Cigna: Cimerli Payer Policy (Beta Access)

TABLE OF CONTENTS

• Cigna: Cimerli Payer Policy (Testing)
  • Line of Business
  • Precertification/Prior Authorization
  • Step Therapy
  • Diagnoses and Criteria
    • Covered Diagnoses
  • Dosing and Administration
  • Reauthorization Criteria
  • Authorization Duration
  • Exclusions
  • HCPCS Codes
  • Additional Notes
  • Sources

This policy outlines the coverage criteria for Cimerli™, a vascular endothelial growth factor (VEGF) inhibitor administered via intravitreal injection. It is indicated for various retinal conditions and requires prior authorization for approval.

Line of Business

This policy applies to health benefit plans administered by Cigna, including:

• Employer and Individual Plans
• Individual and Family Plans

The effective date is May 1, 2024, with a revision date of May 1, 2024.

Precertification/Prior Authorization

• Required: Yes, prior authorization is required for all covered indications.

Step Therapy

• The member must meet oneof the following:
  • Currently receiving Cimerli, Byooviz, or Lucentis; OR
  • Documentation of failure, contraindication, or intolerance to repackaged bevacizumab; OR
  • The prescriber attests that the safety of repackaged bevacizumab or its supplier is of significant concern.
• For diabetic retinopathy, step therapy requirements also apply.

Diagnoses and Criteria

Covered Diagnoses

Cimerli is considered medically necessary when used to treat one of the following:

• Diabetic Macular Edema
• Diabetic Retinopathy
• Macular Edema following Retinal Vein Occlusion
• Myopic Choroidal Neovascularization
• Neovascular (Wet) Age-Related Macular Degeneration
• Ocular Histoplasmosis Syndrome
• Other Neovascular Diseases of the Eye (e.g., neovascular glaucoma, retinopathy of prematurity, sickle cell neovascularization, choroidal neovascular conditions)

Dosing and Administration

• Diabetic Macular Edema & Diabetic Retinopathy:
  • Dose: 0.3 mg administered by intravitreal injection for each eye.
  • Interval: Not more frequent than once every 28 days.
• Other Covered Diagnoses:
  • Dose: 0.5 mg administered by intravitreal injection for each eye.
  • Interval: Not more frequent than once every 28 days.
• Retreatment for Myopic Choroidal Neovascularization may occur as needed.

Reauthorization Criteria

Continuation of Cimerli is considered medically necessary when:

• Initial criteria are met.
• Documentation shows a beneficial response, such as:
  • Stabilization or improvement in best corrected visual acuity (BCVA).
  • Reduced rate of vision decline or new lesions.

Authorization Duration

• Initial Approval: Up to 12 months.
• Reauthorization: Up to 12 months.

Exclusions

Cimerli is not covered for any use considered:

• Experimental
• Investigational
• Unproven

HCPCS Codes

• Q5128: Injection, ranibizumab-eqrn (Cimerli), biosimilar, 0.1 mg.

Additional Notes

• Cimerli, Byooviz, and Lucentis are interchangeable biosimilars used to inhibit VEGF activity and reduce pathological vascularization.
• For all indications, the dosage and duration of therapy should align with FDA-approved guidelines and evidence-based clinical standards.

Sources: https://static.cigna.com/assets/chcp/pdf/coveragePolicies/pharmacy/ip_0543_coveragepositioncriteria_ranibizumab.pdf