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Susvimo™ (ranibizumab)

Policy Number: PH-90634

Intravitreal

Last Review Date: 03/04/2025

Date of Origin: 12/02/2021

Dates Reviewed: 12/2021, 04/2022, 07/2022, 10/2022, 10/2023, 09/2024, 03/2025

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
  • Initial will be provided every 6 months and may be renewed annually.
  1. Dosing Limits

      Max Units (per dose and over time) [HCPCS Unit]:

  • 200 billable units every 24 weeks

(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

For Neovascular (Wet) Age Related Macular Degeneration, Macular Edema following Retinal Vein Occlusion, Diabetic Macular Edema, and Diabetic Retinopathy, bevacizumab, followed by Lucentis or Eylea, are considered the preferred products.

·         Patient must have an intolerance, a contraindication or inadequate response to an adequate trial of at least ONE bevacizumab product followed by an adequate trial of Lucentis or Eylea, before consideration of another product

Note: All other products are considered non-covered unless the patient is continuing treatment with the non-covered product. The use of samples and free goods do not qualify as an established clinical response or adequate trial.

  • 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 vascular endothelial growth factor (VEGF) inhibitors unless supplemental treatment with another ranibizumab product is necessary (refer to sections IV and V); AND
  • Patient has not required removal of a Susvimo implant in the past; AND
  • Patient does not have a hypersensitivity to other ranibizumab products (i.e., Lucentis®, Byooviz™, Cimerli™, etc.); AND
  • Patient’s best corrected visual acuity (BCVA) is measured at baseline and periodically during treatment; AND

Neovascular (Wet) Age-Related Macular Degeneration (AMD) † 1-5,7,8

  • Patient has previously responded to at least two intravitreal injections of a VEGF inhibitor medication

Diabetic Macular Edema (DME) † 1,3,6

  • Patient has previously responded to at least two intravitreal injections of a VEGF inhibitor medication
  • † FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug
  1. Renewal Criteria 1

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 include: endophthalmitis, rhegmatogenous retinal detachment, implant dislocation, septum dislodgement, vitreous hemorrhage, conjunctival erosion, conjunctival retraction, and conjunctival blebs, etc.; AND
    • 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; OR
    • Supplemental treatment ONLY: Patient has had an insufficient response during initial or maintenance therapy with Susvimo administered every 24 weeks and requires supplemental treatment with intravitreal ranibizumab (Refer to Section V for dosing and administration)
  1. Dosage/Administration 1

Indication

Dose

Neovascular (wet) Age-related Macular Degeneration (AMD) & Diabetic Macular Edema (DME)

Initial/Maintenance

2 mg (0.02 mL of 100 mg/mL solution) continuously delivered via the Susvimo ocular implant with refills into the implant administered every 24 weeks (approximately 6 months)

Supplemental Intravitreal Ranibizumab

Supplemental treatment with 0.5 mg (0.05 mL of 10 mg/mL) intravitreal ranibizumab injection may be administered in the affected eye while the Susvimo implant is in place and if clinically necessary.

  • For intravitreal use via Susvimo ocular implant.
  • The initial fill and ocular implant insertion and implant removal procedures must be performed under aseptic conditions by a physician experienced in vitreoretinal surgery.

  1. Billing Code/Availability Information

HCPCS Code(s):

  • J2779 – Injection, ranibizumab, via intravitreal implant (susvimo), 0.1 mg; 1 billable unit = 0.1 mg
  • C1889 – Implantable/insertable device, not otherwise classified (Used for Susvimo Ocular Implant Device)

NDC(s):

  • Susvimo 100 mg/mL, 0.1ml single-dose glass vial: 50242-0078-xx
  • Susvimo 100 mg/mL, 0.1ml injection and initial fill needle kit (carton of 1 dose): 50242-0078-xx
  1. References
  1. Susvimo [package insert].  South San Francisco, CA; Genentech, Inc; February 2025. Accessed February 2025.
  2. 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).
  3. Heimann F, Barteselli G, Brand A, et al. A custom virtual reality training solution for ophthalmologic surgical clinical trials. Adv Simul (Lond). 2021 Apr 16;6(1):12. doi: 10.1186/s41077-021-00167-z.
  4. American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Panel, Hoskins Center for Quality Eye Care. Retina Summary Benchmarks-2022. December 2022.
  5. 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
  6. Wirthlin R, Gill M, Howard D, et al. Port Delivery System with ranibizumab (PDS) stabilizes retinal nonperfusion and macular leakage: results from Pagoda and Pavilion phase 3 trials in diabetic macular edema (DME) and diabetic retinopathy (DR). Invest. Ophthalmol. Vis. Sci. 2024;65(7):6232.
  7. Howard J, Cavichini Cordeiro M, Singh N, et al. Long-term efficacy and safety of the Port Delivery System with ranibizumab in patients with neovascular age-related macular degeneration: Results from the Portal 5-year subgroup analysis. Invest. Ophthalmol. Vis. Sci. 2023;64(8):2188.
  8. American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Panel, Hoskins Center for Quality Eye Care. Retina Summary Benchmarks-2023. December 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)

The preceding information is intended for non-Medicare coverage determinations. 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 Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A

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

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA

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