ModifiedCentenePolicy CP.PHAR.186

Ranibizumab (Byooviz, Cimerli, Lucentis, Nufymco, Susvimo)

Defines medical necessity and prior authorization criteria for ranibizumab products and biosimilars for ophthalmic indications (e.g., nAMD, RVO, mCNV, DME, DR) for Centene lines of business.

Policy Summary

PayerCentene

PolicyRanibizumab (Byooviz, Cimerli, Lucentis, Nufymco, Susvimo)

Policy CodePolicy CP.PHAR.186

Change TypeMaterial clinical and coverage updates

Effective DateMar 1, 2016

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis, ophthalmology prescriber or consultation, age ≥18, prior bevacizumab failure when required, and dosing within specified limits.

SourceLink

POLICY UPDATE CHANGES

Added Nufymco to policy.

Extended continued therapy duration from 6 months to 12 months for DME, DR, RVO, and nAMD.

Simplified FDA indications showing Lucentis and Cimerli additionally indicated for DME and DR; added quantity limit of 1 vial/syringe for Lucentis and biosimilars; revised Susvimo maximum dose.

Added step therapy bypass for Illinois HIM per IL HB 5395.

5ranibizumab product names covered

≥18minimum patient age for approval

Prior bevacizumabstep therapy requirement

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max dose (most indications)

0.3 mg/moDME/DR dose

1 vialLucentis/biosimilar quantity limit

Coverage Criteria

Initial Therapy (Non-DME/DR)

Covered when ALL of the following are met:

Initial Approval (Non-DME/DR): 1) Diagnosis of one of the following: nAMD; macular edema following RVO; or mCNV. 2) Prescribed by or in consultation with an ophthalmologist. 3) Age ≥ 18 years. 4) Failure of bevacizumab intravitreal solution unless contraindicated or clinically significant adverse effects are experienced (prior authorization may be required for bevacizumab; IV formulations of Avastin/Mvasi/Zirabev will not be approved). 5) If request is for Susvimo, member has previously responded to at least 2 intravitreal injections of a VEGF inhibitor and the request is for treatment of nAMD. 6) Dose does not exceed indication- and product-specific limits: for RVO or mCNV: 0.5 mg (1 vial/syringe) per month; for nAMD: Byooviz/Cimerli/Lucentis/Nufymco 0.5 mg (1 vial/syringe) per month OR Susvimo 2 mg (one 100 mg/mL vial) per 6 months.

For Illinois HIM requests, the bevacizumab step therapy requirement does not apply per IL HB 5395.

Initial Therapy (DME/DR)

Covered when ALL of the following are met:

Initial Approval (DME/DR): 1) Request is for Cimerli, Lucentis, Nufymco, or Susvimo. 2) Diagnosis of DME or DR. 3) Prescribed by or in consultation with an ophthalmologist. 4) Age ≥ 18 years. 5) Failure of bevacizumab intravitreal solution unless contraindicated or clinically significant adverse effects are experienced (prior authorization for bevacizumab may be required; IV formulations of Avastin/Mvasi/Zirabev will not be approved). 6) If request is for Susvimo, member has previously responded to at least 2 intravitreal injections of a VEGF inhibitor. 7) Dose does not exceed specified limits: for DME: Cimerli/Lucentis/Nufymco 0.3 mg (1 vial/syringe) per month OR Susvimo 2 mg (one 100 mg/mL vial) per 6 months; for DR: Cimerli/Lucentis/Nufymco 0.3 mg (1 vial/syringe) per month OR Susvimo 2 mg (one 100 mg/mL vial) per 9 months.

Continued Therapy

Continued coverage when ALL of the following are met:

Continued Therapy: 1) Member meets one of the following: a) currently receiving the medication via Centene benefit or previously met initial approval criteria; or b) currently receiving medication and enrolled in a state/product with continuity-of-care regulations. 2) Member is responding positively to therapy as evidenced by at least one of: a) decreased neovascularization; b) improvement in visual acuity; c) maintenance of corrected visual acuity from prior treatment; or d) supportive findings from optical coherence tomography or fluorescein angiography. 3) If the request is for a dose increase, the new dose must not exceed the product- and indication-specific maximums (see dosing tables for DME/DR, RVO, mCNV, and nAMD).

Approval duration: mCNV — 3 months; all other indications — 12 months (continued therapy).

Non-listed Indications / Label Changes

Covered when the following are met:

Non-listed Indications / Label Changes: 1) If the drug label changed within the last 6 months and the change is not yet reflected in this policy, follow the applicable formulary/no-coverage or non-formulary policy for the relevant line of business (see CP.CPA.190, HIM.PA.33, CP.PMN.255 for formulary/no-coverage; CP.CPA.190, HIM.PA.103, CP.PMN.16 for non-formulary). 2) If the requested use (diagnosis, age, dosing) is not listed under section III (Diagnoses/Indications for which coverage is NOT authorized) and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for marketplace, CP.PMN.53 for Medicaid).

