ModifiedCentenePolicy CP.PHAR.186

Ranibizumab (Byooviz, Cimerli, Lucentis, Susvimo) coverage

Defines medical necessity, prior authorization, dosing limits, and coverage criteria for ranibizumab products (Lucentis, Susvimo, Byooviz, Cimerli) across indications including nAMD, RVO-related macular edema, mCNV, DME, and DR for Centene lines of business.

Policy Summary

PayerCentene

PolicyRanibizumab (Byooviz, Cimerli, Lucentis, Susvimo) coverage

Policy CodePolicy CP.PHAR.186

Change TypeBiosimilars addedSusvimo dosing clarifiedquantity limits added

Effective Date03.01.16

Next Review Date

Key ActionObtain prior authorization and submit documentation showing diagnosis and prior bevacizumab failure or contraindication when applicable.

SourceLink

POLICY UPDATE CHANGES

Simplified FDA approved indications to show Lucentis and Cimerli are additionally indicated from Byooviz for DME and DR; added quantity limit of 1 vial/syringe for Lucentis and biosimilars; revised Susvimo maximum dose to 100 mg (1 vial) per 6 months per PI.

Added Byooviz, Cimerli, and Susvimo to policy and their HCPCS codes (Q5124, J2779) at various updates.

Updated Susvimo dosing regimen and maximum dosing schedule (refills every 24 weeks for some indications; 36 weeks for others) per prescribing information.

0.3/0.5/2 mgDose options

6 moTypical approval

3 momCNV approval

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Qty limit (Lucentis)

Q5124, J2778, J2779HCPCS codes

Coverage Criteria

Initial Therapy — Non-DME/DR

Covered when ALL of the following are met:

ALL of the following

Diagnosis of one of the following: neovascular age-related macular degeneration (nAMD), macular edema following retinal vein occlusion (RVO), myopic choroidal neovascularization (mCNV)
For DME and DR see separate DME/DR criteria group below.
Age ≥ 18 years
Prescribed by or in consultation with an ophthalmologist
For non-DME/DR indications: failure of intravitreal bevacizumab (Avastin) unless contraindicated or clinically significant adverse effects experienced
Prior authorization may be required for bevacizumab intravitreal solution. Requests for IV formulations of Avastin, Mvasi, and Zirabev will not be approved.
If request is for Susvimo: member has previously responded to at least 2 intravitreal injections of a VEGF inhibitor (eg, intravitreal bevacizumab)
Requested dose does not exceed the FDA‑approved dosing for the indicated product (see Dosing-based coverage criteria)
Maximums vary by product and indication (Lucentis/Cimerli/Byooviz: typically 0.5 mg/month for nAMD and RVO; Cimerli/Lucentis for DME/DR: 0.3 mg/month; Susvimo: up to 2 mg per implant interval per PI).

Initial Therapy — DME and DR

Covered when ALL of the following are met:

ALL of the following

Request is for Cimerli, Lucentis, or Susvimo
Diagnosis of diabetic macular edema (DME) or diabetic retinopathy (DR)
Age ≥ 18 years
Prescribed by or in consultation with an ophthalmologist
Failure of intravitreal bevacizumab unless contraindicated or clinically significant adverse effects experienced
Prior authorization may be required for bevacizumab intravitreal solution. Requests for IV formulations of Avastin, Mvasi, and Zirabev will not be approved.

Continued Therapy

Covered when ALL of the following are met:

ALL of the following

Member is currently receiving the medication via the Centene benefit or has previously met the Initial Therapy criteria
Continuity of care provisions apply per state/product when applicable.
Member is responding positively to therapy as evidenced by improvement or maintenance of visual acuity, decreased neovascularization, or supportive imaging (eg, OCT or fluorescein angiography)
If request is for a dose increase, the new dose does not exceed FDA‑approved maximums for the product and indication (see Dosing-based coverage criteria)

Dosing-based coverage criteria

Coverage tied to FDA‑approved indications and dosing regimens; prior authorization limits and quantity limits apply.

ALL of the following

Dosing and maximums must align with product-specific FDA‑approved regimens: e.g., Lucentis/Byooviz/Cimerli: 0.5 mg (0.05 mL) intravitreal monthly for nAMD/RVO; Cimerli/Lucentis for DME/DR: 0.3 mg (0.05 mL) intravitreal monthly; Susvimo implant: 2 mg per implant refill interval (typically every 24 weeks for some indications; per PI may be up to 36 weeks for others)
Refer to Dosage and Administration section for full regimens and maximums.
Quantity limit: one vial/syringe per dose for Lucentis and biosimilars where applicable
Requests for IV formulations of Avastin, Mvasi, and Zirabev are not approved; bevacizumab intravitreal solution may require prior authorization and is considered failure criterion when appropriate

Coding and Billing

Therapeutic Alternativesmixed

bevacizumab (Avastin)

Therapeutic alternative listed with dosing 1.25 mg administered by intravitreal injection every 4 weeks (maximum 1.25 mg/month)

