CurrentCentenePolicy CP.PHAR.641

Avacincaptad pegol (Izervay) (PDF)

Defines medical necessity criteria, dosing, exclusions, authorization durations, and coding implications for avacincaptad pegol (Izervay) for treatment of geographic atrophy (GA) secondary to age-related macular degeneration across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyAvacincaptad pegol (Izervay) (PDF)

Policy CodePolicy CP.PHAR.641

Change TypeCoding, criteria alignment, duration revisions

Effective DateDec 1, 2023

Next Review Date

Key ActionProvider must submit documentation (office chart notes, imaging, labs or other clinical information) supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added HCPCS code J2782 and removed C9399 and J3490.

Clarified that diagnostic characteristics must be confirmed on fundus autofluorescence imaging and added exclusions for GA secondary to other conditions and combination intravitreal complement inhibitor therapy.

Removed continued authorization criterion for treatment exceeding 12 months per updated FDA label and increased Medicaid/HIM continued approval duration to 12 months.

Revised Medicaid and HIM initial approval durations to 12 months in 4Q 2025 annual review.

1FDA approved indication

J2782Current HCPCS code

2 mgPer-eye dose limit

Coverage Summary

Policy covers avacincaptad pegol (Izervay) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) when medical necessity criteria are met. Coverage is covered_with_criteria and requires documentation supporting the member meets all approval criteria.

Specific diagnostic and clinical criteria must be documented, including GA characteristics confirmed on fundus autofluorescence imaging, age and visual acuity thresholds, prescribing clinician specialty, and dosing limits. Billing uses HCPCS code J2782, and dose must not exceed 2 mg (0.1 mL of 20 mg/mL solution) in each affected eye every 21 days with monthly dosing regimen described in the policy.

Quick facts / key thresholds

Total GA area≥ 2.5 and ≤ 17.5 mm2 (1 and 7 disk areas)

Multifocal lesion sizeAt least one focal lesion ≥ 1.25 mm2 (0.5 DA)

Minimum age≥ 50 years

BCVA rangeBetween 20/25 and 20/320

Per-eye dose limit2 mg (0.1 mL of 20 mg/mL) every 21 days

Current HCPCS codeJ2782

Initial Therapy Criteria — Geographic Atrophy

Continuation / Renewal Criteria

Other Indications & Exclusions

Other diagnoses/indications and Diagnoses/Indications not authorized

If requested use does not fall under GA criteria or policy not yet updated for label change (must meet one):

Other diagnoses/indications

Recent label change not reflected in policy: If drug label changed within last 6 months and policy not updated, follow relevant formulary/no coverage or non-formulary policy references per line of business (see referenced policies CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16)
Off-label referral: If requested use not specifically listed and above does not apply, refer to off-label use policy per line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53)

Diagnoses/Indications not authorized: Non‑FDA approved indications not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety per off-label use policies

Provider Actions & Requirements

Prior Authorization

Prior authorization required per policy criteria

Requests for avacincaptad pegol (J2782) must undergo prior authorization review against the policy's medical necessity criteria. Approval durations vary by line of business (Commercial: 6 months or to the member's renewal date, whichever is longer; Medicaid/HIM: 12 months).

Documentation Required

Submit supporting documentation

Submit supporting documentation with the prior authorization request, including office chart notes, imaging, laboratory results, or other clinical information that demonstrate the member meets all approval criteria.

Applicable Codes

HCPCS J-code for avacincaptad pegolHCPCSCovered

J2782

Injection, avacincaptad pegol, 0.1 mg

Clinical Evidence & References

GATHER1 & GATHER2Pivotal randomized phase 2/3 (GATHER1) and phase 3 (GATHER2) trials demonstrating efficacy in GA

Izervay PI (Mar 2025)Prescribing information reference: Izervay Prescribing Information, Astellas Pharma (March 2025)

HCPCS J2782Current billing code: Injection, avacincaptad pegol, 0.1 mg (HCPCS J2782)

Key evidence supporting use includes the pivotal randomized phase 2/3 trials GATHER1 and GATHER2 demonstrating efficacy of avacincaptad pegol in geographic atrophy, and the Izervay Prescribing Information (Astellas Pharma, cited March 2025).

