CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Beovu (brolucizumab)

Defines medical-benefit coverage, prior authorization criteria, dosing, durations, and billing codes for Beovu (brolucizumab) for Medicaid, Commercial, and Medicare-Medicaid Plan (MMP) members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBeovu (brolucizumab)

Policy CodePolicy N/A

Change TypeClarified review dates and references

Effective DateJan 1, 2020

Next Review Date

Key ActionCoverage will be reviewed prospectively via the authorization process and requests must meet all listed criteria; use outside guidelines may result in non-payment unless approved under an exception process.

POLICY UPDATE CHANGES

Review dates updated through 02/26/2025 and reference to 2024 Beovu package insert added.

2Covered Indications

6Initial coverage (months)

12Renewal coverage (months)

1HCPCS codes listed

Coverage Summary

Coverage stance: covered_with_criteria for Beovu (brolucizumab). Scope: applies to Medicaid, Commercial, and Medicare-Medicaid Plan (MMP) members as the medical-benefit policy for Beovu. Covered indications (high-level): neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). Important safety concerns noted in the background and evidence include intraocular inflammation and retinal vascular occlusion, which are considered when applying coverage criteria and monitoring requirements.

Thresholds & Key Dosing/Duration

Age>= 18 years

MMP prior receipt exemption window<= 365 days

AMD dosing interval guidance3 monthly loading doses, then maintenance every 8-12 weeks; may decrease from 12 to 8 weeks if disease activity at/after week 16

DME initial dosingEvery 6 weeks for five doses, then every 8 weeks; some patients may use every 12 weeks (maintenance 56-84 days)

Initial coverage duration6 months

Renewal coverage duration12 months

HCPCS (billable units)J0179 = brolucizumab 1 mg; 1 billable unit = 1 mg

Initial Therapy Criteria

Initial Therapy

Covered when ALL of the following are met:

ALL of the following

Patient is at least 18 years of age or olderAge >= 18 years
Prescribed by or in consultation with a Retina Specialist
Patient does not have active intraocular inflammation
Patient is free of ocular and peri-ocular infections
Concomitant anti-VEGF exclusion: Therapy will not be used with other ophthalmic VEGF inhibitors (e.g., aflibercept, bevacizumab, pegaptanib, faricimab, ranibizumab, ranibizumab via ocular implant, etc.)
Concomitant use with other ophthalmic VEGF inhibitors is not allowed
Must have a definitive diagnosis of Neovascular (wet) age related macular degeneration (AMD) or Diabetic Macular Edema (DME)
BCVA documentation: Patient's best corrected visual acuity (BCVA) is measured at baseline and periodically during treatment
BCVA must be documented baseline and during therapy
AMD indication alternative
- For patients with AMD, the patient must have an inadequate treatment response, intolerance or contraindication to treatment with bevacizumab or ranibizumab (Byooviz)
DME indication alternatives
- For patients with DME and baseline visual acuity better than 20/50, the patient must have an inadequate treatment response with bevacizumabBaseline VA better than 20/50
- For patients with DME and baseline visual acuity of 20/50 or worse, must have an inadequate treatment response, intolerance or contraindication to treatment with bevacizumab or ranibizumab (Lucentis)Baseline VA 20/50 or worse
MMP exemption: MMP members who have previously received this medication within the past 365 days are not subject to Therapy Requirements StepPrior receipt within 365 days
Prior receipt within 365 days exempts from therapy step for MMP members

Continuation of Therapy Criteria

Continuation of Therapy

Covered when ALL of the following are met:

ALL of the following

Patient meets all initial criteria
Patient is tolerating treatment with absence of unacceptable toxicity
Examples of unacceptable toxicity: endophthalmitis, retinal detachments, increase in intraocular pressure, arterial thromboembolic events
Patient has had a beneficial response (e.g., improvement in baseline BCVA) and continued administration is necessary for maintenance of the condition

Continuation coverage is linked to monitoring: baseline and periodic measurement of best corrected visual acuity (BCVA) must be documented and used to assess response and need for ongoing therapy. Continuation requires the patient to be tolerating treatment without unacceptable toxicity; examples of unacceptable toxicity include endophthalmitis, retinal detachments, increased intraocular pressure, and arterial thromboembolic events.

Provider Actions & Billing

Prior Authorization

Authorization required

Coverage will be reviewed prospectively via the authorization process and requests must meet all listed criteria. Use outside these guidelines may result in non-payment unless approved through an exception process.

Affected code: J0179
Use outside guidelines may be considered under an exception process; non-payment possible if not approved

Documentation Required

Documentation of BCVA and diagnosis

Providers must document baseline and periodic best corrected visual acuity (BCVA) measurements, a definitive diagnosis of nAMD or DME, and — where applicable — evidence of inadequate response, intolerance, or contraindication to required prior anti-VEGF agents.

Denial Risk

Concomitant anti-VEGF therapy exclusion

Claims may be denied if Beovu is used concomitantly with other ophthalmic VEGF inhibitors; therapy must not be used with other ophthalmic VEGF agents.

Affected code: J0179

Billing Rule

Billing units

HCPCS J0179 represents injection of brolucizumab 1 mg. The policy defines 1 billable unit = 1 mg and provides unit-based dosing guidance for initial and maintenance regimens.

Affected code: J0179

Clinical Evidence

HAWK & HARRIERKey trials demonstrating efficacy vs aflibercept

Label: Beovu PI July 2024Prescribing information reference (accessed Feb 2025)

Evidence summary: Pivotal phase 3 trials HAWK and HARRIER demonstrated efficacy of brolucizumab in nAMD with visual-acuity benefits compared with aflibercept. Safety signals identified in the evidence and label include intraocular inflammation and retinal vascular occlusion; the Beovu package insert (Novartis, July 2024) is cited as the label reference for these findings.

Background

Background/indication: Beovu (brolucizumab) is indicated for neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). It is an ophthalmic anti-VEGF agent used to improve visual outcomes and reduce disease activity in these conditions. Important adverse events highlighted in the policy and brief include intraocular inflammation and retinal vascular occlusion, which inform the coverage criteria and monitoring recommendations.

Definitions

BCVABest corrected visual acuity

nAMDNeovascular (wet) age-related macular degeneration

DMEDiabetic macular edema