ModifiedPremera BluecrossPolicy 5.01.620

Inhibitors for Ocular Disorders

Defines medical necessity and coverage criteria for intravitreal VEGF inhibitor therapies for retinal conditions (nAMD, DME, RVO, DR, mCNV) under the medical benefit.

Policy Summary

PayerPremera Bluecross

PolicyInhibitors for Ocular Disorders

Policy CodePolicy 5.01.620

Change TypeCriteria additions and step-therapy updates (agent additions, indication expansions, and new prior-failure requirements)

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionObtain and document prior authorization showing trial of bevacizumab and, for certain new starts, inadequate response or intolerance to two preferred products before coverage will be approved.

SourceLink

POLICY UPDATE CHANGES

Added Byooviz and Susvimo to the policy for AMD and other retinal indications.

Added coverage criteria for Vabysmo (faricimab-svoa) for AMD and DME, later expanded to macular edema following RVO.

Added coverage criteria for Pavblu (aflibercept-ayyh); updated non-combination rules, prior treatment-step requirements, and Susvimo requirements.

Updated coverage for Eylea HD to include treatment of Macular Edema Following Retinal Vein Occlusion.

Updated multiple agents to prohibit combination use with Pavblu (and earlier with Vabysmo).

Updated Beovu, Eylea, Eylea HD, and Susvimo to require inadequate response or intolerance to two preferred products for new starts, effective Jan 2, 2026.

Updated Susvimo coverage to require prior response to at least two intravitreal VEGF injections and added DME/DR indications in later updates.

Removed Macugen (pegaptanib) as discontinued and no longer available during policy updates.

Added and updated multiple HCPCS/Q-codes across policy history (examples: J0177, J0178, J0179, J2777, Q5124, Q5128, Q5147; some codes termed or removed).

9named drugs listed

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bevacizumabrequired prior agent

2026-02-01last review date

≥14codes referenced

Coverage Criteria for Intravitreal VEGF Inhibitors

Agent-specific medical necessity criteria

Covered when ALL of the following are met (agent-specific statements summarized):

Agent eligibility common requirements: The individual has the specified retinal diagnosis for the agent (e.g., neovascular (wet) AMD, diabetic macular edema (DME), diabetic retinopathy (DR), macular edema following retinal vein occlusion (RVO), or myopic choroidal neovascularization (mCNV) as listed per drug) AND the individual has tried bevacizumab (including biosimilars) and had an inadequate response or intolerance to bevacizumab AND per each eye treated the requested agent is not used in combination with other listed intravitreal agents as specified for that drug

Some agents additionally require documented inadequate response or intolerance to two of a specified list of other agents for individuals not previously treated with the requested therapy.

Covered indications by agent: Byooviz: nAMD, macular edema following RVO, mCNV; Cimerli: nAMD, macular edema following RVO, DME, DR, mCNV; Eylea/Eylea HD/Pavblu: nAMD, DME, DR, macular edema following RVO (Eylea also includes ROP); Lucentis: nAMD, macular edema following RVO, DME, DR, mCNV; Susvimo: nAMD, DME, DR; Vabysmo: nAMD, DME, macular edema following RVO; Beovu: nAMD or DME

Specific agent indications are listed in policy text.

Additional agent-specific prior failure requirement: For certain agents (for example Beovu, Eylea/Eylea HD, and Susvimo) the individual must have had an inadequate response or intolerance to 2 of the following agents: Byooviz (ranibizumab-nuna), Lucentis (ranibizumab), Pavblu (aflibercept-ayyh), or Vabysmo (faricimab-svoa).2 of 4

This 2-of-4 requirement applies only to individuals not previously treated with the requested therapy and must be documented.

Agent-specific coverage summaries

Policy includes agent-specific coverage criteria and restrictions (examples below reflect updates noted in this document chunk):

Vabysmo (faricimab-svoa) coverage: Covered for neovascular (wet) AMD and diabetic macular edema (DME); coverage was later expanded to include macular edema following retinal vein occlusion (RVO). Per-eye combination use with other listed intravitreal agents is not permitted.

Supported by phase II/III trials (TENAYA/LUCERNE, YOSEMITE/RHINE) referenced in policy history and updates.

Susvimo (ranibizumab implant) coverage: Covered for neovascular (wet) AMD in individuals who previously responded to at least two intravitreal VEGF injections; coverage criteria were expanded to include certain individuals with DME and later DR in subsequent updates.response to >=2 prior intravitreal VEGF injections

Added to policy in 2021 and updated in 2024–2025 to require prior response and to expand indications.

