Category Filter
Asset Publisher
Beovu® (brolucizumab-dbll)
Policy Number: PH-0497
Intravitreal
Last Review Date: 10/03/2023
Date of Origin: 10/28/2019
Dates Reviewed: 11/2019, 10/2020, 10/2021, 04/2022, 07/2022, 10/2022, 10/2023
FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill. |
- Length of Authorization
Coverage will be provided annually and may be renewed.
- Dosing Limits
- Quantity Limit (max daily dose) [NDC Unit]:
Neovascular age-related macular degeneration (AMD):
- 6 mg single-dose vial or pre-filled syringe for injection: 1 vial/syringe per eye every 25 days for three doses initially, then 1 vial/syringe every 8 weeks
Diabetic Macular Edema (DME):
- 6 mg single-dose vial or pre-filled syringe for injection : 1 vial/syringe per eye every 6 weeks for five doses initially, then 1 vial/syringe every 8 weeks
- Max Units (per dose and over time) [HCPCS Unit]:
Diagnosis |
MU for Initial Dosing |
MU for Maintenance Dosing |
Neovascular age-related macular degeneration (AMD) |
12 billable units every 25 days x 3 doses |
12 billable units every 56-84 days |
Diabetic Macular Edema (DME) |
12 billable units every 6 weeks x 5 doses |
12 billable units every 56-84 days |
(Max units are based on administration to both eyes)
- Initial Approval Criteria 1
Coverage is provided in the following conditions:
For PEEHIP Members Only |
Bevacizumab is the preferred product for the following conditions: Neovascular (Wet) Age Related Macular Degeneration, Macular Edema following Retinal Vein Occlusion, Diabetic Macular Edema, and Diabetic Retinopathy.
Lucentis or Eylea are the preferred products after bevacizumab products
|
For Commercial Members Only |
Bevacizumab is the preferred product for the following conditions: Neovascular (Wet) Age Related Macular Degeneration, Macular Edema following Retinal Vein Occlusion, Diabetic Macular Edema, and Diabetic Retinopathy.
|
- Patient is at least 18 years of age; AND
Universal Criteria 1
- Patient is free of ocular and/or peri-ocular infections; AND
- Patient does not have active intraocular inflammation; AND
- Therapy will not be used with other ophthalmic VEGF inhibitors (e.g., aflibercept, ranibizumab, bevacizumab, faricimab-svoa, etc.); AND
- Patient’s best corrected visual acuity (BCVA) is measured at baseline and periodically during treatment; AND
- Patient has a definitive diagnosis of the following:
Neovascular (Wet) Age-Related Macular Degeneration (AMD) † 1
Diabetic Macular Edema (DME) † 1
† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug
- Renewal Criteria 1,12
Coverage can be renewed based upon the following criteria:
- Patient continues to meet the universal and indication-specific relevant criteria as identified in section III; AND
- Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity: endophthalmitis and retinal detachment, increase in intraocular pressure, arterial thromboembolic events, retinal vasculitis and/or retinal vascular occlusion, etc.; AND
- Continued administration is necessary for the maintenance treatment of the condition; AND
Neovascular (Wet) Age-Related Macular Degeneration (AMD) 2
- Patient has had a beneficial response to therapy (e.g., improvement in the baseline best corrected visual acuity (BCVA), etc.); AND
- Decreasing the interval of maintenance doses from 12-weeks to 8-weeks will be allowed if the patient has received all 3 loading doses and has evidence of disease activity, indicated by one of the following, at (or beyond) treatment-week 16:
- Decrease in BCVA of ≥ 5 letters compared to baseline; OR
- Decrease in BCVA of ≥ 3 letters and 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 intra-retinal cysts or fluid compared with week 12
Diabetic Macular Edema (DME) 10
- Patient has had a beneficial response to therapy (e.g., improvement in the baseline best corrected visual acuity (BCVA),etc.); AND
