The Centers for Medicare and Medicaid Services (CMS) has assigned a unique, permanent Healthcare Common Procedure Coding System (HCPCS) J-code for Izervay (Iveric Bio/Astellas Pharma), an avacincaptad pegol intravitreal solution approved to treat geographic atrophy (GA). The new J-code, J2782, is effective April 1, 2024.
Izervay is a small synthetic pegylated RNA aptamer that is designed to be a specific inhibitor of complement C5 protein. Inhibition of C5 slows inflammation and cell death associated with development and progression of GA. The US Food and Drug Administration (FDA) approved Izervay for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on August 4, 2023. Since its US launch in September 2023, more than 40,000 Izervay vials have been distributed to physician practices.
“Geographic atrophy is a progressive disease that can lead to irreversible vision loss and early treatment can have a significant impact on patients' lives,” said Michael Petroutsas, head of Astellas Pharma’s commercial operations in the United States. “Receiving a permanent J-code in the U.S. supports our efforts to increase timely patient access to Izervay.”
According to the company, Izervay is the only approved GA treatment with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint across two phase 3 clinical trials (GATHER1 and GATHER2). The permanent J-code for IZERVAY is expected to accelerate patient access in the US and has been published on the CMS website.