UnitedHealthcare Susvimo Coverage Update

Coverage Criteria

Initial and Continuation Therapy

Covered when ALL of the following are met

Initial therapy criteria: Member has one of the specified diagnoses: neovascular (wet) age-related macular degeneration (AMD) OR diabetic macular edema (DME) OR diabetic retinopathy (DR).

Based on policy Coverage Rationale and FDA indication; see applicable ICD-10 code list for diagnosis coding.

Prior-treatment response: Patient has previously responded to at least two intravitreal injections of a VEGF inhibitor (examples: bevacizumab, aflibercept, ranibizumab, faricimab).>= 2 prior intravitreal VEGF injections

Response must be documented in the medical record (e.g., improvement or stabilization in visual acuity or retinal anatomy).

Dosing and labeling: Dosing is in accordance with U.S. Food and Drug Administration approved labeling for Susvimo.

Initial implant and any supplemental intravitreal dosing should follow FDA labeling and trial-based schedules as applicable.

Authorization duration (initial): Initial authorization will be for no longer than 12 months.<= 12 months

Prior authorization is required for HCPCS J2779.

Continuation therapy criteria: For reauthorization, documentation of a positive clinical response AND continued dosing per U.S. FDA labeling; reauthorization will be for no longer than 12 months.<= 12 months

Positive clinical response should be documented (e.g., maintained or improved BCVA or clinical exam findings).

Initial therapy/Indication-based coverage

Covered when ALL of the following are met:

Eligibility for Susvimo (indication-based): Diagnosis of neovascular AMD, diabetic macular edema (DME), or diabetic retinopathy (DR) as listed in the applicable ICD-10 codes.

See Applicable ICD-10 Diagnosis Codes in the coding section for supported codes.

Prior-response requirement (trial-aligned): Member has previously responded to at least two intravitreal injections of a VEGF inhibitor; clinical trials required evidence of prior response before enrollment.>= 2 prior intravitreal VEGF injections

Trials for AMD and DME required prior anti-VEGF dosing and demonstrated response; FDA labeling similarly specifies prior response.

Documentation of prior treatment and response: Documentation of prior intravitreal treatment history and clinical response must be provided.

Include dates, agents, number of injections, and objective clinical response (e.g., BCVA, OCT findings).

This policy applies to Individual Exchange benefit plans in all states except for Massachusetts, Nevada, and New York. Coverage determinations for members should follow the applicability above; where a member’s benefit plan or state law imposes different requirements, those terms may control.

Coverage is subject to the member’s specific benefit plan terms and any applicable state or federal mandates. Some Certificates of Coverage may allow experimental, investigational, or off‑label uses in limited circumstances; consult the member’s certificate of coverage and any applicable mandates before approving such requests.

FDA approval alone is not a basis for coverage; Susvimo is approved for specific retinal indications (see indications) and coverage under this policy is limited to uses and documentation consistent with those indications and the policy criteria.

Use of Susvimo without documentation that the member previously responded to at least two intravitreal injections of a VEGF inhibitor is not consistent with the FDA‑listed indications and may be considered not medically necessary under this policy. Prior response must be documented in the clinical record and included with any prior authorization request.

Requests that do not demonstrate the required prior response or that do not follow FDA‑approved dosing schedules may be denied; providers should include prior treatment history, dates, agents used, and objective evidence of clinical response.

Coding

HCPCS CodesHCPCSCovered

J2779

Injection, ranibizumab, via intravitreal implant, 0.1 mg

Neovascular (Wet) AMD ICD-10 Codes (sample group)ICD-10

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.
H35.3221	Exudative age-related macular degeneration, left eye, with active choroidal neovascularization.
H35.3222	Exudative age-related macular degeneration, left eye, with inactive choroidal neovascularization.
H35.3231	Exudative age-related macular degeneration, bilateral, with active choroidal neovascularization.
H35.3232	Exudative age-related macular degeneration, bilateral, with inactive choroidal neovascularization.
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.

Diabetic Macular Edema (DME) ICD-10 Codes (sample group)ICD-10

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.

Diabetic Retinopathy ICD-10 Codes (sample group)ICD-10

E08.319	Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy without macular edema.
E08.3291	Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema, right eye.
E09.3211	Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye.
E10.3211	Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye.
E11.3211	Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye.

Applicable ICD-10 Diagnosis Codes (selected examples from full list)ICD-10Covered

E08.319	Drug or chemical induced diabetes mellitus with unspecified diabetic retinopathy without macular edema
E08.3291	Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye
E08.3292	Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye
E08.3293	Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral
E08.3299	Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, unspecified eye
E09.3591	Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy without macular edema, right 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
E11.319	Type 2 diabetes mellitus with unspecified diabetic retinopathy without macular edema
E13.319	Other specified diabetes mellitus with unspecified diabetic retinopathy without macular edema

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial and continuation therapy. Initial authorization and any reauthorization are limited to a duration of no longer than 12 months.

Initial and reauthorization duration: ≤ 12 months
Prior authorization required for Susvimo (ranibizumab implant)

Documentation Required

Required Clinical Documentation

Documentation must include evidence of prior clinical response to intravitreal VEGF inhibitor therapy and adherence to FDA‑approved dosing. For continuation requests, include documentation of a positive clinical response while on Susvimo and that dosing remains consistent with FDA labeling.

Document prior treatment history and response to VEGF inhibitors (dates, agents, number of injections)
Document adherence to FDA‑approved dosing regimen

Definitions

Initial therapy defined

DefinitionInitial therapy = the first authorization period during which the member must have one of the specified diagnoses (neovascular/wet AMD, DME, or DR) AND documentation that the patient previously responded to at least two intravitreal injections of a VEGF inhibitor.

Required diagnosesNeovascular (wet) age-related macular degeneration (AMD); Diabetic macular edema (DME); Diabetic retinopathy (DR).

Prior treatment requirementDocumentation of prior response to ≥2 intravitreal VEGF inhibitor injections (examples include bevacizumab, aflibercept, ranibizumab, faricimab).

Authorization durationInitial authorization limited to no longer than 12 months.

Continuation of therapy defined

DefinitionContinuation of therapy = reauthorization period when documentation shows a positive clinical response and dosing follows U.S. FDA–approved labeling.

Background

Susvimo (ranibizumab intravitreal implant) is a port delivery system that provides continuous intravitreal delivery of ranibizumab. The product is indicated for treatment of neovascular (wet) age‑related macular degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy (DR) in patients who have previously responded to at least two intravitreal injections of a VEGF inhibitor.

This policy defines coverage for Susvimo on the medical benefit when used for those approved retinal diagnoses and when prior authorization criteria are met, including documented prior response to ≥2 intravitreal VEGF inhibitor injections, adherence to U.S. FDA‑approved dosing, and provision of required clinical documentation for initial and continuation authorizations.

Revision History

2025-09-01Policy revision - ICD-10 additionsLatest

Revised list of applicable diagnoses for which Susvimo is proven and medically necessary; added diabetic retinopathy and numerous ICD-10 diagnosis codes (E08.*, E09.*, E10.*, E11.*, E13.* series) to the Applicable Codes list.

Supporting information updated

Updated Supporting Information sections including Clinical Evidence, FDA, and References to reflect current information (archived previous policy version IEXD0138.01).

OpenPayer

Susvimo (ranibizumab intravitreal implant) coverage