CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Ranibizumab: Lucentis, Byooviz, Cimerli

Medical benefit coverage and prior authorization criteria for ranibizumab products (Lucentis, Byooviz, Cimerli) for specified retinal conditions across Medicaid, Commercial, and Medicare lines when no NCD/LCD applies.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRanibizumab: Lucentis, Byooviz, Cimerli

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2020

Next Review DateJan 27, 2026

Key ActionSubmit prior authorization with documentation of diagnosis, baseline and periodic BCVA, and evidence of intolerance or inadequate response to bevacizumab as required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+minimum age for coverage

12mo / 3moinitial coverage duration

10 or 6max billed units/28d

Q5124,Q5128,J2778billing codes

Coverage Criteria for Ranibizumab Products

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Age and prescriber: Member is at least 18 years of age or older; prescribed by or in consultation with a Retina Specialist

Diagnosis: Member has a documented diagnosis of one of: neovascular (wet) age-related macular degeneration (AMD); macular edema due to retinal vein occlusion (RVO); diabetic macular edema (DME) (Lucentis and Cimerli only); diabetic retinopathy (DR) (Lucentis and Cimerli only); or myopic choroidal neovascularization (mCNV)

Baseline measurement: Member's best corrected visual acuity (BCVA) is measured at baseline and periodically during treatment

Step therapy for ranibizumab products: For Lucentis, Cimerli or Byooviz, patient must have an inadequate treatment response, documented intolerance, or contraindication to bevacizumab

Additional step for Cimerli: If the requested drug is Cimerli for AMD, RVO or mCNV, the patient must also have an inadequate response, intolerance, or contraindication to Lucentis or Byooviz

Cimerli requires prior failure/intolerance to Lucentis or Byooviz for AMD, RVO, or mCNV

Infection and concomitant therapy: Member is free of ocular and/or peri-ocular infections; therapy will not be used with other ophthalmic VEGF inhibitors

Excludes supplemental use with Susvimo for wet AMD if clinically necessary

Existing therapy exemption: Members currently on treatment with Lucentis, Cimerli, or Byooviz can remain on treatment OR Medicare members who received the medication within the past 365 days are not subject to Step Therapy Requirements

Renewal Therapy

Renewal covered when ALL of the following are met

Meet initial criteria: Member meets all initial criteria

Tolerability: Member is tolerating treatment without unacceptable toxicity (examples include endophthalmitis, retinal detachment, increased intraocular pressure, arterial thromboembolic events)

Clinical benefit or disease activity: Member has had a beneficial response to therapy (e.g., improvement in BCVA) and continued administration is necessary for maintenance; OR for myopic choroidal neovascularization (mCNV) continued administration is necessary due to disease activity (drop in vision, visual symptoms such as metamorphopsia, or presence of intra-/sub-retinal fluid or active leakage)

Requests for ranibizumab used for indications, doses, or regimens not described in this policy will be denied as not medically necessary unless there is supporting evidence from recognized compendia or peer‑reviewed literature. The policy defines accepted indications and dosing consistent with standard references (e.g., AHFS‑DI, Micromedex DrugDex, Clinical Pharmacology, Lexi‑Drugs) or peer‑reviewed published medical literature; uses not supported by these sources are investigational and ineligible for coverage.

Members receiving ranibizumab outside these guidelines may request an exception, but use outside the specified guidelines may result in nonpayment unless approved through the exception process.

Billing and Coding

Applicable billing codesHCPCS

Q5124	Injection, ranibizumab-nuna, biosimilar (byooviz), 0.1mg
Q5128	Injection, ranibizumab-eqrn(cimerli), biosimilar, 0.1mg
J2778	Injection, ranibizumab, 0.1mg

inv-06: Maximum billed units per 28 days

Maximum billed units (AMD, RVO, mCNV)10 units per 28 days (1 billable unit = 0.1 mg)

Maximum billed units (DME, DR)6 units per 28 days (1 billable unit = 0.1 mg)

Unit definitionEach billable unit equals 0.1 mg of ranibizumab

Prior Authorization, Documentation, and Step Edits

Prior Authorization

Prior Authorization Required

Prior authorization is required for prospective review of Lucentis (ranibizumab), Cimerli (ranibizumab) and Byooviz (ranibizumab) under the medical benefit. Requests will be reviewed against the policy criteria prior to coverage.

Applies to all initial requests for Lucentis, Cimerli, and Byooviz
Prospective prior authorization review is required; use the payer's prior authorization portal/process

Step Therapy

Step Therapy / Step Edits

Step therapy requires that bevacizumab be tried first and shown to have an inadequate response, intolerance, or contraindication before covering Lucentis, Cimerli or Byooviz — except where exceptions apply.

Member currently on Lucentis, Cimerli, or Byooviz may remain on therapy without meeting step requirements
Medicare members who received the medication within the past 365 days are exempt from step therapy
If requesting Lucentis, Cimerli, or Byooviz: must document inadequate response/intolerance/contraindication to bevacizumab
If requesting Cimerli for AMD, RVO or mCNV: must also document inadequate response/intolerance/contraindication to Lucentis or Byooviz

Denial Risk

Noncompliant Use / Prior Authorization

Noncompliant use (use outside policy guidelines) may result in nonpayment. Providers must submit required documentation with the prior authorization to avoid denial.

Nonpayment risk if therapy is used outside the clinical criteria in this policy
Prospective prior authorization is the mechanism to approve exceptions to policy when clinically necessary
Ensure documentation supports age, diagnosis, retina specialist involvement, baseline and periodic BCVA, prior treatments and reason for step exception (inadequate response/intolerance/contraindication)

Background

Ranibizumab is an anti‑VEGF intravitreal therapy indicated for treatment of retinal vascular diseases including neovascular (wet) age‑related macular degeneration, macular edema due to retinal vein occlusion, diabetic macular edema and diabetic retinopathy (for Lucentis and Cimerli), and myopic choroidal neovascularization. It acts by inhibiting vascular endothelial growth factor to reduce abnormal neovascularization and vascular leakage, leading to improved visual acuity and reduced retinal thickness.

Clinical use and coverage decisions are aligned with evidence from randomized trials demonstrating visual acuity benefit and established safety considerations; prior authorization and documentation requirements are applied to ensure appropriate use.

Key Definitions

inv-12: BCVA — Best Corrected Visual Acuity

DefinitionBest Corrected Visual Acuity (BCVA) is the visual acuity measured at baseline and periodically during treatment to assess response and guide renewal decisions.

Role in monitoringBCVA is used to document clinical benefit (e.g., improvement in BCVA) which supports renewal when continued administration is necessary for maintenance.

Measurement timingBCVA must be measured at baseline and periodically during treatment as part of required clinical documentation.