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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsMolina Healthcare Izervay Prior Auth | OpenPayer
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    CurrentMolina HealthcarePolicy C26436-A

    Izervay (avacincaptad intravitreal) Coverage Criteria

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    This policy governs Molina Healthcare coverage and prior authorization for intravitreal Izervay (avacincaptad) used to treat geographic atrophy secondary to age-related macular degeneration. It applies to members meeting the documented clinical, prescriber, age, administration, and continuation requirements.

    Policy Summary
    PayerMolina Healthcare
    PolicyIzervay (avacincaptad intravitreal) Coverage Criteria
    Policy CodePolicy C26436-A
    Change TypeAdministrative/contextual revisionno material clinical or coverage change
    Effective DateJul 17, 2025
    Next Review DateOct 1, 2025
    Key ActionDocument geographic atrophy secondary to age-related macular degeneration, baseline visual status, lesion area, and the eye or eyes to be treated in the initial request.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    51+ yearsMinimum member age
    2 mgDose per affected eye
    Every 28 days ± 7 daysAdministration frequency
    6 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.

    Initial authorization
    12 monthsContinuation authorization
    Infection or inflammationContraindications

    Coverage Criteria

    Initial Therapy

    Initial coverage is available when all of the following are met:

    Initial Izervay coverage

    • Member is at least 51 years of ageAge >= 51 years
    • Izervay is prescribed by or in consultation with a board-certified ophthalmologist or retinal specialist
    • Geographic atrophy secondary to age-related macular degeneration is documented
    • Baseline visual status and geographic atrophy lesion area are documented, with the eye or eyes to be treated identified
    • The prescriber attests, or the clinical reviewer finds, that no unaddressed FDA-labeled contraindications are present

      FDA-labeled contraindications identified in the policy include ocular or periocular infections and active intraocular inflammation.

    Continuation Therapy

    Continuation coverage is available when all of the following are met:

    Continuation of Izervay therapy

    • The reauthorization request is for the same eye or eyes as the initial authorizationSame previously treated eye or eyes

      If geographic atrophy develops in an untreated eye, a new request using initial coverage criteria is required.

    • The prescriber attests, or the clinical reviewer finds, that there is no evidence of intolerable adverse effects or drug toxicity
    • Improvement or stabilization of disease state and visual status or geographic atrophy lesion area is documented
    • Administration records document treatment dates and the eye or eyes administered, along with member compliance with the treatment plan

    FDA-Approved Indication

    FDA-approved use:

    Covered indication

    • Treatment of geographic atrophy secondary to age-related macular degeneration

    No compendial approved off-label uses of Izervay are listed.

    Izervay is contraindicated in the presence of ocular or periocular infection or active intraocular inflammation.

    All other uses of Izervay are considered experimental or investigational and are reviewed under Molina's Off-Label policy.

    Coding Information

    HCPCS CodeHCPCS
    J2782Injection, avacincaptad pegol, 0.1 mg

    Provider Requirements and Denial Risks

    Prior Authorization

    Qualified Prescriber and Age

    Izervay must be prescribed by, or in consultation with, a board-certified ophthalmologist or retinal specialist. The member must be 51 years of age or older.

    • If prescribed in consultation, submit consultation notes with the initial request and each reauthorization request.
    Documentation Required

    Initial Clinical Documentation

    The initial request must include clinical documentation supporting the diagnosis and baseline condition before treatment.

    • Document geographic atrophy secondary to age-related macular degeneration.
    • Document baseline visual status and geographic atrophy lesion area, including the eye(s) to be treated.
    • Submit supporting clinical records as required for medical-necessity review.

    Clinical Background

    Geographic atrophy is an advanced form of age-related macular degeneration characterized by progressive loss of retinal tissue and visual function. Izervay (avacincaptad) is an ophthalmic complement C5 inhibitor administered by intravitreal injection for geographic atrophy secondary to age-related macular degeneration.