Diagnostic imaging requirements in this policy (confirmation on fundus autofluorescence imaging) are aligned with the pivotal study design and were clarified to align with competitor (Syfovre) GA criteria per policy revision history.

Background

Avacincaptad pegol (Izervay) is a C5 complement inhibitor and is FDA-approved for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Policy dosing aligns with the product label: GA dosing regimen is 2 mg (0.1 mL of 20 mg/mL solution) via intravitreal injection to each affected eye once monthly (approximately 28 ± 7 days) with a maximum dose of 2 mg/21 days. The policy’s diagnostic imaging requirements and exclusions were aligned with pivotal trials and competitor product criteria per the documented revision history.

Definitions (compact)

AMDAge-related macular degeneration

GAGeographic atrophy

BCVABest corrected visual acuity

DADisk area

Revision History

02.20.24coding_update

Removed HCPCS codes C9399 and J3490 and added HCPCS code J2782 (Injection, avacincaptad pegol, 0.1 mg).

07.19.24criteria_clarification

Clarified that diagnostic characteristics must be confirmed on fundus autofluorescence imaging in alignment with Syfovre GA criteria and pivotal study design; added exclusions for GA secondary to non-AMD conditions and for combination use with other intravitreal complement inhibitor therapies.

02.27.25label_update_and_approval_duration_change

Per updated FDA label removing the one-year duration limit for GA treatment, removed continued authorization criterion for treatment exceeding 12 months and increased Medicaid/HIM continued approval duration from 6 months to 12 months for this chronic condition.

Policy Summary

PayerCentene

PolicyAvacincaptad pegol (Izervay) (PDF)

Policy CodePolicy CP.PHAR.641

Change TypeCoding, criteria alignment, duration revisions

Effective DateDec 1, 2023

Next Review Date

Key ActionProvider must submit documentation (office chart notes, imaging, labs or other clinical information) supporting that member meets all approval criteria.

SourceLink

On This Page

Requests may be denied when GA is secondary to conditions other than AMD (for example, Stargardt disease, cone rod dystrophy, or toxic maculopathies), when there are signs of diabetic retinopathy in either eye, or when there is evidence of choroidal neovascularization in the eye(s) affected by GA.

Concomitant use of Izervay with other intravitreal complement inhibitor therapies (e.g., Syfovre®) is excluded and may result in claim denial.

Documentation Required

Imaging requirement

Fundus autofluorescence imaging must confirm the diagnostic characteristics of GA per the policy (total GA area, focal lesion size if multifocal, presence of hyperautofluorescence in the junctional zone, and GA not centered in the fovea) in alignment with the pivotal trials.

Billing Rule

Dose limitation per eye

Dose must not exceed 2 mg per affected eye (0.1 mL of a 20 mg/mL solution) every 21 days. The recommended regimen is 2 mg via intravitreal injection to each affected eye once monthly (approximately 28 ± 7 days). Requests for dose increases must not exceed the 2 mg per eye/21-day maximum.

Denial Risk

Exclusion conditions may result in denial

Coverage may be denied if the GA is secondary to a non-AMD condition (e.g., Stargardt disease, cone-rod dystrophy, toxic maculopathies), if there are signs of diabetic retinopathy in either eye, evidence of choroidal neovascularization in the affected eye(s), or if Izervay is used concomitantly with other intravitreal complement inhibitor therapy (e.g., Syfovre).

07.15.25annual_reviewLatest

4Q 2025 annual review: revised Medicaid and HIM initial approval durations to 12 months and updated references. Document-level dates: Effective 12.01.23; Last review 11.25.