Viva Health Beovu prior auth Coverage

Coverage Criteria for Beovu (brolucizumab-dbll)

Initial Therapy

Covered when ALL of the following are met:

Initial authorization

Universal criteria: Patient is free of ocular and/or periocular infections; AND patient does not have active intraocular inflammation; AND therapy will not be used concomitantly with other ophthalmic VEGF inhibitors; AND patient's best corrected visual acuity (BCVA) is measured at baseline and periodically during treatment; AND patient has a definitive diagnosis of neovascular (wet) age-related macular degeneration (nAMD) or diabetic macular edema (DME).
Universal Criteria 1

Continuation/Renewal

Renewal authorization requires ALL of the following:

Renewal: Patient continues to meet the universal and indication-specific relevant criteria; AND absence of unacceptable toxicity from the drug (examples: endophthalmitis, retinal detachment, increased intraocular pressure, arterial thromboembolic events, retinal vasculitis and/or retinal vascular occlusion); AND continued administration is necessary for maintenance treatment of the condition.

Renewal Criteria

nAMD disease activity allowing interval change: After receiving all 3 loading doses, evidence of disease activity at or beyond treatment-week 16 demonstrated by any of the following: decrease in BCVA of ≥5 letters compared to baseline; OR decrease in BCVA of ≥3 letters plus central subfield thickness (CST) increase ≥75 µm compared with week 12; OR decrease in BCVA of ≥5 letters due to neovascular AMD disease activity compared with week 12; OR new or worsening intraretinal cysts or fluid compared with week 12.

nAMD criteria for decreasing maintenance interval

DME disease activity allowing interval change: After receiving all 5 loading doses, evidence of disease activity at or beyond treatment-week 28 demonstrated by both: decrease in BCVA of ≥5 letters compared to baseline AND increase in central subfield thickness compared to baseline.

DME criteria for decreasing maintenance interval

Coverage by diagnosis code

Covered when diagnosis aligns with one of the listed ICD-10 codes in Appendix 1:

Diagnosis match: Member has a documented diagnosis that exactly matches one of the ICD-10 codes listed in Appendix 1 (diabetic retinopathy with macular edema [E08–E13 series examples] or exudative age-related macular degeneration [H35.321–H35.329 series examples]).N/A

Partial code lists are present in this excerpt; full list appears in Appendix 1 of the complete policy.

Use of Beovu in combination with other ophthalmic vascular endothelial growth factor (VEGF) inhibitors is generally not permitted. The policy specifically states that therapy will not be used concomitantly with other ophthalmic VEGF inhibitors, and further clarifies that using Beovu as part of an alternating regimen with other ophthalmic VEGF agents is generally not permitted and will be reviewed on a case‑by‑case basis.

For Medicare members, National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and related Local Coverage Articles may impose additional exclusions or requirements that supersede or supplement this policy. Providers must confirm and follow applicable Medicare contractor policies and the Medicare Benefit Policy Manual (Part B) when treating Medicare beneficiaries.

Requests will not meet criteria when the patient does not have a definitive diagnosis of neovascular (wet) age‑related macular degeneration (nAMD) or diabetic macular edema (DME), or when the universal criteria are not satisfied. Universal criteria include absence of ocular/periocular infection, no active intraocular inflammation, documented baseline and periodic best corrected visual acuity (BCVA), and confirmation of an eligible diagnosis.

This excerpt does not include the full list of statements that would be labeled explicitly as “not medically necessary.” Refer to the complete policy for the full not medically necessary criteria and examples; Medicare‑specific guidance in Appendix 2 may also affect determinations for Medicare members.

Billing and Diagnosis Codes

Covered HCPCS CodesHCPCSCovered

J0179

Injection, brolucizumab-dbll, 1 mg; 1 billable unit = 1 mg

NDCsNDC

00078-0827-xx

Beovu 6 mg/0.05 mL single-dose vial kit with injection components / Beovu 6 mg/0.05 mL single-dose pre-filled syringe

Covered ICD-10 Diagnosis Codes (examples; full list continued in document)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

Covered ICD-10 Codes - Diabetic retinopathy with macular edema (partial list)ICD-10Covered

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.
E09.3512	Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye.
E09.3513	Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral.
E09.3519	Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye.
E10.311	Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema.
E10.3211	Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye.
E10.3212	Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye.
E10.3213	Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral.
E10.3219	Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye.

