ModifiedmhnPolicy CP.PHAR.581

Faricimab-svoa (Vabysmo)

Medical necessity and prior authorization criteria for faricimab-svoa (Vabysmo) for ophthalmic indications (nAMD, DME, macular edema following RVO) for members covered by the payer.

Policy Summary

Payermhn

PolicyFaricimab-svoa (Vabysmo) coverage criteria

Policy CodePolicy CP.PHAR.581

Change TypeDosing and policy updatesIL step therapy bypass added

Effective DateJun 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis, prior bevacizumab failure unless contraindicated, prescriber specialty, age ≥18, and dosing consistent with policy.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for Illinois HIM per IL HB 5395 and extended continued therapy duration from 6 months to 12 months for nAMD and DME.

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

Clarified initial approval for RVO is for a total of 6 months of therapy (6 doses) and that treatment >6 months was not evaluated.

Added HCPCS codes C9097 and J2777 and later removed inactive HCPCS codes J3590 and C9097; added newly FDA-approved indications including macular edema following retinal vein occlusion and a prefilled syringe formulation.

Simplified initial approval criteria for DME max dosing to 6 mg every 4 weeks for the first 6 doses per PI and simplified continued therapy criteria for DME max dosing to 6 mg every 4 weeks per PI; extended continued therapy duration from 6 months to 12 months for nAMD and DME; clarified RVO initial approval is for a total of 6 months (6 doses).

Added step therapy bypass for Illinois Health Insurance Marketplace (IL HIM) per IL HB 5395.

3FDA-approved indications

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Vial/syringe strength

12 monthsContinued therapy duration

6 monthsRVO initial treatment

Coverage Criteria

Initial Approval Criteria

Covered when ALL of the following are met

Initial ophthalmic disease criteria: 1) Diagnosis of one of: nAMD, diabetic macular edema (DME), or macular edema following retinal vein occlusion (RVO); 2) Prescribed by or in consultation with an ophthalmologist; 3) Age ≥ 18 years; 4) Failure of intravitreal bevacizumab unless contraindicated or clinically significant adverse effects are experienced (note: prior authorization may be required for bevacizumab and IV formulations of Avastin/Mvasi/Zirabev are not approved); 5) Dose does not exceed indication-specific initial dosing described in policy.

See dosing section for exact initial dose schedules

Indication-specific initial dosing limits

nAMD initial dosing: 6 mg (1 vial/syringe) intravitreal every 4 weeks for the first 4 doses; follow-up OCT and visual acuity evaluation at weeks 8 and 12 to inform maintenance interval (possible maintenance regimens per PI); maximum dose = 6 mg every 4 weeks.4 doses

Maintenance intervals may be 8, 12, or 16 weeks per response; approval duration: 4 months (first 4 doses)

DME initial dosing: 6 mg (1 vial/syringe) intravitreal every 4 weeks for the first 6 doses (per product prescribing information); some regimens allow extension based on central subfield thickness and visual acuity; maximum dose = 6 mg every 4 weeks.6 doses

Policy aligned to PI; approval duration: 6 months (up to 6 doses)

RVO initial dosing: 6 mg (1 vial/syringe) intravitreal every 4 weeks for a total of 6 months of therapy (6 doses); treatment beyond 6 months was not evaluated.6 months

Initial approval limited to total of 6 doses (6 months)

Continued Therapy Criteria

Covered when ALL of the following are met

General continued therapy: 1) Member is currently receiving medication via the benefit or previously met initial approval criteria, or continuity of care regulations apply; 2) Member is responding positively to therapy as evidenced by decreased neovascularization, improvement or maintenance of visual acuity, or supportive OCT/fluorescein angiography findings; 3) If request is for a dose increase, the new dose does not exceed indication-specific maintenance maximums (examples: nAMD maintenance regimens per Appendix D with maximum 6 mg every 4 weeks; DME maintenance per PI: 6 mg every 4 weeks maximum).

Approval duration for maintenance indications (nAMD and DME) = 12 months

Duration and dosing updates

Coverage and duration rules updated in recent reviews

DME initial dosing: Initial DME dosing: maximum 6 mg every 4 weeks for the first 6 doses per product prescribing information; policy language simplified to align with PI.6 doses

Simplified initial approval criteria per 1Q 2025 review

RVO initial approval: Initial RVO approval clarified as a total of 6 months of therapy (6 doses); treatment beyond 6 months was not evaluated.6 months

Clarified in 1Q 2026 review

Continued therapy for nAMD and DME: Continued therapy duration for maintenance medication extended from 6 months to 12 months for chronic conditions (nAMD and DME).12 months

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

When state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, the state Medicaid provisions take precedence. Providers should consult the applicable state Medicaid manual for specific coverage rules and requirements.