Indication-specific dosing coverage

Covered when dosing and indications align with FDA-approved regimens and policy edits (examples below reflect dosing-based coverage guidance):

nAMD / RVO / mCNV: Ranibizumab (Lucentis, Byooviz, Cimerli, Nufymco): 0.5 mg (0.05 mL) intravitreal injection once monthly. Alternative regimens allowed per PI (e.g., once monthly x3 then 4–5 doses over next 9 months, or reduce to q3 months after first 4 injections if monthly not feasible). Maximum dose = 0.5 mg/month.dose-based

Susvimo implant is an alternative delivery option per prescribing information.

DME / DR: Ranibizumab (Lucentis, Cimerli, Nufymco): 0.3 mg (0.05 mL) intravitreal injection once monthly. Maximum dose = 0.3 mg/month.dose-based

Susvimo implant: Ranibizumab (Susvimo): 2 mg (0.02 mL of 100 mg/mL solution) continuously delivered via the Susvimo implant with refills every ~24 weeks (≈6 months) for nAMD/DME; for DR refills may be every ~36 weeks (≈9 months) per indication. Maximum dose = 2 mg per respective interval (e.g., 2 mg/6 months).

Non–FDA labeled uses of ranibizumab products and biosimilars that are not specifically addressed by this policy are not authorized unless the provider submits adequate clinical documentation demonstrating efficacy and safety in accordance with applicable off‑label use policies (e.g., CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, or CP.PMN.53 for Medicaid).

Ranibizumab products (Byooviz, Cimerli, Lucentis, Nufymco) and Susvimo are contraindicated in the presence of ocular or periocular infections and in patients with documented hypersensitivity to the product. In addition, Susvimo has a specific contraindication for active intraocular inflammation and carries a boxed safety concern for a higher observed rate of endophthalmitis compared with monthly intravitreal ranibizumab injections.

Requests for ranibizumab products or biosimilars for off‑label indications will not be approved unless the request includes sufficient supporting evidence of safety and effectiveness consistent with the referenced off‑label use policies; absent that documentation, such uses are considered not covered.

Use of any ranibizumab product or biosimilar in patients who have one of the listed contraindications (e.g., ocular/periocular infection, hypersensitivity, or, for Susvimo, active intraocular inflammation) is not authorized. Operationally, prior authorization requests indicating a contraindication should be denied and documentation should be provided if a provider believes an exception is warranted per line‑of‑business off‑label or medical exception processes.

Coding and Dose Limits

Therapeutic alternatives (example dosing)mixed

bevacizumab 1.25 mg	Bevacizumab intravitreal dosing referenced as therapeutic alternative: nAMD — 1.25 mg intravitreal every 4 weeks (1.25 mg/month).
bevacizumab 1.25 mg (RVO)	Macular edema secondary to RVO — 1.25 mg intravitreal every 4 weeks (1.25 mg/month).
bevacizumab 1.25 mg (DR)	DR — 1.25 mg intravitreal every 6 weeks (1.25 mg/6 weeks).
bevacizumab 1.25–1.5 mg (DME)	DME — 1.25 to 1.5 mg intravitreal every 4 weeks (up to 1.5 mg/month).
bevacizumab 1.25 mg (mCNV)	mCNV — 1.25 mg initial intravitreal injection with monthly evaluation for additional injections as needed (1.25 mg/month).

Referenced HCPCS codesHCPCS

J2778	Injection, ranibizumab, 0.1 mg.
J2779	Injection, ranibizumab, via intravitreal implant (Susvimo), 0.1 mg.
Q5124	Injection, ranibizumab-nuna, biosimilar, (Byooviz), 0.1 mg.
Q5128	Injection, ranibizumab-eqrn, biosimilar (Cimerli), 0.1 mg.

Dose limits — maximums by product and indication

RVO / mCNV maximum0.5 mg (1 vial/syringe) per month

nAMD maximum (most products)0.5 mg (1 vial/syringe) per month for Byooviz, Cimerli, Lucentis, or Nufymco

Susvimo (nAMD) maximum2 mg (one 100 mg/mL vial) per 6 months (delivered via implant)

Quantity limit (Lucentis/biosimilars)1 vial/syringe per dose (policy-level quantity limit)

Maximum doses — key values

Most ranibizumab products (nAMD, RVO, mCNV)0.5 mg/month maximum

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for ranibizumab and its biosimilars for the indications in this policy. Requests must include documentation of the clinical diagnosis, prescriber specialty, patient age, and prior use of bevacizumab when applicable. Prior authorization may also be required for bevacizumab intravitreal solution; IV formulations (Avastin, Mvasi, Zirabev) will not be approved.

Required at time of service authorization
Include diagnosis, prescriber specialty, age, prior bevacizumab use (or contraindication)
Bevacizumab IV formulations (Avastin, Mvasi, Zirabev) are excluded from approval

Prior Authorization

Prior Authorization Durations

For DME, DR, RVO, and nAMD the policy provides modified prior authorization durations — continued therapy (maintenance) duration has been extended to 12 months for these chronic indications in the most recent review.

