CurrentColorado Rocky Mountain Health PlansPolicy CS2026D0118M

Ophthalmologic Complement Inhibitors

Coverage policy for avacincaptad pegol (Syfovre) and pegcetacoplan (Izervay) for treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD); applies to UnitedHealthcare Community Plan medical benefit drug coverage except where state-specific exceptions are noted.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyOphthalmologic Complement Inhibitors

Policy CodePolicy CS2026D0118M

Change TypeNo material change

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization for J2781 or J2782 with documentation confirming GA secondary to AMD and required imaging and clinician attestation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2proven agents listed

J2781, J2782HCPCS drug codes referenced

H35.3113-3134ICD-10 GA codes

12auth period (months)

AdultsFDA indicated population

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Coverage Criteria

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 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.<= 12 months

Continuation of therapy

Covered when ALL of the following are met:

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

For long-term treatment, documentation of titration to the minimum dosing frequency needed 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.<= 12 months

Coverage under this policy excludes macular atrophy that is secondary to conditions other than age-related macular degeneration (AMD). Examples of excluded causes specifically listed in the policy include Stargardt disease, cone‑rod dystrophy, and toxic maculopathies. Requests for treatment of macular atrophy due to these alternative diagnoses do not meet the criteria for Izervay (pegcetacoplan) or Syfovre (avacincaptad pegol) under this policy and may be denied unless the documentation demonstrates GA secondary to AMD.

Coding

Referenced HCPCS/J-codesHCPCS

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

Referenced ICD-10 Diagnosis CodesICD-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 & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for injections billed with HCPCS codes J2781 and J2782. Requests must include documentation that meets either the initial therapy or continuation therapy criteria in the coverage rationale.

Affected codes: J2781 (pegcetacoplan, intravitreal, 1 mg) and J2782 (avacincaptad pegol, 0.1 mg).
Authorizations are issued for up to 12 months and must align with FDA‑approved dosing.

Note

Provider Actions

Providers should prescribe or consult with an ophthalmologist experienced in retinal disease management and ensure all supporting clinical documentation is submitted with the authorization request.

Provider attestation required for continuation requests that patient benefits from continued administration.
For long‑term treatment, document titration to the minimum dosing frequency needed to achieve maximal benefit.

Background

Geographic atrophy (GA) is described in the policy as an advanced manifestation of dry age‑related macular degeneration in which retinal cell loss and progressive lesion enlargement lead to permanent vision loss. Disease progression is confirmed by tests sensitive to GA (for example, optical coherence tomography (OCT) and fundus autofluorescence (FAF)), and these imaging findings are required to document the diagnosis when seeking coverage for complement inhibitor therapy.

The policy notes that complement inhibition with agents such as pegcetacoplan and avacincaptad pegol reduces GA lesion growth in randomized trials and that treatment is intended for adults with GA secondary to AMD. Coverage decisions require that diagnosis and imaging confirmation be provided, that treatment is prescribed by or in consultation with an ophthalmologist experienced in retinal disease, that dosing follows FDA labeling, and that authorization periods do not exceed 12 months.

Definitions

Geographic atrophy (GA) — key facts

DefinitionGeographic atrophy (GA) is an advanced form of dry age-related macular degeneration (AMD) caused by irreversible lesion growth and destruction of retinal cells resulting in progressive, typically fovea‑involving, permanent loss of visual acuity.

Disease courseGA is progressive, often beginning in the perifoveal region and expanding to involve the fovea over time, producing permanent vision loss.

PathophysiologyLesion growth is driven in part by excessive complement activation; complement C3 variants contribute to downstream retinal damage.

Epidemiology (U.S.)Approximately 1 million people in the United States are affected; GA is a leading cause of blindness.

Therapeutic targetComplement pathway inhibition (e.g., C3 or C5 inhibitors) can reduce GA lesion growth; pegcetacoplan is a pegylated complement C3 inhibitor.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyOphthalmologic Complement Inhibitors

Policy CodePolicy CS2026D0118M

Change TypeNo material change

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization for J2781 or J2782 with documentation confirming GA secondary to AMD and required imaging and clinician attestation.

SourceLink

On This Page

Documentation Required

Required Documentation

Submit the following documentation with the prior authorization request to support medical necessity: diagnosis details, diagnostic imaging, laterality, ICD‑10 code(s), and confirmation that macular atrophy is due to AMD and not another condition.

Diagnosis: Geographic atrophy (GA) secondary to age‑related macular degeneration (AMD).
Diagnostic confirmation: imaging sensitive for GA (e.g., OCT, fundus autofluorescence).
Eye laterality and description of subfoveal involvement where applicable.
ICD‑10 code(s): use the most specific code from H35.3113, H35.3114, H35.3123, H35.3124, H35.3133, H35.3134.
Documentation that macular atrophy is not secondary to other conditions (e.g., Stargardt disease, cone‑rod dystrophy, toxic maculopathies).
For continuation: physician attestation of continued benefit and records of dosing/titration to minimum effective frequency.

Denial Risk

Denial Triggers for Initial or Continued Therapy

Authorization may be denied if required criteria or documentation are missing or inconsistent with policy criteria.

Incorrect or missing diagnosis (not GA secondary to AMD).
Lack of diagnostic confirmation (no OCT or FAF imaging documentation).
Documentation shows macular atrophy attributable to another condition (e.g., Stargardt disease).
No provider attestation for continuation requests or lack of evidence of benefit.
Dosing inconsistent with FDA‑approved labeling or missing dosing information.

FDA indication (summary)Avacincaptad pegol and pegcetacoplan injection are indicated in adult patients for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Indicated populationAdults with GA secondary to AMD.

Regulatory noteFDA approval is informational and not alone a basis for coverage determinations.