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    v1.0.28
    OpenPayerPolicy UpdatesSleep MedicineKansas DH&ED Narcolepsy Prior Auth Coverage | Open…
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    CurrentKansas Department of Health and EnvironmentPolicy N/A

    Criteria for Prior Authorization — Narcolepsy Agents

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    Defines prior authorization requirements, initial and renewal approval lengths, and clinical criteria for FDA‑approved narcolepsy agents for prescribers and pharmacies seeking coverage under the payer.

    Policy Summary
    PayerKansas Department of Health and Environment
    PolicyCriteria for Prior Authorization — Narcolepsy Agents
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateJan 8, 2020
    Last ReviewApr 17, 2024
    Next Review DateN/A
    Key ActionSubmit prior authorization with diagnosis confirmation per ICSD-3 and required baseline measures (ESS for EDS; cataplexy frequency for cataplexy).
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    3 monthsinitial approval length
    12 months

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    renewal approval length
    ≥11ESS baseline (EDS)
    ≥25%ESS improvement for renewal
    6 weeksmodafinil trial

    Coverage and Medical Necessity Criteria

    Initial prior authorization

    Covered when ALL of the following are met

    General initial PA requirements

    • Diagnosis verification: Diagnosis of narcolepsy confirmed in accordance with International Classification of Sleep Disorders - Third Edition (ICSD-3)

      See Table 2 for type 1 and type 2 definitions

    Renewal criteria

    Renewal prior authorization (must meet ALL):

    Renewal for EDS: For EDS indications, patient demonstrates an improvement (reduction) in ESS score of ≥ 25% from baseline≥25% ESS improvement

    Required for continued approval for EDS agents

    Renewal for cataplexy: For cataplexy indications, patient has a decrease or maintained decrease in the number of cataplexy episodes per month

    Documented reduction or maintained reduction required

    Dosing limits: Therapy must not exceed dosing limits listed in Table 1

    Noncompliant dosing may preclude renewal

    For drugs with an existing prior authorization requirement but where the PA does not explicitly cover a newly approved indication, a different FDA-approved indication, or changes to age requirements not listed in the policy, the PA request will be evaluated using the products package insert. Review will consider indication, age, dose, and any prerequisite treatment requirements as described in the manufacturer labeling.

    When sodium oxybate products XywavAE or LumryzTRADEMARK are requested in place of XyremAE, the prescriber must provide a compelling clinical rationale explaining why the patient is expected to benefit from Xywav or Lumryz over Xyrem as part of the clinical justification for approval.

    Requests for agents that do not meet the indication, age, or dosing limits listed in Table 1, or requests that fail to include required documentation, are considered not medically necessary and may be denied. Required documentation includes confirmation of a narcolepsy diagnosis per ICSD-3, baseline Epworth Sleepiness Scale (ESS) score for EDS requests, and baseline frequency of cataplexy episodes per month for cataplexy requests.

    Prior authorization is required for all listed narcolepsy agents and for all current and future dose forms; failure to demonstrate prerequisite treatments (for example, a 6-week trial of modafinil and/or armodafinil for EDS) or to provide baseline measures (for example, ESS 2 11) will jeopardize approval and can result in denial of the PA request.

    Drug Listing, Dosing, and Measurement Requirements

    Named Narcolepsy Agents (by brand)mixed
    XywavOxybate salts product listed as a narcolepsy agent
    WakixPitolisant product listed as a narcolepsy agent
    LumryzSodium oxybate product listed as a narcolepsy agent
    XyremSodium oxybate product listed as a narcolepsy agent
    SunosiSolriamfetol product listed as a narcolepsy agent
    Epworth Sleepiness Scale (ESS) — Baseline and renewal thresholds
    Baseline ESS thresholdBaseline Epworth Sleepiness Scale (ESS) score ≥ 11 required for EDS indications
    Renewal ESS improvementRenewal requires ≥25% improvement (reduction) in ESS score from baseline for EDS indications
    Required trial before initial approval (EDS)Patient must have failed a 6‑week trial of or have a contraindication to modafinil and/or armodafinil before approval for EDS
    Sodium oxybate dosing by weight — adult and pediatric weight-based dosing bands
    Adult dosing (sodium oxybate)Adults: 9 grams per night (total)
    Pediatric dosing ≥45 kgPatients ≥45 kg: 4.5 grams per dose and 9 grams per night

    Prescriber and Pharmacy Requirements

    Prior Authorization

    Prior authorization required for all listed agents

    Prior authorization is required for all listed narcolepsy agents and all current and future dose forms; medication-specific criteria including indication, age, and dose in Table 1 must be met.

