IZERVAY (avacincaptad pegol)

IZERVAY (avacincaptad pegol)

Office-Administration – intravitreal injection

Diagnosis considered for coverage:

• GA: indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)

Coverage Criteria:

For diagnosis of GA:

• 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
• GA is not secondary to any other conditions (e.g., Stargardt disease, cone rod dystrophy, toxic maculopathies); AND
• Prescribed by or in consultation with an ophthalmologist experienced in the treatment of retinal diseases

Reauthorization Criteria:

For diagnosis of GA:

• 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

Dosing:

GA:

• Recommended dose: 2 mg (0.1 mL of 20 mg/mL solution) administered by intravitreal injection to each affected eye once monthly for up to 12 months

Coverage Duration: 

• Initial: 6 months
• Reauthorization: 6 months

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• 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
• 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

Policy Updates:

• Effective 6/01/2024 – New policy approved by WHA P&T Committee. (P&T, 5/21/2024)

References:

• Izervay Precribing Information. Iveric Bio, Inc. Parsippany, NJ. August 2023. 
• FDA Product Review. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217225Orig1s000TOC.cfm. Accessed September 11, 2023. 
• 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.