    Definitions

    Geographic Atrophy (GA)
    ConditionGeographic atrophy (GA) secondary to age-related macular degeneration (AMD)
    Clinical contextGA is an advanced form of age-related macular degeneration.
    Covered useTreatment of GA secondary to AMD is the FDA-approved use for Izervay.
    Intravitreal Injection
    AdministrationInjection into the vitreous of the eye.
    RouteIntravitreal injection.
    Drug classOphthalmic Complement C5 Inhibitor.

    Initial Therapy Criteria

    Initial Therapy

    Initial authorization requires all of the following:

    Initial therapy

    • Member is at least 51 years of ageAge >= 51 years
    • Izervay is prescribed by or in consultation with a board-certified ophthalmologist or retinal specialist

      If prescribed in consultation, consultation notes must be submitted with the initial request.

    • Geographic atrophy secondary to age-related macular degeneration is documented
    • Baseline visual status and geographic atrophy lesion area are documented, with the eye or eyes to be treated identified

    Continuation Criteria

    Continuation Therapy

    Continuation authorization requires all of the following:

    Continuation therapy

    • The reauthorization request is for the same eye or eyes as the initial authorizationSame previously treated eye or eyes

      If the member has developed geographic atrophy in an untreated eye, the prescriber must submit a new request using the initial coverage criteria.

    • The prescriber attests, or the clinical reviewer finds, that there is no evidence of intolerable adverse effects or drug toxicity
    • Improvement or stabilization of disease state and visual status or geographic atrophy lesion area is documented
    • Administration records document treatment dates and the eye or eyes administered, along with member compliance with the treatment plan

    Quantity and Administration

    Izervay Quantity Limits
    Dose per affected eye2 mg (0.1 mL) to each affected eye.
    FrequencyOnce monthly.
    Administration intervalEvery 28 days, with an allowable interval of plus or minus 7 days.

    Site of Care Requirements

    Billing Rule

    Use an eligible hospital outpatient setting

    Intravitreal medications under this policy are recommended for pharmacy or medical benefit coverage when administered in a non-inpatient hospital facility-based location.

    Billing Rule

    Qualified physician required for administration

    Izervay must be administered by a qualified physician.

    Policy Summary
    PayerMolina Healthcare
    PolicyIzervay (avacincaptad intravitreal) Coverage Criteria
    Policy CodePolicy C26436-A
    Change TypeAdministrative/contextual revisionno material clinical or coverage change
    Effective DateJul 17, 2025
    Next Review DateOct 1, 2025
    Key ActionDocument geographic atrophy secondary to age-related macular degeneration, baseline visual status, lesion area, and the eye or eyes to be treated in the initial request.
    SourceLink
    On This Page
    Coverage CriteriaCoding InformationProvider Requirements and Denial RisksClinical BackgroundDefinitionsInitial Therapy CriteriaContinuation CriteriaQuantity and AdministrationSite of Care Requirements
    Prior Authorization

    Authorization Duration

    Authorization is issued for an initial period of 6 months. Continuation authorization is issued for 12 months when continuation criteria are met.

    • Initial authorization: 6 months
    • Continuation authorization: 12 months
    Documentation Required

    Medical Necessity Documentation

    Molina may require complete documentation to evaluate medical necessity, including the clinical rationale and records supporting the requested drug or service. Inadequate documentation may result in denial or other appropriate action.

    • Patient records and test results
    • Credentials of the provider ordering or performing the drug or service
    • Documentation supporting that treatment is medically necessary, not investigational or experimental, and within the member’s benefits
    • Additional information may be requested case by case, including member-specific dosing data when applicable
    Documentation Required

    Initial Geographic Atrophy Documentation

    For initial coverage, document geographic atrophy secondary to age-related macular degeneration and establish the member’s pretreatment status.

    • Diagnosis of geographic atrophy secondary to age-related macular degeneration
    • Baseline visual status
    • Geographic atrophy lesion area and the eye(s) being treated
    Documentation Required

    Contraindication Assessment

    The prescriber must attest, or the clinical reviewer must determine, that the member has no FDA-labeled contraindication that remains unaddressed in the submitted documentation.

