CurrentBlue Cross Blue Shield - IowaPolicy 05.04.98

Complement Inhibitors for Geographic Atrophy (Syfovre, Izervay)

This policy describes coverage and prior-authorization criteria for the complement inhibitors Syfovre (pegcetacoplan) and Izervay (avacincaptad pegol) when used to treat geographic atrophy (GA) secondary to age-related macular degeneration for Wellmark/Blue Cross and Blue Shield members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyComplement Inhibitors for Geographic Atrophy (Syfovre, Izervay)

Policy CodePolicy 05.04.98

Change TypeNo material changes

Effective DateJun 9, 2025

Next Review DateOct 1, 2025

Key ActionSubmit prior authorization with imaging-confirmed GA and required documentation for initiation and continuation requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA-approved products covered

12 moInitial approval duration

2.5–17.5 mm2Permitted total GA lesion size

OphthalmologistRequired prescriber specialty

J2781,J2782Active billing (J) codes listed

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Coverage Criteria

Initial Therapy - Syfovre

Covered when ALL of the following are met

Syfovre initial

Diagnosis: Member has a diagnosis of geographic atrophy secondary to age-related macular degeneration confirmed via Fundus Autofluorescence imaging, optical coherence tomography, or other imaging techniques
Prescriber: Syfovre is being prescribed by or in consultation with an ophthalmologist
Lesion size: Total GA lesion size is >= 2.5 and <= 17.5 mm^2; if multifocal, at least one focal lesion >= 1.25 mm^22.5-17.5 mm^2; focal >=1.25 mm^2
Exclusions
- Non-AMD GA: Geographic atrophy that is secondary to a condition other than age-related macular degeneration (e.g., Stargardt disease, cone rod dystrophy, toxic maculopathies)
- Infection: Ocular or periocular infection(s)
- Inflammation: Active intraocular inflammation
Combination therapy: The requested medication will not be used in combination with Izervay

Initial Therapy - Izervay

Covered when ALL of the following are met

Izervay initial

Diagnosis: Member has a diagnosis of geographic atrophy secondary to age-related macular degeneration confirmed via Fundus Autofluorescence imaging, optical coherence tomography, or other imaging techniques
Prescriber: Izervay is being prescribed by or in consultation with an ophthalmologist
Lesion size: Total GA lesion size is >= 2.5 and <= 17.5 mm^2; if multifocal, at least one focal lesion >= 1.25 mm^22.5-17.5 mm^2; focal >=1.25 mm^2
Exclusions

Continuation Therapy - Syfovre

Continued coverage when ALL of the following are met

Syfovre continuation

Prescriber: Syfovre is being prescribed by or in consultation with an ophthalmologist
Clinical response: The member has demonstrated a positive clinical response to therapy (e.g., a reduction or stabilization in the rate of vision decline or the risk of more severe vision loss, stabilization or normalization or reduction in total area of GA lesions)
Examples provided
Exclusions
- Non-AMD GA: Geographic atrophy that is secondary to a condition other than age-related macular degeneration (e.g., Stargardt disease, cone rod dystrophy, toxic maculopathies)

Continuation Therapy - Izervay

Continued coverage when ALL of the following are met

Izervay continuation

Prescriber: Izervay is being prescribed by or in consultation with an ophthalmologist
Clinical response: The member has demonstrated a positive clinical response to therapy (e.g., a reduction or stabilization in the rate of vision decline or the risk of more severe vision loss, stabilization or normalization or reduction in total area of GA lesions)
Examples provided
Exclusions
- Non-AMD GA: Geographic atrophy that is secondary to a condition other than age-related macular degeneration (e.g., Stargardt disease, cone rod dystrophy, toxic maculopathies)

Geographic atrophy (GA) that is secondary to conditions other than age-related macular degeneration (AMD) is excluded from coverage. Examples of non-AMD etiologies include Stargardt disease, cone-rod dystrophy, and toxic maculopathies. (Coverage for Syfovre and Izervay applies only when GA is documented as secondary to AMD by imaging such as fundus autofluorescence or optical coherence tomography.)

For initiation of therapy, total GA lesion size must meet the policy threshold of ≥ 2.5 mm² and ≤ 17.5 mm²; if lesions are multifocal, at least one focal lesion must be ≥ 1.25 mm². Requests that do not document lesion size within these ranges are not eligible under the initial approval criteria.

Use of Syfovre (pegcetacoplan) and Izervay (avacincaptad pegol) in combination is not permitted; each requested medication must be used alone for the treated eye and the request must attest that the agent will not be administered concurrently with the other complement inhibitor.

Treatment is not medically necessary when there is an ocular or periocular infection, active intraocular inflammation, or, for continuation requests, a history of or active choroidal neovascularization/exudative AMD. These active infection and inflammation exclusions must be documented and addressed prior to initiation or continuation of therapy.

Coding

Procedures / Drug Codesmixed

C9162	Injection, avacincaptad pegol, 0.1 mg (cancelled 3/31/2024)
C9151	Injection, pegcetacoplan, 1 mg (cancelled 10/1/2023)
C9399	Unclassified drugs or biologics
J2781	Injection, pegcetacoplan, intravitreal, 1 mg (effective 10/1/2023)
J2782	Injection, avacincaptad pegol, 0.1 mg (effective 4/1/2024)
J3490	Unclassified drugs
J3590	Unclassified biologics

inv-08: Total GA lesion size

Permitted total GA lesion size for initiationTotal GA lesion size must be ≥ 2.5 and ≤ 17.5 mm²

Multifocal lesion ruleIf multifocal, at least one focal lesion must be ≥ 1.25 mm²

Applies to both agentsSame lesion-size thresholds used for initial approval of Syfovre and Izervay

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for both initiation and continuation of therapy. Requests must include sufficient documentation to allow medical necessity review; incomplete submissions may be denied or returned for additional information.

