mhn aflibercept coverage & prior auth update

Coverage Criteria

Initial Approval — Adult ophthalmic indications

Initial Approval Criteria — Neovascular AMD, DME, DR (must meet all):

Initial nAMD/DME/DR: 1. Diagnosis of nAMD OR DME OR DR; 2. Prescribed by or in consultation with an ophthalmologist; 3. Age ≥ 18 years; 4. For all indications except DME in members with baseline best corrected visual acuity (BCVA) 20/50 or worse: failure of bevacizumab intravitreal solution unless contraindicated or clinically significant adverse effects are experienced; 5. Dose does not exceed the regimens specified for the requested product (see dosing notes); 6. Prior authorization may be required for bevacizumab intravitreal solution; IV formulations of Avastin, Mvasi, and Zirabev will not be approved; Approval duration: 6 months

Dose regimens: For Eylea and listed biosimilars (Ahzantive, Enzeevu, Eydenzelt, Opuviz, Pavblu, Yesafili): nAMD — 2 mg every 4 weeks x3 then 2 mg every 8 weeks; DME/DR — 2 mg every 4 weeks for first 5 injections then 2 mg every 8 weeks. For Eylea HD: 8 mg every 4 weeks x3 then 8 mg every 8–16 weeks (nAMD/DME) or every 8–12 weeks (DR).

Initial Approval — RVO

Initial Approval Criteria — Macular Edema following RVO (must meet all):

RVO: 1. Request is for Eylea or a listed biosimilar (Ahzantive, Enzeevu, Eydenzelt, Opuviz, Pavblu, or Yesafili); 2. Diagnosis of macular edema following retinal vein occlusion (RVO); 3. Prescribed by or in consultation with an ophthalmologist; 4. Age ≥ 18 years; 5. Failure of bevacizumab intravitreal solution unless contraindicated or clinically significant adverse effects are experienced; 6. Prior authorization may be required for bevacizumab intravitreal solution; IV formulations of Avastin, Mvasi, and Zirabev will not be approved; 7. Dose does not exceed 2 mg (1 vial/syringe) every 4 weeks; Approval duration: 6 months

Prior authorization for bevacizumab may be required.

Initial Approval — ROP

Initial Approval Criteria — Retinopathy of Prematurity (must meet all):

ROP: 1. Request is for Eylea or a listed biosimilar (Ahzantive, Enzeevu, Eydenzelt, Opuviz, Pavblu, or Yesafili); 2. Diagnosis of ROP with one of: (a) Zone I stage 1+, 2+, 3, or 3+; (b) Zone II stage 2+ or 3+; or (c) Aggressive posterior ROP (AP-ROP); 3. Prescribed by or in consultation with an ophthalmologist; 4. Member meets both: (a) gestational age at birth ≤ 32 weeks OR birth weight ≤ 1,500 g; (b) body weight > 800 g on day of treatment initiation; 5. Failure of bevacizumab intravitreal solution unless contraindicated or clinically significant adverse effects are experienced; 6. Dose does not exceed 0.4 mg one time, with an optional second and third 0.4 mg dose for the same eye spaced at least 10 days apart; Approval duration: 6 months (up to 3 doses per eye per lifetime)

Prior authorization may be required for bevacizumab intravitreal solution; IV Avastin/Mvasi/Zirabev not approved.

Continued Therapy — Adult ophthalmic diseases

Continued Therapy — Adult ophthalmic diseases (must meet all):

Continued therapy eligibility: 1. Member currently receiving medication via Centene benefit or previously met initial approval criteria OR member is receiving medication with applicable continuity of care; 2. Member is responding positively to therapy as evidenced by one of: (a) detained neovascularization; (b) improvement or stabilization in visual acuity; (c) maintenance of corrected visual acuity from prior treatment; (d) supportive OCT or fluorescein angiography findings; 3. If request is for a dose increase, new dose must not exceed the specified maxima for the product unless documentation supports continued disease activity per policy rules; Approval duration: 6 months

Dose maxima: For Eylea and listed biosimilars — generally not to exceed 2 mg every 8 weeks for maintenance (increase to 2 mg every 4 weeks only if documentation supports continued disease activity). For Eylea HD — maxima and interval options per indication (up to every 16 weeks for some nAMD/DME regimens) as detailed in the dosing section.

Continued Therapy — ROP

Continued Therapy — Retinopathy of Prematurity:

ROP reauthorization: 1. Reauthorization beyond the first three doses is not permitted; member must meet initial approval criteria to receive treatment.

Approval duration: Not applicable.

Covered indications and dosing

Covered when dosing and indication-specific criteria are met per approved regimens:

nAMD (standard Eylea): Initial regimen: 2 mg intravitreal once monthly for 3 months then 2 mg every 2 months; some patients may require every-4-week dosing after the initial period; maximum 2 mg/month.

