Beovu (Brolucizumab) - CAM 919

Description

Brolucizumab (Beovu®) is a humanized monoclonal single-chain variable fragment (scFv) that binds and inhibits vascular endothelial growth factor A (VEGF-A) a key mediator in the pathogenesis of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). VEGF is a signal protein that promotes the growth of new blood vessels from pre-existing vessels. By targeting VEGF-A, Beovu reduces abnormal blood vessel growth and vascular permeability in the retina.

Beovu is classified as a second-generation anti-VEGF agent, offering a higher molar dose per injection compared to earlier agents. This allows for potentially longer dosing intervals and greater reductions in central retinal thickness (CRT), particularly in patients with persistent fluid despite prior anti-VEGF therapy.

Of note, Beovu has been associated with a higher incidence of intraocular inflammation (IOI), retinal vasculitis, and retinal artery occlusion (RAO) compared to other agents such as aflibercept and ranibizumab. These risks, while rare, are clinically significant and warrant careful patient selection and monitoring. Use is cautioned in individuals with a history of IOI or vasculitis.

Policy

Coverage is provided when the criteria below are met. For nonpreferred products, there must be documentation of trial and failure of TWO preferred therapies. 

Exceptions to the preferred therapy requirement include:

  • Pregnancy or breastfeeding
  • Age 17 years or younger
  • Prior unsuccessful attempt to switch agents due to lack of efficacy or adverse event(s) and
  • Uncontrolled disease despite treatment

Preferred medications include: Byooviz, Cimerli, Lucentis, and Vabysmo.

Initial Criteria:

  • Member has one of the following diagnoses:
    • Neovascular (wet) age-related macular degeneration (nAMD)
    • Diabetic macular edema (DME)
  • Prescribed by or in consultation with an ophthalmologist
  •  No evidence of ocular or periocular infection
  •  No evidence of active intraocular inflammation
  • Therapy will not be used with other ophthalmic VEGF inhibitors (i.e., aflibercept, bevacizumab, pegaptanib, faricimab, ranibizumab, ranibizumab via ocular implant etc.)

Initial Authorization Duration: 6 months

 

Reauthorization Criteria:

  • Documentation of a positive clinical response to therapy, demonstrated by at least one of the following:
    • Improvement in best corrected visual acuity (BCVA) compared to baseline
    • Stabilization of BCVA with no further decline
    • Reduction or resolution of intraretinal or subretinal fluid on optical coherence tomography (OCT)
    • Decrease in central subfield thickness (CST) on OCT
  • Absence of new or worsening intraocular inflammation or other adverse events related to treatment

Reauthorization Duration: 12 months

References

  1. U.S. Food and Drug Administration. Drug Trials Snapshots: BEOVU (brolucizumab-dbll). FDA. Updated 2025. Accessed July 11, 2025. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-beovu
  2. Dugel PU, Jaffe GJ, Sallstig P, et al. Brolucizumab versus aflibercept in participants with neovascular age-related macular degeneration: a randomized trial. Ophthalmology. 2017;124:1296e1304.. Accessed July 11, 2025.
  3. Novartis Pharmaceuticals. Beovu (brolucizumab-dbll) Injection, for Intravitreal Use: Prescribing Information. Revised December 2022. Accessed July 11, 2025. https://www.accessdata.fda.gov
  4. Solomon SD, Chew E, Duh EJ, et al. Diabetic Retinopathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Mar; 40(3):412-418. 5.
  5. American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Panel, Hoskins Center for Quality Eye Care. Diabetic Retinopathy PPP – Accessed July 11, 2025.
  6. American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Panel, Hoskins Center for Quality Eye Care. Retinal Vein Occlusions PPP – Accessed July 11, 2025.
  7. American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Panel, Hoskins Center for Quality Eye Care. Age-Related Macular Degeneration PPP. Accessed July 11, 2025.

Coding Section

Code

Number

Description

HCPCS

J0179

Injection, brolucizumab-dbll, 1mg

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

History From 2024 Forward

07/17/2025 Annual review, updated policy verbiage in description and policy sections, updated reference list.

07/01/2024

New Policy

 

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