Clinical coverage criteria, authorization rules, and quantity limits for prescription drugs treating narcolepsy, cataplexy, idiopathic hypersomnia, OSA-related sleepiness, and shift work disorder; applies to Premera Bluecross pharmacy benefits.
Policy Summary
PayerPremera Bluecross
PolicyPharmacologic Treatment of Sleep Disorders
Policy CodePolicy PHARMACY POLICY -5.01.599
Change TypeMaterial updates to indications, age requirements, and added generic sodium oxybate
Effective DateMay 1, 2026
Next Review Date
Key ActionSubmit prior authorization with documentation of diagnostic sleep study results, prior therapy trials, age, dosing, and any required registration in limited distribution programs.
Added generic sodium oxybate to the policy with the same criteria as Xyrem (sodium oxybate).
Added indication and criteria for Xywav for the treatment of idiopathic hypersomnia (IH) in adults and added diagnostic criteria for IH.
Clarified that diagnosis of narcolepsy requires an in-laboratory sleep study.
Updated age requirements: Wakix age threshold changed to 6 years or older; Lumryz and other sodium oxybate products updated to 7 years or older where applicable.
Added criteria that Xyrem, Sunosi, and Wakix are not to be used as combination therapy with each other due to lack of evaluated safety and efficacy.
Reviewed prescribing information for all drugs in policy and updated background and trial summaries through 2022.
9 g/daymax oxybate dose
150 mg/daySunosi limit
Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.
35.6 mg/dayWakix limit
30 packetsLumryz limit
2-4pivotal trials cited
in-labin-lab sleep study
Coverage Criteria
Lumryz (sodium oxybate) — Cataplexy in narcolepsy (Initial therapy)
Covered when ALL of the following are met
Age: The individual is aged 7 years or older
Cataplexy documentation: Cataplexy is documented by brief episodes of sudden bilateral loss of muscle tone with maintained consciousness precipitated by an emotional trigger such as laughter or joking
Prior oxybate trial: Prior therapy with brand or generic sodium oxybate or Xyrem (sodium oxybate) was ineffective, not tolerated, or contraindicated
Dose limited to 9 grams per day<=9 g/day
Contraindicated combinations: Lumryz is not used in combination with Sunosi (solriamfetol), Wakix (pitolisant), sodium oxybate/Xyrem, or Xywav
EDS frequency: Excessive daytime sleepiness documented by recurrent periods at least 3 times per week for at least 3 months>=3 times/week for >=3 months
Diagnostic sleep study: Diagnosis of narcolepsy documented by an in‑laboratory sleep study with either nocturnal PSG showing REM sleep latency ≤15 minutes OR MSLT showing mean sleep latency ≤8 minutes with ≥2 sleep onset REM periodsPSG REM latency <=15 min OR MSLT mean <=8 min with >=2 SOREMPs
Prior therapies:
Brand sodium oxybate, generic sodium oxybate, Xyrem — Cataplexy and EDS in narcolepsy
Covered when ALL of the following are met
Age: The individual is aged 7 years or older
Cataplexy presentations: Cataplexy is documented by typical brief episodes precipitated by an emotional trigger OR in children/individuals within 6 months of onset by spontaneous grimaces, jaw‑opening with tongue thrusting, or global hypotonia
Dose limited to 9 grams per day<=9 g/day
Contraindicated combinations: Brand or generic sodium oxybate and Xyrem are not used in combination with Lumryz, Sunosi, Wakix, or Xywav
Nuvigil (armodafinil) and Provigil (modafinil) — Wakefulness agents
Covered when ALL of the following are met
Age: The individual is aged 18 years or older
Applies to Nuvigil and Provigil
Generic trial: Has tried and had an inadequate response or intolerance to generic armodafinil (for Nuvigil) or generic modafinil (for Provigil)
Dose limits: Nuvigil 250 mg/day for narcolepsy or OSA and 150 mg/day for SWD; Provigil ≤200 mg/day<=250 mg/day (Nuvigil narcolepsy/OSA); <=150 mg/day (Nuvigil SWD); <=200 mg/day (Provigil)
Sunosi (solriamfetol) — Narcolepsy and OSA
Covered when ALL of the following are met
Age: The individual is aged 18 years or older
EDS frequency: Excessive daytime sleepiness documented by recurrent periods at least 3 times per week for at least 3 months>=3 times/week for >=3 months
