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    v1.0.31
    OpenPayerPolicy UpdatesOphthalmology/OptometryClover Health Aflibercept Prior Auth | OpenPayer
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    CurrentClover HealthPolicy 2507-A

    Eylea, Eylea HD, and Aflibercept Biosimilars Coverage Criteria

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    This policy governs Medicare Part B coverage and prior authorization for Eylea, Eylea HD, and specified aflibercept biosimilars for ophthalmic conditions when documented coverage criteria are met.

    Policy Summary
    PayerClover Health
    PolicyEylea, Eylea HD, and Aflibercept Biosimilars Coverage Criteria
    Policy CodePolicy 2507-A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization for Eylea, Eylea HD, or a listed aflibercept biosimilar when treating a covered indication.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    8products covered by the policy
    5FDA-approved indication categories addressed
    12 monthsstandard authorization period for listed indications
    3continuation-of-therapy criteria
    5

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    products restricted to listed retinal indications

    Covered Indications and Authorization Criteria

    Diabetic macular edema

    Authorization of 12 months may be granted for treatment of diabetic macular edema.

    Diabetic macular edema: The requested aflibercept product is being used to treat diabetic macular edema.12-month authorization

    The policy lists this as a covered indication for the applicable products.

    Diabetic retinopathy

    Authorization of 12 months may be granted for treatment of diabetic retinopathy.

    Diabetic retinopathy: The requested aflibercept product is being used to treat diabetic retinopathy.12-month authorization

    The policy lists this as a covered indication for the applicable products.

    Neovascular (wet) age-related macular degeneration

    Authorization of 12 months may be granted for treatment of neovascular (wet) age-related macular degeneration.

    Neovascular (wet) age-related macular degeneration: The requested aflibercept product is being used to treat neovascular (wet) age-related macular degeneration.12-month authorization

    The policy lists this as a covered indication for the applicable products.

    Macular edema following retinal vein occlusion

    Authorization of 12 months may be granted for treatment of macular edema following retinal vein occlusion.

    Macular edema following retinal vein occlusion: The requested product is Eylea or an aflibercept biosimilar and is being used to treat macular edema following retinal vein occlusion.12-month authorization

    This indication is limited to Eylea and biosimilars; Eylea HD is not included in this indication-specific criterion.

    Retinopathy of prematurity

    Authorization of 12 months may be granted for treatment of retinopathy of prematurity.

    Retinopathy of prematurity: The requested product is Eylea or an aflibercept biosimilar and is being used to treat retinopathy of prematurity.12-month authorization

    This indication is limited to Eylea and biosimilars.

    Continuation of therapy

    Authorization of 12 months may be granted when ALL of the following criteria are met.

    • Current aflibercept therapy: The member is currently receiving therapy with an aflibercept product.
    • Covered indication: The requested medication is being used to treat an indication in the coverage criteria section.
    • Positive clinical response: The member demonstrated a positive clinical response to therapy, such as improvement or maintenance in best corrected visual acuity or vision field, or a reduction in the rate of vision decline or the risk of more severe vision loss.

    Authorization and Documentation Requirements

    Prior Authorization

    Obtain prior authorization before initial therapy

    Prior authorization is required for Eylea, Eylea HD, and the listed aflibercept biosimilars. Authorization of 12 months may be granted when the requested product is used for an indication listed in the coverage criteria and all approval criteria are met.

    Prior Authorization

    Meet continuation authorization requirements

    For continuation authorization, the member must be currently receiving therapy with the requested agent and an aflibercept product, the medication must be used for a covered indication, and the member must have demonstrated a positive clinical response. Authorization may be granted for 12 months when all criteria are met.

    Documentation Required

    Policy Background

    This policy addresses aflibercept therapy for retinal diseases, including neovascular (wet) age-related macular degeneration, diabetic macular edema, diabetic retinopathy, macular edema following retinal vein occlusion, and retinopathy of prematurity. Coverage is based primarily on listed FDA-approved indications; other indications are assessed individually when supported by evidence from Medicare-approved compendia.

    Products and Clinical Terms

    Covered aflibercept products
    Eylea productsEylea and Eylea HD (aflibercept)
    Aflibercept biosimilarsAhzantive (aflibercept-mrbb), Enzeevu (aflibercept-abzv), Eydenzelt (aflibercept-boav), Opuviz (aflibercept-yszy), Pavblu (aflibercept-ayyh), and Yesafili (aflibercept-jbvf)
    Product namingListed products include brand and generic names, as well as all dosage forms and strengths unless otherwise stated.
    Neovascular (wet) age-related macular degeneration
    DefinitionNeovascular, or wet, age-related macular degeneration is a retinal indication addressed by this policy.
    Eylea and Eylea HDBoth Eylea and Eylea HD are indicated for treatment of neovascular (wet) age-related macular degeneration.
    Policy Summary
    PayerClover Health
    PolicyEylea, Eylea HD, and Aflibercept Biosimilars Coverage Criteria
    Policy CodePolicy 2507-A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization for Eylea, Eylea HD, or a listed aflibercept biosimilar when treating a covered indication.
    SourceLink
    On This Page
    Covered Indications and Authorization CriteriaAuthorization and Documentation RequirementsPolicy BackgroundProducts and Clinical Terms

    Submit compendial support for other indications

    For an indication other than those listed in the policy, submit supporting evidence from Medicare-approved compendia with the authorization request.

    Documentation Required

    Document response to ongoing therapy

    For continuation therapy, document current treatment with an aflibercept product, the covered indication being treated, and a positive clinical response to therapy.

    • Positive clinical response may include improvement or maintenance in best corrected visual acuity or vision field.
    • A positive response may also include a reduction in the rate of vision decline or the risk of more severe vision loss.
    Denial Risk

    Unlisted indications require compendial support

    Coverage may be denied when the requested indication is not listed in the policy and the submission does not include supporting evidence from Medicare-approved compendia.

    Denial Risk

    Avoid denial by meeting all continuation criteria

    Continuation authorization may be denied if the member is not currently receiving an aflibercept product, the requested medication is not being used for an indication in the coverage criteria section, or the member has not demonstrated a positive clinical response.

    Listed biosimilarsAhzantive, Enzeevu, Eydenzelt, Opuviz, Pavblu, and Yesafili are listed for treatment of neovascular (wet) age-related macular degeneration.
    Positive clinical response
    Visual acuity or vision fieldImprovement or maintenance in best corrected visual acuity (BCVA) or vision field.
    Vision declineA reduction in the rate of vision decline.
    Severe vision lossA reduction in the risk of more severe vision loss.