Susvimo™

Drug - Susvimo™ (ranibizumab) [Genentech, Inc.]

April 2022

Therapeutic Area - Macular Degeneration Agents

Initial approval criteria

Universal Criteria

Patient is free of ocular and/or peri-ocular infections AND
Patient does not have active ocular inflammation AND
Therapy will not be used with other ophthalmic VEGF inhibitors (e.g., aflibercept, pegaptanib, brolucizumab, bevacizumab, ranibizumab) unless supplemental treatment is necessary (find more information in renewal criteria) 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™, 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)

Patient has previously responded to at least two intravitreal injections of a vascular endothelial growth factor (VEGF) inhibitor medication (e.g., aflibercept, pegaptanib, brolucizumab, bevacizumab, ranibizumab)
Initial approval is for 6 months

Patient continues to meet the universal and indication-specific relevant criteria as identified in the initial approval criteria AND
Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: endophthalmitis, rhegmatogenous retinal detachment, implant dislocation, 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 AND
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
Renewal approval is for 6 months

Initial/Maintenance:

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

Supplemental

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

MHCP Provider Resource Center 651-431-2700 or 1-800-366-5411