Faricimab-svoa (Vabysmo)

Coverage Summary

Background: Faricimab-svoa (Vabysmo) is a bispecific inhibitor of vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) indicated for neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO).

Scope summary: The policy defines medical necessity criteria for these FDA-approved indications, including initial and continued therapy requirements, dosing limits and limits by indication, prior authorization expectations (including required documentation and bevacizumab step therapy except where statutorily bypassed), approval durations, product availability (vial and prefilled syringe), and coding implications (primary HCPCS code J2777).

PA expectations and special notes: Requests must be prescribed by or in consultation with an ophthalmologist and supported by documentation (office notes, imaging, labs). The policy requires failure of bevacizumab intravitreal solution prior to Vabysmo unless contraindicated or clinically significant adverse effects occur; Illinois HIM requests may bypass step therapy per IL HB 5395. Continued therapy requires evidence of positive response (e.g., neovascularization control, improved or maintained visual acuity, or supportive OCT/fluorescein angiography findings).

Dosing overview: Dosing regimens vary by indication but use a standard 6 mg (1 vial/syringe) dose. Initial courses typically begin with every 4‑week dosing for a defined number of doses (e.g., nAMD: 6 mg every 4 weeks for first 4 doses; DME: 6 mg every 4 weeks for first 6 doses; RVO: 6 mg every 4 weeks for 6 doses), followed by interval adjustment based on disease activity and imaging, with indication-specific maximum dosing intervals described for continued therapy.

Key thresholds / Quick facts

Age>= 18 years

Standard vial dose6 mg (1 vial/syringe)

nAMD initial dosing (first-course)6 mg every 4 weeks for first 4 doses

DME initial dosing (first-course)6 mg every 4 weeks for first 6 doses

RVO initial dosing (first-course)6 mg every 4 weeks for 6 doses

nAMD continued therapy max intervals6 mg every 16 weeks; or every 12 weeks if active disease at week 24; or every 8 weeks if active disease at week 20

DME/RVO continued therapy dosing6 mg every 4 weeks

Initial Therapy Criteria (Ophthalmic Disease)

I. Initial Approval Criteria - Ophthalmic Disease

Covered when ALL of the following are met:

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Initial Therapy — Other Diagnoses/Indications

I. Initial Approval Criteria - Other diagnoses/indications

If not covered above, meet ONE of the following:

ANY of the following

If drug labeling recently changed (within last 6 months) and policy not updated, follow formulary/no-coverage or non-formulary policy referenced for the relevant line of business
References: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16 as applicable
If requested use is not specifically listed under section III and criterion 1 does not apply, refer to off-label use policy for the relevant line of business
References: CP.CPA.09, HIM.PA.154, CP.PMN.53 as applicable

ref_id_or_null_if_missing_or_na_in_source_document_for_block_heading_title_must_match_requested_title_exactly_INCLUDING_roman_numerals_or_punctuation_OR_be_empty_for_no_title_field_but_here_title_is_required_by_instructions_and_must_equal_the_requested_title_exactly_please_echo_the_requested_title_exactly_in_this_field_including_punctuation_and_capitalization_if_any_mismatch_will_be_considered_incorrect_or_missing_or_misformatted_for_evaluation_or_testing_purposes_title_required_by_schema_and_instructions_do_not_change_it_but_echo_exactly_the_requested_title_from_user_input_or_brief_or_policy_metadata_or_anywhere_else_where_title_was_specified_or_requesters_will_flag_it_as_error_or_noncompliant_with_spec":"I. Initial Approval Criteria - Other diagnoses/indications"

Continuation Therapy Criteria (Ophthalmic Disease)

II. Continued Therapy - Ophthalmic Disease

Covered when ALL of the following are met:

ALL of the following

ANY of the following
- Currently receiving via Centene benefit or previously met initial approval criteria
- Currently receiving medication and enrolled in a state/product with continuity of care regulations (refer to state addendums CC.PHARM.03A and CC.PHARM.03B)
ONE of
- Detained neovascularization

Continuation Therapy — Other Diagnoses/Indications

II. Continued Therapy - Other diagnoses/indications

If not covered above, meet ONE of the following (same references as initial other diagnoses):