Every-8-week maintenance should be attempted before increasing to every-4-week dosing for most patients; see Eylea HD options for extended intervals.

Macular edema following RVO: Standard aflibercept dosing: 2 mg intravitreal once every 4 weeks (monthly); maximum 2 mg/month. Requests may specify Eylea or specified biosimilars per policy.

DME/DR: Biosimilars dosing: 2 mg intravitreal once monthly for initial series (first 5 injections for DME/DR in many biosimilars), followed by 2 mg every 2 months for maintenance; some patients may require every-4-week dosing after the initial period.

ROP (Eylea and select biosimilars):

Non-FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation demonstrating safety and efficacy consistent with the applicable off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, CP.PMN.53 for Medicaid) or relevant evidence of coverage documents.

Coding lists included in this policy are provided for informational purposes only. Inclusion of a HCPCS/CPT/ICD code in the policy does not guarantee coverage; providers should verify coding and coverage rules against current payer billing guidance before claim submission.

Uses not explicitly listed in Section III — and not covered by a recent label change addressed per the policy — should be managed under the applicable off‑label use or no‑coverage/non‑formulary policies for the member’s line of business (see CP.CPA.09, HIM.PA.154, CP.PMN.53 and CP.CPA.190/HIM.PA.103/CP.PMN.16 as applicable). When a recent FDA label change (within the last 6 months) is not yet reflected here, follow the referenced formulary/no‑coverage or non‑formulary policies until this policy is updated.

Routine maintenance dosing of aflibercept at every 4 weeks for most patients has not shown additional efficacy compared with every 8 weeks in pivotal trials; therefore, every‑8‑week maintenance should be attempted before increasing frequency to every 4 weeks, reserving monthly maintenance for patients with documented ongoing disease activity requiring the shorter interval.

Coding and Identifiers

Referenced HCPCS/Q codesHCPCS

J0178	Injection, aflibercept, 1 mg.
J0177	Injection, aflibercept hd, 1 mg.
Q5147	Injection, aflibercept-ayyh (pavblu), biosimilar, 1 mg.
Q5149	Injection, aflibercept-abzv (enzeevu), biosimilar, 1 mg.
Q5150	Injection, aflibercept-mrbb (ahzantive), biosimilar, 1 mg.
Q5153	Injection, aflibercept-yszy (opuviz), biosimilar, 1 mg.
Q5155	Injection, aflibercept-jbvf (yesafili), biosimilar, 1 mg.

inv-13: ROP body weight requirement — body weight > 800 g on day of treatment initiation.

ROP body weight requirementBody weight > 800 g on day of treatment initiation.

ApplicabilityRequired for initial ROP treatment requests for Eylea and listed biosimilars.

DocumentationProvider must document measured body weight on day of treatment initiation in supporting records.

inv-14: ROP gestational/birth weight criteria — gestational age at birth ≤ 32 weeks OR birth weight ≤ 1,500 g.

Gestational age / birth weight criteriaGestational age at birth ≤ 32 weeks OR birth weight ≤ 1,500 g.

Applicability

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Providers must demonstrate the member meets listed initial or continued therapy criteria for approval. Approval duration is generally 6 months unless otherwise specified in the indication-specific criteria.

Prior authorization required for aflibercept products (Eylea and biosimilars).
Approval durations: typically 6 months.

Documentation Required

Documentation Requirement

Providers must submit supporting documentation (such as office chart notes, diagnostic test results, best corrected visual acuity measurements, prior treatment records, and laboratory or imaging results as applicable) demonstrating the member meets all approval criteria. Failure to provide adequate documentation may result in denial of the request. Maintain documentation consistent with accepted standards of care and the Health Plan's medical necessity requirements.

Background

Aflibercept (Eylea) and the listed biosimilars are vascular endothelial growth factor (VEGF) inhibitors indicated for ophthalmic conditions including neovascular (wet) age‑related macular degeneration (nAMD), diabetic macular edema (DME), diabetic retinopathy (DR), macular edema following retinal vein occlusion (RVO), and retinopathy of prematurity (ROP). Eylea HD is a higher‑dose aflibercept formulation (single‑dose 8 mg vial) with dosing intervals that differ by indication.

Definitions

inv-25: Abbreviations — nAMD, DME, DR, RVO, ROP defined.

nAMDneovascular (wet) age-related macular degeneration

DMEdiabetic macular edema

DRdiabetic retinopathy

RVOmacular edema following retinal vein occlusion

ROPretinopathy of prematurity

inv-26: Eylea HD — High-dose aflibercept formulation (8 mg vial) definition.

DefinitionEylea HD is the high‑dose aflibercept formulation supplied as an 8 mg single‑dose vial for intravitreal injection.

OpenPayer

Aflibercept (Eylea, Eylea HD) and listed biosimilars — coverage criteria

Coverage Criteria

Coding and Identifiers

Provider Actions and Requirements

Background

Definitions