Last Review Date: 10/03/2023

Date of Origin: 12/02/2021

Dates Reviewed: 12/2021, 04/2022, 07/2022, 10/2022, 10/2023

1. Length of Authorization

• Coverage will be provided every 6 months and may be renewed.

2. Dosing Limits

A. Quantity Limit (max daily dose) [NDC unit]:

• Susvimo 100 mg/mL solution for injection single-dose vial: 1 vial per eye every 24 weeks

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

   Neovascular Age-related Macular Degeneration (AMD)

• 200 billable units every 24 weeks

(Max units are based on administration to both eyes)

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Universal Criteria ^1-5

• 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 (e.g., aflibercept, brolucizumab-dbll, bevacizumab, ranibizumab, faricimab-svoa, etc.) unless supplemental treatment with ranibizumab is necessary (see below); 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

• Patient has previously responded to at least two intravitreal injections of a VEGF inhibitor medication (e.g., aflibercept, pegaptanib, brolucizumab-dbll, bevacizumab, ranibizumab, faricimab-svoa, etc.)

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ^1-5

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)

5. Dosage/Administration ¹

6. 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

7. References

1. Susvimo [package insert].  South San Francisco, CA; Genentech, Inc; April 2022. Accessed September 2023.
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

Appendix 1 – Covered Diagnosis Codes

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): N/A