For the indication of macular edema following retinal vein occlusion (RVO), clinical evidence reviewed for this policy evaluated treatment up to a total of 6 months (6 doses). Treatment beyond the evaluated durations (for example, RVO > 6 months) was not evaluated and re‑authorization for extended therapy is not permitted under this policy.

This clinical policy is intended as a guide to medical necessity to assist in coverage determinations and benefit administration; it does not guarantee payment. Coverage decisions remain subject to the member's plan terms, conditions, exclusions, limitations, and applicable state and federal law, as well as Health Plan administrative policies and procedures.

Coding

HCPCS CodesHCPCS

J2777

Injection, faricimab-svoa, 0.1 mg

HCPCS coding historyHCPCS

C9097	HCPCS codeadded then later removed (inactive) per history
J2777	HCPCS code added per history
J3590	HCPCS code removed (inactive) per history

Vial strength — 6 mg/0.05 mL

Vial strength6 mg per 0.05 mL (single vial/syringe)

Unit1 vial/syringe = 6 mg

Administration formIntravitreal injection

DME initial dosing — 6 mg every 4 weeks for the first 6 doses

DME initial dosing6 mg intravitreal every 4 weeks for the first 6 doses

Post-loading optionsAfter initial 6 doses, dosing may be adjusted per CST and visual acuity (e.g., extend interval to every 8 weeks) as described in dosing regimens

Provider Actions / How to Request Coverage

Prior Authorization

Prior authorization required

Prior authorization is required for faricimab-svoa; providers must document the member's diagnosis, prior failure of intravitreal bevacizumab unless contraindicated, prescriber specialty (ophthalmologist or in consultation with an ophthalmologist), age ≥ 18 years, and that the requested dose is consistent with the policy dosing limits.

Document diagnosis (nAMD, DME, or macular edema following RVO).
Document prior bevacizumab failure unless contraindicated or clinically significant adverse effects.
Confirm prescriber is an ophthalmologist or consult note with an ophthalmologist.
Document member age ≥ 18 and requested dosing consistent with policy.

Billing Rule

Background

Faricimab‑svoa (Vabysmo) is an intravitreal biologic that inhibits both vascular endothelial growth factor (VEGF) and angiopoietin‑2 (Ang‑2) and is FDA‑approved for three ophthalmic indications: neovascular age‑related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). Dosing regimens vary by indication; typical dosing uses a 6 mg/0.05 mL intravitreal dose with initial loading schedules and subsequent interval adjustments based on clinical response and imaging. Specific initial schedules include monthly loading doses (e.g., nAMD: every 4 weeks for the first 4 doses; DME: every 4 weeks for the first 6 doses per prescribing information; RVO: every 4 weeks for up to 6 months), after which maintenance intervals are determined by response.

Definitions

BCVA — Best-corrected visual acuity

DefinitionBest-corrected visual acuity

AbbreviationBCVA

Use in policyUsed as an efficacy measure to assess response to therapy (improvement or maintenance of visual acuity)

CST — Central subfield thickness

DefinitionCentral subfield thickness

AbbreviationCST

Use in policyOCT-measured CST guides dosing interval adjustments based on resolution of edema

Revision History

2022-03-03policy_created

Clinical policy created (Policy created entry).

2022-05-22p_and_t_approval

Policy received P&T approval (P&T Approval Date = 05.22).

2022-06-30coding_added

Added HCPCS code C9097 to the policy coding history.

Policy Summary

Payermhn

PolicyFaricimab-svoa (Vabysmo) coverage criteria

Policy CodePolicy CP.PHAR.581

Change TypeDosing and policy updatesIL step therapy bypass added

Effective DateJun 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis, prior bevacizumab failure unless contraindicated, prescriber specialty, age ≥18, and dosing consistent with policy.

