ModifiedCentenePolicy CP PHAR.641

Avacincaptad Pegol (Izervay) - Coverage Criteria

Covers medical necessity criteria, dosing, and authorization requirements for Izervay (avacincaptad pegol) for treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) for Centene lines of business.

Policy Summary

PayerCentene

PolicyAvacincaptad Pegol (Izervay) - Coverage Criteria

Policy CodePolicy CP PHAR.641

Change TypeMaterial clinical and operational clarifications (imaging confirmation, exclusions, coding, authorization duration)

Effective DateDec 1, 2023

Next Review DateN/A

Key ActionSubmit prior authorization with documentation including fundus autofluorescence imaging to confirm GA characteristics and verify member meets initial or continued therapy criteria.

SourceLink

POLICY UPDATE CHANGES

Diagnostic characteristics must be confirmed on fundus autofluorescence imaging per health plan request in alignment with Syfovre GA criteria and pivotal study design.

Added exclusions for GA that is secondary to a condition other than AMD and for combination use with other intravitreal complement inhibitor therapies.

Increased Medicaid/HIM continued approval duration from 6 months to 12 months for this chronic condition.

Removed continued authorization criterion limiting treatment to one year following updated FDA label.

Updated HCPCS coding: removed unspecified codes and added J2782 and later added J27821; removed C9399 and J3490.

2 mg/0.1 mLstandard per-eye dose

every 21 days

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Coverage Criteria for Izervay (avacincaptad pegol)

Initial Therapy

Covered when ALL of the following are met for Initial Approval:

Initial Approval - GA due to AMD: 1. Diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Reference: diagnosis requirement.

FAF imaging subcriteria: 2. GA characteristics confirmed on fundus autofluorescence (FAF) imaging; must meet all FAF criteria: a) total GA area >= 2.5 mm^2 and < 17.5 mm^2 (1–7 disk areas); b) if multifocal, at least one lesion >= 1.25 mm^2 (0.5 DA); c) presence of hyperautofluorescence in the junctional zone; d) GA is not centered in the fovea.

These imaging criteria align with pivotal trial definitions and policy FAF confirmation requirement.

Prescriber and age: 3. Prescribed by or in consultation with an ophthalmologist; and member is age >= 50 years.

Prescriber and age requirements.

Visual acuity: 4. Best corrected visual acuity (BCVA) in the affected eye between 20/25 and 20/320.BCVA 20/25–20/320

Visual acuity eligibility range.

Exclusions (must NOT have): 5. Member does not have any of the following: a) GA secondary to a condition other than AMD (e.g., Stargardt disease, cone‑rod dystrophy, toxic maculopathies); b) evidence of choroidal neovascularization in the eye(s) affected by GA; c) signs of diabetic retinopathy in either eye.

Exclusion conditions.

Combination therapy exclusion: 6. Izervay is not used in combination with other intravitreal complement inhibitor therapies.

Combination therapy excluded.

Dose limit: 7. Dose does not exceed 2 mg (0.1 mL of 20 mg/mL solution) per affected eye every 21 days.2 mg every 21 days

Per dosing regimen and maximum per‑eye dose.

Continuation Therapy

Covered when ANY of the following are met for Continued Therapy:

Continued therapy criteria: a) Member is currently receiving the medication via a Centene benefit or has previously met initial approval criteria; AND member is responding positively to therapy; OR b) Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations.

Continued therapy requires current treatment or prior meeting of initial criteria and evidence of response; continuity of care provisions apply where relevant.

Combination therapy exclusion for continuation: Izervay must not be used in combination with other intravitreal complement inhibitor therapies for continued authorization.

Continuation limited to monotherapy per policy.

Dose increase check: If request is for a dose increase, the new dose does not exceed 2 mg (0.1 mL of 20 mg/mL solution) per affected eye every 21 days.2 mg every 21 days

Dose limit applies to continued therapy and dose increase requests.

Coverage prerequisites (excerpted)

Covered when ALL of the following are met (as clarified in document):

Imaging and diagnosis: Diagnostic characteristics of GA must be confirmed on fundus autofluorescence imaging per health plan request in alignment with Syfovre GA criteria and pivotal study design.

FAF imaging confirmation required.

Primary disease: GA must not be secondary to a condition other than age-related macular degeneration (exclusion added).

Non‑AMD GA excluded.

Therapy combinations: Use in combination with other intravitreal complement inhibitor therapies is excluded per policy update.

Combination therapy excluded.

Continuation / duration

Continuation authorization:

Duration: Continued authorization criterion limiting treatment to 12 months was removed after the FDA removed the one‑year duration limit; Medicaid/HIM continued approval duration increased from 6 months to 12 months. Commercial continued approvals remain 6 months or to the member's renewal date, whichever is longer.Medicaid/HIM: 12 months; Commercial: 6 months or to renewal date

Authorization duration updated per label and policy revisions.

The policy excludes treatment of geographic atrophy (GA) when GA is secondary to a condition other than age‑related macular degeneration (AMD) (for example, Stargardt disease, cone‑rod dystrophy, or toxic maculopathies). Diagnostic confirmation for GA used in approval decisions must include fundus autofluorescence imaging showing the lesion characteristics required by the policy (total GA area, multifocal lesion size, junctional hyperautofluorescence, and non‑foveal location). Requests with evidence of choroidal neovascularization in the affected eye(s) or signs of diabetic retinopathy in either eye are also excluded from coverage.