Diagnostic criteria narcolepsy: Diagnosis of narcolepsy documented by in‑lab sleep study with nocturnal PSG REM latency ≤15 minutes OR MSLT mean sleep latency ≤8 minutes with ≥2 SOREMPs
Diagnostic criteria OSA: OSA diagnosis documented by sleep study with AHI ≥15 events/hour (minimum 30 events) OR AHI 5–14 events/hour (minimum 10 events) plus one qualifying comorbidity/feature (e.g., stroke, hypertension, ischemic heart disease, cognitive/mood symptoms, ESS>10, >20 desaturations <85% or any desaturation <70%, BMI>35)
Wakix (pitolisant) — Cataplexy and EDS in narcolepsy
Covered when ALL of the following are met
Age: The individual is aged 6 years or older
Cataplexy documentation: Cataplexy documented by typical episodes OR in early onset by spontaneous grimaces, jaw‑opening with tongue thrusting, or global hypotonia
Hepatic impairment: The individual does not have severe hepatic impairment (Child‑Pugh Class C) as documented by laboratory testsChild‑Pugh != Class C
Child‑Pugh scoring provided in policy
Dose limited to 35.6 mg once daily<=35.6 mg/day
Xywav (calcium, magnesium, potassium, and sodium oxybates) — Cataplexy, EDS, and idiopathic hypersomnia
Covered when ALL of the following are met (varies by indication)
Age (narcolepsy): Individual aged 7 years or older for narcolepsy indications
Cataplexy documentation: Cataplexy documented by typical episodes OR pediatric/early‑onset manifestations (spontaneous grimaces, jaw‑opening with tongue thrusting, global hypotonia)
Prior oxybate trial: Prior therapy with brand or generic sodium oxybate or Xyrem was ineffective, not tolerated, or contraindicated (exception may be granted for concomitant heart failure, hypertension, or renal impairment)
Dose limited to 9 grams per day<=9 g/day
Covered indications with trial-based criteria
Coverage supported when clinical trial evidence demonstrates benefit for the specified indication and FDA approval or established trial data exist.
Xywav for narcolepsy (Study 1): Efficacy established in a randomized‑withdrawal Study 1 in adults 18–70 with narcolepsy with cataplexy (baseline history ≥14 cataplexy attacks per 2 weeks); randomized continuation on Xywav showed significant reductions in cataplexy and ESS versus placeboage 18-70; >=14 cataplexy attacks/2 weeks
Study design: open‑label titration, 2‑week stable dose, 2‑week randomized‑withdrawal
Xywav for idiopathic hypersomnia (Study 2): Efficacy established in randomized‑withdrawal Study 2 in adults 19–75 with idiopathic hypersomnia; withdrawal to placebo resulted in significant worsening in ESS compared with continued Xywavage 19-75
Study included open‑label titration and randomized‑withdrawal; concomitant stimulants allowed in many subjects
Xyrem evidence:
All uses of the medications listed in this policy that are not specifically described in the coverage criteria are considered investigational and are at risk for denial. This includes any off‑label indications or clinical situations not enumerated in the approved criteria. The policy notes that these medications remain subject to the product’s FDA prescribing information when used, and investigational uses will not be supported under this policy.
Dose limits in this policy reflect the maximum doses supported by clinical evidence. For sodium oxybate products (including Xyrem, Xywav, brand and generic sodium oxybate, and Lumryz) the dose is limited to 9 g/day; doses greater than 9 g/day are considered not medically necessary. For other agents, the policy specifies maximum doses by product (see individual product criteria and quantity limits), and requests exceeding those specified limits will be considered not medically necessary.
The policy does not support combined use of Xyrem (sodium oxybate), Sunosi (solriamfetol), and Wakix (pitolisant) with each other. Combination therapy among these products is excluded because the safety and efficacy of such combinations have not been evaluated, and therefore concurrent use may be denied.
A historical policy update effective 05/01/20 explicitly added the restriction that Xyrem (sodium oxybate), Sunosi (solriamfetol), and Wakix (pitolisant) are not to be used as combination therapy with each other. This administrative clarification was recorded in the policy history as an added criterion based on lack of evaluated safety and efficacy for those combinations.
