Sierra Health and Life Susvimo Coverage Update

Coverage Criteria for Susvimo (ranibizumab intravitreal implant)

Initial Therapy — Covered when ALL of the following are met for initial therapy

Covered when ALL of the following are met for initial therapy

Initial therapy requirements: (1) Diagnosis is one of the following: neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), or diabetic retinopathy (DR); (2) Patient has previously responded to at least two intravitreal injections of a VEGF inhibitor (examples include bevacizumab, aflibercept, ranibizumab, faricimab); (3) Dosing is in accordance with United States FDA–approved labeling; (4) Initial authorization will be for no longer than 12 months.

Continuation Therapy — Covered when ALL of the following are met for continuation of therapy

Covered when ALL of the following are met for continuation of therapy

Continuation therapy requirements: (1) Documentation of a positive clinical response to Susvimo; (2) Dosing is in accordance with United States FDA–approved labeling; (3) Reauthorization will be for no longer than 12 months.

Documentation must include evidence of prior response to ≥2 intravitreal VEGF injections as described in initial criteria.

Coverage for Susvimo (ranibizumab implant) — Covered when ALL of the following are met (FDA indications and trial references)

Covered when ALL of the following are met

FDA indication and prior response: Patient has one of the FDA‑indicated conditions (neovascular AMD, diabetic macular edema, or diabetic retinopathy) AND has previously responded to at least two intravitreal injections of a VEGF inhibitor.>=2 prior intravitreal VEGF injections

Aligns coverage to FDA indications and to the inclusion criteria used in pivotal Susvimo trials (see AMD NCT03677934, DME NCT04108156, DR NCT04503551).

The following procedure and diagnosis code lists are provided for reference only and may not be all inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or non‑covered health service. Benefit coverage for health services is determined by the member‑specific benefit plan document and applicable laws. Inclusion of a code in this policy does not guarantee reimbursement or claim payment; other policies and guidelines may apply.

Information on U.S. Food and Drug Administration (FDA) approval is provided for context only. FDA approval alone is not a basis for coverage. Susvimo (ranibizumab injection) is FDA‑labeled for neovascular (wet) AMD, diabetic macular edema (DME), and diabetic retinopathy (DR) in patients who previously responded to at least two intravitreal VEGF inhibitor injections, but coverage is determined by the member‑specific benefit plan and any applicable federal or state mandates.

When applying this policy, providers must consult the member‑specific benefit plan document because plan terms may differ from the standard policy. Where there is a conflict, the member‑specific benefit plan governs; state or federal mandates that require coverage supersede plan language.

Use of Susvimo for indications not supported by the member’s benefit plan or for uses outside the FDA‑labeled indications may be considered experimental, investigational, or unproven unless the member‑specific benefit plan or applicable state mandates explicitly allow such coverage. Always consult the member‑specific benefit document when considering off‑label or non‑labeled uses.

Relevant Billing and Diagnosis Codes

Applicable HCPCS CodesHCPCSCovered

J2779

Injection, ranibizumab, via intravitreal implant, 0.1 mg

Neovascular (Wet) AMD ICD-10 CodesICD-10Covered

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 (selection of ICD-10 codes listed)ICD-10Covered

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
E08.3311	Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, right eye
E08.3312	Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, left eye
E08.3313	Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, bilateral
E08.3319	Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye
E08.3411	Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, right eye

Diabetic Retinopathy (selection of ICD-10 codes listed)ICD-10Covered

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
E08.3292	Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema, left eye
E08.3293	Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema, bilateral
E08.3299	Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without 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

Diabetic retinopathy — drug/chemical induced (examples)ICD-10

E09.3393	Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, bilateral
E09.3399	Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, unspecified eye
E09.3491	Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye
E09.3492	Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye
E09.3493	Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral
E09.3499	Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, unspecified eye
E09.3521	Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye

Diabetic retinopathy — drug/chemical induced (continued)ICD-10

E09.3522	Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye
E09.3523	Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral
E09.3529	Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, unspecified eye
E09.3531	Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye

