ModifiedCentenePolicy CP.PHAR.581

Faricimab-svoa (Vabysmo)

Criteria and coverage rules for use of faricimab-svoa (Vabysmo) for neovascular AMD, diabetic macular edema, and macular edema following retinal vein occlusion for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyFaricimab-svoa (Vabysmo)

Policy CodePolicy CP.PHAR.581

Change TypeMaterial updates (step therapy, dosing durations, coding)

Effective DateJun 1, 2022

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, prescriber involvement, age, and evidence of bevacizumab failure unless contraindicated.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for Illinois HIM per IL HB 5395.

Extended continued therapy duration from 6 months to 12 months for nAMD and DME.

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 code J2777.

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

3FDA-approved indications

6 mgDME initial max dose

6 dosesRVO initial approval

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12 monthsExtended continued therapy

Coverage Criteria for Faricimab-svoa (Vabysmo)

Initial Approval

Covered when ALL of the following are met

Initial Approval - Ophthalmic Disease: 1) Diagnosis of one of the following: nAMD OR 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 bevacizumab intravitreal solution unless contraindicated or clinically significant adverse effects are experienced (prior authorization may be required for bevacizumab; IV formulations of Avastin, Mvasi, and Zirabev will not be approved).

Provider must submit documentation (office chart notes, labs, or other clinical information) supporting that member has met all approval criteria.

Initial Dose and Duration

Dose and Initial Approval Duration: nAMD: 6 mg (1 vial/syringe) every 4 weeks for the first 4 doses (approval duration: 4 months). DME: 6 mg (1 vial/syringe) every 4 weeks for the first 6 doses (approval duration: 6 months). RVO: 6 mg (1 vial/syringe) every 4 weeks for a total of 6 months (6 doses) (approval duration: 6 months).

Dosing and intervals per product PI; follow-up OCT and visual acuity evaluations guide interval adjustments as described in Dosage and Administration.

Continued Therapy - RVO

Continued Therapy - Macular Edema Following RVO: Re-authorization is not permitted; Vabysmo treatment for greater than 6 months was not evaluated in clinical studies.

Approval duration: Not applicable.

Continued Therapy - nAMD and DME

For nAMD and DME continued therapy (must meet all):

Continued Therapy Criteria: 1) Member is currently receiving medication via the Centene benefit or previously met initial approval criteria, or member is under continuity-of-care provisions; 2) Member is responding positively to therapy as evidenced by one or more of: decreased neovascularization, improvement in visual acuity, maintenance of corrected visual acuity from prior treatment, or supportive OCT/fluorescein angiography findings; 3) If request is for a dose increase, new dose must not exceed indication-specific maximums (nAMD: up to 6 mg at intervals of every 16, 12, or 8 weeks depending on documented disease activity per Appendix D; DME: 6 mg every 4 weeks as clinically indicated).

Approval duration for continued therapy: 12 months (extended from 6 months for nAMD and DME).

Dosing and duration criteria (summary)

Policy updates specify initial and continued therapy dosing limits and durations for covered indications.

DME initial dosing: Initial DME maximum dosing limited to 6 mg every 4 weeks for the first 6 doses per product prescribing information.6 mg q4w x6

Simplified in 1Q 2025

RVO initial therapy: Initial approval for RVO is for a total of 6 months of therapy (6 doses); treatment beyond 6 months was not evaluated per product information.6 doses

Clarified in 1Q 2025

nAMD and DME continued therapy: Continued therapy duration for maintenance medication was extended from 6 months to 12 months for nAMD and DME.12 months

Requests for indications that are not FDA‑approved and are not specifically addressed in this policy will not be authorized unless the provider supplies adequate supporting 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 coverage is required by the member’s evidence of coverage documents.

Per the product prescribing information and the policy revisions, treatment of macular edema following retinal vein occlusion with faricimab beyond the durations evaluated in clinical trials was not assessed. The policy therefore clarifies that Vabysmo treatment for greater than 6 months was not evaluated per the PI, and initial approval for RVO is limited to the evaluated course (a total of 6 doses / 6 months as specified in the criteria).

Off‑label requests must follow the health plan’s off‑label use requirements. Specifically, non‑FDA indications will be reviewed only when the provider submits sufficient clinical documentation demonstrating efficacy and safety according to the referenced off‑label policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) and any applicable evidence of coverage provisions.

Inactive HCPCS entries previously present in coding history (for example C9097 and J3590) were removed from active code lists during routine updates. Providers should use current, active HCPCS codes (e.g., J2777 for faricimab‑svoa) for billing and authorization requests.

Coding and Dose Information

HCPCS CodesHCPCSCovered

J2777

Injection, faricimab-svoa, 0.1 mg

HCPCS codes (added/removed history)HCPCS

C9097	HCPCS code (removed as inactive)
J3590	HCPCS code (removed as inactive)
J2777	HCPCS code (added)

Dose strength — single-dose vial/syringe strength

Single-dose vial/syringe strength6 mg per 0.05 mL (one vial/syringe)

Maximum per-dose statementMaximum dose per product PI is 6 mg every 4 weeks

Route of administrationIntravitreal injection

DME per-dose maximum — 6 mg every 4 weeks for the first 6 doses per product PI

DME per-dose maximum (initial series)6 mg every 4 weeks for the first 6 doses (per product PI)

Post-initial intervalAfter initial 6 doses, dosing may be adjusted (e.g., 6 mg every 8 weeks) per PI and clinical response

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must include documentation of diagnosis, prescriber specialty, member age, and evidence that step therapy requirements were met (failure of bevacizumab intravitreal solution) unless a contraindication or clinically significant adverse event is documented. Providers should reference HCPCS J2777 (faricimab, 0.1 mg) when billing. Initial and continued therapy duration limits described in the policy and coding sections apply.

