Cigna: Susvimo (ranibizumab implant) deemed experimental for DME, DR, Wet AMD

Effective March 1, 2026, Cigna classifies the intravitreal implant Susvimo (ranibizumab ocular implant) as experimental, investigational, or unproven for Diabetic Macular Edema, Diabetic Retinopathy, and Neovascular (Wet) AMD due to insufficient evidence of safety and improved health outcomes. The policy retains an overview of FDA-labeled indications (including prior response to ≥2 intravitreal VEGF injections) but separates that from the payer’s noncoverage decision and will be revisited only as new published data emerge. Key safety concerns driving noncoverage include a boxed warning for endophthalmitis and higher rates of implant- and procedure-related ocular adverse events (e.g., implant dislocation, conjunctival erosion, retinal detachment) observed in trials and extension phases. Although pivotal trials showed efficacy equivalent or noninferior to monthly ranibizumab injections on primary endpoints, the aggregate safety signal and reported endophthalmitis events underpin Cigna’s current noncoverage stance.

This revision (Effective 2026-03-01) for Cigna's Ophthalmology topic MDC 02 clarifies the coverage stance for the intravitreal implant product Susvimo™ (ranibizumab intravitreal injection via ocular implant - Genentech). The document explicitly states that Susvimo is considered "experimental, investigational, or unproven" for the three labeled ophthalmic indications addressed: Diabetic Macular Edema (DME), Diabetic Retinopathy, and Neovascular (Wet) Age-Related Macular Degeneration (AMD) due to insufficient data establishing safety, efficacy, and improved health outcomes.

The policy retains the product overview language that lists Susvimo's FDA indications (DME, diabetic retinopathy, and wet AMD in patients who previously responded to at least two intravitreal VEGF inhibitor injections) but separates that from the payer's noncoverage determination. The revision emphasizes that coverage criteria will be updated only as new published data become available.

Cigna's coverage position is consistent across the three clinical indications examined: DME, Diabetic Retinopathy, and Neovascular (Wet) AMD. For each indication the policy states that approval is not recommended "due to the safety data," and that Susvimo is considered experimental, investigational, or unproven for those conditions regardless of FDA approval status. The policy explicitly notes that criteria may be updated when new published data are available.

The policy identifies safety concerns as the primary reason for noncoverage. A central concern is the boxed warning for endophthalmitis that is unique to Susvimo among VEGF inhibitors. In the active comparator period of AMD trials, Susvimo was associated with a higher rate of endophthalmitis (1.7%) compared with monthly intravitreal ranibizumab injections (0.5%), and across extension phases 2% (n=11/555) of Susvimo-treated patients experienced endophthalmitis. The policy also documents timeframe ranges and medians for reported events (Days 5–853, median 173 days in AMD trials).

For DME and diabetic retinopathy trials the policy reports lower or absent event rates in the primary comparison periods (0% in Susvimo vs. 0.3% in intravitreal ranibizumab for the DME active-controlled period; none in Susvimo during the observational comparator period for diabetic retinopathy), but notes that events occurred during extension phases (DME: 0.7% [4/556], reported Days 625–1,016, median 824 days; diabetic retinopathy: 0.8% [1/128] reported Day 695). The policy highlights that many, but not all, endophthalmitis cases were associated with conjunctival retraction or erosion.

Beyond endophthalmitis, the policy lists additional implant- and procedure-related ocular adverse events observed with Susvimo. These include rhegmatogenous retinal detachment, implant dislocation, vitreous hemorrhage, conjunctival erosion or retraction, conjunctival bleb, postoperative decrease in visual acuity, air bubbles causing improper filling of the implant, and deflection of the implant.

The document also notes that overall ocular adverse events were more frequent with Susvimo compared with intravitreal ranibizumab injection in clinical trials, and that patients treated with Susvimo require regular monitoring to evaluate for these adverse events. This aggregate safety signal underpins the payer's conclusion that evidence is insufficient to establish improved health outcomes despite trial efficacy equivalence for some primary endpoints.

The policy juxtaposes trial efficacy findings with the safety concerns that drive the noncoverage determination. For both the pivotal AMD and DME trials, Susvimo demonstrated efficacy equivalent or non-inferior to monthly intravitreal ranibizumab injections for primary endpoints: the AMD pivotal trial showed equivalence on the primary efficacy endpoint, and the DME pivotal trial demonstrated non-inferiority. In diabetic retinopathy, Susvimo-treated patients achieved a high rate (80%) of ≥2-step improvement on the ETDRS-DRSS at Week 52 in the treated cohort compared with 9% in the observational comparator cohort.

Despite these efficacy results, the policy underscores that the safety profile—particularly the boxed warning for endophthalmitis and higher rates of ocular adverse events observed in trials and extension phases—results in the current determination that Susvimo is experimental, investigational, or unproven for the listed ophthalmic indications.

OpenPayer

March 2026 Revision: Cigna determination and emphasis on insufficient evidence

Coverage stance across DME, Diabetic Retinopathy, and Wet AMD

Safety profile emphasis: boxed warning and endophthalmitis data

Other implant-related adverse events and monitoring implications

Efficacy findings in trials versus payer's noncoverage rationale