SourceLink

On This Page

Updated in 1Q 2026 review

May be dosed as frequently as every 4 weeks, but additional efficacy not demonstrated over 8-week in most patients

RVO initial approval duration — total of 6 months (6 doses)

Initial approval duration (RVO)Total of 6 months of therapy (6 doses)

Dosing schedule6 mg intravitreal every 4 weeks for 6 months

Re-authorization noteTreatment beyond 6 months was not evaluated and re-authorization is not permitted per policy

Use current HCPCS codes for PA

Use current, active HCPCS codes when requesting prior authorization and submitting claims; the policy lists J2777 (Injection, faricimab-svoa, 0.1 mg) and records a history of code additions and removals, so providers should reference up‑to‑date coding guidance prior to submission.

Primary billing code documented in policy: J2777 (Injection, faricimab-svoa, 0.1 mg).
Policy history shows addition and later removal of codes (C9097, J3590); verify current active codes before PA/claims.

Step Therapy

Bevacizumab step therapy

Step therapy requires documented failure of intravitreal bevacizumab unless contraindicated; include evidence of prior bevacizumab use and reasons for failure or contraindication in the PA request.

Document prior intravitreal bevacizumab therapy and clinical response, or documented contraindication/adverse events preventing bevacizumab use.
Note that prior authorization may also be required for bevacizumab intravitreal solution per policy.

Note

IL step therapy bypass

Per IL HB 5395, step therapy requirements do not apply to Illinois Health Insurance Marketplace (IL HIM) requests — providers submitting IL HIM requests should indicate payer and marketplace plan status to apply the statutory bypass; local state program exceptions (e.g., Medicaid) may still apply.

Include plan type (IL HIM) on the request to trigger statutory step therapy bypass.
Be aware that state Medicaid or other local program rules may supersede or differ.

Documentation Required

Required documentation

Providers must submit supporting clinical documentation with the prior authorization request such as office chart notes, imaging (OCT/fluorescein angiography), visual acuity records, and any relevant laboratory or diagnostic results that demonstrate the member meets approval criteria.

Office chart notes documenting diagnosis and prior treatments.
Imaging reports (OCT, fluorescein angiography) and visual acuity measurements.
Documentation of prior bevacizumab therapy or contraindication, if applicable.

Documentation Required

Medical necessity guidance and documentation

When requesting coverage or submitting documentation, follow the Health Plan's administrative policies and applicable coverage documents; this clinical policy is a guide to medical necessity but does not guarantee payment.

Adhere to Health Plan administrative procedures and evidence of coverage requirements when preparing PA requests.
Use this policy in conjunction with any plan-level forms or processes.

Denial Risk

Documentation missing or off-label without evidence

Requests lacking documentation that the member meets the approval criteria — or requests for non‑FDA‑approved indications without sufficient off‑label justification per the plan's off‑label use policies — may be denied.

For off‑label indications, include sufficient efficacy and safety documentation as required by CP.CPA.09, HIM.PA.154, or CP.PMN.53.
Failure to provide evidence of prior bevacizumab failure or contraindication can result in denial.

Note

Coverage subject to plan terms

Coverage decisions are subject to the terms, conditions, exclusions, and limitations of the member's coverage documents and applicable law; if plan or legal requirements conflict with this policy, those requirements govern.

Verify member-specific benefits, exclusions, and limitations in the evidence of coverage or contract.
State Medicaid provisions may take precedence where applicable.

DME dosing — DME max dosing

DME maximum initial dosing6 mg intravitreal every 4 weeks for the first 6 doses (per product PI)

Maintenance dosingAfter loading doses, may continue as 6 mg every 8 weeks or adjust per CST and BCVA

Maximum frequencyMaximum dose frequency described is 6 mg every 4 weeks

2022-09-29coding_added

Added HCPCS code J2777 and applied template changes to diagnoses/continued therapy sections.

2023-01-25coding_removed

Removed inactive HCPCS codes J3590 and C9097 during 2Q 2023 annual review; references updated.

2023-10-31indication_added

Added newly FDA‑approved indication: macular edema following retinal vein occlusion.

2024-01-31appendix_update

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

2024-07-17formulation_added

Added newly approved prefilled syringe formulation to policy (RT4 update).

2024-11-15dosing_clarified

1Q 2025 annual review: simplified initial and continued DME dosing per PI (6 mg every 4 weeks for first 6 doses) and clarified RVO treatment beyond 6 months was not evaluated.

2025-10-29policy_revisionLatest

1Q 2026 annual review: added step therapy bypass for Illinois HIM per IL HB 5395; extended continued therapy duration for nAMD and DME from 6 to 12 months; clarified RVO initial approval is for a total of 6 months (6 doses).