members who are new to the plan within the past 90 days and are already receiving the requested medication at the time of enrollment. This exception does not apply to medications obtained as samples or through a manufacturer's patient assistance program; those cases are excluded from the review exception and will require standard prior authorization review.

Therapy is not approvable when required diagnostic confirmation, age criteria, or specified prior medication trials are not documented. Specifically, approvals require documentation of sleep laboratory confirmation of the diagnosis; absence of this documentation is a basis for denial. Age applicability must match the product and indication (for example, many oxybate products require the member be ≥7 years for narcolepsy, and idiopathic hypersomnia approvals require the member be ≥18 years).

Use is also not approvable when required prior medication steps have not been tried or documented. For excessive daytime sleepiness and cataplexy in narcolepsy, the member must have had an inadequate response, intolerance, or contraindication to at least one CNS stimulant (e.g., amphetamine, dextroamphetamine, or methylphenidate). For members ≥18 years seeking treatment for EDS, documentation must also show trials (or intolerance/contraindication) of at least one CNS wakefulness-promoting drug (e.g., modafinil or armodafinil) and of Sunosi. For Xywav in idiopathic hypersomnia, trials (or documented intolerance/contraindication) of at least one CNS stimulant and at least one wakefulness-promoting agent are required.

Product Age Indications & Coding

Minimum age per product and indication

Lumryz / Xyrem / Xywav — narcolepsy indicationsFDA-approved and approvable for excessive daytime sleepiness and cataplexy in members 7 years of age and older

Wakix — EDS indicationFDA-approved and approvable for excessive daytime sleepiness in members 6 years of age and older

Wakix — cataplexy indicationFor cataplexy, Wakix applicability and related step requirement apply to members 18 years of age and older

Product-specific age summaryOverall policy: Lumryz, Xyrem, and Xywav generally require age ≥7 years for narcolepsy indications; Wakix age ≥6 years for EDS and ≥18 years for cataplexy-related sequencing

Provider Actions and Operational Requirements

Prior Authorization

Prior Authorization and Duration

Prior authorization is required through the pharmacy benefit for covered products. Initial approvals and reauthorizations will be granted for 12 months. Quantity limits may apply: Xyrem (sodium oxybate) — 540 mL per 30 days; Xywav — 540 mL per 30 days; Lumryz — 30 tablets per 30 days; Wakix — 60 tablets per 30 days.

Prior authorization required (Pharmacy Benefit).
Initial and reauthorization duration: 12 months.
Quantity limits: Xyrem 540 mL/30 days; Xywav 540 mL/30 days; Lumryz 30 tablets/30 days; Wakix 60 tablets/30 days.

Documentation Required

Required Documentation for Initial and Continuation Approvals

For initial approval, provide documentation of the diagnosis and confirmatory sleep evaluation (sleep lab) relevant to the requested indication (e.g., narcolepsy with excessive daytime sleepiness or cataplexy; idiopathic hypersomnia). For reauthorization, provide physician documentation of continued benefit and positive response to therapy, for example decreased daytime sleepiness or decreased cataplexy episodes compared to baseline.

Definitions

Excessive daytime sleepiness (EDS) in narcolepsy

Definition (EDS in narcolepsy)Excessive daytime sleepiness (EDS) is a symptom of narcolepsy characterized by excessive sleepiness during the day and is the treated indication in this policy

Sleep-lab confirmation requirementDiagnosis of EDS in narcolepsy must be confirmed by sleep lab evaluation prior to authorization

Therapeutic-step requirementMember must have had inadequate response, intolerance, or contraindication to at least one CNS stimulant (e.g., amphetamine, dextroamphetamine, methylphenidate); additional adult (≥18) steps require trials of a CNS wakefulness-promoting drug (e.g., modafinil/armodafinil) and Sunosi

Idiopathic hypersomnia

Definition (Idiopathic hypersomnia)Idiopathic hypersomnia is a central hypersomnolence disorder and an approved indication for Xywav per this policy

Adult age applicability

Background

Sodium oxybate formulations include branded products such as Lumryz and Xyrem, and oxybate salts formulations are represented by Xywav (oxybate salts of calcium, magnesium, potassium, and sodium). These agents exert their effects largely through GABAB receptor activity at noradrenergic, dopaminergic, and thalamocortical neurons and are FDA-approved for treatment of narcolepsy symptoms. Xywav also has an FDA-approved indication for idiopathic hypersomnia.

Pitolisant (Wakix) is a separate agent classified as an H3 receptor antagonist/inverse agonist and is approved for narcolepsy symptoms; policy requirements reference Wakix in sequencing for certain oxybate approvals.