Diabetic retinopathy — Type 1, Type 2, and other specified (examples)ICD-10

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
E10.3391	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
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
E11.3521	Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye

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Applicable ICD-10 diagnosis codes (selected examples; full list in policy history)ICD-10Covered

E13.3551	Other specified diabetes mellitus with stable proliferative diabetic retinopathy, right eye
E13.3552	Other specified diabetes mellitus with stable proliferative diabetic retinopathy, left eye
E13.3553	Other specified diabetes mellitus with stable proliferative diabetic retinopathy, bilateral
E13.3559	Other specified diabetes mellitus with stable proliferative diabetic retinopathy, unspecified eye
E13.3591	Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye
E13.3592	Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye
E13.3593	Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral
E13.3599	Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, unspecified eye
E08.319	ICD-10 diagnosis code added (see policy history for full list)

Prior VEGF response — requirement (inv-15)

Required prior responsePreviously responded to at least two intravitreal injections of a VEGF inhibitor

Examples of VEGF inhibitorsBevacizumab (Avastin), Aflibercept (Eylea, Eylea HD), Ranibizumab (Lucentis), Faricimab (Vabysmo), Aflibercept biosimilars (Pavblu)

Role in coverage decisionPrior response is required for FDA-indicated populations (AMD, DME, DR) to meet coverage criteria for Susvimo

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required — requests must document the specific ocular diagnosis and the agent. The prior authorization request should explicitly reference the member's ICD-10 diagnosis code (including diabetes type, laterality, and severity where applicable) and identify the VEGF inhibitor agent(s) previously used.

Reference the exact ICD-10 code from the member record that corresponds to the billed diagnosis (e.g., E10.3291, E10.3492, etc.).
Indicate the VEGF inhibitor agent(s) previously administered (examples: bevacizumab, aflibercept, ranibizumab, faricimab, pavblu) and dates of administration.

Prior Authorization

Susvimo Prior Authorization Considerations

Prior authorization for Susvimo must align with FDA indications and established policy criteria. For both initial and continuation requests, include documentation that the patient previously responded to at least two intravitreal injections of a VEGF inhibitor, and confirm dosing will follow the FDA‑approved labeling.

For initial therapy: document diagnosis (neovascular AMD, DME, or DR) and prior positive response to ≥2 intravitreal VEGF inhibitor injections.

Background and Clinical Evidence

Susvimo is an implantable port delivery system delivering ranibizumab (a VEGF inhibitor) for sustained intravitreal therapy. The FDA‑labeled indications include 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.

The coverage criteria in this policy align with the FDA indications and pivotal clinical trial populations used to evaluate Susvimo. For initiation, documented prior response to intravitreal VEGF therapy (≥2 injections) and adherence to FDA dosing are required; continuation requires documentation of a positive clinical response and dosing consistent with the U.S. FDA label.

Ranibizumab mechanism — monoclonal antibody fragment (inv-30)

Drug class and targetMonoclonal antibody fragment that binds VEGF-A, preventing VEGF-A interaction with VEGFR1/VEGFR2

Mechanism effectReduces endothelial cell proliferation, vascular leakage, and ocular neovascularization

Clinical relevanceMechanistic rationale for use in neovascular AMD and other VEGF-mediated retinal diseases

Definitions and Key Terms

Previously responded — clinical improvement after ≥2 VEGF injections (inv-29)

Definition — Previously respondedClinical improvement or positive response following at least two intravitreal injections of a VEGF inhibitor (examples: bevacizumab, aflibercept, ranibizumab, faricimab)

Examples of positive responseReduction in retinal neovascularization, decreased vascular leakage, or improvement/stabilization of visual acuity documented after treatment

Documentation neededMedical records should document the response to ≥2 prior intravitreal VEGF injections for authorization and continuation

OpenPayer

Susvimo (ranibizumab intravitreal implant) coverage criteria

Coverage Criteria for Susvimo (ranibizumab intravitreal implant)

Relevant Billing and Diagnosis Codes

Provider Requirements, Prior Authorization, and Documentation

Background and Clinical Evidence

Definitions and Key Terms