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Asset Publisher
Susvimo™ (ranibizumab)
Policy Number: PH-0634
Intravitreal
Last Review Date: 09/05/2024
Date of Origin: 12/02/2021
Dates Reviewed: 12/2021, 04/2022, 07/2022, 10/2022, 10/2023, 09/2024
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
Initial coverage will be provided for 6 months and may be renewed annually thereafter.
- Dosing Limits
- Quantity Limit (max daily dose) [NDC unit]:
- Susvimo 100 mg/mL solution for injection single-dose vial: 1 vial per eye every 24 weeks
- 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)
- Initial Approval Criteria 1
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
|
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 periocular 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, bevacizumab, ranibizumab, faricimab, etc.) unless supplemental treatment with ranibizumab 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
- Patient has previously responded to at least two intravitreal injections of a VEGF inhibitor medication (e.g., aflibercept, brolucizumab, bevacizumab, ranibizumab, faricimab, etc.)
† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug
- 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 best corrected visual acuity (BCVA) from baseline, 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)
- Dosage/Administration 1
Indication |
Dose |
Neovascular (wet) Age-related Macular Degeneration (AMD) |
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. |
|
- 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, 0.1 ml single-dose glass vial: 50242-0078-xx
- Susvimo 100 mg/mL, 0.1 ml injection and initial fill needle kit (carton of 1 dose): 50242-0078-xx
- References
- Susvimo [package insert]. South San Francisco, CA; Genentech, Inc; April 2022. Accessed July 2024.
- 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).
- 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.
- American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Panel, Hoskins Center for Quality Eye Care. Retina Summary Benchmarks - 2023. December 2023.
- 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
ICD-10 |
ICD-10 Description |
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 |