Eylea / Eylea HD / Pavblu coverage: Eylea and Eylea HD cover AMD, DME, DR, and macular edema following RVO; Eylea also includes ROP. Pavblu (aflibercept-ayyh) was added as an aflibercept biosimilar/product. Combination use with listed agents is disallowed per-eye and certain new starts require prior inadequate response or intolerance to two preferred products.

Selected coverage criteria and step therapy

Coverage for listed intravitreal agents is subject to specific indication-based criteria and prior-failure/step therapy requirements for certain agents.

New start requirement for select agents: For new starts of Beovu, Eylea, Eylea HD, and Susvimo the individual must have had an inadequate response or intolerance to two preferred products.2 preferred products failed/intolerant

This requirement is effective January 2, 2026 per the policy history and applies to individuals initiating these agents.

Susvimo prior response requirement: Susvimo coverage requires that the individual previously responded to at least two intravitreal injections of a VEGF inhibitor.response to >=2 prior VEGF injections

Requirement added in 2025 updates and reiterated in subsequent history entries; documentation must show prior response.

Eylea HD indication expansion:

All uses of the medications listed in this policy that are not specifically described in the policy indications and coverage criteria are considered investigational. The listed agents are subject to the product's FDA dosage and administration prescribing information, and requests for indications outside those enumerated in this policy will not meet medical necessity.

Use of the agents listed in this policy in combination with Vabysmo (faricimab-svoa) — and later with Pavblu (aflibercept-ayyh) — is not included in coverage. Combination use is evaluated on a per eye basis and the policy explicitly disallows co-administration with these agents unless otherwise specified in an agent-specific statement.

Per-eye combination therapy with multiple intravitreal agents is restricted: for each eye treated the requested agent must not be used in combination with the other listed intravitreal agents identified in the policy (agent-specific exceptions are noted in each drug section). Examples of prohibited combinations include Beovu, Byooviz, Cimerli, Eylea/Eylea HD, Lucentis, Pavblu, Susvimo, and Vabysmo as referenced in the agent-specific criteria.

Pegaptanib (Macugen) is rarely used in contemporary practice and historical evidence did not show improvement in visual acuity versus controls; therefore it is no longer considered generally medically necessary for current treatment of neovascular AMD and has effectively been discontinued from routine use.

Coverage and authorization are subject to the member's specific benefit booklet and any applicable plan limits. Prior authorization may be required for the intravitreal biologic HCPCS/Q-codes listed in this policy, and approvals (initial and reauthorization) may be granted for up to 12 months when the policy criteria are met.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior authorization and approval length

Prior authorization may be required for drugs listed in this policy. Non-formulary exception reviews and other authorizations for any drug in this policy may be approved up to 12 months. Authorizations (initial and reauthorization) are granted only when the drug-specific coverage criteria are met and chart notes demonstrate continued positive clinical response. Medications are subject to the product's FDA dosing and administration prescribing information.

Non-formulary exception and other approvals may be granted up to 12 months.
Medications subject to FDA dosing and administration guidance.

Prior Authorization

Prior-response requirements for select products

Some products (for example Susvimo) require prior documented response to intravitreal VEGF therapy before coverage. Specifically, Susvimo requires that the individual previously responded to at least two intravitreal injections of a VEGF inhibitor prior to use.

Susvimo: prior response to ≥2 intravitreal VEGF injections required (per updated prescribing information).

HCPCS / Q-codes and Billing Guidance

Covered HCPCS CodesHCPCSCovered

J0177	Injection, aflibercept hd (Eylea HD) 1 mg
J0178	Injection, aflibercept (Eylea), 1 mg
J0179	Injection, brolucizumab-dbll (Beovu,) 1 mg
J2503	Injection, pegaptanib sodium (Macugen), 0.3 mg (code termed 10/01/25)
J2777	Injection, faricimab-svoa (Vabysmo), 0.1 mg
J2778	Injection, ranibizumab (Lucentis), 0.1 mg
J2779	Injection, ranibizumab, via intravitreal implant (Susvimo) 0.1 mg
J3590	Unclassified biologics

Covered Q-codes (biosimilars)HCPCSCovered

Q5124	Injection, ranibizumab-nuna, biosimilar (Byooviz) 0.1 mg
Q5128	Injection, ranibizumab-eqrn biosimilar (Cimerli) 0.1 mg
Q5147	Injection, aflibercept-ayyh (Pavblu), biosimilar, 1 mg (new code effective 04/01/25)

