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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsWashington HCA Oxervate Prior Auth | OpenPayer
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    CurrentWashington State Health Care AuthorityPolicy 86.77.00.AA-1

    Ophthalmic Agents: Cenegermin-bkbj (Oxervate)

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    This policy governs Washington Apple Health coverage and prior authorization for cenegermin-bkbj (Oxervate) ophthalmic solution for patients with neurotrophic keratitis, including clinical criteria, dosing limits, and lifetime treatment restrictions.

    Policy Summary
    PayerWashington State Health Care Authority
    PolicyOphthalmic Agents: Cenegermin-bkbj (Oxervate)
    Policy CodePolicy 86.77.00.AA-1
    Change TypeNo material clinical or coverage changes
    Effective DateApr 1, 2024
    Next Review DateN/A
    Key ActionObtain prior authorization and document at least a 14-day trial of antibiotic drops combined with preservative-free artificial tears before requesting Oxervate.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    8 weeksAuthorized initial treatment duration
    6 times dailyFDA-approved dosing frequency
    14 daysMinimum conventional therapy trial
    112 mLMaximum quantity per lifetime

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    Stage 2 or 3
    Eligible disease severity

    Coverage Criteria

    Initial Therapy

    Covered when all required criteria are met.

    Initial therapy requirements

    • Clinical and treatment requirements

      • The patient has a diagnosis of neurotrophic keratitis.
      • Cenegermin-bkbj (Oxervate) is prescribed by, or provided in consultation with, an ophthalmologist or optometrist.
      • Antibiotic drops in combination with preservative-free artificial tears have been ineffective, contraindicated, or not tolerated after a minimum 14-day trial.Minimum 14-day trial
      • The patient has not received prior cenegermin-bkbj (Oxervate) therapy in the requested eye during their lifetime.

    • Disease severity pathway

      • Stage 3: The patient has Stage 3 neurotrophic keratitis characterized by corneal ulceration, corneal perforation, or corneal stromal melting.Stage 3

      • Stage 2

        • The patient has Stage 2 neurotrophic keratitis characterized by a persistent epithelial defect.Stage 2
        • A therapeutic contact lens, specifically a scleral lens, has been ineffective, contraindicated, or not tolerated.

    Reauthorization

    Reauthorization is not available under this policy.

    Reauthorization restriction

    • The patient is not eligible for reauthorization.
    • Treatment beyond the initial eight-week duration is considered experimental and investigational.Initial course limited to eight weeks

    Treatment beyond the initial eight-week course is considered experimental and investigational under this policy. Reauthorization is not available.

    Initial approval is excluded when the patient has received prior cenegermin-bkbj (Oxervate) therapy in the requested eye at any time during the patient’s lifetime.

    Provider Actions

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for cenegermin-bkbj (Oxervate). New-to-market agents in this class listed as non-preferred on the Apple Health Preferred Drug List are also subject to these PA criteria.

    • Non-preferred agents require inadequate response or documented intolerance due to severe adverse reaction or contraindication to at least two preferred agents.
    • If only one preferred agent is available in the class, document inadequate response to that one preferred agent.
    • New FDA-approved indications are reviewed case by case according to FDA labeling.
    Step Therapy

    Required Prior Therapies

    Document that antibiotic drops used in combination with preservative-free artificial tears were ineffective, contraindicated, or not tolerated before requesting cenegermin-bkbj.

    • A minimum 14-day trial is required.

    Background

    Neurotrophic keratitis is a degenerative corneal disease caused by damage to the trigeminal nerve. This damage results in reduced or absent corneal sensation, impaired epithelial healing, and risk of ulceration, corneal stromal melting, and perforation.

    Disease Stage Definitions

    Stage 3 Definition
    Stage 3 neurotrophic keratitisCorneal ulceration, corneal perforation, or corneal stromal melting.
    Stage 2 Definition
    Stage 2 neurotrophic keratitisPersistent epithelial defect.

    Initial Therapy Criteria

    Initial Therapy

    Cenegermin-bkbj (Oxervate) may be approved when all criteria are met.

    Initial therapy requirements

    • The patient has a diagnosis of neurotrophic keratitis.
    • Treatment is prescribed by, or provided in consultation with, an ophthalmologist or optometrist.
    • Antibiotic drops plus preservative-free artificial tears have been ineffective, contraindicated, or not tolerated after at least 14 days.At least 14 days
    • The requested eye has never previously been treated with cenegermin-bkbj (Oxervate).

    • Disease severity pathway

    Continuation Criteria

    No Reauthorization

    Continuation therapy is not eligible for authorization.

