Susvimo (ranibizumab) intravitreal implant — Medical Benefit Drug Policy
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This UnitedHealthcare medical benefit drug policy governs coverage and authorization criteria for Susvimo (ranibizumab intravitreal implant) for Commercial and Individual Exchange plans.
Transferred content to shared policy template that applies to both UnitedHealthcare Commercial and Individual Exchange benefit plans.
Added Application section to indicate this policy applies to UnitedHealthcare Commercial and Individual Exchange benefit plans.
Updated FDA and References sections to reflect the most current information.
Archived previous policy versions 2025D0138B and IEXD0138.02.
Coverage Criteria
Initial Therapy
Covered when ALL of the following are met for initial therapy:
Based on FDA-indicated conditions listed in policy.
FDA labeling and policy require documented prior response to ≥2 intravitreal VEGF inhibitor injections.
Treatment must follow FDA-approved dosing schedules.
Initial authorization limit per policy.
Continuation Therapy
Covered when ALL of the following are met for continuation of therapy:
Provider must document improvement consistent with clinical expectations.
Reauthorization requires continued adherence to FDA dosing.
Continuation authorizations are limited to periods of up to 12 months per policy.
Initial Coverage Criteria
Covered when the following FDA-indicated conditions and prior-treatment responses are met:
FDA indications summarized in policy clinical evidence and FDA section.
FDA labeling and policy require prior response to ≥2 intravitreal VEGF inhibitor injections.
Informational: reflects trial populations and dosing used in pivotal studies; not an additional coverage requirement beyond prior-response rule unless specified by plan.
The list of procedure and diagnosis codes included in this policy is provided for reference only and does not by itself imply coverage or guarantee claim payment. Benefit coverage is determined by the member specific benefit plan document and applicable laws; other policies or guidelines may also apply. The HCPCS code shown for Susvimo is J2779: Injection, ranibizumab, via intravitreal implant, 0.1 mg.
No explicit coverage exclusions are stated in the provided code listings. The document segment containing diagnosis codes is descriptive and does not itself define exclusionary rules.
The policy aligns coverage with FDA-labeled indications and requires prior clinical response: indications that are not supported by FDA labeling or cases where the patient has not previously responded to at least two intravitreal VEGF inhibitor injections are not consistent with the FDA-described criteria for Susvimo.
Within the provided document segments there are no explicit statements using the phrase 'not medically necessary.'
Use of Susvimo for experimental, investigational, or unproven indications may be governed by the member’s Certificate of Coverage and any applicable state mandates; the member specific benefit plan document should be consulted to determine whether such uses are eligible for coverage under that plan.
Coding
| J2779 | Injection, ranibizumab, via intravitreal implant, 0.1 mg |
| 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 |
| E08.3531 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye. |
| E08.3532 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye. |
| E08.3533 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral. |
| E08.3539 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, unspecified eye. |
| E08.3541 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye. |
| E08.3542 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye. |
| E08.3543 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral. |
| E08.3549 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, unspecified eye. |
| E08.3551 | Diabetes mellitus due to underlying condition with stable proliferative diabetic retinopathy, right eye. |
| E08.3552 | Diabetes mellitus due to underlying condition with stable proliferative diabetic retinopathy, left eye. |
| E08.3559 | Diabetes mellitus due to underlying condition with stable proliferative diabetic retinopathy, unspecified eye. |
| E08.3591 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy without macular edema, right eye. |
| E08.3592 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy without macular edema, left eye. |
| E08.3593 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy without macular edema, bilateral. |
| E08.3599 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy without macular edema, unspecified eye. |
| E09.319 | Drug or chemical induced diabetes mellitus with unspecified diabetic retinopathy without macular edema. |
| E09.3291 | Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye. |
| E09.3292 | Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye. |
| E09.3293 | Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral. |
| E09.3299 | Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, unspecified eye. |
| E10.319 | Type 1 diabetes mellitus with unspecified diabetic retinopathy without macular edema. |
| E10.3291 | Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye. |
| E10.3292 | Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye. |
| E10.3293 | Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral. |
| E10.3299 | Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, unspecified eye. |
| E10.3391 | Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye. |
| E10.3491 | Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye. |
| E10.3521 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye. |
| E10.3531 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye. |
| E11.319 | Type 2 diabetes mellitus with unspecified diabetic retinopathy without macular edema. |
| E11.3291 | Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye. |
| E11.3391 | Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye. |
| E11.3491 | Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye. |
| E11.3521 | Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye. |
| E11.3531 | Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye. |
| E13.319 | Other specified diabetes mellitus with unspecified diabetic retinopathy without macular edema. |
| E13.3291 | Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye. |
| E13.3391 | Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye. |
| E13.3491 | Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye. |
| E13.3521 | Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye. |
| E13.3392 | Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, left eye. |
| E13.3393 | Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, bilateral. |
| E13.3399 | Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, unspecified eye. |
| E13.3491 | Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye. |
| E13.3492 | Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye. |
| E13.3493 | Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral. |
| E13.3499 | Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, unspecified eye. |
| E13.3521 | Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye. |
| E13.3522 | Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye. |
| E13.3523 | Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral. |
Provider Actions and Requirements
Prior authorization required; 12‑month initial limit
Prior authorization is required for Susvimo; initial authorizations will be for no longer than 12 months and continuation/reauthorization requires documentation of a positive clinical response with dosing per FDA-approved labeling.
