Aetna: Byooviz Payer Policy

Created by C. Denise Burrell, Modified on Wed, 8 Jan at 1:47 PM by C. Denise Burrell

Aetna: Byooviz Payer Policy (Beta Access)

TABLE OF CONTENTS


 MEDICARE PART B


HCPCS Code(s):Q5124
Precertification Required? Yes (Click Here for Full Policy)
Step Therapy Required? Yes (Click Here for Full Policy)
Provider Fax Form:Byooviz Fax Form(✅ Available in SamaCare)
FDA Approved Indications:
  • Neovascular (wet) age-related macular degeneration (AMD)
  • Macular edema following retinal vein occlusion (RVO)
  • Myopic choroidal neovascularization (mCNV)
Recommended Dosage:

Not Specified


Note: Byooviz is considered preferred after a trial of bevacizumab (Avastin)



Other Pertinent Information

  1. Byooviz is listed as a Tier 2 Preferred Product after bevacizumab (Avastin).
  2. Submissions for non-listed indications require supporting evidence from Medicare-approved compendia (NCCN, Micromedex, AHFS-DI, Lexi-Drugs).


  • Exclusion(s):
    • All indications not listed as FDA-approved or supported by Medicare-approved compendia. 


Initial Approval Criteria

Authorization for 12 months may be granted for the following conditions:

  1. Neovascular (wet) age-related macular degeneration (AMD)
  2. Macular edema following retinal vein occlusion (RVO)
  3. Myopic choroidal neovascularization (mCNV)


Continuation Criteria

Authorization for 12 months may be granted if:

  1. The member is currently receiving therapy with Byooviz.
  2. Byooviz is being used to treat an approved indication.
  3. The medication has been effective in treating the condition (e.g., improvement or maintenance of visual acuity).

Sources:



COMMERCIAL

HCPCS Code(s):Q5124
Precertification Required?✅ Yes (Click Here For Full Policy)
Step Therapy Required?  Yes (Click Here For Full Policy)
Provider Fax Form: Byooviz Fax Form(✅ Available in SamaCare)
FDA Approved Indications:
  • Neovascular (wet) age-related macular degeneration (AMD)
  • Diabetic macular edema (DME)
  • Diabetic retinopathy (DR)
  • Macular edema following retinal vein occlusion (RVO)
  • Myopic choroidal neovascularization (mCNV)

Recommended Dosage:

Ranibizumab-nuna is available as Byooviz 10 mg/mL solution in a single-dose glass vial designed to provide 0.05 mL for intravitreal injection.

  • The recommended dosing is 0.5 mg (0.05 mL of 10 mg/mL solution) administered by intravitreal injection once a month (approximately 28 days) for the following indications:
    • Macular edema following retinal vein occlusion (RVO)
      • Myopic choroidal neovascularization (mCNV)
        • Neovascular (Wet) age-related macular degeneration (AMD)
Note: Byooviz is considered more costly than Avastin (bevacizumab) and is only covered when there is failure, contraindication, or intolerance to Avastin. 

Other Pertinent Information

  • Exclusion(s):
    • All other indications not listed above are considered not medically necessary. 

Initial Approval Criteria

Authorization is considered medically necessary for 12 months when the member meets the following:

  1. Diagnosis of one of the following:
    • Neovascular (wet) age-related macular degeneration (AMD)
    • Diabetic macular edema (DME)
    • Diabetic retinopathy (DR)
    • Macular edema following retinal vein occlusion (RVO)
    • Myopic choroidal neovascularization (mCNV)
  2. Failure, contraindication, or intolerance to Avastin (bevacizumab).


Continuation Criteria

Authorization is considered medically necessary for 12 months if:

  1. The member is currently receiving therapy with Byooviz.
  2. Documentation of positive clinical response to therapy (e.g., improvement or maintenance in best corrected visual acuity [BCVA]).


Sources:

⚠️ Disclaimer: This article is a policy summary and does not guarantee coverage or approval. 

Policies may vary based on plan, payer-specific rules, state or regional requirements, benefit structure, formulary placement, and patient-specific considerations like diagnosis or clinical history. Always review the full policy and confirm details directly with the payer to ensure compliance. 


 

We're here to guide you through your prior authorization quest!





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