- Decreasing the interval of maintenance doses from 12-weeks to 8-weeks will be allowed if the patient has received all 5 loading doses and has evidence of disease activity, indicated by one of the following, at (or beyond) treatment-week 28:
- Decrease in BCVA of ≥ 5 letters compared to baseline; AND
- Increase in central subfield thickness compared to baseline
- Dosage/Administration 1,2,10
Indication |
Dose |
Neovascular (Wet) Age-Related Macular Degeneration (AMD) |
Administer 6 mg (0.05 mL of 120 mg/mL solution) administered by intravitreal injection per affected eye monthly (approximately every 25-31 days) for the first three doses, followed by 6 mg (0.05 mL) once every 8-12 weeks*. |
Diabetic Macular Edema (DME) |
Administer 6 mg (0.05 mL of 120 mg/mL solution) administered by intravitreal injection per affected eye every 6 weeks (approximately every 39-45 days) for the first five doses, followed by 6 mg (0.05 ml) once every 8-12 weeks*. |
* For many patients, every 12 weeks frequency is sufficient. For some patients who show continued disease activity, increasing the frequency to every 8 weeks may be considered |
- Billing Code/Availability Information
HCPCS:
- J0179 – Injection, brolucizumab-dbll, 1 mg; 1 mg = 1 billable unit
NDC(s):
- Beovu 6 mg/0.05 mL single-dose vial kit with injection components: 00078-0827-xx
- Beovu 6 mg/0.05 mL single-dose pre-filled syringe: 00078-0827-xx
- References
- Beovu [package insert]. East Hanover, NJ; Novartis Pharmaceuticals, Inc.; December 2022. Accessed September 2023.
- Dugel PU, Koh A, Ogura Y, et al. HAWK and HARRIER: Phase 3, Multicenter, Randomized, Double-Masked Trials of Brolucizumab for Neovascular Age-Related Macular Degeneration. Ophthalmology. 2019 Apr 12. pii: S0161-6420(18)33018-5.
- 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.
- 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.
- American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Committee, Hoskins Center for Quality Eye Care. Diabetic Retinopathy PPP – Update 2019. Oct 2019 (Interim update March 2022).
- American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Committee, Hoskins Center for Quality Eye Care. Retinal Vein Occlusions PPP – Update 2019. Oct 2019.
- American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Committee, Hoskins Center for Quality Eye Care. Age-Related Macular Degeneration PPP – Update 2019. Oct 2019. (Interim update March 2022).
- Royal College of Ophthalmologists. Clinical Guidelines – Retinal Vein Occlusion (RVO) Guidelines – July 2015. Accessed at https://www.rcophth.ac.uk/standards-publications-research/clinical-guidelines.
- Garweg J. A Randomized, Double-Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Patients with Visual Impairment due to Diabetic Macular Edema (KITE). Klin Monbl Augenheilkd. 2020 Apr;237(4):450-453. doi: 10.1055/a-1101-9126. Epub 2020 Mar 4.
- Brown D, Emanuelli A, Bandello F, et al. KESTREL and KITE: 52-Week Results From Two Phase III Pivotal Trials of Brolucizumab for Diabetic Macular Edema. Am J Ophthalmol
2022 Jun;238:157-172. doi: 10.1016/j.ajo.2022.01.004. Epub 2022 Jan 14.
- American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Panel, Hoskins Center for Quality Eye Care. Retina Summary Benchmarks-2022. December 2022.
- Chandra S, McKibbin M, Mahmood S, et al. The Royal College of Ophthalmologists Commissioning guidelines on age macular degeneration: executive summary. Eye 36, 2078–2083 (2022). https://doi.org/10.1038/s41433-022-02095-2
- National Government Services, Inc. Local Coverage Article: Billing and Coding: Ranibizumab and biosimilars, Aflibercept, Brolucizumab-dbll and Faricimab-svoa (A52451). Centers for Medicare & Medicaid Services, Inc. Updated on 03/24/2023 with effective date of 04/01/2023. Accessed September 2023.
