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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.
  1. Length of Authorization

Coverage will be provided annually and may be renewed.

  1. Dosing Limits
  1. 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
  1. 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)

  1. 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.

  • Patient must have either an intolerance, a contraindication or inadequate response to an adequate trial of at least ONE bevacizumab product prior to initiating therapy with a non-preferred ophthalmic anti-VEGF agent. Patients who have been receiving a non-preferred agent may continue therapy with that product; AND

Lucentis or Eylea are the preferred products after bevacizumab products

  • All other products are considered non-preferred unless the patient is continuing treatment with a non-preferred product; OR
  • Patient must have either an intolerance, a contraindication or inadequate response to an adequate trial of both preferred products prior to moving to a non-preferred product; AND

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 must have either an intolerance, a contraindication or inadequate response to an adequate trial of at least ONE bevacizumab product prior to initiating therapy with a non-preferred ophthalmic anti-VEGF agent. Patients who have been receiving a non-preferred agent may continue therapy with that product: AND
  • 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

  1. 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
  1. 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

  1. 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
  1. References
  1. Beovu [package insert].  East Hanover, NJ; Novartis Pharmaceuticals, Inc.; December 2022. Accessed September 2023.
  2. 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.
  3. 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.
  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. 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).
  6. 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.
  7. 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).
  8. 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.
  9. 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.
  10. 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.

  1. American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Panel, Hoskins Center for Quality Eye Care. Retina Summary Benchmarks-2022. December 2022.
  2. 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
  3. 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

https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a52451&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP

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