Prior authorization required with supportive clinical documentation (office notes, labs, imaging).
Bill using HCPCS: J2777 = Injection, faricimab-svoa, 0.1 mg.

Denial Risk

Off‑Label/Unlisted Indication Denial Risk

Requests for indications that are not FDA‑approved and not addressed by this policy may be denied unless adequate off‑label justification and supporting evidence are provided in accordance with the plan’s off‑label use policies (commercial, HIM, Medicaid) or the member’s evidence of coverage.

Background

Faricimab‑svoa (Vabysmo) is a dual mechanism intravitreal agent that inhibits vascular endothelial growth factor (VEGF) and angiopoietin‑2 (Ang‑2). It 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). The marketed dose strength is 6 mg (0.05 mL) per vial/syringe administered by intravitreal injection. Dosing regimens differ by indication: for nAMD an initial monthly schedule consists of 6 mg every 4 weeks for the first 4 doses; for DME the initial recommendation is 6 mg every 4 weeks for the first 6 doses; and for RVO the initial approval aligns with the evaluated course of 6 doses (total ~6 months). Subsequent maintenance intervals are guided by disease activity and the product PI, and continued therapy durations for chronic indications (nAMD and DME) are addressed in the policy.

Definitions and Key Terms

Key ophthalmic terms — BCVA, CST, OCT definitions and abbreviations

BCVABest-corrected visual acuity

CSTCentral subfield thickness

OCTOptical coherence tomography

RVO initial therapy — definition/summary of initial approval duration for RVO

Definition of initial approval (RVO)Initial approval for macular edema following retinal vein occlusion is for a total of 6 months of therapy (6 doses)

Dosing schedule during initial RVO therapy6 mg (1 vial/syringe) administered by intravitreal injection every 4 weeks

Evaluation and continued use

Policy Summary

PayerCentene

PolicyFaricimab-svoa (Vabysmo)

Policy CodePolicy CP.PHAR.581

Change TypeMaterial updates (step therapy, dosing durations, coding)

Effective DateJun 1, 2022

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, prescriber involvement, age, and evidence of bevacizumab failure unless contraindicated.

SourceLink

On This Page

Frequency allowanceMay be dosed as frequently as every 4 weeks although additional efficacy was not demonstrated in most patients compared to 8-week dosing

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

RVO initial therapy durationInitial approval is for a total of 6 months of therapy (6 doses)

Per-dose amount for RVO6 mg administered by intravitreal injection every 4 weeks

Continued therapy for RVORe-authorization is not permitted; treatment >6 months was not evaluated per PI

Off‑label requests must follow CP.CPA.09 (commercial), HIM.PA.154 (HIM/Marketplace), and CP.PMN.53 (Medicaid) as applicable.

Denial Risk

Step Therapy Denial Risk

Failure to meet step therapy (i.e., documented trial and inadequate response or intolerance to bevacizumab intravitreal solution) may result in denial of Vabysmo unless a contraindication or clinically significant adverse event is documented.

Step therapy requires prior failure of bevacizumab intravitreal solution unless contraindicated or adverse event precludes use.
Prior authorization reviews will verify prior therapy or documented contraindication.

Denial Risk

Denial Risk from Coverage Document Mismatch

Coverage determinations are subject to the member’s specific coverage documents and state Medicaid rules. If state Medicaid provisions conflict with this clinical policy, the state Medicaid manual takes precedence.

Medicaid members: follow applicable state Medicaid coverage manuals where they differ from this policy.

Documentation Required

Required Documentation

Provider must submit supportive documentation (office chart notes, lab results, imaging, operative reports, or other clinical information) demonstrating that the member meets all approval criteria. Documentation will be reviewed during prior authorization and on appeals.

Include documentation of diagnosis, treating ophthalmologist (or consultation), age, prior treatments and responses, and any contraindications/adverse events.
Incomplete documentation may delay review or result in denial.

Step Therapy

Step Therapy Bypass for IL HIM

Per Illinois Health Insurance Marketplace (HIM) law (IL HB 5395), the step therapy requirements do not apply for IL HIM requests; a step therapy bypass is required for these members.

IL HIM (per IL HB 5395): step therapy bypass applies — do not require prior bevacizumab trial for Vabysmo.
Providers must indicate member is IL HIM to allow bypass during authorization.

Re-authorization for RVO is not permitted; treatment beyond 6 months was not evaluated per product PI

DME max dosing — maximum per-dose amount and initial dosing schedule per product PI

Maximum per-dose amount (DME)6 mg per dose (1 vial/syringe)

Initial DME dosing schedule6 mg every 4 weeks for the first 6 doses (per product PI)

Alternate DME regimen after initial seriesOption to extend intervals (e.g., 6 mg every 8 weeks) based on CST and visual acuity evaluations per PI