Complement inhibitors for geographic atrophy (pegcetacoplan, avacincaptad pegol) — Coverage Criteria
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Coverage criteria for the use of complement inhibitor intravitreal therapies (pegcetacoplan, avacincaptad pegol) to treat geographic atrophy (GA) secondary to age‑related macular degeneration for Wellmark/Blue Cross Blue Shield members.
FDA-approved agents Syfovre (pegcetacoplan) and Izervay (avacincaptad pegol) are listed as indicated for treatment of geographic atrophy secondary to age-related macular degeneration.
Updated billing/CPT-HCPCS codes for pegcetacoplan and avacincaptad pegol (J2781, J2782) and cancellation notes for older codes.
Defined lesion-size eligibility thresholds and other inclusion/exclusion clinical criteria for both agents and specified 12-month approval period.
Coverage Criteria for Complement Inhibitor Intravitreal Therapies
Initial Therapy — Syfovre (pegcetacoplan)
Covered when ALL of the following are met
Approval for 12 months
Initial Therapy — Izervay (avacincaptad pegol)
Covered when ALL of the following are met
Approval for 12 months
Continuation Therapy
Covered when ALL of the following are met
Continuation approvals per policy
Geographic atrophy (GA) that is secondary to conditions other than age-related macular degeneration (AMD) is excluded from coverage. Examples of excluded etiologies listed in the policy include Stargardt disease, cone-rod dystrophy, and toxic maculopathies. Concurrent use of both listed complement inhibitors (pegcetacoplan and avacincaptad pegol) is also excluded.
Use of these intravitreal complement inhibitors is restricted in the presence of active ocular or periocular infection and active intraocular inflammation; such conditions render therapy not medically necessary. Additionally, members with a history of or active choroidal neovascularization (exudative AMD) are excluded from continuation therapy. The policy further specifies that the medications must not be used in combination with the other listed complement inhibitor (Syfovre vs Izervay) and therapy must be prescribed by or in consultation with an ophthalmologist.
Procedure and Lesion Measurement Coding
| C9162 | Injection, avacincaptad pegol, 0.1 mg (cancelled 3/31/2024) |
| C9399 | Unclassified drugs or biologics |
| C9151 | Injection, pegcetacoplan, mg (cancelled 10/1/2023) |
| J2781 | Injection, pegcetacoplan, intravitreal, mg (effective 10/1/2023) |
| J2782 | Injection, avacincaptad pegol, 0.1 mg (effective 4/1/2024) |
| J3490 | Unclassified drugs |
| J3590 | Unclassified biologics |
Prior Authorization, Documentation, and Prescriber Requirements
Prior authorization required for initial and continuation requests
Prior authorization is required for both initial and continuation requests; each request must meet the policy’s clinical criteria and include the required imaging and chart documentation.
- Initial and continuation requests must meet the documented clinical criteria (diagnosis, prescriber specialty, lesion size thresholds, exclusion criteria).
- Include required imaging and chart documentation as specified for initial or continuation requests.
No step-therapy specified; combination use prohibited
No step therapy or required trial of alternative agents is specified; however, the requested complement inhibitor must not be used in combination with the other listed agent (Syfovre and Izervay cannot be combined).
- Therapy choice must meet the listed coverage criteria for the selected agent.
- Requests proposing combined use of Syfovre (pegcetacoplan) and Izervay (avacincaptad pegol) will not meet policy criteria.
Required documentation for initial and continuation requests
Initial requests must include chart notes or medical record documentation confirming GA secondary to AMD with supporting imaging (Fundus Autofluorescence, OCT, or other imaging); continuation requests must include chart notes or medical record documentation confirming a positive clinical response to therapy.
- Initial documentation: chart notes or medical record confirming diagnosis of GA secondary to AMD and supporting imaging (Fundus Autofluorescence, optical coherence tomography, or other imaging).
- Continuation documentation: chart notes or medical record confirming a positive clinical response (e.g., reduction or stabilization in rate of vision decline or stabilization/reduction in total area of GA lesions).
Triggers for denial
Requests may be denied if required documentation is missing, if the prescriber is not an ophthalmologist or the request is not in consultation with an ophthalmologist, if lesion size is outside the policy’s thresholds, if excluded conditions are present, or if there is lack of demonstrated clinical response for continuation.
- Missing chart notes or required imaging for initial requests.
- Prescriptions not from or not in consultation with an ophthalmologist.
- Lesion size outside policy-defined range (total GA lesion size <2.5 mm2 or ≥17.5 mm2; multifocal cases without a focal lesion ≥1.25 mm2).
- Presence of excluded conditions (GA secondary to other diseases, ocular/periocular infection, active intraocular inflammation, history of or active choroidal neovascularization/exudative AMD).
- Requests proposing combination therapy with the other listed complement inhibitor.
Clinical Background
Geographic atrophy (GA) is an advanced manifestation of age-related macular degeneration characterized by progressive atrophy of the retinal pigment epithelium and overlying photoreceptors leading to worsening visual function over time. The policy addresses use of intravitreal complement inhibitors (pegcetacoplan and avacincaptad pegol) that are intended to slow progression of GA secondary to AMD; diagnosis must be confirmed by imaging such as fundus autofluorescence or optical coherence tomography. Coverage decisions are based on lesion-size thresholds, confirmation of GA secondary to AMD, and absence of excluded conditions, with approvals for initial and continuation therapy contingent on meeting these clinical criteria.
Key Definitions
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