- Initial authorization limited to no longer than 12 months.
- Reauthorization requires documentation of positive clinical response and dosing consistent with FDA label.
ICD‑10 code listing only — no PA directive in these chunks
This section of the document provides ICD‑10 diagnosis code listings only and does not state prior authorization directives in the provided chunks.
Confirm indication and member benefit plan; verify prior VEGF response
Verify the patient meets the FDA‑indicated diagnosis and that the member’s benefit plan permits coverage; confirm the patient has the required prior response to VEGF inhibitor therapy before approving Susvimo.
- Reference the member specific benefit plan document to determine coverage applicability.
- Confirm the patient meets indication criteria and prior VEGF response per policy and FDA labeling.
Prior VEGF inhibitor response required (≥2 intravitreal injections)
Documented prior response to at least two intravitreal injections of a VEGF inhibitor is required for FDA‑indicated use and for coverage consideration.
- Examples of VEGF inhibitors listed in policy: bevacizumab, aflibercept, ranibizumab, aflibercept-ayyh, faricimab.
- Requirement applies to AMD, DME, and DR indications per FDA labeling.
—
Document prior intravitreal VEGF therapy and response
For FDA‑labeled indications, document prior intravitreal VEGF therapy and that the patient previously responded to at least two intravitreal injections of a VEGF inhibitor medication.
- Policy lists the FDA indications (AMD, DME, DR) each requiring prior response to ≥2 intravitreal VEGF injections.
- Include prior treatment details in the request documentation.
Include diagnosis and documented response to ≥2 prior intravitreal injections
Documentation submitted with an authorization request must show the diagnosis (neovascular AMD, DME, or DR) and that the patient previously responded to at least two intravitreal injections of a VEGF inhibitor; dosing intent must follow FDA labeling.
- State the diagnosis and laterality as applicable using the appropriate ICD‑10 code.
- Provide records of prior anti‑VEGF injections and clinical response.
- Specify planned dosing consistent with FDA‑approved labeling.
—
Reference member benefit plan and document treatment details
When requesting coverage, reference the member specific benefit plan and any applicable federal or state mandates; document the treatment indication, prior VEGF responses, and member plan applicability.
- Member specific benefit plan governs in case of conflicts with this policy.
- Include documentation of prior VEGF treatment and response and note plan applicability (Commercial, Individual Exchange, or mandates).
Denial risk if no qualifying diagnosis or insufficient prior‑VEGF documentation
Requests that do not document a qualifying diagnosis (neovascular AMD, DME, or diabetic retinopathy) or lack documentation of prior response to at least two intravitreal VEGF inhibitor injections may be denied.
- Absence of documented prior response to ≥2 intravitreal VEGF injections is a risk for coverage denial.
- Lack of an applicable diagnosis per policy (AMD, DME, DR) may result in denial.
No authorization/denial instructions in this segment
This segment contains only diagnosis code listings and does not include explicit prior authorization or denial instructions in the provided chunks.
Apply prior‑response requirement for non‑meeting indications
Use this prior‑response requirement when evaluating indications that do not meet the FDA‑described prior response standard; patients without documented response to at least two intravitreal VEGF injections may not meet coverage criteria.
- Apply denial risk for indications lacking the ≥2 prior‑injection documented response required by FDA labeling.
Background
Susvimo is an implantable intravitreal formulation of ranibizumab intended to provide continuous intravitreal delivery of the VEGF‑A inhibitor for retinal disease. The FDA‑approved indications listed in the policy are: treatment of neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy (DR), each limited to patients who have previously responded to at least two intravitreal injections of a VEGF inhibitor medication. Clinical trials summarized in the policy enrolled patients with prior anti‑VEGF exposure (trial-specific prior dosing/loading requirements are described in the FDA/trial sections) to support efficacy in these labeled indications.
Definitions
Revision History
Content was migrated to a shared policy template and an Application section was added to clarify applicability to UnitedHealthcare Commercial and Individual Exchange benefit plans.
FDA and References sections were updated to reflect the most current information.
Previous policy versions 2025D0138B and IEXD0138.02 were archived.
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