Pharmacy Prior Authorization Criteria

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: 6 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., reduction in growth rate of GA lesion)
AND
• Patient has not exceeded a total of 12 months treatment per eye [B, 1]

P & T Revisions

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

References

1. Izervay Precribing Information. Iveric Bio, Inc. Parsippany, NJ. February 2024.
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.

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End Notes

1. In GATHER1 and GATHER2, the mean rate of GA growth (slope) from baseline to Month 12, measured by Fundus Autofluorescence (FAF) was evaluated at 3 time points: baseline, Month 6, and Month 12. [1]
2. The recommended dose for Izervay is 2 mg (0.1 mL of 20 mg/mL solution) administered by intravitreal injection to each affected eye once monthly (approximately 28 ± 7 days) for up to 12 months. [1]

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Revision History

• 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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