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

Line of Business

This policy applies to the following lines of business:

• Medicare
• Medicaid – Florida
• Medicaid – Kentucky
• Medicaid – South Carolina

The effective date is January 1, 2025, with a revision date of January 1, 2025, and a review date of November 20, 2024.

Diagnoses and Criteria

Neovascular (Wet) Age-Related Exudative Macular Degeneration (AMD)

• The member has a diagnosis of neovascular (wet) age-related macular degeneration.
• The member has a contraindication or intolerance to bevacizumab.
• Alternatively, the member has had prior therapy with bevacizumab, and the provider attests that the member has not demonstrated a positive clinical response (e.g., improvement or maintenance in best-corrected visual acuity, visual field, or a reduction in the rate of vision decline).
• For Medicare Part B requests, the step therapy requirement does not apply if the request is a continuation of prior therapy within the past 365 days.
• Florida Medicaid requests are exempt from step therapy requirements.
• Approval Duration: Approval is for the plan year duration or as determined through clinical review.

Diabetic Macular Edema (DME)

• The member has a diagnosis of diabetic macular edema.
• The member has a contraindication or intolerance to bevacizumab.
• Alternatively, the member has had prior therapy with bevacizumab, and the provider attests that the member has not demonstrated a positive clinical response (e.g., improvement or maintenance in best-corrected visual acuity, visual field, or a reduction in the rate of vision decline).
• Step therapy requirements do not apply for members with 20/50 vision or worse.
• For Medicare Part B requests, the step therapy requirement does not apply if the request is a continuation of prior therapy within the past 365 days.
• Florida Medicaid requests are exempt from step therapy requirements.
• Approval Duration: Approval is for the plan year duration or as determined through clinical review.

Diabetic Retinopathy (DR)

• The member has a diagnosis of diabetic retinopathy.
• The member has a contraindication or intolerance to bevacizumab.
• Alternatively, the member has had prior therapy with bevacizumab, and the provider attests that the member has not demonstrated a positive clinical response (e.g., improvement or maintenance in best-corrected visual acuity, visual field, or a reduction in the rate of vision decline).
• Step therapy requirements do not apply for members with 20/50 vision or worse.
• For Medicare Part B requests, the step therapy requirement does not apply if the request is a continuation of prior therapy within the past 365 days.
• Florida Medicaid requests are exempt from step therapy requirements.
• Approval Duration: Approval is for the plan year duration or as determined through clinical review.

Macular Edema following Retinal Vein Occlusion (RVO)

• The member has a diagnosis of macular edema following retinal vein occlusion.
• The member has a contraindication or intolerance to bevacizumab.
• Alternatively, the member has had prior therapy with bevacizumab, and the provider attests that the member has not demonstrated a positive clinical response (e.g., improvement or maintenance in best-corrected visual acuity, visual field, or a reduction in the rate of vision decline).
• For Medicare Part B requests, the step therapy requirement does not apply if the request is a continuation of prior therapy within the past 365 days.
• Approval Duration: Approval is for the plan year duration or as determined through clinical review.

Exclusions

• Pavblu is contraindicated in:
  • Patients with active intraocular inflammation.
  • Patients with ocular or periocular infections.
• Concurrent use of Pavblu with other VEGF inhibitors is not recommended unless documentation specifies that the products are being used in different eyes.

Additional Notes

• Step therapy requirements are waived for Medicare Part B requests if the therapy is a continuation of treatment within the past 365 days.
• Dosage, quantity limits, and continuation criteria are not specified in the policy