ModifiedCentenePolicy CP.PHAR.581

Faricimab-svoa (Vabysmo) Clinical Policy / Coverage Criteria

Defines Centene's medical necessity, prior authorization, and coverage criteria for faricimab-svoa (Vabysmo) when used to treat neovascular AMD, diabetic macular edema, and macular edema following retinal vein occlusion for applicable lines of business.

Policy Summary

PayerCentene

PolicyFaricimab-svoa (Vabysmo) Clinical Policy / Coverage Criteria

Policy CodePolicy CP.PHAR.581

Change TypeMaterial coverage revisions and state-mandated step therapy bypass

Effective DateJun 1, 2022

Next Review DateN/A

Key ActionSubmit prior authorization with supporting clinical documentation and use HCPCS code J2777 for billing.

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 (6 doses); later removed the 6-month total treatment duration restriction and allowed re-authorization per PI.

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

3FDA-approved indications

6 mgProduct strength

J2777HCPCS code

12 moContinued therapy duration

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Coverage Criteria for Faricimab-svoa (Vabysmo)

inv-01: Initial Approval Criteria — Ophthalmic Disease

Covered when ALL of the following are met:

Initial Ophthalmic Criteria: Member has a diagnosis of one of the following: neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), or macular edema following retinal vein occlusion (RVO); prescribed by or in consultation with an ophthalmologist; age ≥ 18 years; failure of bevacizumab intravitreal solution unless contraindicated or clinically significant adverse effects are experienced.

Prior authorization may be required for bevacizumab intravitreal solution. Requests for IV formulations of Avastin, Mvasi, and Zirabev will not be approved. For Illinois HIM requests, step therapy requirements do not apply per IL HB 5395.

Initial Dosing Limits: Dose does not exceed per-indication initial regimens: for nAMD: 6 mg (1 vial/syringe) every 4 weeks for the first 4 doses; for DME: 6 mg (1 vial/syringe) every 4 weeks for the first 6 doses; for RVO: 6 mg (1 vial/syringe) every 4 weeks for 6 doses.

Approval duration (per earlier policy language): nAMD - 4 months; DME and RVO - 6 months.

inv-02: Continued Therapy — Ophthalmic Disease

Re-authorization covered when ALL of the following are met:

Continued Eligibility: Member is currently receiving the medication via the Centene benefit or previously met initial approval criteria, or member is covered under applicable continuity of care regulations; and member is responding positively to therapy as evidenced by one of the following: decreased neovascularization, improvement in visual acuity, maintenance of corrected visual acuity from prior treatment, or supportive findings from optical coherence tomography (OCT) or fluorescein angiography (FA).

Approval duration: 12 months.

Dose Increase Limits: If the request is for a dose increase, the new dose must not exceed the following per indication: for nAMD one of: 6 mg every 16 weeks; 6 mg every 12 weeks if member has documented active disease at week 24; or 6 mg every 8 weeks if member has documented active disease at week 20; for DME or RVO: 6 mg every 4 weeks.

See Appendix D for definition of documented active disease.

inv-03: Not Authorized

Non-FDA Indications: Coverage is not authorized for non-FDA approved indications that are not addressed in this policy unless sufficient documentation of efficacy and safety is provided according to the referenced off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents.

Refer to the listed off-label use policies for submission requirements.

inv-04: Dosing and authorization duration rules — Key coverage determinations and dosing limits

Key coverage determinations reflected in revisions and dosing limits

Dosing and duration alignment: Initial approval and continued therapy must follow the prescribing information: DME maximum dosing simplified to 6 mg every 4 weeks for the first 6 doses per PI; RVO initial approval clarified as 6 doses (6 months) though later iterations removed the absolute 6-month total restriction and allow re-authorization per PI; continued therapy for nAMD and DME extended from 6 months to 12 months.

Exact clinical eligibility criteria (diagnoses, prior treatments, visual acuity thresholds) are referenced elsewhere in the policy.

Contraindications include active ocular or periocular infection, active intraocular inflammation, and hypersensitivity to the product or its components. These safety considerations are listed in Appendix C and should be reviewed prior to administration.

No additional specific coverage exclusions are listed in the provided excerpt beyond the contraindications and the diagnoses/indications sections. Operational and coding updates are described elsewhere in the policy.

Use of faricimab-svoa for non–FDA‑approved indications that are not addressed in this policy is not authorized unless the request includes sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for marketplace, and CP.PMN.53 for Medicaid). Clinical justification and supporting documentation must be submitted with the prior authorization request.

The excerpt does not include an explicit statement using the phrase 'not medically necessary.' Instead, it specifies that coverage is not authorized for non‑FDA indications lacking sufficient off‑label documentation and otherwise defines covered uses and contraindications.

Billing and Coding

Covered HCPCS CodesHCPCSCovered

J2777

Injection, faricimab-svoa, 0.1 mg

inv-10: Dose strength — 6 mg (1 vial/syringe) per intravitreal injection

Dose strength6 mg (1 vial/syringe) administered by intravitreal injection

Volume per dose0.05 mL (per product strength listing)

PreparationSingle vial/syringe presentation for intravitreal use

inv-11: Faricimab per-dose max — 6 mg every 4 weeks (per PI)

Per-dose maximum6 mg every 4 weeks (maximum per PI)

nAMD maximum dosing noteAlthough may be dosed as frequently as every 4 weeks, additional efficacy not demonstrated in most patients vs. every 8 weeks; some patients may need every 4‑week dosing after initial loading

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must include supporting clinical documentation and use HCPCS code J2777 for billing when applicable.

Prior authorization required
Use HCPCS code J2777 when billing

Documentation Required

Documentation and Indications

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

Office notes, labs, or other clinical information required
Incomplete documentation may result in denial

Background

Faricimab‑svoa (Vabysmo) is described as a targeted intravitreal therapy indicated for neovascular age‑related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). Per the policy and prescribing information, the dose strength is 6 mg (1 vial/syringe) per intravitreal injection, with initial loading and interval‑based maintenance dosing determined by disease activity and clinical assessment. The policy aligns authorization to the PI, with DME initial dosing simplified to 6 mg every 4 weeks for the first 6 doses, RVO initial approval historically described as 6 doses (6 months) though later iterations allow re‑authorization per the PI, and continued therapy durations for nAMD and DME extended to 12 months for maintenance therapy.

Definitions and Abbreviations

inv-21: central subfield thickness (CST)

DefinitionCentral subfield thickness (CST): central macular thickness measurement on OCT used to assess macular edema/response

Assessment roleUsed to determine resolution of edema after initial dosing and to guide interval adjustments

Measurement modalityOptical coherence tomography (OCT)

inv-22: best-corrected visual acuity (BCVA)

DefinitionBest-corrected visual acuity (BCVA): standardized measure of visual acuity with optimal correction

Use in policyBCVA is used alongside OCT findings to assess clinical response and eligibility for continued therapy