HCPCS / policy-listed codes (added/termed/removed over time)HCPCS

J0177
J0178
J0179
J2503
J2777
J2778
J2779
J3590
C9093
C9097

1–10 of 14

1/2

Approval duration

Maximum approval lengthInitial authorization and re-authorization may be approved for up to 12 months when criteria are met

Re-authorization conditionRe-authorization up to 12 months requires chart notes demonstrating continued positive clinical response to therapy

Applies toNon-formulary exception reviews and all other reviews for drugs listed in this policy

Definitions and Drug Summaries

Neovascular (wet) AMD

DefinitionNeovascular (wet) age-related macular degeneration (nAMD) is characterized by growth of abnormal vessels into the subretinal space (typically from the choroidal circulation) leading to exudation and risk of severe vision loss

Clinical featuresAssociated with choroidal neovascularization, exudation, and potential geographic atrophy or hemorrhage

SignificanceAccounts for >80% of AMD cases that result in severe visual loss or legal blindness

Diabetic retinopathy / DME

DefinitionDiabetic retinopathy is retinal microvascular disease due to diabetes that can cause vascular leakage, retinal thickening (macular edema), and proliferative neovascularization that threatens vision

Stages

Background and Evidence Summary

Neovascular (wet) AMD, diabetic retinopathy (including diabetic macular edema), and macular edema from retinal vein occlusion are retinal vascular conditions driven largely by VEGF-mediated neovascularization and vascular leakage. Intravitreal VEGF inhibitors improve visual outcomes in these conditions by neutralizing VEGF signaling; newer agents (for example, faricimab/Vabysmo) target additional pathways such as Ang-2 in addition to VEGF-A, and Susvimo is an implanted ranibizumab delivery system indicated for patients who previously responded to intravitreal VEGF therapy.

Policy Revision History and Material Changes

2020-12-01policy_created

New policy approved (includes Beovu, Eylea, Lucentis, Macugen) with HCPCS codes J0178, J0179, J2503, and J2778 listed; effective for dates of service on or after 2021-03-03 following 90-day provider notification.

2021-01-01annual_review

Annual review added biosimilar Byooviz and Susvimo to the policy; updated combination-use restrictions to include Byooviz and Susvimo and added HCPCS codes C9093 and Q5124 (04/01/22 coding update later).

2022-05-01annual_review

Added coverage criteria for Vabysmo (faricimab-svoa) for AMD and DME; clarified per-eye combination restrictions and added Vabysmo to HCPCS reporting (J3590); multiple coding updates followed in 2022 adding/removing codes (C9097, J2779, J2777, etc.).

Policy Summary

PayerPremera Bluecross

PolicyInhibitors for Ocular Disorders

Policy CodePolicy 5.01.620

Change TypeCriteria additions and step-therapy updates (agent additions, indication expansions, and new prior-failure requirements)

Effective DateFeb 1, 2026

Next Review DateN/A

SourceLink

On This Page

prior inadequate response/intolerance to 2 preferred products for some new starts

Eylea HD indication expanded for RVO in 2026; Pavblu added in 2025 with non-combination rules.

Beovu (brolucizumab-dbll) safety note: Clinical trial data demonstrated efficacy comparable to aflibercept, but post-marketing reports of retinal vasculitis/occlusive retinal vasculitis have been raised; these safety observations may influence utilization and clinician decision-making.

ASRS safety communications and history entries referenced in policy (Feb 2020 ASRS noted cases).

Eylea HD coverage includes treatment of macular edema following retinal vein occlusion (RVO).

Updated in the 02/01/26 annual review (history entry).

Step Therapy

Step therapy — prior failure requirement for select agents

For new starts of selected agents (Beovu, Eylea, Eylea HD, Susvimo), the individual must have documentation of inadequate response or intolerance to two preferred products before initiating the requested therapy.

Applies to new starts of Beovu, Eylea, Eylea HD, and Susvimo.
Required documentation: inadequate response or intolerance to two preferred products (examples: Byooviz, Lucentis, Pavblu, Vabysmo as listed in drug-specific criteria).

Documentation Required

Required documentation

Medical records submitted for review must document that medical necessity criteria are met. Records should include office visit notes containing the diagnosis, relevant history, medication history, and physical evaluation, and must document prior treatments (including bevacizumab) and the clinical response or intolerance to those therapies.