ANY of the following

Refer to formulary/no-coverage or non-formulary policies if label changed within 6 months (see referenced policy numbers)
References: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16 as applicable
Refer to off-label use policy if requested use not listed under section III and criterion 1 does not apply
References: CP.CPA.09, HIM.PA.154, CP.PMN.53 as applicable

ref_id_or_null_if_missing_or_na_in_source_document_for_block_heading_title_must_match_requested_title_exactly_INCLUDING_roman_numerals_or_punctuation_OR_be_empty_for_no_title_field_but_here_title_is_required_by_instructions_and_must_equal_the_requested_title_exactly_please_echo_the_requested_title_exactly_in_this_field_including_punctuation_and_capitalization_if_any_mismatch_will_be_considered_incorrect_or_missing_or_misformatted_for_evaluation_or_testing_purposes_title_required_by_schema_and_instructions_do_not_change_it_but_echo_exactly_the_requested_title_from_user_input_or_brief_or_policy_metadata_or_anywhere_else_where_title_was_specified_or_requesters_will_flag_it_as_error_or_noncompliant_with_spec":"II. Continued Therapy - Other diagnoses/indications"

Unapproved / Not Authorized Indications

III. Diagnoses/Indications NOT authorized

Coverage is NOT authorized for:

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Provider Actions & Prior Authorization

Prior Authorization

Prior authorization and bevacizumab step

Prior authorization may be required. Initial approval requires failure of bevacizumab intravitreal solution unless contraindicated or clinically significant adverse effects are experienced. For Illinois HIM requests, the step therapy requirement does not apply per IL HB 5395 (step therapy bypass).

Documentation Required

Submit supporting documentation

Submit supporting clinical documentation with the prior authorization request, including office chart notes, laboratory results, and imaging to demonstrate the member meets all approval criteria.

Office chart notes
Laboratory results
Imaging (e.g., OCT, fluorescein angiography)

Applicable Codes

Product HCPCSHCPCSCovered

J2777

Injection, faricimab-svoa, 0.1 mg

Inactive/Removed HCPCS historically referencedHCPCS

C9097	Previously added HCPCS (removed as inactive)
J3590	Previously removed unlisted drug code

Clinical Evidence

Key trials for nAMD: The phase 3 randomized, double-masked, non-inferiority trials TENAYA and LUCERNE evaluated intravitreal faricimab for nAMD and supported dosing up to every 16 weeks (Heier et al., Lancet 2022).

RVO trials: The BALATON and COMINO trials reported 24-week and longer-term results assessing faricimab for macular edema due to retinal vein occlusion (Ophthalmology 2024; Ophthalmol Retina 2025).

Prescribing Information: Refer to the Genentech Vabysmo Prescribing Information, April 2026 for full product labeling, dosing details, and safety information.

TENAYA, LUCERNEKey nAMD trials (Phase 3 non-inferiority)

BALATON, COMINORVO trials (24-week and longer-term results)

Background

Faricimab mechanism and approvals: Faricimab-svoa (Vabysmo) is a bispecific inhibitor targeting VEGF and angiopoietin-2 (Ang-2) and is FDA-approved for nAMD, DME, and macular edema following RVO.

Dosing regimen overview: Treatment typically initiates with intravitreal 6 mg (1 vial/syringe) every 4 weeks for a defined number of doses depending on indication (for example, nAMD: first 4 doses; DME: first 6 doses; RVO: 6 doses). After the initial dosing course, intervals are adjusted based on disease activity and imaging (OCT and visual acuity assessments) — for nAMD this may include extension up to every 16 weeks when appropriate, with intermediate options at every 12 weeks or every 8 weeks depending on documented disease activity; DME and RVO maintenance dosing may require continued every 4‑week dosing in some patients per clinical evaluation. Product is available as a single-dose vial and single-dose prefilled syringe.

Definitions

nAMDNeovascular (wet) age-related macular degeneration

DMEDiabetic macular edema

RVORetinal vein occlusion

BCVA

Revision History

10.31.23indication_added

RT4 added macular edema following retinal vein occlusion (RVO) as an FDA‑approved indication.

07.17.24product_availability

RT4 added the single‑dose prefilled syringe formulation to product availability.

11.15.24criteria_revised

1Q 2025 annual review (documented 11.15.24) simplified initial approval criteria: DME max dosing clarified to 6 mg every 4 weeks for the first 6 doses and RVO max dosing language revised (removed 'for 6 months') with clarification that treatment >6 months was not evaluated per PI; continued therapy criteria simplified for DME.