CurrentViva HealthPolicy IC-0659

Vabysmo (faricimab-svoa) (Intravitreal)

Prior authorization and medical necessity criteria for intravitreal Vabysmo (faricimab-svoa) for retinal conditions (nAMD, DME, RVO) for Viva Health members aged ≥18.

Policy Summary

PayerViva Health

PolicyVabysmo (faricimab-svoa) (Intravitreal) - coverage with criteria

Policy CodePolicy IC-0659

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization; member must have trialed and failed (or have contraindication/intolerance to) bevacizumab and be ≥18 years old.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsinitial prior authorization validity

J2777HCPCS code

6 mgper-dose strength

18+minimum age

~70+ICD-10 codes listed

Coverage and Medical Necessity Criteria

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inv-01: Initial Approval — Covered when ALL of the following are met:

Covered when ALL of the following are met:

Initial approval main requirements: 1) Patient has a documented contraindication, intolerance, or prior therapeutic failure to a bevacizumab product prior to consideration of another ophthalmic VEGF‑inhibitor; AND 2) Member is at least 18 years of age; AND 3) Member is free of ocular and/or periocular infections; AND 4) There is no active intraocular inflammation; AND 5) Therapy will not be used concomitantly with other ophthalmic VEGF inhibitors; AND 6) Best corrected visual acuity (BCVA) is measured at baseline and periodically during treatment; AND 7) Member has a definitive diagnosis of neovascular (wet) age‑related macular degeneration (nAMD), diabetic macular edema (DME), or macular edema following retinal vein occlusion (RVO).

Use of alternating VEGF inhibitors is generally not permitted and is reviewed case‑by‑case.

inv-02: Renewal Criteria — Renewal when ALL of the following are met:

Renewal when ALL of the following are met:

Renewal requirements: 1) Member continues to meet the universal and indication‑specific criteria identified for initial approval; AND 2) Absence of unacceptable toxicity from the drug (examples include endophthalmitis, retinal detachment, increase in intraocular pressure, arterial thromboembolic events, retinal vasculitis and/or retinal vascular occlusion); AND 3) Member has had a beneficial response to therapy (e.g., improvement from baseline BCVA or clinically meaningful stabilization) and continued administration is necessary for maintenance treatment of the condition.

Document ongoing benefit and absence of unacceptable toxicity for renewal requests.

inv-03: Dosage/Administration Criteria — Coverage aligned with indicated dosing schedules:

Coverage aligned with indicated dosing schedules:

nAMD dosing: Initiation: 6 mg intravitreally per affected eye once every 4 weeks (approximately every 28 days ±7 days) for the first four doses (16 weeks). Maintenance: assess with OCT and visual acuity at weeks 8 and 12 after the initial four doses and continue 6 mg at extended intervals per one of the regimens (every 16 weeks or every 12 weeks) with the option to increase frequency stepwise if loss of response occurs.6 mg per dose

120 HCPCS units = 6 mg per dose; some patients may require monthly dosing after the first four doses.

DME dosing: Option A: Administer 6 mg intravitreally per affected eye once every 4 weeks (approximately every 28 days ±7 days) for at least four doses; then extend dosing by up to 4‑week increments (or reduce interval up to 8 weeks) based on CST by OCT and visual acuity assessments. OR Option B: Administer 6 mg once every 4 weeks for the first six doses followed by 6 mg every 8 weeks for maintenance. Stepwise adjustments permitted for loss of response.6 mg per dose

Assessments should use OCT central subfield thickness (CST) and BCVA.

inv-04: Covered Diagnoses — Covered diagnosis codes (use these ICD-10 codes to support medical necessity for intravitreal therapies):

Covered diagnosis codes (use these ICD-10 codes to support medical necessity for intravitreal therapies):

ICD-10 match: The submitted diagnosis for claim submission must be one of the ICD‑10 codes listed in Appendix 1 (examples include diabetic retinopathy with macular edema codes in the E09/E10/E11/E13 series, retinal vein occlusion codes H34.81x–H34.83x with macular edema, and exudative AMD codes H35.321x–H35.329x).

See Appendix 1 (chunks 18–25) for the complete list of covered ICD‑10 codes.

Concomitant intravitreal administration of Vabysmo with other ophthalmic vascular endothelial growth factor (VEGF) inhibitors is generally not permitted. Alternating or combined VEGF‑inhibitor regimens may be considered only on a case‑by‑case basis with clinical justification and supporting documentation demonstrating medical necessity and safety.

