CurrentEmblemHealthPolicy MGMM.PH.396

Izervay (avacincaptad pegol), intravitreal injection

Covers medical necessity and authorization criteria for Izervay (avacincaptad pegol) intravitreal injections to treat geographic atrophy secondary to age-related macular degeneration for EmblemHealth members and participating providers.

Policy Summary

PayerEmblemHealth

PolicyIzervay (avacincaptad pegol), intravitreal injection

Policy CodePolicy MGMM.PH.396

Change TypeLength of Authorization updated

Effective DateOct 13, 2023

Next Review Date

Key ActionSubmit clinical evidence that the member meets the coverage criteria for Izervay when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

Updated Length of Authorization to 12 months.

Annual review noted with no criteria changes.

2 mgrecommended per-eye dose

12 monthsinitial length of authorization

J2782HCPCS code listed

82829-0002-01NDC

20/25–20/320BCVA range

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Coverage Criteria for Izervay (avacincaptad pegol)

Initial Authorization

Covered when ALL of the following are met:

Initial Authorization Criteria: Patient has geographic atrophy secondary to age-related macular degeneration.

Medication is administered by or under the supervision of an ophthalmologist.

Best corrected visual acuity (BCVA) in the affected eye is between 20/25 and 20/320.20/25 to 20/320

Dosing and Authorization Period: Recommended dose: 2 mg intravitreal injection to each affected eye once monthly; coverage provided for up to 12 months when criteria are met.2 mg monthly; up to 12 months

Coverage is limited to treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The policy does not list other indications as covered. Coverage is provided when all policy criteria are met, including documentation that the patient has GA secondary to AMD and that the medication is administered by or under the supervision of an ophthalmologist.

Patients with a best corrected visual acuity (BCVA) in the affected eye that is outside the range of 20/25 to 20/320 do not meet the policy’s eligibility criteria and are not covered under this policy.

Coding: HCPCS, NDC, and Diagnosis Codes

Applicable HCPCS/Codes for drugHCPCSCovered

J2782

Injection, avacincaptad pegol, 0.1 mg

Applicable NDCsNDCCovered

82829-0002-01

Izervay 2 mg/0.1 mL solution for injection in a single-dose vial

Applicable ICD-10 DiagnosesICD-10Covered

H35.3113	Nonexudative age-related macular degeneration, right eye advanced atrophic without subfoveal involvement
H35.3114	Nonexudative age-related macular degeneration, right eye advanced atrophic with subfoveal involvement
H35.3123	Nonexudative age-related macular degeneration, left eye advanced atrophic without subfoveal involvement
H35.3124	Nonexudative age-related macular degeneration, left eye advanced atrophic with subfoveal involvement
H35.3133	Nonexudative age-related macular degeneration, bilateral eye advanced atrophic without subfoveal involvement
H35.3134	Nonexudative age-related macular degeneration, bilateral eye advanced atrophic with subfoveal involvement
H35.3193	Nonexudative age-related macular degeneration, unspecified eye advanced atrophic without subfoveal involvement
H35.3194	Nonexudative age-related macular degeneration, unspecified eye advanced atrophic with subfoveal involvement

inv-07: Minimum interval between doses

Minimum interval between dosesNot more frequent than once every 21 days for each eye being treated

Per‑eye dosing unitDose is 2 mg (0.1 mL of 20 mg/mL solution) administered by intravitreal injection for each eye

Operational noteInterval applies separately to each eye when both eyes are treated

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required before initiation of Izervay (pegcetacoplan intravitreal injection). When criteria are met, coverage will be provided for up to 12 months.

Procedure/Drug code: J2782
Authorization duration: up to 12 months

Note

Provider Action / Submission Alert

The treating physician or primary care provider must submit clinical evidence that the member meets the criteria for treatment. This documentation is required for preauthorization and for any post-payment review; without it EmblemHealth will not be able to properly review the request.

Submit complete clinical records supporting diagnosis and eligibility
Include treating ophthalmologist details and administration plan

Documentation Required

Required Clinical Documentation

Required clinical documentation to support preauthorization must include all of the items listed below. Failure to submit the required clinical evidence may result in denial of the request or inability to complete review.

Documentation of diagnosis: geographic atrophy secondary to age-related macular degeneration (AMD)
Best corrected visual acuity (BCVA) in the affected eye between 20/25 and 20/320
Evidence the medication will be administered by or under the supervision of an ophthalmologist
Proposed dosing schedule (Izervay 2 mg intravitreal injection monthly, approximately every 28 days) and plan for up to 12 months of therapy
Relevant prior treatments, if any, and reason for use of Izervay

Denial Risk

Documentation Submission Required

Failure to submit the required clinical documentation may prevent proper review of the preauthorization request and can lead to denial or delay. Ensure all requested records and objective findings are included at time of submission.

Include diagnostic test results, visual acuity measurements, and treating provider notes
Attach prior authorization forms and any relevant imaging or ophthalmology consult notes

Definitions and Eligibility Details

inv-13: Izervay — key facts

Drug name (brand/generic)Izervay (avacincaptad pegol)

Drug classComplement C5 inhibitor

IndicationTreatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)

Recommended dose and route2 mg (0.1 mL of 20 mg/mL solution) intravitreal injection to each affected eye once monthly

inv-14: BCVA eligibility

BCVA requirement (affected eye)Best corrected visual acuity between 20/25 and 20/320

ApplicabilityRequirement applies to the affected eye being considered for treatment

Coverage implicationPatients with BCVA outside this range do not meet the policy’s eligibility criteria

Policy Revision History

2025-05-06revisionLatest

Updated Length of Authorization to 12 months.

2025-03-31review

Annual review completed with no changes to coverage criteria.

2024-02-16revision

Annual review: no criteria changes; added code C9162 and removed J3490 and C9399.

2023-10-13creation

Policy created (Policy New).