CurrentCignaPolicy IP0581

Ophthalmology - Izervay

Defines prior authorization, dosing, and coverage criteria for Izervay for treatment of geographic atrophy secondary to age-related macular degeneration for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOphthalmology - Izervay

Policy CodePolicy IP0581

Change TypeCoding and administrative updates

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and ensure Izervay is prescribed by or in consultation with an ophthalmologist; approvals are for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Updated policy title from 'Avacincaptad Intravitreal Injection' to 'Ophthalmology - Izervay.'

Updated coding: Removed C9399, J3490, J3590 and added J2782 (effective 4/1/2024).

Prior authorization is required and prescribing must be by or in consultation with a specialist ophthalmologist.

1 yrinitial approval duration when criteria met

2 mgrecommended dose per eye

20/25–20/320eligible BCVA range

J2782covered HCPCS code

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Geographic Atrophy - Initial Approval

Approve for 1 year if the patient meets ALL of the following (A, B, and C):

FDA-Approved Indication criteria: A) Patient has geographic atrophy secondary to age-related macular degeneration;

FDA-Approved Indication criteria: B) Patient has a best corrected visual acuity (BCVA) in the affected eye of between 20/25 and 20/320 letters;BCVA 20/25–20/320

FDA-Approved Indication criteria: C) The medication is administered by or under the supervision of an ophthalmologist.

Approval duration: 1 year.

Dosing and Frequency

Dosing criteria — Approve if the dose meets BOTH criteria (A and B):

Dosing: A) The dose is 2 mg (0.1 mL of 20 mg/mL solution) administered by intravitreal injection for each eye being treated;dose 2 mg

Dosing: B) The dosing interval is not more frequent than once every 21 days for each eye being treated.interval >= 21 days

Recommended interval once monthly (approximately every 28 ± 7 days).

Izervay for any use other than the FDA‑approved indication described in this policy is not medically necessary and is not covered. This policy’s coverage is limited to the conditions and dosing described under the Geographic Atrophy initial approval and dosing sections; criteria will be updated if new published data become available.

Use of Izervay for indications other than geographic atrophy secondary to age‑related macular degeneration is considered not medically necessary and is not covered under this policy.

Provider Actions, Authorization, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for prescription benefit coverage of Izervay. Approvals are granted for 1 year when criteria are met. Because of the specialized skills required for evaluation, diagnosis, and monitoring, Izervay must be prescribed by or in consultation with a physician who specializes in the condition being treated (ophthalmologist).

Approval duration: 1 year when criteria met
Prescriber requirement: prescribed by or in consultation with a specialist ophthalmologist

Step Therapy

No step therapy requirements are specified in this policy.

Denial Risk

Coding and Claims Denial Risk

Claims submitted without covered diagnosis or procedure codes will be denied. Services must be billed using the most appropriate codes as of the date of service; reimbursement is not allowed for services billed for conditions or diagnoses not covered under this policy.

Use covered diagnosis/procedure codes only — claims lacking covered codes will be denied
When billing, providers must use the most appropriate codes as of the date of service

Background

Geographic atrophy (GA) is the non‑neovascular, advanced form of age‑related macular degeneration for which Izervay is FDA‑indicated. GA involves progressive atrophy of outer retinal tissues with loss of photoreceptors and retinal pigment epithelium, which can lead to severe and irreversible vision loss. This policy limits coverage of Izervay to patients with GA secondary to AMD who meet the specified clinical criteria, including a best corrected visual acuity in the affected eye between 20/25 and 20/320 and administration by or under the supervision of an ophthalmologist.

Definitions

Geographic atrophy (GA) — definition and clinical features

DefinitionGeographic atrophy (GA) is an advanced form of non‑neovascular age‑related macular degeneration characterized by localized atrophy of outer retinal tissue with irreversible loss of photoreceptors, retinal pigment epithelium, and choriocapillaris.

Clinical significanceGA involving the foveal center can cause severe vision loss and accounts for about 10% of AMD‑related vision loss to 20/200 or worse.

Typical patient visual acuity range used in trials and indicationBest‑corrected visual acuity (BCVA) in eligible patients: between 20/25 and 20/320.

Pathophysiology noteGA represents localized outer retinal atrophy leading to irreversible photoreceptor loss and degeneration of the supporting retinal pigment epithelium and choriocapillaris.

Relation to AMD subtypesGA is the advanced non‑neovascular (dry) form of AMD distinct from neovascular (wet) AMD; advanced AMD includes either neovascular AMD or GA involving the macular center.