    No continuation therapy

    • Reauthorization is not eligible.
    • Treatment beyond the initial eight-week duration is considered experimental and investigational.Eight-week maximum course

    Step Therapy Requirements

    StepRequired therapyMinimum trial or conditionRequired outcome
    1Antibiotic drops combined with preservative-free artificial tearsMinimum 14-day trialIneffective, contraindicated, or not tolerated before Oxervate approval
    2 (Stage 2 disease only)Therapeutic contact lens, specifically a scleral lensNo duration specifiedIneffective, contraindicated, or not tolerated before Oxervate approval

    Quantity Limits

    Quantity Limits
    Dosage formOxervate 0.002% (20 mcg/mL) vial
    Quantity per affected eye56 mL
    Maximum quantity per lifetime112 mL
    Policy Summary
    PayerWashington State Health Care Authority
    PolicyOphthalmic Agents: Cenegermin-bkbj (Oxervate)
    Policy CodePolicy 86.77.00.AA-1
    Change TypeNo material clinical or coverage changes
    Effective DateApr 1, 2024
    Next Review DateN/A
    Key ActionObtain prior authorization and document at least a 14-day trial of antibiotic drops combined with preservative-free artificial tears before requesting Oxervate.
    SourceLink
    On This Page
    Coverage CriteriaProvider ActionsBackgroundDisease Stage DefinitionsInitial Therapy CriteriaContinuation CriteriaStep Therapy RequirementsQuantity Limits
  1. The response, contraindication, or intolerance must be documented.
    2. Documentation Required

    Clinical Documentation

    Submit clinical documentation supporting the diagnosis and treatment request, including the affected or requested eye and the disease stage.

    • Diagnosis of neurotrophic keratitis.
    • Prescription by, or consultation with, a specialist such as an ophthalmologist or optometrist.
    • Disease stage and stage-specific findings: Stage 3 includes corneal ulceration, perforation, or stromal melting; Stage 2 is a persistent epithelial defect.
    • Identify the affected/requested eye and document relevant prior-treatment history.
    Documentation Required

    Prior Conventional Therapy

    Document at least a 14-day trial of antibiotic drops in combination with preservative-free artificial tears and the patient’s response before requesting treatment.

    • The prior therapy must be ineffective, contraindicated, or not tolerated.
    • Include the treatment dates, agents used, affected eye, and response when submitting the request.
    Step Therapy

    Stage 2 Treatment History

    For Stage 2 neurotrophic keratitis, document that a therapeutic contact lens—specifically a scleral lens—was ineffective, contraindicated, or not tolerated.

    • Stage 2 requires a persistent epithelial defect.
    • This scleral-lens criterion applies in addition to the required antibiotic-drop and preservative-free-artificial-tear trial.
    Denial Risk

    Clinical Criteria Not Met

    The request may be denied when the clinical criteria are not met, including an unsupported diagnosis, prescriber who is not a qualified specialist or consultant, or failure to satisfy any required treatment-history or disease-stage criterion.

    • Neurotrophic keratitis must be documented.
    • The drug must be prescribed by, or in consultation with, an ophthalmologist, optometrist, or other qualifying specialist.
    • Required prior therapies, disease-stage requirements, and documentation must be satisfied.
    Denial Risk

    Prior Treatment in Requested Eye

    Cenegermin-bkbj is not eligible when the patient has previously received cenegermin-bkbj (Oxervate) in the requested eye at any time during their lifetime.

    • Confirm and document treatment history for the requested eye before submitting the request.
    Denial Risk

    Repeat or Extended Treatment

    Reauthorization is not available. Treatment beyond the initial eight-week course, including repeat treatment, may be denied because it is considered experimental and investigational.

    • Authorization, when all criteria are met, is limited to the initial eight-week course.
    • Do not request treatment beyond eight weeks or repeat treatment in the same requested eye.
    Billing Rule

    Quantity Limit Exceeded

    Requests exceeding the quantity limits may be denied. The limit is 56 mL per affected eye and 112 mL per lifetime.

    • Oxervate dosing: 1 drop into the affected eye(s) 6 times daily for 8 weeks.
    • Quantity limit: 56 mL per affected eye.
    • Lifetime quantity limit: 112 mL.
    • Stage 3: The patient has Stage 3 neurotrophic keratitis characterized by corneal ulceration, corneal perforation, or corneal stromal melting.Stage 3

    • Stage 2

      • The patient has Stage 2 neurotrophic keratitis characterized by a persistent epithelial defect.Stage 2
      • A therapeutic scleral lens has been ineffective, contraindicated, or not tolerated.