Prior authorization required for initiation and continuation of Syfovre (pegcetacoplan) and Izervay (avacincaptad pegol).
Include documentation with initial and renewal requests as described below.
Approval duration: 12 months when criteria are met.

Step Therapy

Combination Therapy Prohibited

The requested medication must not be used in combination with the other agent. Combination therapy with Syfovre and Izervay is prohibited; do not request both agents concurrently for the same eye. There is no allowable sequencing or step-therapy between these agents within the same treatment period.

Syfovre must not be used in combination with Izervay.

Background

Geographic atrophy (GA) is an advanced manifestation of age-related macular degeneration characterized by progressive atrophy of the retinal pigment epithelium and photoreceptors, leading to irreversible central visual loss. Complement inhibitors pegcetacoplan (Syfovre) and avacincaptad pegol (Izervay) are FDA-approved to slow progression of GA secondary to AMD and require image-confirmed diagnosis and management by an ophthalmologist.

Continuation of therapy requires documentation of a positive clinical response such as reduction or stabilization in the rate of vision decline or stabilization/reduction in the total area of GA lesions. Prescriber specialty and exclusion of non-AMD causes, active infection, and active intraocular inflammation are required for both initiation and continuation decisions.

Definitions

inv-14: Geographic atrophy (GA) secondary to age-related macular degeneration

DefinitionGeographic atrophy (GA) secondary to age-related macular degeneration: GA due to AMD as confirmed by imaging modalities such as Fundus Autofluorescence or optical coherence tomography

Imaging confirmation requiredDiagnosis must be confirmed via Fundus Autofluorescence imaging, optical coherence tomography, or other imaging techniques

Exclusion of non-AMD causesGA secondary to conditions other than AMD (e.g., Stargardt disease, cone rod dystrophy, toxic maculopathies) is excluded

Related FDA indicationsSyfovre and Izervay are FDA‑approved for treatment of GA secondary to AMD

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyComplement Inhibitors for Geographic Atrophy (Syfovre, Izervay)

Policy CodePolicy 05.04.98

Change TypeNo material changes

Effective DateJun 9, 2025

Next Review DateOct 1, 2025

Key ActionSubmit prior authorization with imaging-confirmed GA and required documentation for initiation and continuation requests.

SourceLink

On This Page

Non-AMD GA: Geographic atrophy that is secondary to a condition other than age-related macular degeneration (e.g., Stargardt disease, cone rod dystrophy, toxic maculopathies)

Infection: Ocular or periocular infection(s)

Inflammation: Active intraocular inflammation

Combination therapy: The requested medication will not be used in combination with Syfovre

Infection: Ocular or periocular infection(s)

Inflammation: Active intraocular inflammation

CNV/exudative AMD: History of or active choroidal neovascularization or exudative age-related macular degeneration

Infection: Ocular or periocular infection(s)

Inflammation: Active intraocular inflammation

CNV/exudative AMD: History of or active choroidal neovascularization or exudative age-related macular degeneration

Izervay must not be used in combination with Syfovre.

Concurrent or sequential requests that imply combined use for the same eye will be denied.

Documentation Required

Required Documentation for Prior Authorization

Submit the following documentation with initial prior authorization requests and include updated/ongoing documentation for continuation requests. Failure to provide required documentation is a common trigger for denial.

Chart notes or medical record documentation confirming diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration.
Imaging confirmation: Fundus autofluorescence (FAF), optical coherence tomography (OCT), or other ophthalmic imaging confirming GA.
Lesion measurements: Total GA lesion area (documented in mm²). If multifocal, documentation that at least one focal lesion is ≥ 1.25 mm² and total GA lesion size is ≥ 2.5 and ≤ 17.5 mm².
Prescriber specialty: Indication that the medication is prescribed by or in consultation with an ophthalmologist.
For continuation requests: Evidence of positive clinical response (e.g., reduction or stabilization in rate of vision decline, reduced risk of severe vision loss, stabilization/normalization or reduction in total GA lesion area).
Relevant exclusions: Documentation ruling out GA due to other etiologies (e.g., Stargardt disease, cone-rod dystrophy, toxic maculopathies), absence of ocular or periocular infection, and absence of active intraocular inflammation.
For continuation: documentation of no history of or active choroidal neovascularization or exudative AMD (if applicable per agent criteria).

Denial Risk

Denial Triggers / Common Missing Documentation

Common reasons claims or prior authorization requests are denied — ensure submissions address these items to reduce denials.

Missing diagnostic confirmation or absent ophthalmic imaging to verify GA secondary to AMD.
Lesion size not documented or outside of required range (total GA lesion size < 2.5 mm² or > 17.5 mm²; if multifocal, focal lesion < 1.25 mm²).
Prescriber is not an ophthalmologist and no consultation with an ophthalmologist is documented.
Requested therapy is for GA due to an excluded etiology (e.g., Stargardt disease).
Concurrent use or documentation suggesting combination therapy with the alternate agent (Syfovre and Izervay).
Active ocular infection or intraocular inflammation documented, or history of choroidal neovascularization when exclusion applies.
For continuation: lack of documented positive clinical response or absence of follow-up imaging/clinical notes.