The policy identifies that specified doses beyond those supported by clinical evidence and formulations or quantities that exceed the listed quantity limits are considered not medically necessary. Examples include sodium oxybate dosing above 9 g/day and product‑specific quantity limits such as the 270 g/30 day limit for the 0.5 g/mL sodium oxybate formulation and a 30‑packet limit per 30 days for Lumryz; requests for higher doses or quantities are not supported.
Use of sodium oxybate (Xyrem) for the treatment of fibromyalgia is not supported by this policy. The FDA previously rejected sodium oxybate for fibromyalgia because of concerns about abuse and diversion and insufficient evidence of benefit relative to these risks; therefore such use is considered not medically necessary and investigational for this indication.
Coding
Codingmixed
No codes listed
Codingmixed
No codes listed
Apneic/Hypopneic Index (AHI) — diagnostic thresholds
AHI ≥15 events/hour>= 15 events/hour (including a minimum of 30 events documented per sleep study)
AHI 5–14 events/hour with minimum eventsAHI 5–14 events/hour (including a minimum of 10 events documented per sleep study)
Additional qualifying features for AHI 5–14When AHI is 5–14 events/hour, requires documentation of at least one qualifying comorbidity or feature (e.g., history of stroke, hypertension, ischemic heart disease, cognitive/mood symptoms, ESS>10, >20 desaturations <85% or any desaturation <70%, BMI>35)
Idiopathic hypersomnia 24‑hour sleep time threshold
24‑hour total sleep time thresholdTotal 24‑hour sleep time >= 660 minutes on a 24‑hour polysomnography (PSG)
Provider Actions and Authorization
Prior Authorization
Prior Authorization Required
Prior authorization is required for medications listed in this policy. Clinical documentation must demonstrate that all specific criteria are met (age, diagnostic testing, prior therapies tried and their outcomes, dose limits, and absence of prohibited combination therapy). Include chart notes, sleep study reports (in-laboratory PSG or MSLT as applicable), and documentation of prior regimen failures, intolerance, or contraindications.
Prior auth may be approved up to 12 months when criteria are met
Dose limits (e.g., ≤9 g/day for sodium oxybates) must be documented
Documentation Required
Pharmacy Benefit Management and Limited/Restricted Distribution
This policy is managed through the pharmacy benefit. Xyrem (sodium oxybate) is available only through a limited distribution single‑pharmacy program (the Xyrem Success Program); both prescribers and members must be enrolled to obtain product. Providers should coordinate enrollment and ordering with the specialty pharmacy.
Background
Excessive daytime sleepiness (EDS) can arise from conditions such as narcolepsy, obstructive sleep apnea (OSA), and other neurologic disorders and can significantly impair daytime function and safety. Evaluation of EDS should include assessment for underlying causes and objective testing where required; treatment may include wakefulness‑promoting agents or sodium oxybate products when diagnostic and prior‑therapy criteria are met. The policy highlights the public health impact by noting an estimated population affected by EDS from OSA or narcolepsy and specifies that pharmacologic treatment decisions should follow diagnosis‑specific criteria (for example, documented cataplexy or in‑lab sleep study findings) and ongoing monitoring for effectiveness and safety.
