ModifiedHealth NetPolicy N/A

Clinical Policy: Faricimab-svoa (Vabysmo)

Medical necessity and coverage criteria for faricimab-svoa (Vabysmo) for nAMD, DME, and macular edema following retinal vein occlusion for Health Net lines of business.

Policy Summary

PayerHealth Net

PolicyFaricimab-svoa (Vabysmo) — coverage criteria for nAMD, DME, RVO

Policy CodePolicy N/A

Change TypeMaterial clinical and coding updates (dosing clarifications, RVO indication, J2777)

Effective Date06.01.22

Next Review DateN/A

Key ActionSubmit prior authorization (J2777) with documentation showing member meets initial approval criteria and dosing per PI (e.g., DME: 6 mg q4w x 6).

SourceLink

POLICY UPDATE CHANGES

Simplified initial approval criteria for DME maximum dosing to 6 mg every 4 weeks for the first 6 doses per prescribing information.

For RVO, removed 'for 6 months' from maximum dosing and clarified that Vabysmo treatment beyond 6 months was not evaluated per prescribing information.

Added newly FDA-approved indication of macular edema following retinal vein occlusion (RVO).

Added HCPCS code J2777 (referenced for prior authorization and billing).

Added newly approved prefilled syringe formulation (6 mg/0.05 mL) to product availability.

3FDA-approved indications

6 mg q4w x 6DME initial dosing

First 4 doses

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nAMD initial loading

RT4 (3)Regulatory updates

≥1HCPCS codes referenced

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial Approval

Dose limits: nAMD: 6 mg (1 vial/syringe) every 4 weeks for the first 4 doses; DME: 6 mg (1 vial/syringe) every 4 weeks for the first 6 doses; RVO: 6 mg (1 vial/syringe) every 4 weeks.

Operational notes: Requests for IV formulations of Avastin, Mvasi, and Zirabev will not be approved; prior authorization may be required for bevacizumab intravitreal solution.

Continuation Therapy

Re-authorization and maintenance criteria:

Continued Therapy: Re-authorization is not permitted; Vabysmo treatment for greater than 6 months was not evaluated. For members currently receiving medication, continuation may be allowed if the member previously met initial approval criteria and is responding positively to therapy as evidenced by decreased neovascularization, improvement or maintenance of visual acuity, or supportive OCT/FA findings.

Maintenance dosing (nAMD): If member has documented active disease at the protocol-specified assessment timepoints, maintenance dosing options include: 6 mg every 8 weeks, 6 mg every 12 weeks (if active disease documented at week 24), or 6 mg every 16 weeks as supported by documentation; dosing must be guided by OCT and visual acuity assessments.

Maintenance dosing (DME): DME maintenance dosing per PI: may continue at 6 mg every 4 weeks as indicated; interval extension or reduction should be based on CST and visual acuity evaluations.

Dose increase requests: If request is for a dose increase, the new dose must not exceed the specified maintenance schedules for the indication and must be supported by documented active disease or clinical findings.

Dosing-based coverage clarifications

Policy coverage and approval criteria reference product prescribing information and the Clinical Pharmacology appendix; notable dosing clarifications and operational notes include:

DME initial dosing: Initial DME maximum dosing is limited to 6 mg every 4 weeks for the first 6 doses per the product prescribing information.6 mg q4w x 6

Simplified in 1Q 2025 review; providers should document dosing per PI and Appendix B.

nAMD initial dosing: Initial nAMD dosing is 6 mg every 4 weeks for the first 4 doses, followed by OCT and visual acuity evaluation to inform maintenance interval adjustments per prescribing information.

Follow PI-guided interval adjustments (8–16 weeks) based on documented activity and Appendix guidance.

Reference materials: Dosing regimens and off-label indication clarifications are detailed in Appendix B (Clinical Pharmacology); providers should reference the PI and Appendix when documenting dosing decisions.

RVO duration/coverage clarification

RVO-related coverage notes and duration limits:

RVO dosing/duration: RVO initial dosing: 6 mg (1 vial/syringe) every 4 weeks. The phrase 'for 6 months' was removed from RVO maximum dosing language and Vabysmo treatment beyond 6 months was not evaluated per the product prescribing information.

Clinicians should follow the PI for management beyond evaluated periods; Appendix D contains RVO clinical trial duration details.

Continuation considerations: Because treatment beyond the evaluated durations was not studied in clinical trials, continuation or re-authorization beyond those periods requires documentation of ongoing clinical benefit and alignment with PI or local continuity-of-care regulations.

Non–FDA approved indications are not addressed by this policy and are excluded from coverage unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (e.g., CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, CP.PMN.53 for Medicaid) or other evidence of coverage documents.

