CurrentCignaPolicy IP0542

Faricimab (Vabysmo) intravitreal injection coverage

Cigna coverage policy for faricimab-svoa (Vabysmo) intravitreal injection specifying medical necessity, dosing limits, preferred product criteria for employer and individual/family plans, authorization durations, reauthorization requirements, excluded uses, and applicable HCPCS code.

Policy Summary

PayerCigna

PolicyFaricimab (Vabysmo) intravitreal injection coverage

Policy CodePolicy IP0542

Change TypeDosing and preferred product criteria revisions

Effective DateFeb 1, 2025

Next Review Date

Key ActionRequests must meet medical necessity and preferred product documentation per employer or individual plans; prior authorization is required.

SourceLink

POLICY UPDATE CHANGES

Dosing wording updated to specify '6 mg administered by intravitreal injection for each eye being treated' and reiterate dosing interval not more frequent than once every 4 weeks for each eye for all indications.

Preferred Product Table criteria added requiring documentation of current Vabysmo use or one of failure/contraindication/intolerance to repackaged bevacizumab or prescriber safety concern about repackaged bevacizumab.

New exclusion criterion added: for DME, prescriber must document baseline ETDRS BCVA of 20/50 or worse (< 69 letters) when used as the basis for preferred product criteria.

Annual revision noted 'No criteria changes' on 02/15/2025.

3Covered Indications

12m / 6mInitial auth durations (DME/nAMD / RVO)

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Coverage Summary

Coverage stance: Covered with criteria for faricimab (Vabysmo) for Diabetic Macular Edema (DME), Macular Edema following Retinal Vein Occlusion (RVO), and Neovascular (wet) Age-Related Macular Degeneration (nAMD). Initial authorization durations are up to 12 months for DME and nAMD, and up to 6 months for RVO. Refer to the Genentech Vabysmo prescribing information (October 2023) and the policy medical necessity criteria for full details.

Initial Therapy Criteria (Medical Necessity)

Medical Necessity Criteria

Faricimab (Vabysmo) is considered medically necessary when ONE of the following is met:

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Employer Plans Preferred Product Criteria

Employer Plans Preferred Product Criteria (applies within Medical Necessity 'Preferred product criteria')

Documentation of ONE of the following is required:

ANY of the following

If not currently receiving Vabysmo, ONE of the following must be documented
- Currently receiving Vabysmo
- ANY of the following
  - ETDRS BCVA pathway: According to the prescriber, patient has diabetic macular edema and a baseline ETDRS BCVA of 20/50 or worse (< 69 ETDRS letters)
  - Bevacizumab failure/contraindication/intolerance: Documentation of failure, contraindication, or intolerance to repackaged bevacizumab
  - Prescriber safety concern: Prescriber professional opinion that the safety of using the repackaged bevacizumab or the supplier of the repackaged bevacizumab is of significant concern

Individual & Family Plans Preferred Product Criteria

Individual and Family Plans Preferred Product Criteria (applies within Medical Necessity 'Preferred product criteria')

Documentation of ONE of the following is required:

ANY of the following

If not currently receiving Vabysmo, ONE of the following must be documented
- Currently receiving Vabysmo
- ANY of the following
  - ETDRS BCVA pathway: According to the prescriber, patient has diabetic macular edema and a baseline ETDRS BCVA of 20/50 or worse (< 69 ETDRS letters)
  - Bevacizumab failure/contraindication/intolerance:

Continuation Therapy Criteria (Reauthorization)

Continuation and dosing thresholds: requested dosing must be 6 mg administered by intravitreal injection for each eye being treated, and the dosing interval must be not more frequent than once every 4 weeks (approximately every 28 ± 7 days). The ETDRS BCVA threshold used in preferred product criteria for DME is 20/50 or worse (< 69 ETDRS letters).

Provider Actions & Prior Authorization

Prior Authorization

Medical necessity review / prior authorization required

Requests for Vabysmo require medical necessity review and prior authorization. Submit requests referencing HCPCS code J2777 (Injection, faricimab‑svoa, 0.1 mg) as applicable.

Documentation Required

Prescriber documentation for preferred product criteria

Prescriber must document ONE of the following for preferred product criteria: currently receiving Vabysmo; OR for DME, baseline ETDRS BCVA of 20/50 or worse (< 69 ETDRS letters); OR documentation of failure, contraindication, or intolerance to repackaged bevacizumab; OR prescriber professional opinion that the safety of using the repackaged bevacizumab or its supplier is of significant concern.

Documentation Required

Documentation of beneficial response for reauthorization

Applicable Codes

Drug HCPCSHCPCSCovered

J2777

Injection, faricimab-svoa, 0.1 mg

Clinical Evidence & References

Prescribing information reference — Genentech Vabysmo prescribing information, October 2023. Dosing guidance per the prescribing information includes a 6 mg intravitreal injection per eye with recommended intervals specific to indication (see dosing regimens); for RVO the prescribing information recommends use for 6 months.

Background

Background: Vabysmo (faricimab-svoa) is a VEGF and angiopoietin-2 (Ang-2) inhibitor indicated for DME, RVO-related macular edema, and nAMD. Dosing regimens vary by indication and include initial loading doses with possible extension intervals based on clinical evaluation (for example, DME regimens include initial every-4-week dosing for a series of doses then extension increments; nAMD may be extended up to every 16 weeks depending on clinical response). For RVO, prescribing information recommends use for 6 months.

Key Thresholds

ETDRS BCVA threshold for DME20/50 or worse (< 69 ETDRS letters)

Dose per injection6 mg administered by intravitreal injection for each eye being treated

Minimum dosing intervalNot more frequent than once every 4 weeks (approximately every 28 ± 7 days)

Definitions

Definitions: ETDRS BCVA — Early Treatment Diabetic Retinopathy Study best-corrected visual acuity, measured in letters; the policy uses a threshold of < 69 letters (20/50 or worse).

Revision History

2024-12-01material_change

Dosing wording updated to explicitly require two items: 1) 6 mg administered by intravitreal injection for each eye being treated; and 2) dosing interval not more frequent than once every 4 weeks for each eye being treated (applied to all indications).

2024-12-01material_change

Preferred Product Table criteria added for both employer plans and individual & family plans requiring documentation of either current Vabysmo use or ONE of: failure/contraindication/intolerance to repackaged bevacizumab, or prescriber concern about safety/supplier of repackaged bevacizumab.

2024-12-01