Definitions
Cataplexy — definition
Core definitionBrief episodes of sudden bilateral loss of muscle tone with maintained consciousness, often precipitated by an emotional trigger (e.g., laughter or joking)
Pediatric/early‑onset noteIn children or early onset, cataplexy may present as spontaneous grimaces, jaw‑opening with tongue thrusting, or global hypotonia
Documentation implicationClinical documentation should describe typical brief bilateral tone loss with preserved consciousness and any emotional trigger
Excessive daytime sleepiness — definition and frequency
EDS core definitionRecurrent periods within the same day of an irrepressible need to sleep, lapsing into sleep, or napping
Age requirement: Age thresholds vary by drug (Lumryz/Xywav/Xyrem: ≥7 years; Wakix: ≥6 years; Nuvigil/Provigil/Sunosi: ≥18 years)
Diagnostic requirement: Diagnosis of narcolepsy, idiopathic hypersomnia, or OSA must be documented by in‑laboratory sleep study when specified by product criteria
In‑lab PSG or MSLT criteria per drug
Prior therapy requirements: Prior trials of stimulants and modafinil/armodafinil (and prior sodium oxybate for certain oxybate products) documented as ineffective, not tolerated, or contraindicated are required where specified
Continuation / Re-Authorization Criteria
Re-authorization — requirements for continued coverage
Re-authorization requirements for continued coverage
Continued response: Documentation of continued clinical response is required at re‑authorization
Applies to oxybates, Nuvigil, Provigil, Sunosi, Wakix as specified
Dose limits at reauth: Dose must remain within policy‑specified limits at re‑authorization
Prior sleep study requirement: Diagnosis must have been documented by a sleep study performed prior to starting therapy for individuals started on therapy with a prior insurer
Prior therapy with a stimulant medication (e.g., methylphenidate) must have been ineffective, not tolerated, or contraindicated before approval
Prior modafinil/armodafinil trial
Lumryz, Xywav, Sunosi and other narcolepsy/EDS indications
Prior therapy with modafinil (Provigil) or armodafinil (Nuvigil) must have been ineffective, not tolerated, or contraindicated before approval
Prior sodium oxybate trial
Certain oxybate products (e.g., Xywav; Lumryz exceptions noted)
Prior therapy with brand or generic sodium oxybate or Xyrem must have been ineffective, not tolerated, or contraindicated before approval; exception for Xywav may be granted with concomitant heart failure, hypertension, or renal impairment
Documentation of failure
All above prior-therapy requirements
Prior trials must be documented as ineffective, not tolerated, or contraindicated in the medical record
Policy note
Implication
Details / Action
Periodic review of prescribing information
All included products
Policy indicates ongoing review of prescribing information and updates; providers should consult current product labeling and policy updates when considering therapy
Combination therapy restrictions noted
Xyrem, Sunosi, Wakix, Lumryz, Xywav
Policy states these agents are not to be used in combination with each other because safety and efficacy of such combinations have not been evaluated (added 05/01/20)
No explicit additional step edits in this section
Policy-level review statements
Although combination restrictions and prescribing-information review are noted, this section does not define further step sequencing beyond prior-therapy requirements; consult product-specific criteria for sequencing
Historical sequencing note
Products affected
Guidance
Past requirement for Xyrem first in some Xywav cases
Xywav (and Xyrem)
Historically the policy included sequencing where Xyrem was required before Xywav in some cases; consult product-specific criteria and history notes for any current exceptions
Sequencing varies by product and indication
Sodium oxybate products and related agents
Policy history documents specific sequencing and exceptions (e.g., 12/01/20 added concomitant diagnosis exception to Xywav prior-oxyabte requirement); check individual product criteria for current sequencing rules
Quantity Limits
Sodium oxybate (0.5 g/mL) — quantity limit
Sodium oxybate 0.5 g/mL quantity limit270 grams (540 mL; equivalent to 3 bottles) per 30 days
Applies to formulationsLimit applies to brand and generic sodium oxybate, Xyrem, and Xywav 0.5 g/mL formulation
Dose cap contextPolicy additionally limits daily doses to <=9 g/day (separate dose limit) and doses >9 g/day are not supported
Lumryz — packet quantity limit
Lumryz packet limit30 packets per 30 days
Packet strengths noted in policyLumryz packets available in 4.5 g, 6 g, 7.5 g, and 9 g per packet formulations (per product labeling referenced)
Site of Care / Benefit Application
Billing Rule
Pharmacy benefit management & Xyrem limited distribution
This policy is managed through the pharmacy benefit and Xyrem is distributed via a limited single‑pharmacy program (Xyrem Success Program); ensure pharmacy route and program enrollment are arranged for dispensing.
Xyrem dispensing requires registration in the Xyrem Success Program for both prescriber and patient.
Documentation Required
Narcolepsy requires an in‑laboratory sleep study for documentation
For narcolepsy diagnoses referenced in this policy, the required diagnostic testing must be an in‑laboratory sleep study (PSG and/or MSLT as specified by the drug criteria); ensure sleep study reports are in the chart when submitting for authorization.
Examples: PSG REM latency ≤15 minutes OR MSLT mean sleep latency ≤8 minutes with ≥2 SOREMPs are acceptable documentation when specified.