Coding Implications / Referenced HCPCS and Q-codesHCPCS

J2778	Injection, ranibizumab 0.1 mg
J2779	Injection, ranibizumab 0.5 mg
Q5124	Injection, ranibizumab-nuna biosimilar (Byooviz)
Q5128	Injection, ranibizumab-eqrn, biosimilar (Cimerli) 0.1 mg

Age — Typical age requirement

Typical age requirement>= 18 years

Source contextAge requirement appears in initial and DME/DR criteria as '2 18 years' (>=18)

Applies toAll indications covered by this policy (nAMD, RVO-related macular edema, mCNV, DME, DR)

Maximum dose per interval — Ranibizumab and Susvimo dosing summary

Ranibizumab (Lucentis/Byooviz/Cimerli) typical monthly dose0.5 mg (0.05 mL) intravitreal once monthly for nAMD, RVO, and mCNV; maximum = 0.5 mg/month

Ranibizumab for DME/DR0.3 mg (0.05 mL) intravitreal once monthly; maximum = 0.3 mg/month

Provider Actions and Requirements

Prior Authorization

Prior Authorization and Coding for Ranibizumab Products

Prior authorization is required for ranibizumab products (Byooviz, Cimerli, Lucentis, and Susvimo). Providers must document the ICD-10 diagnosis and supply clinical records (e.g., office notes, imaging) demonstrating that the member meets all applicable criteria in the policy. For requests involving bevacizumab intravitreal solution, document prior bevacizumab failure or a contraindication when applicable.

Prior authorization may be required for bevacizumab intravitreal solution; IV formulations of Avastin, Mvasi, and Zirabev will not be approved.
If request is for Susvimo, document prior response to at least 2 intravitreal injections of a VEGF inhibitor (e.g., intravitreal bevacizumab) unless contraindicated.
Quantity limit: 1 vial/syringe per month for Lucentis and biosimilars (see policy dosing limits).
Susvimo: maximum 100 mg (one 100 mg/mL vial) per 6 months per PI.

Denial Risk

Background

Ranibizumab products are vascular endothelial growth factor (VEGF) inhibitors formulated for intravitreal administration and are approved for multiple retinal conditions, including neovascular (wet) age‑related macular degeneration (nAMD), macular edema following retinal vein occlusion (RVO), myopic choroidal neovascularization (mCNV), diabetic macular edema (DME), and diabetic retinopathy (DR), depending on the specific ranibizumab formulation.

Definitions

DME — diabetic macular edema

DefinitionDiabetic macular edema (DME)

Context in policyDME is listed as a covered diagnosis for ranibizumab products (Cimerli, Lucentis, Susvimo) when criteria are met

Typical ranibizumab dose for DMECimerli or Lucentis: 0.3 mg/month; Susvimo dosing differs (implant refills per PI)

nAMD — neovascular (wet) age-related macular degeneration

DefinitionNeovascular (wet) age-related macular degeneration (nAMD)

Policy dosing for ranibizumabLucentis/Byooviz/Cimerli: 0.5 mg monthly (maximum 0.5 mg/month); Susvimo: 2 mg implant with refills ~24 weeks for nAMD

Revision History

03.04.21ad_hoc

Redirection language updated to emphasize use of bevacizumab intravitreal solution given availability of generic bevacizumab intravitreal solution and to minimize use of IV bevacizumab products; language initially converted toward a 'must use' goal.

08.03.21ad_hoc

Redirection language converted from a 'must use' requirement to a 'failure of bevacizumab intravitreal solution' requirement, indicating step-therapy now requires prior trial/failure of bevacizumab before ranibizumab approval.

11.09.21annual_review

1Q 2022 annual review: added Byooviz and Susvimo to policy and updated approval durations (shortened mCNV to 3 months and other indications to 6 months) and removed redirection to Mvasi for DME in legacy WCG rules.

Policy Summary

PayerCentene

PolicyRanibizumab (Byooviz, Cimerli, Lucentis, Susvimo) coverage

Policy CodePolicy CP.PHAR.186

Change TypeBiosimilars addedSusvimo dosing clarifiedquantity limits added

Effective Date03.01.16

Next Review Date

Key ActionObtain prior authorization and submit documentation showing diagnosis and prior bevacizumab failure or contraindication when applicable.

SourceLink

On This Page

If request is for Susvimo: member has previously responded to at least 2 intravitreal injections of a VEGF inhibitor (eg, intravitreal bevacizumab)

Requested dose does not exceed the FDA‑approved dosing for the product and indication (see Dosing-based coverage criteria)

For DME: Cimerli or Lucentis 0.3 mg/month; for DR: Susvimo dosing per PI (eg, 2 mg per implant interval).

Susvimo implant refill dosingSusvimo: 2 mg continuously delivered via implant with refills every ~24 weeks (nAMD/DME) or ~36 weeks (DR); policy states maximum per interval: 2 mg per 6 months (or per 9 months for DR per PI)

Policy maximums and revisionsPolicy language references Susvimo maximum dose as 2 mg per refill (100 mg/mL vial) per PI-specified intervals and clarifies Susvimo maximums in continued therapy (100 mg/1 vial per 6 months in some entries).