    Prior Authorization

    Approval lengths and renewal requirements

    Initial authorizations are approved for 3 months; renewal approvals are for 12 months. Renewal requires demonstrated clinical benefit and adherence to the dosing limits in Table 1.

    • Initial approval length: 3 months
    • Renewal approval length: 12 months
    • Renewal requires demonstrated clinical benefit and adherence to dosing limits

    Clinical Background

    Narcolepsy is a chronic sleep disorder characterized primarily by excessive daytime sleepiness (EDS), occurring with or without cataplexy (sudden, transient loss of muscle tone). Diagnosis follows ICSD-3 criteria and requires persistent daytime sleepiness for at least 3 months plus objective testing (multiple sleep latency testing with mean sleep latency ≤8 minutes and presence of SOREMPs) or, for type 1, supportive low cerebrospinal fluid hypocretin-1 levels.

    Clinical management commonly includes wake-promoting agents and sodium oxybate formulations; the policys criteria require confirmation of diagnosis per ICSD-3 and use of indicated agents within the approved age and dosing limits to determine medical necessity for coverage.

    Diagnostic Definitions (ICSD-3)

    Type 1 narcolepsy (ICSD-3) — criteria summary for Type 1
    Minimum duration of symptomsDaily periods of irrepressible need to sleep or daytime lapses into sleep occurring for at least 3 months
    Cataplexy or objective testingPresence of cataplexy plus mean sleep latency ≤ 8 minutes and ≥ 2 SOREMPs on MSLT (nocturnal PSG SOREMP may substitute for one MSLT SOREMP)
    CSF hypocretin-1 criterionCSF hypocretin-1 ≤ 110 pg/mL or < 1/3 of mean control values on the same assay qualifies as diagnostic for type 1
    Type 2 narcolepsy (ICSD-3) — criteria summary for Type 2
    Minimum duration of symptomsDaily periods of irrepressible need to sleep or daytime lapses into sleep occurring for at least 3 months
    MSLT criteriaMean sleep latency ≤ 8 minutes and ≥ 2 SOREMPs on MSLT (nocturnal PSG SOREMP may substitute for one MSLT SOREMP)
    Policy Summary
    PayerKansas Department of Health and Environment
    PolicyCriteria for Prior Authorization — Narcolepsy Agents
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateJan 8, 2020
    Last ReviewApr 17, 2024
    Next Review DateN/A
    Key ActionSubmit prior authorization with diagnosis confirmation per ICSD-3 and required baseline measures (ESS for EDS; cataplexy frequency for cataplexy).
    SourceLink
    On This Page
    Coverage and Medical Necessity CriteriaDrug Listing, Dosing, and Measurement RequirementsPrescriber and Pharmacy RequirementsClinical BackgroundDiagnostic Definitions (ICSD-3)
    Pediatric dosing 30 to <45 kgPatients 30 to <45 kg: 3.75 grams per dose and 7.5 grams per night
    Pediatric dosing 20 to <30 kgPatients 20 to <30 kg: 3 grams per dose and 6 grams per night
    Under 20 kg guidanceManufacturer labeling provides insufficient information for <20 kg; consider lower initial and maximum nightly doses per clinical judgment
    Step Therapy

    6-week trial of modafinil/armodafinil required for EDS

    For excessive daytime sleepiness (EDS) indications, the patient must have failed a 6-week trial of or have a documented contraindication to modafinil and/or armodafinil before coverage of non-preferred agents.

    • Required trial duration: 6 weeks unless contraindicated
    Documentation Required

    Required diagnostic and baseline clinical documentation

    Prescriber must confirm the diagnosis of narcolepsy per ICSD-3 (see Table 2). For EDS, provide a baseline Epworth Sleepiness Scale (ESS) score; for cataplexy, provide the baseline frequency of cataplexy episodes per month. For Xywav® or Lumryz™, provide a compelling clinical rationale if Xyrem® is an available alternative.

    • Diagnosis confirmation per ICSD-3 required
    • Baseline ESS score required for EDS indications
    • Baseline cataplexy episode frequency required for cataplexy indications
    • Clinical rationale required when requesting Xywav® or Lumryz™ over Xyrem®
    Denial Risk

    Denial risks for missing information or out-of-range use

    Requests may be denied if required clinical information is not provided or if the drug is used outside the listed indication, age, or dosing limits in Table 1.

    • Failure to provide baseline ESS for EDS or baseline cataplexy frequency may trigger denial
    • Use outside indicated age, indication, or dosing limits may render the request not medically necessary
    Absence of cataplexy and hypocretinCataplexy must be absent and CSF hypocretin-1 is either not measured or > 110 pg/mL (or > 1/3 of mean control values)