Policy Summary
PayerPremera Bluecross
PolicyPharmacologic Treatment of Sleep Disorders
Policy CodePolicy PHARMACY POLICY -5.01.599
Change TypeMaterial updates to indications, age requirements, and added generic sodium oxybate
Effective DateMay 1, 2026
Next Review Date
Key ActionSubmit prior authorization with documentation of diagnostic sleep study results, prior therapy trials, age, dosing, and any required registration in limited distribution programs.
Prior therapy with a stimulant medication and with modafinil (Provigil) or armodafinil (Nuvigil), and prior therapy with brand or generic sodium oxybate or Xyrem was ineffective, not tolerated, or contraindicated
Dose limited to 9 grams per day<=9 g/day
Contraindicated combinations: Lumryz is not used in combination with Sunosi (solriamfetol), Wakix (pitolisant), sodium oxybate/Xyrem, or Xywav
Prior therapies: Prior therapy with a stimulant and modafinil/armodafinil was ineffective, not tolerated, or contraindicated
Dose limit and combinations: Dose limited to 150 mg once daily (policy references higher limits elsewhere for Nuvigil) and not used in combination with Lumryz, Wakix, sodium oxybate/Xyrem, or Xywav<=150 mg/day
Contraindicated combinations: Wakix is not used in combination with Lumryz, Sunosi, sodium oxybate/Xyrem, or Xywav
Contraindicated combinations: Xywav is not used in combination with Lumryz, Sunosi, Wakix, sodium oxybate/Xyrem, or Xyrem
Idiopathic hypersomnia criteria: For idiopathic hypersomnia (individuals ≥18 years): daily irrepressible sleep or daytime lapses ≥3 months; absence of cataplexy; no other identifiable cause; confirmed by MSLT mean sleep latency ≤8 minutes with <2 SOREMPs OR total 24‑hour sleep time ≥660 minutes on 24‑hour PSG
Randomized, double‑blind, placebo‑controlled trials of Xyrem showed doses of 6–9 g/night reduced cataplexy frequency and improved ESS and MWT versus placebo (3 g had little effect)
doses 6-9 g/night
High concomitant stimulant use limits independent assessment
Sunosi evidence: TONES trials demonstrated dose‑related improvements in MWT and ESS with clinically meaningful ESS benefit mainly at 150–300 mg in narcolepsy and OSA trialsdoses up to 300 mg studied
Safety data limited to 8–12 weeks
Wakix evidence: HARMONY trials showed pitolisant superior to placebo on ESS and reduced cataplexy; not non‑inferior to modafinil for ESS in HARMONY Iadult subjects >=18
Monitor hepatic function and QTc when indicated
Indication context
Used to confirm idiopathic hypersomnia when MSLT/SOREMP criteria are not met
Age applicabilityApplies to adult idiopathic hypersomnia criteria in Xywav coverage (>=18 years)
MSLT mean sleep latency
MSLT mean sleep latency cutoffMSLT mean sleep latency ≤ 8 minutes
Role in narcolepsy diagnosisMSLT mean ≤8 min plus ≥2 SOREMPs supports narcolepsy diagnosis
Role in idiopathic hypersomniaMSLT mean ≤8 min with <2 SOREMPs may support idiopathic hypersomnia when combined with clinical criteria
MSLT sleep‑onset REM periods
Narcolepsy criterion (SOREMPs)>= 2 sleep‑onset REM periods on MSLT for narcolepsy diagnosis
Idiopathic hypersomnia distinction< 2 sleep‑onset REM periods on MSLT is consistent with idiopathic hypersomnia when other IH criteria met
Combined interpretationMSLT interpretation depends on mean sleep latency plus number of SOREMPs to differentiate narcolepsy vs idiopathic hypersomnia
Epworth Sleepiness Scale (ESS)
Epworth Sleepiness Scale threshold> 10 (may be used as alternative documentation of excessive daytime sleepiness)
Context of useESS >10 is listed as one qualifying feature for OSA patients with AHI 5–14
Documentation roleESS can supplement objective testing when documenting excessive sleepiness
Child‑Pugh classification thresholds
Child‑Pugh scoring componentsScore based on bilirubin, albumin, INR, ascites, and hepatic encephalopathy (points 1–3 per component)
Class A (well‑compensated)Total points 5–6 = Class A
Class B (significant compromise)Total points 7–9 = Class B
Class C (decompensated)Total points 10–15 = Class C
Bilirubin adjustment noteIf primary biliary cirrhosis or sclerosing cholangitis, bilirubin thresholds are reclassified (<68 =1, 68–170 =2, >170 =3)
Pharmacy benefit management: drugs in this policy billed through pharmacy benefit
Xyrem restricted distribution: Xyrem Success Program registration required for prescriber and patient
Denial Risk
Investigational Indications — Denial Risk
All uses of the listed products that are not described in this policy are considered investigational and are at risk for denial. Coverage is limited to FDA‑approved and policy‑specified indications and dosing.