Denials may be issued when documentation is insufficient or when requests are for non‑FDA approved indications without supporting off‑label evidence per off‑label policies. Lack of documentation showing prior bevacizumab trial or contraindication when required, requests for IV formulations of bevacizumab biosimilars, doses exceeding policy limits, or requests that do not meet the listed clinical criteria may be denied.

Non‑FDA approved indications not addressed in this policy require sufficient supporting documentation per CP.CPA.09 (commercial), HIM.PA.154 (marketplace), or CP.PMN.53 (Medicaid).
Requests for IV Avastin/Mvasi/Zirabev formulations will not be approved.
Denied if provider fails to submit office chart notes, imaging, or other clinical information supporting criteria.
Denial likely if bevacizumab trial requirement is not met and no documented contraindication or clinically significant adverse effect exists.

Step Therapy

Step Therapy: Bevacizumab Trial

Step therapy requires documented failure of bevacizumab intravitreal solution prior to approval of ranibizumab products, unless a contraindication or clinically significant adverse effect to bevacizumab is documented. For Susvimo, additional requirement: prior clinical response to at least 2 intravitreal VEGF inhibitor injections unless contraindicated.

Bevacizumab dosing alternative: intravitreal bevacizumab 1.25 mg every 4 weeks (per Appendix B therapeutic alternatives).
Prior authorization may be required for bevacizumab intravitreal solution.
Failure of bevacizumab is required except when contraindicated or when clinically significant adverse effects occurred.

Note

Step Therapy Involving Bevacizumab (Policy History)

Policy history reflects multiple updates to step/redirection language involving bevacizumab—currently the policy requires failure of bevacizumab intravitreal solution (rather than an absolute "must use") before approving ranibizumab products. Providers should follow the current step-therapy requirement and document prior bevacizumab use and outcome.

Ad hoc updates in 2021 changed redirection language from "must use" to requirement of failure of bevacizumab intravitreal solution.
Do not submit requests for IV formulations of bevacizumab biosimilars for intravitreal ophthalmic indications.

Covered indicationnAMD is an FDA-indicated condition for ranibizumab products per policy dosing sections

DR — diabetic retinopathy

DefinitionDiabetic retinopathy (DR)

Policy inclusionDR (with or without DME) is an indicated diagnosis for ranibizumab formulations when criteria are met

Typical ranibizumab dose for DRCimerli or Lucentis: 0.3 mg/month; Susvimo implant: 2 mg with refills every ~36 weeks for DR (per PI)

RVO — retinal vein occlusion

DefinitionRetinal vein occlusion (RVO)

Policy indicationMacular edema following RVO is a covered diagnosis for ranibizumab products

Typical ranibizumab dose for RVO-related macular edema0.5 mg (0.05 mL) intravitreal once monthly; maximum = 0.5 mg/month

mCNV — myopic choroidal neovascularization

DefinitionMyopic choroidal neovascularization (mCNV)

Policy dosing and durationRanibizumab 0.5 mg monthly for up to 3 months; approval duration for mCNV: 3 months

Covered by policymCNV is listed among indications for ranibizumab formulations when criteria are met

VEGF — vascular endothelial growth factor

DefinitionVascular endothelial growth factor (VEGF)

RoleVEGF is the molecular target of ranibizumab products; policy references prior response to VEGF inhibitors as part of Susvimo criteria

Clinical contextPolicy notes ranibizumab products are anti-VEGF agents used across listed retinal neovascular indications

Loss/gain of ≥15 letters — Trial endpoint used to compare efficacy

Endpoint definitionLoss or gain of >= 15 letters on visual acuity testing is a clinical trial endpoint used to compare efficacy across agents

Example trialsANCHOR and VIEW trials reported proportions losing fewer than 15 letters or gaining at least 15 letters to compare ranibizumab vs comparators

Use in policyPolicy references these trial endpoints when summarizing efficacy comparisons between ranibizumab and other agents

Susvimo — Ranibizumab intravitreal implant with scheduled refills (~24–36 weeks)

Product descriptionSusvimo is a ranibizumab intravitreal implant that provides continuous delivery of ranibizumab and requires scheduled refills

Refill intervals per PIRefills every ~24 weeks (approximately 6 months) for some indications and every ~36 weeks (approximately 9 months) for others (e.g., DR)

Dosing strength per refillRefill delivers 2 mg (0.02 mL of 100 mg/mL solution); policy references Susvimo as '2 mg' per refill and ties maximums to PI-specified intervals

11.15.24annual_reviewLatest

1Q 2025 annual review: simplified FDA-indication listings (Lucentis and Cimerli noted for DME and DR alongside Byooviz), added quantity limit of 1 vial/syringe for Lucentis and biosimilars, and revised Susvimo maximum dose to 100 mg (1 vial) per 6 months per prescribing information (P&T Approval Date = 02.25).

02.12.25rt4_update

RT4 update: Susvimo FDA indication updated to include DME per internal update records.

05.28.25rt4_update

RT4 update entry recorded (internal date) related to Susvimo indication updates per source; P&T approval details pending in document.