Geographic atrophy that is secondary to a non‑AMD condition is explicitly excluded from coverage. In addition, use of Izervay in combination with other intravitreal complement inhibitor therapies is not permitted and is excluded. These exclusions were added during policy updates to align with comparator product criteria and recent reviews.

Indications that are not FDA‑approved and are not addressed in this policy are not authorized unless the request is supported by documentation of efficacy and safety consistent with applicable off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid) or by other evidence of coverage.

Requests to use Izervay concurrently with another intravitreal complement inhibitor are considered not medically necessary and will be denied. The policy clarification expressly prohibits combination intravitreal complement inhibitor therapy and identifies such requests as a basis for exclusion or denial.

Billing and Coding

Covered HCPCS CodesHCPCSCovered

J2782

Injection, avacincaptad pegol, 0.1 mg

Removed/previous HCPCS CodesHCPCS

C9399	Unclassified drugs or biologicals (removed)
J3490	Unclassified drugs (removed)

HCPCS codesHCPCS

J27821	HCPCS code added for avacincaptad pegol (intravitreal)
C9399	Previously listed HCPCS code removed (miscellaneous)
J3490	Previously listed HCPCS code removed (unclassified drug)

Maximum per-eye dose — Dosing summary

Maximum per-eye dose2 mg (0.1 mL of 20 mg/mL solution) per affected eye every 21 days

Dosing regimen (documented)Intravitreal injection to each affected eye once monthly (maximum: 2 mg/21 days)

Conformance with approval criteriaDose must not exceed 2 mg (0.1 mL of 20 mg/mL) in each affected eye every 21 days to meet coverage criteria

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required

Prior authorization required — Provider must demonstrate member meets initial or continued therapy criteria before approval.

Provider must submit supporting documentation (office chart notes, lab results, imaging) demonstrating member meets all approval criteria.

Documentation Required

Required Documentation

Required documentation — Provider must submit documentation (chart notes, labs, fundus autofluorescence imaging) supporting approval criteria.

Include fundus autofluorescence imaging showing diagnostic characteristics of GA, BCVA results, documentation of GA area and focal lesion measurements, and ophthalmologist consultation notes.

Documentation Required

Background

Avacincaptad pegol (Izervay) is an intravitreal complement inhibitor indicated for treatment of geographic atrophy (GA) secondary to age‑related macular degeneration (AMD). The policy requires diagnostic confirmation of GA characteristics using fundus autofluorescence imaging, consistent with pivotal study design and Syfovre GA criteria, and specifies lesion size and imaging features used to determine eligibility. Policy updates included coding changes and clarified imaging and exclusion criteria during the 4Q 2024 review and subsequent label‑driven authorization updates.

Definitions and Abbreviations

Geographic atrophy (GA) definition

TermGeographic atrophy (GA): progressive atrophic lesion(s) of the retina occurring secondary to age-related macular degeneration

FAF imaging requirementGA diagnostic characteristics must be confirmed on fundus autofluorescence imaging per health plan request (aligned with pivotal trial/Syfovre criteria)

ExclusionsGA secondary to a condition other than AMD (e.g., Stargardt disease, cone-rod dystrophy, toxic maculopathies) is excluded from coverage

Best corrected visual acuity (BCVA) definition

TermBest corrected visual acuity (BCVA)

Coverage eligibility rangeBCVA between 20/25 and 20/320 required for initial approval

Policy Summary

PayerCentene

PolicyAvacincaptad Pegol (Izervay) - Coverage Criteria

Policy CodePolicy CP PHAR.641

Change TypeMaterial clinical and operational clarifications (imaging confirmation, exclusions, coding, authorization duration)

Effective DateDec 1, 2023

Next Review DateN/A

Key ActionSubmit prior authorization with documentation including fundus autofluorescence imaging to confirm GA characteristics and verify member meets initial or continued therapy criteria.

SourceLink

On This Page

Note

Formulary / Off‑Formulary Routing

Formulary / off‑formulary routing — If the requested indication or use is not listed in this policy, follow the appropriate formulary or off‑label routing policies.

For drugs on formulary/PDL (commercial/marketplace/Medicaid) follow the relevant line-of-business no coverage criteria policies: CP.CPA.190 (commercial), HIM.PA.33 (marketplace), CP.PMN.255 (Medicaid).
For drugs NOT on formulary/PDL follow non‑formulary policies: CP.CPA.190 (commercial), HIM.PA.103 (marketplace), CP.PMN.16 (Medicaid).
For off‑label uses not specifically listed, refer to off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (marketplace), CP.PMN.53 (Medicaid).

Denial Risk

Excluded Diagnoses / Combination Therapy

Excluded diagnoses or combination therapy — Use for GA secondary to non‑AMD conditions or concurrent use with other intravitreal complement inhibitors can trigger denial.

GA secondary to conditions such as Stargardt disease, cone‑rod dystrophy, or toxic maculopathies is excluded.
Concurrent use with other intravitreal complement inhibitor therapies is not authorized.

Denial Risk

Insufficient Documentation or Non‑Covered Indication

Insufficient documentation / non‑covered indication — Requests lacking documentation that member meets all approval criteria or for non‑FDA indications without sufficient off‑label justification may be denied.

Requests missing required clinical documentation (eg, imaging, BCVA, ophthalmology consultation, lesion measurements) may be denied.
Non‑FDA approved indications not addressed in this policy require sufficient documentation of efficacy and safety per off‑label policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or will be considered not authorized.