CurrentCignaPolicy IP0581

Ophthalmology - Izervay

Defines Cigna prior authorization, coverage criteria, dosing limits, and coding for Izervay (avacincaptad pegol) for treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Applies to prescription benefit coverage and specifies prescriber requirements and authorization duration.

Policy Summary

PayerCigna

PolicyOphthalmology - Izervay

Policy CodePolicy IP0581

Change TypeRevised (coding and title)

Effective Date

Next Review Date

Key ActionPrior Authorization is required; approvals are for 1 year and Izervay must be prescribed by or in consultation with an ophthalmologist with documentation of BCVA and GA diagnosis.

POLICY UPDATE CHANGES

Updated policy title from 'Avacincaptad Intravitreal Injection' to 'Ophthalmology - Izervay.'

Updated coding: Removed C9399, J3490, J3590; Added J2782 (effective 4/1/2024).

1Covered Indication(s)

1 yrInitial Approval Duration

J2782Primary Billing Code

Coverage Summary & Criteria

Covered with criteria; prior authorization required and approvals provided for 1 year for the FDA-approved indication of geographic atrophy (GA) secondary to age-related macular degeneration. Izervay is administered intravitreally by or under the supervision of an ophthalmologist; recommended dosing is 2 mg (0.1 mL of 20 mg/mL) intravitreal injection once monthly (approximately 28 ± 7 days).

FDA-Approved Indication (Initial Approval)

Approve for 1 year if the patient meets ALL of the following (A, B, and C):

A: Patient has geographic atrophy secondary to age-related macular degeneration
B: Patient has a best corrected visual acuity (BCVA) in the affected eye of between 20/25 and 20/320 lettersbetween 20/25 and 20/320 letters
C: The medication is administered by or under the supervision of an ophthalmologist

Dosing Criteria

Approve if the dose meets BOTH criteria (A and B):

A: Dose is 2 mg (0.1 mL of 20 mg/mL solution) administered by intravitreal injection for each eye being treated2 mg (0.1 mL of 20 mg/mL)
B: Dosing interval is not more frequent than once every 21 days for each eye being treatedminimum interval: not more frequent than once every 21 days
Recommended dosing interval is once monthly (approximately every 28 ± 7 days)

Applicable Codes

Covered HCPCS/J-codeHCPCSCovered

J2782

Injection, avacincaptad pegol, 0.1 mg

Previously listed / Removed Codesmixed

C9399	Not specified (removed)
J3490	Unclassified drugs (removed)
J3590	Unclassified biologics (removed)

Primary billing code: J2782 effective 4/1/2024. Claims billed with previously listed or non-covered/removed codes (for example, C9399, J3490, J3590) may be denied; providers must bill using the most appropriate codes effective on the date of service.

Prior Authorization, Documentation & Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for prescription benefit coverage of Izervay. Approvals are provided for the duration noted (1 year for the FDA indication) and require the prescription to be made by or in consultation with an ophthalmologist.

J2782
Approval duration: 1 year

Documentation Required

Prescriber Specialty and Administration Documentation

Approval requires that Izervay be prescribed by or under the supervision of an ophthalmologist and that documentation supporting best corrected visual acuity (BCVA) and the diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) be available to support coverage.

Billing Rule

Use Appropriate Codes at Time of Service

Providers must bill using the most appropriate codes effective on the date of service. Claims submitted without covered code(s) under this policy will be denied as not covered.

Use J2782
Removed codes (no longer listed/covered): C9399, J3490, J3590 — claims using non-covered/deleted codes will be denied

Clinical Evidence & References

1 yearInitial approval duration for FDA‑approved indication

20/25–20/320BCVA requirement in affected eye (best corrected visual acuity)

Key evidence includes a Phase 2/3 randomized pivotal trial (Jaffe et al. 2021) and the Phase 3 GATHER2 trial (Khanani et al. 2023), plus the Izervay prescribing information (March 2025). Recommended dosing from the prescribing information and policy is 2 mg (0.1 mL of 20 mg/mL) intravitreal injection with a recommended interval of once monthly (≈28 ± 7 days) and a minimum interval not more frequent than 21 days between doses per eye.

Background & Definitions

Izervay (avacincaptad pegol) is indicated for geographic atrophy secondary to age-related macular degeneration, is a complement C5 inhibitor, and the recommended dose is 2 mg (0.1 mL of 20 mg/mL solution) administered by intravitreal injection to each affected eye once monthly.

Term	Definition
{"text":"BCVA","status":""},{"text":"Best corrected visual acuity","status":""}
{"text":"GA","status":""},{"text":"Geographic atrophy secondary to age-related macular degeneration","status":""}

Policy Revision History

2024-04-01coding update

Updated coding: Removed C9399, J3490, J3590; Added J2782 (effective 4/1/2024)

2024-11-15annual revision