Documentation must show trial of bevacizumab (including biosimilars) and inadequate response or intolerance when required by the drug-specific criteria.
Chart notes should demonstrate that the individual continues to show a positive clinical response for reauthorization requests.

Nonproliferative stages: microaneurysms, intraretinal hemorrhages, venous dilation; Proliferative: neovascularization prone to vitreous hemorrhage and retinal detachment

Risk factors/prevalenceMajor risk factor is duration of diabetes; prevalence among adults with diabetes aged ≥40 in US ~28.5%

Retinal Vein Occlusion (RVO)

DefinitionRetinal vein occlusion (RVO) is partial or complete obstruction of a retinal vein (central CRVO or branch BRVO) causing retinal vascular leakage and macular edema

ClassificationCRVO: obstruction at/behind optic nerve head; BRVO: obstruction at a branch/tributary of the central retinal vein

Epidemiology/riskSecond most common retinal vascular disorder after diabetic retinopathy; risk increases with older age and systemic vascular disease

Faricimab / Vabysmo

AgentFaricimab (Vabysmo)

MechanismBispecific antibody that simultaneously neutralizes angiopoietin-2 (Ang-2) and vascular endothelial growth factor A (VEGF-A)

Evidence basePhase II/III trials (e.g., TENAYA/LUCERNE, STAIRWAY, AVENUE) demonstrated noninferior visual outcomes and extended durability compared with aflibercept or ranibizumab

Susvimo (ranibizumab implant)

AgentSusvimo (ranibizumab ocular implant)

Approval noteFDA-approved for treatment of individuals with neovascular (wet) AMD who previously responded to at least two intravitreal injections of a VEGF inhibitor

FormulationOcular implant delivering ranibizumab via implant reservoir (see prescribing information)

Susvimo (implant) — additional reference

Device descriptionSusvimo is an ocular ranibizumab implant for intravitreal delivery of ranibizumab via the Susvimo implant system

Policy prior-response requirementPolicy requires prior documented response to at least two intravitreal VEGF injections for Susvimo candidates

ReferenceSee Susvimo prescribing information (revised September 2025) for implant details and administration guidance

Faricimab / Vabysmo — alternate reference

AgentFaricimab (Vabysmo)

PharmacologyFirst-in-class bispecific agent targeting Ang-2 and VEGF-A via simultaneous and independent binding

Trial supportPrimary efficacy evidence for nAMD from TENAYA and LUCERNE trials; additional phase II studies (STAIRWAY, AVENUE) support dosing durability

2023-06-01annual_review

Added coverage for Eylea for retinopathy of prematurity (06/01/23) and added Eylea HD coverage later in 11/01/23; coding updates included Q5128 and other code adjustments in 2023-04-01.

2025-04-01annual_review

Added coverage criteria for Pavblu (aflibercept-ayyh) and updated Susvimo to require prior response to at least two intravitreal VEGF injections; clarified non-formulary exception approvals may be granted up to 12 months and added HCPCS code Q5147.

2025-09-01interim_review

Interim review added Susvimo coverage for diabetic retinopathy (approved 08/12/2025).

2025-10-01coding_update

Removed termed HCPCS code J2503 (removed 10/01/25).

2025-11-01interim_review

Removed Macugen (pegaptanib) from the policy as discontinued and no longer available (approved 10/27/2025).

2026-01-02clinical_criteria_change

Effective January 2, 2026 (after 90-day provider notification), new starts of Beovu, Eylea, Eylea HD, and Susvimo require documented inadequate response or intolerance to two preferred products.

2026-02-01annual_reviewLatest

Annual review updated Eylea HD coverage to include treatment of Macular Edema Following Retinal Vein Occlusion (RVO); policy approved 01/26/2026 and effective 02/01/2026.

Material clinical coverage changes in recent updates include addition of biosimilar and implant products (for example, Byooviz (ranibizumab-nuna) and Susvimo (ranibizumab implant)) and new agents (Vabysmo, faricimab-svoa and later Pavblu, aflibercept-ayyh) to the policy. The policy was updated to clarify non-combination rules with Vabysmo and Pavblu and to add or revise step-therapy requirements: for many listed agents the individual must have tried bevacizumab (or biosimilar) and had an inadequate response or intolerance, and effective January 2, 2026 new starts of Beovu, Eylea, Eylea HD, and Susvimo require documentation of inadequate response or intolerance to two preferred products following a 90-day provider notification period. Non-formulary exception reviews and authorizations may be approved for up to 12 months when criteria are met.