Appendix 1 – Covered Diagnosis Codes
ICD-10 |
ICD-10 Description |
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 |
E08.3212 |
Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, left eye |
E08.3213 |
Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, bilateral |
E08.3219 |
Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye |
E08.3311 |
Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, right eye |
E08.3312 |
Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, left eye |
E08.3313 |
Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, bilateral |
E08.3319 |
Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye |
E08.3411 |
Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, right eye |
E08.3412 |
Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, left eye |
E08.3413 |
Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, bilateral |
E08.3419 |
Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye |
E08.3511 |
Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, right eye |
E08.3512 |
Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, left eye |
E08.3513 |
Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, bilateral |
E08.3519 |
Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, unspecified eye |
E09.311 |
Drug or chemical induced diabetes mellitus with unspecified diabetic retinopathy with macular edema |
E09.3211 |
Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye |
E09.3212 |
Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye |
E09.3213 |
Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral |
E09.3219 |
Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye |
E09.3311 |
Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye |
E09.3312 |
Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye |
E09.3313 |
Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral |
E09.3319 |
Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye |
E09.3411 |
Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye |
E09.3412 |
Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye |
E09.3413 |
Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral |
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 |
E10.3311 |
Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye |
E10.3312 |
Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye |
E10.3313 |
Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral |
E10.3319 |
Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye |
E10.3411 |
Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye |
E10.3412 |
Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye |
E10.3413 |
Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral |
E10.3419 |
Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye |
E10.3511 |
Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye |
E10.3512 |
Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye |
E10.3513 |
Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral |
E10.3519 |
Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye |
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 |
E11.3411 |
Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye |
E11.3412 |
Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye |
E11.3413 |
Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral |
E11.3419 |
Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye |
E11.3511 |
Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye |
E11.3512 |
Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye |
E11.3513 |
Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral |
E11.3519 |
Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye |
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 |
E13.3311 |
Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye |
E13.3312 |
Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye |
E13.3313 |
Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral |
E13.3319 |
Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye |
E13.3411 |
Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye |
E13.3412 |
Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye |
E13.3413 |
Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral |
E13.3419 |
Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye |
E13.3511 |
Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye |
E13.3512 |
Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye |
E13.3513 |
Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral |
E13.3519 |
Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye |
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 |
H35.3232 |
Exudative age-related macular degeneration, bilateral, with inactive choroidal neovascularization |
H35.3233 |
Exudative age-related macular degeneration, bilateral, with inactive scar |
H35.3290 |
Exudative age-related macular degeneration, unspecified eye, stage unspecified |
H35.3291 |
Exudative age-related macular degeneration, unspecified eye, with active choroidal neovascularization |
H35.3292 |
Exudative age-related macular degeneration, unspecified eye, with inactive choroidal neovascularization |
H35.3293 |
Exudative age-related macular degeneration, unspecified eye, with inactive scar |
Appendix 2 – Centers for Medicare and Medicaid Services (CMS)
Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.
Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA):
Jurisdiction(s): 6, K |
NCD/LCD Document (s): A52451 |
Medicare Part B Administrative Contractor (MAC) Jurisdictions |
||
Jurisdiction |
Applicable State/US Territory |
Contractor |
E (1) |
CA, HI, NV, AS, GU, CNMI |
Noridian Healthcare Solutions, LLC |
F (2 & 3) |
AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ |
Noridian Healthcare Solutions, LLC |
5 |
KS, NE, IA, MO |
Wisconsin Physicians Service Insurance Corp (WPS) |
6 |
MN, WI, IL |
National Government Services, Inc. (NGS) |
H (4 & 7) |
LA, AR, MS, TX, OK, CO, NM |
Novitas Solutions, Inc. |
8 |
MI, IN |
Wisconsin Physicians Service Insurance Corp (WPS) |
N (9) |
FL, PR, VI |
First Coast Service Options, Inc. |
J (10) |
TN, GA, AL |
Palmetto GBA, LLC |
M (11) |
NC, SC, WV, VA (excluding below) |
Palmetto GBA, LLC |
L (12) |
DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA) |
Novitas Solutions, Inc. |
K (13 & 14) |
NY, CT, MA, RI, VT, ME, NH |
National Government Services, Inc. (NGS) |
15 |
KY, OH |
CGS Administrators, LLC |