Iveric Bio, An Astellas Company announced the U.S. Centers for Medicare and Medicaid Services (CMS) has assigned a unique, permanent Healthcare Common Procedure Coding System (HCPS) J-code for IZERVAY (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The new J-code, J2782, is effective April 1, 2024.
Michael Petroutsas, Head of US Commercial
"Geographic atrophy is a progressive disease that can lead to irreversible vision loss and early treatment can have a significant impact on patients' lives. Receiving a permanent J-code in the U.S. supports our efforts to increase timely patient access to IZERVAY, the first and only FDA approved GA treatment to demonstrate a statistically significant reduction in the rate of GA progression in just 12 months across two pivotal trials."
J-codes are used by U.S. government and commercial payers, as well as physicians and their office staff, to streamline the billing and reimbursement process for intravitreal injections and certain other treatments.
Since its U.S. launch in September 2023, more than 40,000 IZERVAY vials have been distributed to physician practices. The permanent J-code for IZERVAY is expected to accelerate patient access in the U.S. and has been published on the CMS website.
About IZERVAY (avacincaptad pegol intravitreal solution)
U.S. INDICATION
IZERVAY (avacincaptad pegol intravitreal solution) is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
IMPORTANT U.S. SAFETY INFORMATION
CONTRAINDICATIONS
- IZERVAY is contraindicated in patients with ocular or periocular infections and in patients with active intraocular inflammation.
WARNINGS AND PRECAUTIONS
- Endophthalmitis and Retinal Detachments
- Intravitreal injections, including those with IZERVAY, may be associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering IZERVAY in order to minimize the risk of endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately.
- Neovascular AMD
- In clinical trials, use of IZERVAY was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (7% when administered monthly and 4% in the sham group) by Month 12. Patients receiving IZERVAY should be monitored for signs of neovascular AMD.
- Increase in Intraocular Pressure
- Transient increases in intraocular pressure (IOP) may occur after any intravitreal injection, including with IZERVAY. Perfusion of the optic nerve head should be monitored following the injection and managed appropriately.
ADVERSE REACTIONS
- Most common adverse reactions (incidence ≥5%) reported in patients receiving IZERVAY were conjunctival hemorrhage, increased IOP, blurred vision, and neovascular age-related macular degeneration.
Please see full Prescribing Information for more information.