TL;DR: Aetna, a CVS Health company, modified CPB 1041 covering avacincaptad pegol (Izervay) for geographic atrophy secondary to age-related macular degeneration, effective September 26, 2025. Izervay is now a second-line therapy under Aetna's commercial plans — your team must document Syfovre failure, contraindication, or intolerance before billing HCPCS J2782 or expect a claim denial.
This is a step-therapy restriction that changes everything about how you build your prior authorization file. Aetna's Izervay coverage policy now explicitly names Syfovre (pegcetacoplan) as the preferred alternative. If your ophthalmology practice bills for Izervay as a first-line treatment under CPB 1041 Aetna, those claims will not get paid.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Avacincaptad Pegol (Izervay) |
| Policy Code | CPB 1041 |
| Change Type | Modified |
| Effective Date | September 26, 2025 |
| Impact Level | High |
| Specialties Affected | Ophthalmology |
| Key Action | Document Syfovre trial, contraindication, or intolerance before submitting prior auth for Izervay |
Aetna Izervay Coverage Criteria and Medical Necessity Requirements 2025
The coverage policy for Izervay under CPB 1041 has two distinct layers. First: Aetna covers Izervay for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Second — and this is the change that matters — Aetna now treats Izervay as medically necessary only when the member has a contraindication, intolerance, or an ineffective response to Syfovre.
Aetna's stated rationale is cost. The policy says directly that Izervay is more costly to Aetna than Syfovre, and that reliable evidence of Izervay's superiority does not exist. That's a payer making a formulary-style cost determination inside a medical benefit policy. Expect more of this pattern with other complement inhibitors.
Prior authorization is mandatory. Precertification is required for all Aetna participating providers in applicable plan designs. Call (866) 752-7021 for commercial plans or fax your Statement of Medical Necessity (SMN) form to (888) 267-3277. No prior authorization, no reimbursement — full stop.
For initial approval, the prescribing physician must be an ophthalmologist or work in consultation with one. Your PA submission needs to include the GA secondary to AMD diagnosis (ICD-10 codes from the H35.31xx family — more on those below) plus documentation of the Syfovre step-therapy requirement.
Continuation of therapy has its own standard. At reauthorization, you must show a positive clinical response. Aetna defines that as improvement or maintenance in best corrected visual acuity (BCVA), improvement or maintenance in visual field, a reduction in the rate of vision decline, or a reduction in the risk of more severe vision loss. Document any of those outcomes clearly in your reauth submission.
The dosing Aetna's policy references is 2 mg (0.1 mL of a 20 mg/mL solution) given by intravitreal injection once monthly — approximately every 28 ± 7 days. Each injection bills as CPT 67028 (intravitreal injection of a pharmacologic agent) paired with HCPCS J2782 (injection, avacincaptad pegol, 0.1 mg). Know your unit count: J2782 is billed per 0.1 mg, and the standard dose is 2 mg, so you're billing 20 units per eye per injection.
Aetna Izervay Exclusions and Non-Covered Indications
Aetna draws a hard line on the underlying condition. Izervay is not covered for geographic atrophy secondary to anything other than AMD. That means GA caused by Stargardt disease, cone-rod dystrophy, or toxic maculopathies is explicitly excluded.
This matters for your ICD-10 selection. Do not use an H35.30 or H35.31xx code if the GA in your patient's chart traces back to one of those other conditions. Aetna will classify that claim as experimental, investigational, or unproven — and the denial will be correct.