Continued therapy duration: 12 months for DME, DR, RVO, and nAMD (maintenance)
See policy for initial approval durations and any indication-specific limits

Definitions

Definition — DME (abbreviation)

DMEdiabetic macular edema

Usage noteReferenced in Appendix A as abbreviation for diabetic macular edema

ContextAppears in initial and continued therapy sections specific to dosing and approval durations

Definition — DR (abbreviation)

DRdiabetic retinopathy

Usage noteDefined in Appendix A as diabetic retinopathy

ContextDR dosing and Susvimo refill interval (9 months) specified separately in policy

Background

Ranibizumab and its biosimilars are intravitreal vascular endothelial growth factor (VEGF) inhibitors used to treat 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). Susvimo provides an alternative implant‑based delivery of ranibizumab with distinct prior‑response requirements and dosing intervals noted in product labeling.

Policy Summary

PayerCentene

PolicyRanibizumab (Byooviz, Cimerli, Lucentis, Nufymco, Susvimo)

Policy CodePolicy CP.PHAR.186

Change TypeMaterial clinical and coverage updates

Effective DateMar 1, 2016

Next Review Date

SourceLink

On This Page

Policy clarifies Susvimo maximum dosing and refill intervals per PI; Susvimo associated with specific safety considerations noted in contraindications.

DME and DR (Lucentis, Cimerli, Nufymco)

0.3 mg/month maximum

Susvimo refill cadence and maximumSusvimo implant delivers 2 mg using one 100 mg/mL vial with refills every ~24 weeks (≈6 months) for nAMD/DME; for DR refills every ~36 weeks (≈9 months); maximum 2 mg per respective interval

Step Therapy

Bevacizumab Step Therapy Requirement

Step therapy requires failure of intravitreal bevacizumab before ranibizumab or biosimilars will be approved, unless bevacizumab is contraindicated or causes clinically significant adverse effects.

Document prior bevacizumab trials (dosing, dates, response, adverse effects)
If bevacizumab is contraindicated, provide clinical rationale

Prior Authorization

State-specific Step Therapy Bypass (Illinois HIM)

Illinois Health Insurance Marketplace (HIM) requests: per IL HB 5395, the step therapy requirement (failure of bevacizumab) does not apply; include appropriate HIM identifiers when submitting a bypass request.

IL HB 5395 allows step therapy bypass for Illinois HIM members
Document payer/plan and member HIM status on the request

Documentation Required

Required Documentation

Submit supporting clinical documentation with all prior authorization requests. Typical acceptable documentation includes office/clinic notes, imaging and test results, and prior treatment records that demonstrate treatment response or intolerance.

Office/clinic notes documenting diagnosis and ophthalmologist involvement
Imaging (e.g., OCT), visual acuity measurements, and relevant lab results if applicable
Records of prior intravitreal bevacizumab treatments (dates, doses, outcomes, adverse events)

Note

Support With Current Prescribing Information and Guidelines

Providers should reference current prescribing information and relevant clinical guidelines when making treatment decisions and when submitting documentation to support medical necessity.

Prescribing information is the authoritative source for dosing and product-specific limits
Clinical guidelines (AAO PPP) support indication and monitoring decisions

Denial Risk

Denial Triggers

Common reasons for denial include missing or insufficient documentation, failure to meet policy criteria (including age, diagnosis, prescriber specialty), and not meeting the bevacizumab step therapy requirement when applicable.

Missing office notes, imaging, or prior treatment records
Prescriber not an ophthalmologist or no documented consultation
Age criteria not met (must be ≥ 18 years where specified)
No documentation of prior bevacizumab trial or documented contraindication

Billing Rule

Coding Omission May Trigger Denial

Inclusion of billing or procedure codes in this policy is for informational purposes only. Failure to include appropriate codes or following outdated coding guidance may result in claim denials; always verify current professional coding resources before claim submission.

Codes listed in the policy are informational; verify payer-specific and up-to-date coding guidance
Ensure the correct J/Q codes and modifiers are used per current coding manuals and payer instructions

Definition — mCNV (abbreviation)

mCNVmyopic choroidal neovascularization

Usage noteDefined in Appendix A as myopic choroidal neovascularization

ContextListed among ophthalmic diseases other than DME/DR for initial approval

Definition — nAMD

nAMDneovascular (wet) age-related macular degeneration

Usage noteTerm appears in initial approval criteria and dosage sections; defined in Appendix D

ContextIndication with specific 0.5 mg monthly dosing for most ranibizumab products and special Susvimo criteria

Definition — RVO

RVOretinal vein occlusion

Usage noteListed in Appendix D and treated with ranibizumab 0.5 mg/month in policy dosing guidance

ContextIncluded in initial approval for ophthalmic disease other than DME/DR

Definition — VEGF

VEGFvascular endothelial growth factor

Usage noteRanibizumab and biosimilars are VEGF inhibitors; prior response to VEGF injections required for Susvimo

ContextAppears in clinical rationale and Susvimo prior-response requirements