Medical Drug Criteria (MDC)

MDC Num:       P01.001.002
MDC Name:     Beovu
MDC ID:          [P01.001.002] [Ac / L / M / P ] [0.00.00]


Last Review:       July 8, 2022
Next Review:      July 8, 2023
Issue:                   7: 2022

Related MDC: None

Beovu

Popultation Reference No. Populations
1 Individuals:
  • 18 years of age or older

Summary

BEOVU is a prescription medicine used to treat Neovascular (Wet) Age-Related Macular Degeneration (AMD) and Diabetic Macular Edema (DME). Beovu is a recombinant human vascular endothelial growth factor inhibitor. 

Policy Statements

BEOVU is covered under the Medical Benefit when used within the following guidelines. Use outside of these guidelines may result in non-payment unless approved under an exception process.

Policy Guidelines

1.    Coverage of Beovu is available when the following criteria have been met:

a.    Member is at least 18 years of age AND 
b.    Diagnosis of: 
           Neovascular (Wet) Age-related Macular Degeneration (AMD) OR
           Diabetes Macular Edema (DME) 
c.    Diagnosis is made and drug is administered by an ophthalmologist specialist
 

DOSAGE/ADMINISTRATION

Neovascular (Wet) Age-related Macular Degeneration (AMD) 
•    Initial, 6 mg injected intravitreally once monthly (approximately every 25 to 31 days) for 3 doses.
•    Maintenance, 6 mg intravitreally once every 8 to 12 weeks 

Diabetic Macular Edema 
•    Initial, 6 mg every six weeks (approximately every 39-45 days) for the first 5 doses
•    Maintenance, 6 mg every 8-12 weeks
 

REQUIRED MEDICAL INFORMATION

Initial Approval Criteria

a.    Patient is free of ocular and/or peri-ocular infections; AND


b.    Patient does not have active intraocular inflammation; AND


c.    Therapy will not be used with other ophthalmic VEGF inhibitors (i.e., aflibercept, ranibizumab, pegaptanib, bevacizumab, etc.); AND


d.    Patient’s best corrected visual acuity (BCVA) is measured at baseline and periodically during treatment, AND


e.    Patient has a definitive diagnosis of the following:


a.    Neovascular (Wet) Age-Related Macular Degeneration (AMD)
b.    Diabetic Macular Edema (DME)  

Renewal Approval Criteria

a.    Patient continues to meet the universal and indication-specific relevant criteria as identified in section III; AND


b.    Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: endophthalmitis and retinal detachment, increase in intraocular pressure, arterial thromboembolic events, retinal vasculitis and/or retinal vascular occlusion; AND


c.    Patient has had a beneficial response to therapy (e.g., improvement in the baseline best corrected visual acuity (BCVA), etc.) and continued administration is necessary for the maintenance treatment of the condition.

EXCLUSION CRITERIA

a.    Ocular or periocular infections.
b.    Active intraocular inflammation. 
 

BENEFIT APPLICATION

BlueCard/National Account Issues: None

 OTHER CRITERIA

•    Validate product prescribing information for dosage information. 

Population Reference No. 1 Policy Statement [ x ] MedicallyNecessary [ ] Investigational [ ] Not Medically Necessary

References

1.    Brolucizumab-dbll. In: DRUGDEX [database on the Internet]. Greenwood Village (CO): IBM Corporation; 2022 [cited 2022 Jun 14]. Available from: www.micromedexsolutions.com. Subscription required to view.
2.    BEOVU [prescribing information] East Hanover, NJ. Novartis: 2019.
 

Codes

Codes Number Description
HCPCS J0179 Injection, brolucizumab-dbll, 1 mg
ICD-10 CM H35.3210 – H35.3293  Exudative age-related macular degeneration

Applicable Modifiers

N/A

Policy History

Date Action Description
7/08/2022 MDC Created New MDC