Inclusion of a HCPCS or other code in this policy does not by itself guarantee that a request or claim will be covered or reimbursed; coding listed in the clinical policy is provided for informational purposes only. Providers must use current, authoritative coding guidance and submit all required documentation to support medical necessity when requesting prior authorization or submitting claims.

Per the product prescribing information and as reflected in this policy, treatment durations beyond those evaluated in clinical studies are not supported by evidence in the label. Specifically, Vabysmo treatment for greater than 6 months was not evaluated for macular edema following retinal vein occlusion, and continuation beyond evaluated periods should be guided by the PI and documented clinical rationale.

No additional explicit conditions labeled "not medically necessary" are provided in the cited policy excerpts. Decisions about medical necessity should follow the policy criteria, clinical documentation, and applicable medical‑policy rules.

Coding

Referenced HCPCS CodesHCPCS

J2777

Faricimab-svoa injection (HCPCS) — referenced in policy

Referenced HCPCS/J codesHCPCS

J2777	HCPCS code referenced/added (description not provided in chunk)
C9097	HCPCS code added 06.30.22 then removed as inactive during 2Q 2023 review (description not provided in chunk)
J3590	HCPCS code removed as inactive during 2Q 2023 annual review (description not provided in chunk)

inv-11: CST increase threshold for active nAMD

Threshold> 50 µm increase in central subfield thickness compared to the average CST over the previous 2 visits

ContextUsed to define active neovascular AMD (nAMD) when evaluating OCT changes to guide treatment frequency

Source noteFrom policy Appendix C: 'Increase in CST > 50 µm compared to average central subfield thickness (CST) over previous 2 visits'

inv-12: CST increase vs lowest

Threshold≥ 75 µm increase in CST compared with the lowest CST recorded at either of the previous 2 visits

ContextAlternate OCT criterion for defining active nAMD when comparing to the lowest recent measurement

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Vabysmo. Providers must obtain prior authorization before initiating therapy and should reference applicable HCPCS codes when submitting requests. Inclusion or exclusion of codes in this policy does not guarantee coverage; providers should reference current professional coding guidance and payer billing rules when submitting claims.

Inclusion/exclusion of codes does not guarantee coverage — verify with current coding guidance and payer rules
Reference HCPCS J2777 when applicable for intravitreal product billing

Documentation Required

Document Dosing per PI and Appendices

Providers must document dosing consistent with the product labeling (PI) and the Clinical Pharmacology appendices included with this policy. Submission of office chart notes, dosing records, and other clinical information that confirm dose, frequency, and indication is required to support both initial and continued authorization requests.

Definitions and Key Terms

inv-24: CST — Central subfield thickness (OCT) definition and use

DefinitionCentral subfield thickness (CST) — thickness of the central macular subfield measured by optical coherence tomography (OCT)

Clinical useCST is used to assess macular edema and to guide dosing adjustments and interval changes for intravitreal therapy

Measurement contextPolicy criteria reference CST changes (e.g., >50 µm, ≥75 µm) across recent visits to define active disease

inv-25: BCVA — Best-corrected visual acuity definition and use

DefinitionBest-corrected visual acuity (BCVA) — the best possible visual acuity achieved with refractive correction

Clinical useBCVA changes are used with OCT findings to define active neovascular disease and to guide treatment frequency

Background

Faricimab‑svoa (Vabysmo) is an intravitreal bispecific antibody that targets vascular endothelial growth factor and angiopoietin‑2 and is FDA‑approved to treat neovascular age‑related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). Dosing varies by indication and includes initial monthly loading doses (for example, nAMD: 6 mg every 4 weeks for the first 4 doses; DME: 6 mg every 4 weeks for the first 6 doses), with subsequent maintenance intervals determined by disease activity assessed using OCT (central subfield thickness) and best‑corrected visual acuity.

Revision History

2022-03-03policy_created

Policy created (initial policy document).

2022-05-22p_and_t_approval

Policy P&T committee approval recorded.

2022-06-30code_added

Added HCPCS code C9097 (later removed when found inactive).

Policy Summary

PayerHealth Net

PolicyFaricimab-svoa (Vabysmo) — coverage criteria for nAMD, DME, RVO

Policy CodePolicy N/A

Change TypeMaterial clinical and coding updates (dosing clarifications, RVO indication, J2777)

Effective Date06.01.22

Next Review DateN/A

Key ActionSubmit prior authorization (J2777) with documentation showing member meets initial approval criteria and dosing per PI (e.g., DME: 6 mg q4w x 6).