Medicare beneficiaries may be subject to additional coverage rules. Applicable Medicare National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) — and the Medicare Benefit Policy Manual Chapter 15 §50 — can impose exclusions or conditions for Medicare Part B drug claims; providers must follow those CMS documents where applicable.

Vabysmo is not covered unless the member has had a documented trial with a bevacizumab product that resulted in contraindication, intolerance, or treatment failure, unless there is clear documentation explaining why a bevacizumab trial was not appropriate. Additionally, members must be at least 18 years of age and be free of ocular or periocular infection and active intraocular inflammation; use in patients under 18 or in the presence of active ocular infection/inflammation does not meet medical necessity.

Billing Codes and Diagnosis Lists

HCPCSHCPCSCovered

J2777

Injection, faricimab-svoa, 0.1 mg; 1 billable unit = 0.1 mg

NDCNDC

50242-0096-xx

Vabysmo 6 mg/0.05 mL single-dose vial or prefilled syringe NDC (partial)

Covered ICD-10 Diagnosis Codes (examples from list)ICD-10Covered

E08.311	Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema
E08.3211	Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, right eye
E09.3213	Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral
E10.311	Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema

Covered ICD-10 Codes (partial list shown)ICD-10Covered

E09.3219	Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye.
E09.3311	Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye.
E09.3312	Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye.
E09.3313	Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral.
E09.3319	Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye.
E09.3411	Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye.
E09.3412	Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye.
E09.3413	Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral.
E09.3419	Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye.
E09.3511	Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye.

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Covered ICD-10 Codes (Retinal vein occlusion, AMD)ICD-10Covered

H34.8110	Central retinal vein occlusion, right eye, with macular edema.
H34.8120	Central retinal vein occlusion, left eye, with macular edema.
H34.8130	Central retinal vein occlusion, bilateral, with macular edema.
H34.8190	Central retinal vein occlusion, unspecified eye, with macular edema.
H34.8310	Tributary (branch) retinal vein occlusion, right eye, with macular edema.
H34.8320	Tributary (branch) retinal vein occlusion, left eye, with macular edema.
H34.8330	Tributary (branch) retinal vein occlusion, bilateral, with macular edema.
H34.8390	Tributary (branch) retinal vein occlusion, unspecified eye, with macular edema.
H35.3210	Exudative age-related macular degeneration, right eye, stage unspecified.
H35.3211	Exudative age-related macular degeneration, right eye, with active choroidal neovascularization.

1–10 of 24

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Covered ICD-10 Codes (Other specified diabetes)ICD-10Covered

E13.311	Other specified diabetes mellitus with unspecified diabetic retinopathy with macular edema.
E13.3211	Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye.
E13.3212	Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye.
E13.3213	Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral.
E13.3219	Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye.
E13.3311	Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye.
E13.3312	Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye.
E13.3313	Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral.
E13.3319	Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye.
E13.3411	Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye.

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HCPCS unit conversion and per-dose amount

HCPCS unit conversion120 billable units = 6 mg per intravitreal dose (document lists 120 units every ~28 days for initial and maintenance schedules)

Units per 0.1 mg HCPCS code (J2777)J2777 describes 0.1 mg per billable unit; 6 mg dose equals 60 units of 0.1 mg OR billed per document as 120 units per dosing interval per plan-specific MU

Billing frequency mappingPolicy specifies 120 billable units every ~28 days for initial and maintenance dosing across indications (see dosing schedules)

Reference to CMS documents

Primary CMS referenceMedicare Benefit Policy Manual (Pub. 100-02), Chapter 15, §50 — Drugs and Biologicals

Local/contractor determinationsApplicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may apply and must be followed where relevant

Search resourceCMS Coverage Database: https://www.cms.gov/medicare-coverage-database/search.aspx

Prior Authorization, Documentation & Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required and, when approved, is valid for 12 months initially and renewable every 12 months.

Initial authorization: 12 months (365 days).
Renewal: may be renewed every 12 months (365 days).

Billing Rule

Diagnosis Code Requirement

Diagnosis for claim submission should match one of the ICD-10 codes listed in Appendix 1.

Step Therapy

Bevacizumab Trial Required

A trial and documented failure, intolerance, or contraindication to a bevacizumab product is required prior to consideration of alternative ophthalmic VEGF‑inhibitor therapy.

Document prior bevacizumab product trial, reason for discontinuation (failure, intolerance, or contraindication).

