Currentsierra health and lifePolicy 2025D0118G

Ophthalmologic Complement Inhibitors

Policy governs medical benefit coverage criteria for avacincaptad pegol (Syfovre) and pegcetacoplan (Izervay) for treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) for UnitedHealthcare members; affects prescribers and reviewers of ophthalmologic drug benefits.

Policy Summary

Payersierra health and life

PolicyOphthalmologic Complement Inhibitors

Policy CodePolicy 2025D0118G

Change TypeAdministrative (references updated)

Effective DateDec 1, 2025

Next Review Date

Key ActionSubmit prior authorization with diagnosis, confirmatory OCT or FAF imaging, prescriber specialty/consultation, and dosing per FDA labeling.

SourceLink

POLICY UPDATE CHANGES

Updated References section to reflect the most current information and archived previous policy version 2024D0118F.

2drugs addressed

12 monthsmax auth period

1,258pegcetacoplan trial pts

6,331total injections

Coverage Criteria

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial Therapy

Covered when ALL of the following are met

Initial therapy criteria: Diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Diagnosis has been confirmed by GA-sensitive tests (e.g., optical coherence tomography [OCT], fundus autofluorescence [FAF] imaging).

Macular atrophy is not secondary to any conditions other than AMD (e.g., Stargardt disease, cone rod dystrophy, toxic maculopathies).

Prescribed by or in consultation with an ophthalmologist experienced in treatment of retinal diseases.

Dosing is in accordance with the United States Food and Drug Administration approved labeling.

Authorization is for no more than 12 months.

Continuation Therapy

Covered when ALL of the following are met

Continuation therapy criteria: Physician attestation that the patient would benefit from continued administration.

For long-term treatment, documentation of titration to the minimum dosing frequency to achieve maximum benefit.

Dosing is in accordance with the United States Food and Drug Administration approved labeling.

Authorization is for no more than 12 months.

Macular atrophy that is secondary to conditions other than age-related macular degeneration (AMD) is excluded from coverage under this policy. Examples include Stargardt disease, cone-rod dystrophy, and toxic maculopathies. Requests for treatment of macular atrophy due to these non-AMD etiologies do not meet the coverage criteria and may be denied.

Information about U.S. Food and Drug Administration approval of avacincaptad pegol and pegcetacoplan is provided for reference only. FDA approval alone is not a basis for coverage; coverage determinations must be made in the context of the member’s specific benefit plan and applicable plan documents.

Coding

Covered HCPCS/J-codes (listed for reference)HCPCS

J2781	Injection, pegcetacoplan, 1 mg
J2782	Injection, avacincaptad pegol, 0.1 mg

Relevant ICD-10 codes for GA due to AMDICD-10

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, advanced atrophic without subfoveal involvement
H35.3134	Nonexudative age-related macular degeneration, bilateral, advanced atrophic with subfoveal involvement

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit documentation of the diagnosis (GA secondary to AMD), confirmatory imaging, prescriber specialty or consultation note, and dosing consistent with FDA labeling. Authorizations are issued for up to 12 months.

Prior authorization required for initial and continuation therapy
Include prescriber: ophthalmologist experienced in retinal disease or documentation of consultation
Authorization duration: up to 12 months

Note

Provider actions for prior auth submission

Provide documentation of prior treatments, physician attestation for continuation, and evidence of dose titration to the minimum effective frequency when applicable. Ensure billing uses the appropriate HCPCS (J2781, J2782) and ICD-10 diagnosis codes for nonexudative (advanced atrophic) AMD (see applicable codes).

List prior treatments and dates when reporting failure or intolerance
Include physician attestation that patient benefits from continued therapy for continuation requests
For long-term treatment, document titration to minimum dosing frequency per FDA labeling

Documentation Required

Documentation Requirements

Required documentation must include confirmatory imaging: optical coherence tomography (OCT) and/or fundus autofluorescence (FAF). Documentation must explicitly state that macular atrophy is due to AMD and exclude other causes (e.g., Stargardt disease, cone–rod dystrophy, toxic maculopathies). Also include the diagnosis code(s) corresponding to advanced atrophic nonexudative AMD and the specific drug HCPCS code (J2781 or J2782).

Confirmatory imaging: OCT and/or FAF
Statement excluding non-AMD causes of macular atrophy
Diagnosis code(s): H35.3113, H35.3114, H35.3123, H35.3124, H35.3133, H35.3134
Drug HCPCS: J2781 (pegcetacoplan 1 mg), J2782 (avacincaptad pegol 0.1 mg)

Denial Risk

Denial Triggers / Risk of Incomplete Requests

Claims or requests lacking required elements may be denied. Common denial triggers include: missing confirmatory imaging or images not demonstrating GA due to AMD; documentation that fails to exclude other causes of macular atrophy; absence of ophthalmology prescriber or consultation note; dosing inconsistent with FDA labeling; or failure to provide physician attestation or evidence of benefit for continuation requests.

No OCT/FAF confirming GA secondary to AMD
Imaging or notes that do not exclude non-AMD causes
No ophthalmologist prescriber or consultation documented
Dosing not aligned with FDA-approved labeling
Missing physician attestation of benefit for continuation

Background

Geographic atrophy (GA) is an advanced, progressive form of dry age-related macular degeneration characterized by progressive, irreversible retinal cell loss and expansion of atrophic lesions that lead to permanent decline in visual acuity. Lesion growth in GA is partly driven by dysregulation of the complement system, and complement-targeting therapies have been developed to slow progression. Clinically, GA is confirmed using sensitive imaging modalities such as optical coherence tomography (OCT) or fundus autofluorescence (FAF), which document the characteristic atrophic changes and support treatment decisions consistent with the policy’s diagnostic criteria.

Definitions

Geographic atrophy (GA)

DefinitionAn advanced form of dry age-related macular degeneration (AMD) characterized by progressive, irreversible retinal lesion growth that typically begins in the perifoveal region and expands to involve the fovea, leading to permanent loss of visual acuity.

PathophysiologyLesion growth is driven in part by excessive complement system activation; genetic variants of complement C3 contribute to disease progression.

Clinical courseProgressive disease causing irreversible retinal cell loss and eventual permanent vision decline; affects approximately 1 million people in the U.S.

Pegcetacoplan

Drug classPegylated complement C3 inhibitor peptide.

Mechanism of actionRegulates excessive activation of the complement cascade by inhibiting complement component C3, a central driver of downstream complement-mediated retinal damage.

Clinical relevanceTargets a pathogenic pathway implicated in the progression of geographic atrophy (GA) secondary to AMD.

OpenPayer