SourceLink

On This Page

Source noteAppendix C specifies: 'Increase in CST ≥ 75 compared with lowest CST recorded at either of previous 2 visit'

inv-13: BCVA worsening to define active disease

Threshold ADecrease of ≥ 5 letters of BCVA compared with the average BCVA over the previous 2 visits (due to nAMD)

Threshold BDecrease of ≥ 10 letters of BCVA compared with the highest BCVA recorded over the previous 2 visits (due to nAMD)

ContextBCVA declines are used alongside OCT findings (CST changes, new hemorrhage) to define active disease warranting more frequent dosing

inv-14: DME initial dosing threshold

Initial dosing limit6 mg administered intravitreally every 4 weeks for the first 6 doses

Policy alignmentClarified in 1Q 2025 review and reflected in Appendix/PI-directed dosing guidance

Use caseApplies to diabetic macular edema (DME) initial treatment period per product prescribing information

Document dosing per PI: e.g., nAMD — 6 mg every 4 weeks for the first 4 doses; DME — 6 mg every 4 weeks for the first 6 doses; RVO — 6 mg every 4 weeks (per PI and policy appendices)

Include office chart notes, labs, and other clinical documentation with PA submission

Step Therapy

Step Therapy / Therapeutic Alternatives

Failure of bevacizumab intravitreal solution is required prior to approval of Vabysmo unless bevacizumab is contraindicated or associated with clinically significant adverse effects. IV formulations of Avastin, Mvasi, and Zirabev will not be approved for intravitreal use.

Step therapy: trial and failure of bevacizumab intravitreal solution required unless contraindicated
IV formulations (Avastin, Mvasi, Zirabev) are not approved for intravitreal administration

Documentation Required

Required Documentation

Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria. Requests lacking adequate supporting documentation may be denied.

Include clinical rationale, prior treatment history, and dosing records with the PA request
Insufficient documentation is a denial trigger

Denial Risk

Denial Triggers / Non‑Covered Indications

Requests for indications not approved by the FDA are not covered under this policy unless there is sufficient documentation per applicable off-label use policies and evidence of efficacy and safety.

Non‑FDA approved indications are not authorized unless supported by off‑label use policies (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53) and evidence of efficacy/safety
Denial triggers include IV formulations for intravitreal use and non‑covered indications

Billing Rule

Coding Inclusion Not Guarantee of Coverage

Coding references in this clinical policy are informational. Inclusion or exclusion of any codes does not guarantee coverage or correct billing. Providers should verify coding for claim submission using the most current professional resources and payer-specific billing instructions.

Codes referenced (informational): HCPCS J2777
Verify up-to-date coding guidance before claim submission

Thresholds referencedPolicy uses BCVA declines (≥5 letters vs average of prior 2 visits or ≥10 letters vs highest of prior 2 visits) as activity criteria

inv-26: DME max dosing (initial period) — Clarified to 6 mg q4w x 6 per PI

Clarified maximum (initial period)6 mg every 4 weeks for the first 6 doses (DME initial dosing per PI)

Policy note1Q 2025 review simplified initial DME max dosing to align with product PI and Appendix B Clinical Pharmacology updates

ImplicationProviders should document dosing consistent with this clarified initial-period maximum when submitting PA requests

inv-27: RVO indication update — Newly FDA-approved indication for macular edema following RVO added in RT4

UpdateAdded newly FDA‑approved indication: macular edema following retinal vein occlusion (RVO) — RT4 update

Policy timingRT4 entry dated 10.31.23 documents the addition of the RVO indication; further Appendix/clinical trial duration details updated in 2Q 2024

Dosing/duration caveatPolicy also clarifies that treatment beyond 6 months for RVO was not evaluated per the PI and was removed from the RVO max dosing phrasing

2022-09-29template_update

Template changes to other diagnoses/indications and continued therapy section applied; HCPCS code J2777 added.

2023-01-25annual_review

2Q 2023 annual review: removed inactive HCPCS codes J3590 and C9097; references reviewed and updated.

2023-10-31indication_added

RT4 update added FDA-approved indication for macular edema following retinal vein occlusion (RVO).

2024-01-31annual_review

2Q 2024 annual review: added RVO clinical trial duration details to Appendix D; references reviewed and updated.

2024-07-17formulation_update

RT4 update added newly approved prefilled syringe formulation (6 mg/0.05 mL) to product availability.

2024-11-15appendix_update

Appendix B updated per Clinical Pharmacology to clarify dosing regimens and off-label indications.

2025-01-01annual_review_material_changeLatest

1Q 2025 annual review: simplified initial approval criteria for DME to 6 mg every 4 weeks for the first 6 doses and clarified RVO dosing duration per product PI.