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Covered ICD-10 Codes - Type 2 diabetic retinopathy with macular edema (partial list)ICD-10Covered

E11.311	Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema.
E11.3211	Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye.
E11.3212	Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye.
E11.3213	Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral.
E11.3219	Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye.
E11.3311	Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye.
E11.3312	Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye.
E11.3313	Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral.
E11.3319	Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye.

Covered ICD-10 Codes - Other specified diabetes with retinopathy (partial list)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.

Covered ICD-10 Codes - Exudative (wet) age-related macular degenerationICD-10Covered

H35.3210	Exudative age-related macular degeneration, right eye, stage unspecified.
H35.3211	Exudative age-related macular degeneration, right eye, with active choroidal neovascularization.
H35.3212	Exudative age-related macular degeneration, right eye, with inactive choroidal neovascularization.
H35.3213	Exudative age-related macular degeneration, right eye, with inactive scar.
H35.3220	Exudative age-related macular degeneration, left eye, stage unspecified.
H35.3221	Exudative age-related macular degeneration, left eye, with active choroidal neovascularization.
H35.3222	Exudative age-related macular degeneration, left eye, with inactive choroidal neovascularization.
H35.3223	Exudative age-related macular degeneration, left eye, with inactive scar.
H35.3230	Exudative age-related macular degeneration, bilateral, stage unspecified.
H35.3231	Exudative age-related macular degeneration, bilateral, with active choroidal neovascularization.

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BCVA letter change and CST — examples of activity thresholds used in policy

nAMD disease-activity thresholdsDecrease in BCVA ≥5 letters vs baseline OR decrease in BCVA ≥3 letters plus CST increase ≥75 µm vs week 12 OR decrease in BCVA ≥5 letters due to nAMD vs week 12 OR new/worsening intraretinal cysts or fluid vs week 12 (after 3 loading doses, assessed at/after week 16)

DME disease-activity thresholdsDecrease in BCVA ≥5 letters vs baseline AND increase in central subfield thickness vs baseline (after 5 loading doses, assessed at/after week 28)

Purpose of thresholdsUsed to determine need for decreasing maintenance interval from 12 weeks to 8 weeks when disease activity is documented

Provider Responsibilities, Documentation, and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approval is provided for 12 months and may be renewed every 12 months if renewal criteria are met.

Initial approval duration: 12 months
Renewal: May be renewed every 12 months when renewal criteria are satisfied

Note

Check Medicare NCD/LCD Applicability

Medicare National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may supersede or apply. Providers should verify applicable Medicare contractor policies for Medicare members and follow Medicare Benefit Policy Manual Chapter 15 §50 where relevant.

Search NCD/LCD/LCA documents: https://www.cms.gov/medicare-coveragedatabase/search.aspx
Medicare Part B coverage rules and contractor LCDs may affect coverage and claims payment

Background

Beovu (brolucizumab‑dbll) is an intravitreal vascular endothelial growth factor (VEGF) inhibitor approved for treatment of neovascular (wet) age‑related macular degeneration (nAMD) and diabetic macular edema (DME). It is administered as a 6 mg intravitreal injection per affected eye with specified loading and maintenance schedules; baseline and periodic measurement of best corrected visual acuity (BCVA) is required during treatment.

Key Definitions

BCVA — Best corrected visual acuity; measurement requirements.

DefinitionBest corrected visual acuity (BCVA); must be measured at baseline and periodically during treatment

Use in criteriaBCVA change is used to assess response and disease activity for both nAMD and DME (see specific letter-change thresholds)

Documentation requirementBaseline and periodic BCVA measurements must be recorded in the clinical documentation supporting authorization

Billable unit — HCPCS J0179: 1 billable unit = 1 mg of brolucizumab-dbll.

HCPCS codeJ0179 - Injection, brolucizumab-dbll, 1 mg

Billable unit definition1 billable unit = 1 mg of brolucizumab-dbll

OpenPayer

Beovu (brolucizumab-dbll) (Intravitreal) — Prior authorization coverage criteria

Coverage Criteria for Beovu (brolucizumab-dbll)

Billing and Diagnosis Codes

Provider Responsibilities, Documentation, and Authorization

Background

Key Definitions