Iveric Bio Inc., an Astellas Pharma Inc. company, announced that IZERVAY (avacincaptad pegol intravitreal solution) has received a J-code from the U.S. Centers for Medicare and Medicaid Service (CMS).
Refresh me on IZERVAY.
Approved by the FDA in August 2023, IZERVAY is the first and only GA treatment with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint.
Developed initially under the name ACP/Zimura, IZERVAY is a complement C5 inhibitor formulated to slow GA progression.
Per the prescribing information, a 2 mg (0.1 mL of 20 mg/mL solution) is to be administered via intravitreal injection to each affected eye once a month for up to 12 months.
How did it perform in clinical trials?
The formulation’s approval was based on positive data from two phase 3 clinical trials: GATHER1 (NCT02686658) and GATHER2 (NCT04435366).
ACP met its primary endpoint in both trials, which was based on GA area measured by fundus autofluorescence (FAF) at three timepoints: baseline, 6 months, and 12 months.
Based on the data, the mean rate of growth in the GA area from baseline to month 12 was 35% in GATHER1 and 18% in GATHER2. The formulation was also found to slow the loss of photoreceptors and GA progression as early as 6 months.
See here for additional data.
Most recently, in November 2023, 2-year data from the GATHER2 trial demonstrated that IZERVAY continued to reduce the rate of GA lesion growth for both monthly and every-other-month (EOM) dosing when compared to sham through 2 years of treatment.
Now this J-code…Give me a refresher on what this is.
A J-code is a permanent reimbursement, Healthcare Common Procedure Coding System (HCPCS) Level II code used to designate non-orally administered drugs and other medical devices.
Note: HCPCS standardizes claims for medical services and supplies.
Also, this type of code is used by government payors and commercial insurers to simplify and facilitate the billing and reimbursement process for medical providers’ products and services.
How does this differ from other HCPCS codes?
Here’s a breakdown of the three major codes:
- J-codes (J0120 - J8999) refer to drugs administered via routes that exclude oral methods.
- C-codes (C1713 - 9899) refer to the outpatient prospective patient system (OPPS).
- V-codes (V2020 - V2799) refer to vision services.
Gotcha. So what’s IZERVAY’s new code?
Per CMS: J2782 (for context: its previous code was C9162, which expires on March 31, 2024).
See it here (scroll to page 24).
And when is this effective?
April 1, 2024.