CurrentUnitedHealthcarePolicy 2025D0118G

Ophthalmologic Complement Inhibitors – Commercial Medical Benefit Drug Policy

Defines UnitedHealthcare commercial medical benefit policy coverage criteria for avacincaptad pegol (Syfovre) and pegcetacoplan (Izervay) for treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), including initial and continuation criteria, applicable procedure and diagnosis codes, evidence summary, and references.

Policy Summary

PayerUnitedHealthcare

PolicyOphthalmologic Complement Inhibitors – Commercial Medical Benefit Drug Policy

Policy CodePolicy 2025D0118G

Change TypeSupporting information/references updated

Effective DateDec 1, 2025

Next Review Date

Key ActionAuthorization is required for treatment and is limited to no more than 12 months for both initial and continuation therapy.

SourceLink

POLICY UPDATE CHANGES

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

2Drugs covered (by name)

6ICD-10 diagnosis codes listed

2HCPCS/J drug codes listed

12 monthsMaximum authorization duration

Coverage Summary

Initial Therapy Criteria

Initial therapy

Covered when ALL of the following are met:

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

Diagnosis has been confirmed by geographic atrophy secondary to age-related macular degeneration 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 of Therapy Criteria

Continuation of therapy

Covered when ALL of the following are met:

Physician attestation that 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.

Exclusions / Not Covered

Macular atrophy that is secondary to causes other than age-related macular degeneration is not covered: the policy requires that macular atrophy be due to AMD and explicitly excludes other etiologies such as Stargardt disease, cone rod dystrophy, and toxic maculopathies. Diagnostic confirmation by AMD-sensitive tests (e.g., OCT or FAF) and documentation that atrophy is not from non-AMD causes are required.

Applicable Codes

HCPCS/J-codes (drug codes)HCPCS

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

ICD-10-CM diagnosis codes (GA/advanced atrophic AMD)ICD-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

Prior Authorization

Authorization required and duration limit

Authorization is required for treatment and is limited to no more than 12 months for both initial and continuation therapy.

J2781
J2782
Authorization limited to no more than 12 months

Documentation Required

Diagnostic confirmation documentation

Provider must document a diagnosis of geographic atrophy (GA) secondary to AMD confirmed by OCT or FAF imaging and must verify that macular atrophy is due to AMD and not other causes (e.g., Stargardt disease, cone rod dystrophy, toxic maculopathies).

Documentation Required

Specialist involvement

Prescription must be by or in consultation with an ophthalmologist experienced in treatment of retinal diseases.

Documentation Required

Continuation attestation and titration

For continuation of therapy, a physician attestation that the patient benefits is required and documentation of titration to the minimum dosing frequency for long-term treatment must be provided.

Billing Rule

Dosing per FDA labeling

Dosing and frequency must follow the United States Food and Drug Administration–approved labeling for each agent.

J2781
J2782

Clinical Evidence Summary

17%DERBY+OAKS combined: monthly pegcetacoplan reduction in GA lesion growth at 12 months

14%DERBY+OAKS combined: every‑other‑month pegcetacoplan reduction in GA lesion growth at 12 months

OAKSOAKS met primary endpoint; DERBY did not

Safety signals observed in pivotal trials include increased rates of new-onset exudation/choroidal neovascularization and rare events of infectious endophthalmitis and intraocular inflammation. Complement inhibition mechanism is relevant: pegcetacoplan inhibits C3 (regulating excessive complement activation implicated in GA progression), while avacincaptad pegol inhibits C5; differences in target likely relate to effects on disease biology and observed adverse events.

Background

Geographic atrophy (GA) is an advanced progressive form of dry AMD characterized by irreversible lesion growth that destroys retinal cells and leads to permanent vision loss as lesions expand from the perifoveal region to involve the fovea. Lesion growth is driven in part by excessive complement activation, with genetic variants of complement C3 playing a central role in disease progression. Avacincaptad pegol (a C5 inhibitor) and pegcetacoplan (a C3 inhibitor) have demonstrated efficacy in randomized trials, showing statistically significant reductions in GA lesion growth compared to sham.

Definitions: GA = Geographic atrophy secondary to age-related macular degeneration; OCT = Optical coherence tomography; FAF = Fundus autofluorescence imaging.

Policy Summary

PayerUnitedHealthcare

PolicyOphthalmologic Complement Inhibitors – Commercial Medical Benefit Drug Policy

Policy CodePolicy 2025D0118G

Change TypeSupporting information/references updated

Effective DateDec 1, 2025

Next Review Date

Key ActionAuthorization is required for treatment and is limited to no more than 12 months for both initial and continuation therapy.

SourceLink

On This Page

OpenPayer

Ophthalmologic Complement Inhibitors – Commercial Medical Benefit Drug Policy

Coverage Summary

Initial Therapy Criteria

Continuation of Therapy Criteria

Exclusions / Not Covered

Applicable Codes

Provider Actions

Clinical Evidence Summary

Background

Revision History