Investigational (not covered) = uses not outlined in this policy for Lumryz, Nuvigil, Provigil, Sunosi, brand/generic sodium oxybate, Wakix, Xyrem, Xywav
Denial Risk
Benefit and Medical Necessity Limits
Coverage is subject to member benefit limits and the terms of the member's plan. Even when medical necessity criteria are met, requests may be denied or limited if the member's benefit does not cover the drug, quantity, or dispensing channel. Prior authorization decisions do not guarantee payment — verify benefits.
Consult member benefit booklet or customer service for coverage and benefit limits
Policy decisions are subject to benefit application and may be denied if benefits do not cover service
Documentation Required
Re‑authorization Documentation Required
For re‑authorization (continuation) requests, provide documentation of continued clinical response and prior diagnostic testing. For sodium oxybates and related agents, re‑auth requests should include evidence of ongoing symptomatic improvement, confirmation that dose remains within policy limits, and documentation of an appropriate baseline sleep study performed prior to initiation (when required or performed by prior insurer).
Re‑authorization up to 12 months when documentation shows continued clinical response
Sleep study documentation performed prior to starting therapy (applies when patient was started on therapy with a prior insurer)
Step Therapy
Step Therapy / Sequencing and Prior Therapy Requirements
When sequencing therapies, prior trials of specified agents must be documented as ineffective, not tolerated, or contraindicated before approving downstream agents. Examples: trial of modafinil/armodafinil and stimulants required before sodium oxybates for EDS; prior trial of brand or generic sodium oxybate or Xyrem required before Lumryz or Xywav in some circumstances. Combination use of Xyrem, Sunosi, Wakix, Lumryz, sodium oxybate, or Xywav is not permitted per policy.
Document prior therapy trials and outcomes (ineffective, not tolerated, contraindicated)
Combination therapy restriction: do not use listed agents together
Documentation Required
Required Documentation to Support Medical Necessity
Required documentation to demonstrate medical necessity includes: medical records and chart notes describing symptoms and response to therapy, in‑laboratory sleep study reports (PSG or MSLT) when indicated, prior medication trial histories with dates and outcomes, dosing and monitoring plans, and specialty pharmacy enrollment (for limited distribution products). Failure to provide these elements may result in denial.