Documentation Required

Required Documentation

Document baseline and periodic best corrected visual acuity (BCVA), definitive diagnosis consistent with the covered indications, prior therapy details (including bevacizumab trial and outcome), absence of active ocular/periocular infection or intraocular inflammation, and any adverse events or toxicity.

Baseline and periodic BCVA measurements.
Definitive diagnosis consistent with Appendix 1 codes.
Details of prior therapies and reasons for discontinuation.
Documentation of absence of active ocular/periocular infection or intraocular inflammation.
Records of adverse events (e.g., endophthalmitis, retinal detachment, increased intraocular pressure, retinal vasculitis/vascular occlusion).

Denial Risk

Triggers for Denial

Denial risks include failure to document prior unsuccessful use/intolerance/contraindication to bevacizumab; patient under 18 years of age; presence of active ocular or periocular infection, active intraocular inflammation, or use concomitantly with other ophthalmic VEGF inhibitors; lack of documentation of benefit or unacceptable toxicity.

No documented bevacizumab trial or reason for not using bevacizumab.
Member age < 18 years.
Active ocular/periocular infection or active intraocular inflammation.
Concomitant use with other ophthalmic VEGF inhibitors.
Lack of documentation of clinical benefit or presence of unacceptable toxicity.

Note

Medicare Coverage Alignment & CMS Guidance

Claims and coverage for Medicare Part B (outpatient drugs) are governed by the Medicare Benefit Policy Manual, Chapter 15 §50, and by applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs) and Local Coverage Articles (LCAs). Where Medicare rules apply, comply with the relevant NCD/LCD/LCA; local contractor guidance may affect coverage and claims payment.

Comply with applicable NCDs, LCDs, and LCAs for Medicare Part B drug coverage determinations.
Local contractor guidance (e.g., National Government Services, A52451) may apply for Medicare claims payment.

Key Terms and Abbreviations

best corrected visual acuity (BCVA)

DefinitionBest corrected visual acuity (BCVA) — visual acuity measured with the patient’s optimal refractive correction, documented at baseline and periodically to assess response to intravitreal therapy

Purpose in policyUsed to determine treatment response and to support renewal (document baseline and periodic BCVA)

Assessment timingBCVA should be measured at baseline and at follow-up visits aligned with dosing and OCT evaluations (per dosing schedule)

central subfield thickness (CST) measured by OCT

DefinitionCentral subfield thickness (CST) — the central macular thickness measured by optical coherence tomography (OCT) used to evaluate resolution of macular edema and guide dosing interval extensions or adjustments

Role in dosing decisionsCST improvement on OCT is used to determine eligibility to extend dosing intervals (e.g., after ≥4 doses in DME) or adjust frequency based on edema resolution

Measurement timingAssess CST by OCT at baseline and during follow-up OCT evaluations referenced in maintenance dosing assessments

H35.321x-H35.329x series — Exudative age-related macular degeneration (wet AMD)

Code seriesH35.321x–H35.329x — Exudative age-related macular degeneration (wet AMD) codes covering right, left, bilateral, and unspecified eye and stages (active/inactive CNV, scar)

Examples includedH35.3211 (right eye with active CNV), H35.3221 (left eye with active CNV), H35.3231 (bilateral with active CNV), H35.3291 (unspecified eye with active CNV)

Use in claimsThese codes are listed in Appendix 1 as acceptable diagnoses to support medical necessity for intravitreal therapy for exudative AMD

E09.x, E10.x, E11.x, E13.x series — Diabetic retinopathy with macular edema codes

Code seriesE09.x, E10.x, E11.x, E13.x series — Diabetic mellitus codes with diabetic retinopathy and macular edema across drug-induced, type 1, type 2, and other specified diabetes

Examples includedE10.311 (Type 1 with unspecified retinopathy with macular edema), E11.3213 (Type 2 mild NPDR with macular edema, bilateral), E13.3511 (Other specified diabetes with proliferative DR and macular edema, right eye)

Use in claimsThese ICD-10 codes appear in Appendix 1 and must be used as the diagnosis on claim submissions to support medical necessity for DME indications

OpenPayer

Vabysmo (faricimab-svoa) (Intravitreal)

Coverage and Medical Necessity Criteria

Billing Codes and Diagnosis Lists

Prior Authorization, Documentation & Billing Guidance

Clinical Background

Key Terms and Abbreviations

Policy Revision Timeline