    • Ocular or periocular infection
    • Active intraocular inflammation
    Documentation Required

    Continuation Documentation

    A continuation request must document ongoing clinical appropriateness and treatment administration for the previously authorized eye(s).

    • Improvement or stabilization of disease state, visual status, or geographic atrophy lesion area
    • No intolerable adverse effects or drug toxicity
    • Administration dates and eye(s) administered
    • Member compliance with the treatment plan
    Documentation Required

    Specialist Consultation Notes

    When the prescriber acts in consultation with a qualified specialist, consultation documentation must accompany the request.

    • Submit consultation notes with the initial request.
    • Submit consultation notes with each reauthorization request.
    Billing Rule

    Qualified Physician Administration

    Izervay must be administered by a qualified physician.

    • Document the qualified physician’s administration of Izervay in the applicable treatment records.
    Denial Risk

    Insufficient Supporting Documentation

    Molina may deny reimbursement or take other appropriate action when submitted documentation does not support medical necessity, non-investigational use, or coverage within the member’s benefits.

    • Provide patient records, test results, provider credentials, and other requested supporting documentation.
    • Documentation may also be reviewed for inappropriate or excessive billing or other practice concerns.
    Denial Risk

    Unaddressed Contraindication

    Coverage is at risk when an ocular or periocular infection or active intraocular inflammation is present and has not been addressed by the prescriber in the submitted documentation.

    • The prescriber must address the contraindication in the clinical documentation, or the clinical reviewer must find that it has been addressed.
    Denial Risk

    Different Eye in Continuation Request

    Continuation authorization applies only to the same eye(s) covered under the initial authorization. A request for an untreated eye requires a new request using the initial coverage criteria.

    • A different treatment eye in a continuation request may result in denial or require submission as a new initial request.
    Denial Risk

    Continuation Criteria Not Met

    Continuation authorization may be denied when required continuation criteria are not met, including treatment toxicity, lack of improvement or stabilization, missing administration records, or other unmet requirements.

    • No evidence of intolerable adverse effects or drug toxicity
    • Documented improvement or stabilization of disease state, visual status, or geographic atrophy lesion area
    • Administration records showing dates and eye(s) treated
    • Documentation of member compliance with the treatment plan
    Denial Risk

    Non-Covered or Investigational Use

    Coverage is limited to geographic atrophy secondary to age-related macular degeneration. All other uses of Izervay are considered experimental or investigational and are subject to Molina’s Off-Label policy.

    • Non-covered or investigational uses may be denied under the applicable policy.
    Denial Risk

    Contraindications

    Izervay is contraindicated in the presence of ocular or periocular infections or active intraocular inflammation.

    • Coverage is precluded when these contraindications are present and have not been addressed in the submitted documentation.
    Geographic Atrophy (GA)
    Disease classificationAn advanced form of age-related macular degeneration.
    Retinal changesProgressive and irreversible lesions develop in the retinal pigment epithelium (RPE).
    Potential impactLesions can impair vision or lead to blindness, particularly as progressive GA affects the fovea.
    Age-Related Macular Degeneration (AMD)
    Disease stagesAMD progresses through early, intermediate, and advanced stages.
    GA relationshipGA occurs only in the intermediate or advanced stages of AMD.
    Foveal involvementIn intermediate AMD, GA affects the RPE without involving the foveal center; in advanced AMD, GA also affects the foveal center.
    Choroidal Neovascularization (CNV)
    DefinitionChoroidal neovascularization (CNV) is abnormal blood-vessel growth that may occur during advanced AMD.
    Disease associationAMD with CNV is often referred to as exudative AMD, neovascular AMD, or wet AMD.
    Stage relationshipCNV may occur during the advanced stage of age-related macular degeneration.
  1. No unaddressed FDA-labeled contraindications are present

    The contraindications identified in the policy are ocular or periocular infections and active intraocular inflammation.