CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Izervay (avacincaptad pegol) (Intravitreal) — Coverage Criteria for Geographic Atrophy

Policy governs coverage, dosing limits, and medical necessity criteria for Izervay (intravitreal avacincaptad pegol) for treatment of geographic atrophy secondary to age-related macular degeneration for Neighborhood Health Plan of Rhode Island members (Medicaid, Commercial, MMP).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIzervay (avacincaptad pegol) intravitreal for geographic atrophy

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date01/01/2024

Next Review DateN/A

Key ActionSubmit prior authorization for initial 6‑month approval with documentation of baseline BCVA, FAF, and OCT; quantity limit 1 vial (2 mg/0.1 mL) per eye every 28 days.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2 mgrecommended intravitreal dose per eye

every 28 daysdosing interval

35% / 18%GA lesion growth reduction

≥2.5–≤17.5 mm2allowed total GA lesion size

BCVA 20/25–20/320visual acuity window

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Coverage and Medical Necessity Criteria

Initial Therapy

Covered when ALL of the following are met

Initial Approval Criteria: Patient is at least 18 years of age; prescriber is or in consultation with a retina specialist; baseline assessment documented including best corrected visual acuity (BCVA), fundus autofluorescence (FAF) imaging, and optical coherence tomography (OCT); no ocular and/or peri‑ocular infection; no active intraocular inflammation; will not be used in combination with other intravitreal complement inhibitor therapies; patient does not have category 6 (no light perception) visual impairment; no history of or active choroidal neovascularization (CNV) in the eye(s) to be treated; chart notes/medical records confirming diagnosis of geographic atrophy (GA) secondary to age‑related macular degeneration (AMD) with phenotype of well‑demarcated retinal pigment epithelium (RPE) and/or choriocapillaris atrophy; other causes of GA ruled out (e.g., Stargardt disease, cone‑rod dystrophy, toxic maculopathies); total GA lesion size >= 2.5 mm2 and <= 17.5 mm2 (if multifocal, at least one focal lesion >= 1.25 mm2); GA is nonfoveal (lesions within 1500 µm of the foveal center not involving the center point); BCVA between 20/25 and 20/320; MMP members previously treated with this medication within the past 365 days are exempt from step therapy requirements.see thresholds

All items required

Continuation / Renewal

Renewal when ALL of the following are met

Renewal Criteria: Patient is at least 18 years of age; prescriber is or in consultation with a retina specialist; patient continues to meet the initial criteria in Section III; absence of unacceptable toxicity from the drug (examples include endophthalmitis, retinal detachment, neovascular/wet AMD or CNV, uncontrolled increased intraocular pressure, etc.); evidence of disease stabilization or slowing of rate of progression while on therapy compared to pre‑treatment baseline as measured by FAF, OCT, or BCVA; continued administration is necessary for maintenance and patient and provider have discussed potential decrease in dosing frequency.clinical assessment

All items required

Use of Izervay at a dose or for a condition other than FDA‑approved indications or those recognized in standard compendia is considered investigational and is not covered. Coverage is limited to indications and dosing supported by FDA approval or accepted drug compendia; requests for uses outside those parameters will be denied as investigational.

Coverage is not provided for eyes with active choroidal neovascularization (CNV) or for patients with category 6 visual impairment (no light perception). These situations do not meet the medical necessity criteria for initiation of therapy and are explicit exclusions from coverage.

Billing, Codes, and Key Parameters

HCPCS / BillingHCPCS

J2782

Injection, avacincaptad pegol, 0.1 mg

NDCNDC

82829-0002-xx

Izervay 2 mg/0.1 mL single-dose vial

Covered Diagnosis CodesICD-10Covered

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 eye advanced atrophic without subfoveal involvement
H35.3134	Nonexudative age-related macular degeneration, bilateral eye advanced atrophic with subfoveal involvement
H35.3193	Nonexudative age-related macular degeneration, unspecified eye advanced atrophic without subfoveal involvement
H35.3194	Nonexudative age-related macular degeneration, unspecified eye advanced atrophic with subfoveal involvement

inv-08: Total GA lesion size — allowed lesion size parameters

Allowed total GA lesion areaTotal GA lesion size must be ≥2.5 mm² and ≤17.5 mm²

Multifocal GA requirementIf GA is multifocal, at least one focal lesion must be ≥1.25 mm²

Measurement basisLesion size assessed per baseline imaging (FAF and OCT) as documented in chart notes

inv-09: Nonfoveal definition — distance/definition for nonfoveal lesions

Nonfoveal definitionGA is considered nonfoveal when lesions are within 1500 μm of the foveal center but do not involve the center point of the fovea

Imaging for determination

Prior Authorization, Documentation, and Renewal Actions

Prior Authorization

Prior authorization, quantity and duration

Prior authorization is required. Initial authorizations are provided for six months and may be renewed for an additional six months. Quantity limits: Izervay 2 mg/0.1 mL single‑dose vial — 1 vial per eye every 28 days; maximum 4 mg (40 HCPCS units) every 28 days (based on administration to both eyes).

Initial approval length: 6 months; renewals may be granted for 6 months [[see citations]]

Step Therapy

Step therapy exemption for recent users (365 days)

Members in the Medicare-Medicaid Plan (MMP) who received this medication within the past 365 days are exempt from step therapy requirements and are not subject to the step therapy requirement for initiation.

Exemption window: previous treatment within 365 days

Background and Clinical Context

Izervay (intravitreal avacincaptad pegol) is a complement C5 inhibitor indicated for treatment of geographic atrophy (GA) secondary to age‑related macular degeneration. In the clinical program, pivotal trials demonstrated a statistically significant slowing of GA lesion growth over 12 months. Common ocular adverse events reported in trial populations include conjunctival hemorrhage, increased intraocular pressure, blurred vision, and choroidal neovascularization. Baseline assessment with BCVA, fundus autofluorescence (FAF), and OCT is required prior to initiation.

Definitions and Key Clinical Terms

inv-16: Geographic Atrophy (GA) secondary to AMD — definition and phenotype characteristics

Definition of GA secondary to AMDGeographic atrophy is defined by a phenotype of central GA with one or more zones of well‑demarcated retinal pigment epithelium (RPE) and/or choriocapillaris atrophy in the setting of nonexudative AMD

Nonexudative phenotypePolicy requires a nonexudative AMD phenotype without active choroidal neovascularization in the eye(s) to be treated

Supporting clinical contextIzervay (avacincaptad pegol) is a complement C5 inhibitor approved for GA secondary to AMD; pivotal trials (GATHER1, GATHER2) showed reduction in GA lesion growth