Sleep study reports (in‑laboratory PSG or MSLT) when required
Prior medication trial history with dates and outcomes
Specialty pharmacy program enrollment documentation for Xyrem
Occurs at least 3 times per week for at least 3 months to meet policy documentation criteria
Use in diagnostic algorithmsEDS documentation is required across narcolepsy, OSA, and certain drug coverage criteria as part of medical necessity assessments
EDS — persistence and duration
Formal EDS definitionInability to stay awake and alert during usual waking hours that occurs almost daily and persists for at least three months
Clinical significanceEDS increases risk of impaired cognition, accidents, reduced productivity, and decreased quality of life
Differentiation noteTiredness, fatigue, and lack of energy are distinct complaints — EDS requires documented recurrent lapses into sleep
Child‑Pugh classification — points and classes
Child‑Pugh components and scoringPoints assigned for total bilirubin, serum albumin, INR, presence/degree of ascites, and presence/degree of hepatic encephalopathy; sum determines class
Class ATotal 5–6 points = Class A (well‑compensated)
Class BTotal 7–9 points = Class B (significant functional compromise)
Class CTotal 10–15 points = Class C (decompensated disease) — severe hepatic impairment
Cataplexy with emotional triggerDocumented by brief episodes of sudden bilateral loss of muscle tone with maintained consciousness precipitated by an emotional trigger such as laughter or joking
Clinical documentation tipProvider notes should indicate the emotional precipitant (e.g., laughter) when present to support cataplexy diagnosis
Pediatric manifestationIn children, describe any atypical presentations (grimacing, jaw‑opening, tongue thrusting, global hypotonia) to support diagnosis
Dose limits:
Dosing must be within policy‑specified limits (examples: oxybates ≤9 g/day; Sunosi ≤150 mg/day for most indications; Wakix ≤35.6 mg/day; Nuvigil/Provigil dose limits apply)
Combination‑use restrictions: Not used in combination with specified products (e.g., Xyrem, Xywav, Lumryz, Sunosi, Wakix) due to lack of evaluated safety and efficacy
Policy update (05/01/20) prohibits combination use of certain agents
Initial therapy rules and evidence
Covered when ALL of the following are met
Trial evidence supports initiation: Initiation of sodium oxybate products and other agents is supported by randomized trials that used titration and optimization periods with target nightly doses commonly 6–9 g for oxybates and product‑specific titration for pitolisant and solriamfetol6-9 g/night typical for oxybates; Sunosi up to 300 mg; pitolisant up to ~35.6–40 mg/day
Xyrem distributed through restricted pharmacy (Xyrem Success Program); Xywav has lower sodium content than Xyrem
Sunosi initiation: TONES trials evaluated Sunosi doses from 37.5 to 300 mg with meaningful ESS benefit at 150–300 mg; titration to effective dose per labelup to 300 mg
Safety data limited to 8–12 weeks
Pitolisant initiation: Pitolisant was titrated in pivotal trials (example 10–40 mg/day) with demonstrated reductions in ESS and cataplexy; monitor hepatic function and QTc as indicatedadult dosing per trial up to ~35.6–40 mg/day
Randomized‑withdrawal studies support continued benefit for enrolled, stabilized patients.
Continuation on Xywav: Individuals taking stable doses of Xywav who were randomized to placebo experienced significant worsening in cataplexy frequency and ESS compared with those continuing Xywav, supporting continuation for respondersstable dose prior to randomization
Study designs included open‑label titration and 2‑week randomized‑withdrawal periods
Dose cap reminderPolicy dose limit remains <=9 g/day; quantities beyond packet limit are not supported
Nuvigil (armodafinil) — quantity limits
Nuvigil 50 mg limit50 mg: 60 tablets per 30 days
Nuvigil 150/200/250 mg limits150 mg, 200 mg, 250 mg: 30 tablets per 30 days (dose‑specific limits apply)
Most actionable: Nuvigil dose capsDoses greater than 250 mg once daily for narcolepsy/OSA or >150 mg once daily for shift work disorder are not supported (check diagnosis‑specific limits)
Provigil (modafinil) — quantity limits
Provigil 100 mg limitProvigil 100 mg: 30 tablets per 30 days
Provigil 200 mg limitProvigil 200 mg: 30 tablets per 30 days
Dose ceilingDoses greater than 200 mg once daily are not supported by clinical evidence
Sunosi (solriamfetol) — 75 mg and 150 mg quantity limits
Sunosi 75 mg limitSunosi 75 mg: 60 tablets per 30 days
Sunosi 150 mg limitSunosi 150 mg: 30 tablets per 30 days
Most actionable: Sunosi dose capDoses greater than 150 mg once daily are not supported by clinical evidence
Sunosi — 150 mg quantity limit
Sunosi 150 mg limitSunosi 150 mg: 30 tablets per 30 days
Lower‑dose optionSunosi 75 mg limited to 60 tablets per 30 days as an alternative lower dose option
Dose‑response notePolicy notes clinically meaningful ESS benefit primarily at 150–300 mg in trials; >150 mg/day not supported for routine coverage
Wakix (pitolisant) — quantity limit
Wakix 17.8 mg limitWakix 17.8 mg: 60 tablets per 30 days
Maximum daily dosing guidanceDoses greater than 35.6 mg once daily are not supported by clinical evidence
Hepatic impairment noteWakix is contraindicated in severe hepatic impairment (Child‑Pugh C) — verify liver function when prescribing