BEOVU (PDF) - OpenPayer

Coverage Summary

Brolucizumab-dbll (Beovu) is a VEGF inhibitor indicated for neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). The policy covers Beovu with criteria (covered_with_criteria) defining medical necessity for these FDA‑approved indications across Centene-affiliated lines of business. Dosing follows a loading phase then maintenance: 6 mg (1 vial or pre-filled syringe) every 4 weeks for the first 3 doses for nAMD, and 6 mg every 6 weeks for the first 5 doses for DME, then 6 mg every 8 to 12 weeks as maintenance. Product is available as a 6 mg single‑dose vial and a 6 mg pre-filled syringe. The policy purpose is to provide medical necessity criteria, initial and continued approval rules, dosing limits, exclusions, and coding guidance for brolucizumab-dbll (Beovu).

Initial Therapy Criteria (Ophthalmic Disease)

I. Initial Approval Criteria - Ophthalmic Disease

Covered when ALL of the following are met:

ALL of the following

ONE of
- nAMD
- DME
Prescribed by or in consultation with an ophthalmologist
Age ≥ 18 years≥ 18 years
Failure of bevacizumab intravitreal solution, unless contraindicated or clinically significant adverse effects are experienced
Prior authorization may be required for bevacizumab intravitreal solution; requests for IV formulations of Avastin, Mvasi, and Zirabev will not be approved
ONE of
- nAMD dosing limit: 6 mg (1 vial) every 4 weeks for the first 3 doses, then every 8 to 12 weeks thereafter6 mg (1 vial) every 4 weeks x3 then q8-12w
- DME dosing limit: 6 mg (1 vial) every 6 weeks for the first 5 doses, then every 8 to 12 weeks thereafter6 mg (1 vial) every 6 weeks x5 then q8-12w

Initial Therapy Criteria (Other Diagnoses/Indications)

I. Initial Approval Criteria - Other diagnoses/indications

If not covered above, meet ONE of the following:

ANY of the following

If drug label changed within the last 6 months and change not reflected in policy, follow relevant formulary/no-coverage or non-formulary policy per line of business (references provided: CP.CPA.190; HIM.PA.33; CP.PMN.255; HIM.PA.103; CP.PMN.16)
If requested use is not listed under section III and criterion 1 above does not apply, refer to off-label use policy per line of business (CP.CPA.09; HIM.PA.154; CP.PMN.53)

Continuation Therapy Criteria (Ophthalmic Disease)

II. Continued Therapy - Ophthalmic Disease

Continued therapy is approved when ALL of the following are met:

ALL of the following

ONE of
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations (refer to state addendums CC.PHARM.03A and CC.PHARM.03B)
ONE of
- Detected neovascularization

Continuation Therapy Criteria (Other Diagnoses/Indications)

II. Continued Therapy - Other diagnoses/indications

If not covered above, meet ONE of the following:

ANY of the following

If drug label changed within the last 6 months and not reflected in policy, follow relevant formulary/no-coverage or non-formulary policy per line of business (references: CP.CPA.190; HIM.PA.33; CP.PMN.255; HIM.PA.103; CP.PMN.16)
If requested use not listed under section III and prior condition does not apply, refer to off-label use policy per line of business (CP.CPA.09; HIM.PA.154; CP.PMN.53)

Diagnoses / Indications Not Authorized

III. Diagnoses/Indications NOT authorized

Not covered unless meeting off-label evidence/policies:

Non-FDA approved indications which are not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety is provided per off-label use policies (CP.CPA.09; HIM.PA.154; CP.PMN.53) or evidence of coverage documents

Provider Actions & Billing Rules

Prior Authorization

Documentation required for approval

Providers must submit office chart notes, lab results, and other clinical information supporting that the member meets all approval criteria. This documentation should demonstrate the diagnosis, prior treatments, and clinical findings that satisfy the policy requirements. Note: prior authorization may be required for bevacizumab intravitreal solution.

Step Therapy

Bevacizumab step therapy requirement

Approval requires failure of bevacizumab intravitreal solution prior to use of Beovu unless bevacizumab is contraindicated or clinically significant adverse effects occurred. Operationally, requests for IV formulations of Avastin, Mvasi, and Zirabev will not be approved.

Bevacizumab intravitreal solution failure required unless contraindicated
IV formulations of Avastin, Mvasi, and Zirabev will not be approved

Applicable Codes

HCPCS - drug codeHCPCSCovered

J0179

Injection, brolucizumab-dbll, 1mg

Clinical Evidence

6.1/6.6/6.8HAWK least squares mean BCVA change (3 mg=6.1; 6 mg=6.6) vs aflibercept=6.8

6.9/7.6HARRIER least squares mean BCVA change (brolucizumab 6 mg=6.9 vs aflibercept=7.6)

49.4-55.6% / 51%Probability of maintaining q12w dosing through Week 48 (HAWK: 49.4% for 3 mg, 55.6% for 6 mg; HARRIER: 51%)

Phase 3 pivotal trials (HAWK and HARRIER) demonstrated that brolucizumab (3 mg and 6 mg) was non-inferior to aflibercept 2 mg for mean best corrected visual acuity through Week 48, with least squares mean BCVA changes reported for HAWK (3 mg = 6.1; 6 mg = 6.6; aflibercept = 6.8) and HARRIER (6 mg = 6.9; aflibercept = 7.6). The HAWK study also showed a formal superiority versus aflibercept for duration of effect after the loading phase, and both studies showed anatomical advantages for brolucizumab 6 mg at Week 16 and Week 48. Probabilities of maintaining exclusive q12w dosing through Week 48 for brolucizumab-treated eyes were approximately 49.4%–55.6% (HAWK) and ~51% (HARRIER). KESTREL and KITE were the Phase 3 trials supporting efficacy in DME. Brolucizumab is supplied as a 6 mg single‑dose vial and a 6 mg pre-filled syringe; dosing regimens use a loading phase followed by q8–12 week maintenance intervals per label.

Background & Definitions

Additional context: Beovu is FDA‑approved for both nAMD and DME and must be prescribed by or in consultation with an ophthalmologist per policy requirements. Prior authorization and a step‑therapy requirement for failure of bevacizumab intravitreal solution apply unless contraindicated (with IV Avastin formulations not approved). The dosing overview aligns with label guidance: 6 mg per administration (one vial or syringe), with specific loading intervals for nAMD and DME then maintenance every 8–12 weeks, and dose limits/approval rules are defined in the policy to ensure appropriate use and documentation of response for continued therapy.

Revision History

02.25.2025material_change

1Q 2025 annual review P&T approval: revised initial approval duration to 6 months for all indications; revised initial criteria maximum dosage to include dosing schedule after loading doses; revised continued therapy to only apply to requests for dose increase; Appendix B dosing updates; references reviewed and updated.

02.26.2026material_changeLatest

1Q 2026 annual review P&T approval: added step therapy bypass for Illinois HIM per IL HB 5395 (noted 10.29.25); extended continued therapy approval duration from 6 months to 12 months for maintenance medication for chronic conditions; references reviewed and updated.

2021-2024non_material_update