All other indications beyond GA secondary to AMD are also considered experimental and investigational under this coverage policy. There is no off-label pathway here. If your prescriber is using Izervay for anything outside of GA secondary to AMD, do not expect Aetna coverage.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| GA secondary to AMD — initial therapy | Covered (after Syfovre step) | J2782, CPT 67028, H35.30, H35.31xx | Requires prior auth; Syfovre must be tried, contraindicated, or not tolerated first |
| GA secondary to AMD — continuation | Covered | J2782, CPT 67028, H35.30, H35.31xx | Requires documented positive clinical response at reauth |
| GA secondary to Stargardt disease | Not Covered | — | Explicitly excluded by policy |
| GA secondary to cone-rod dystrophy | Not Covered | — | Explicitly excluded by policy |
| GA secondary to toxic maculopathies | Not Covered | — | Explicitly excluded by policy |
| All other indications | Experimental / Investigational / Unproven | — | No coverage pathway exists under CPB 1041 |
Aetna Izervay Billing Guidelines and Action Items 2025
| # | Action Item |
|---|---|
| 1 | Build your step-therapy documentation before September 26, 2025. If you have patients currently on Izervay or planning to start, your PA file needs Syfovre history — prior trial, documented intolerance, or clinical contraindication. Missing this is the single most common reason these claims deny. |
| 2 | Update your charge capture for J2782 and CPT 67028. These are your two codes for every Izervay injection encounter. J2782 bills at 20 units for the standard 2 mg dose per eye. If you're treating both eyes in one session, bill the injection procedure (CPT 67028) for each eye with the appropriate bilateral modifier or separate line items per your billing guidelines. |
| 3 | Confirm the prescriber is an ophthalmologist. Aetna requires this medication to be prescribed by or in consultation with an ophthalmologist. If the order originates outside ophthalmology without a documented consult, your PA will be denied at the prescriber-specialty check. |
| 4 | Set up reauthorization triggers with outcome documentation. Continuation of therapy requires proof of positive clinical response. Build a workflow that captures BCVA measurements, visual field results, or documented rate-of-decline data before each reauth window opens. Don't wait until you're 30 days from expiration. |
| 5 | Audit your ICD-10 selection on all GA claims. The covered codes are the nonexudative AMD codes in the H35.30 and H35.31xx families. GA from other etiologies is not covered. If your encounter documentation doesn't clearly link the GA to AMD, your coder needs that specificity before the claim goes out. |
| 6 | Confirm plan design eligibility. The policy states precertification is required "in applicable plan designs." Not every Aetna commercial plan works the same way. Before you submit a PA, verify that the member's specific plan includes this benefit under the medical benefit — not the pharmacy benefit. If you're unsure how the step-therapy requirement applies to a specific member's plan, talk to your billing consultant or compliance officer before submitting. |
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
CPT, HCPCS, and ICD-10 Codes for Avacincaptad Pegol (Izervay) Under CPB 1041
Covered CPT Codes (When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| 67028 | CPT | Intravitreal injection of a pharmacologic agent (separate procedure) |
Covered HCPCS Codes (When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| J2782 | HCPCS | Injection, avacincaptad pegol, 0.1 mg |
Key ICD-10-CM Diagnosis Codes
Aetna's policy lists 181 ICD-10-CM codes. The covered codes span nonexudative (dry) AMD with geographic atrophy. Below are the primary code families you'll encounter in practice:
| Code | Description |
|---|---|
| H35.30 | Unspecified macular degeneration [Geographic atrophy] |
| H35.3110 | Nonexudative age-related macular degeneration, right eye, stage unspecified |
| H35.3111 | Nonexudative age-related macular degeneration, right eye, early dry AMD |
| H35.3112 | Nonexudative age-related macular degeneration, right eye, intermediate dry AMD |
| 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 |
| H35.3120 | Nonexudative age-related macular degeneration, left eye, stage unspecified |
| H35.3121 | Nonexudative age-related macular degeneration, left eye, early dry AMD |
| H35.3122 | Nonexudative age-related macular degeneration, left eye, intermediate dry AMD |
| 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 |
| H35.3130 | Nonexudative age-related macular degeneration, bilateral, stage unspecified |
| H35.3131 | Nonexudative age-related macular degeneration, bilateral, early dry AMD |
| H35.3132 | Nonexudative age-related macular degeneration, bilateral, intermediate dry AMD |
| 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 |
The full list of 181 codes in the H35.30–H35.31xx range is available in CPB 1041 on Aetna's site. Your coders should reference the full code set and match laterality and stage to the clinical documentation precisely. Aetna's policy does not restrict by stage within the AMD/GA family — the coverage criteria focus on the drug selection logic, not the AMD staging code.
What the Step-Therapy Requirement Really Means for Your Practice
This is the same pattern Aetna has used in other specialty drug categories — prefer one agent, require failure or intolerance before covering the other. The GA market is a two-drug market right now: Izervay (avacincaptad pegol) and Syfovre (pegcetacoplan). Aetna picked Syfovre as the preferred agent.
That's not a clinical judgment your practice gets to override without documentation. If your ophthalmologist has a clinical reason to start with Izervay — patient history, tolerability concerns, prior adverse reaction to Syfovre — that reasoning needs to be in the chart and in the PA submission. Vague notes won't cut it. Aetna will ask for specifics.
The real risk for Izervay billing is the claim denial pattern that follows a policy like this. If your team doesn't flag this change and continues submitting Izervay claims without step-therapy documentation, you'll see a surge in denials starting in late September 2025. Reversing those denials takes time you don't have.
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