Izervay (avacincaptad pegol)

Indications for Prior Authorization

Izervay (avacincaptad pegol)
  • For diagnosis of Geographic Atrophy (GA)
    Indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Criteria

Izervay

Prior Authorization (Initial Authorization)

Length of Approval: 6 months [A, 1]

  • Diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration
  • AND
  • Disease is confirmed by one of the following:
    • Fundus photography (e.g. fundus autofluorescence [FAF])
    • Optical coherence tomography (OCT)
    • Fluorescein angiography
    AND
  • Prescribed by or in consultation with an ophthalmologist experienced in the treatment of retinal diseases
Izervay

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

  • Patient demonstrates positive clinical response to therapy (e.g., reduction in growth rate of GA lesion)
P & T Revisions

1970-01-01, 2024-10-02, 2024-06-18, 2023-11-20, 2023-09-25

  1. Izervay Precribing Information. Iveric Bio, Inc. Parsippany, NJ. February 2025.
  2. FDA Product Review. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217225Orig1s000TOC.cfm. Accessed September 11, 2023.
  3. Lexicomp. Izervay. Available at: https://www.uptodate.com/contents/avacincaptad-pegol-drug-information?search=geotrophic%20atropgy%20secondary%20to%20amd&source=search_result&selectedTitle=5~150&usage_type=default&display_rank=5. Accessed September 11, 2023.

  1. In GATHER1 and GATHER2, the mean rate of GA growth (slope), measured by Fundus Autofluorescence (FAF), was evaluated at every 6 month time points from baseline. [1]

  • 2024-10-02: 2024 Annual Review. No criteria changes. Updated references.
  • 2024-06-18: Removed criterion "GA is not secondary to any other conditions."
  • 2023-11-20: update guideline
  • 2023-09-25: New UM PA Program

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