Apellis Pharmaceuticals announced that Syfovre (pegcetacoplan injection) has been assigned a permanent and product-specific J-code by the Centers for Medicare and Medicaid (CMS).
Refresh me on Syfovre.
Syfovre was approved by the FDA in February 2023 as the first and only treatment for geographic atrophy secondary to dry age-related macular degeneration (AMD).
Per the prescribing information, a 15 mg (0.1 mL out of a 150 mg/mL solution) single-dose vial is to be intravitreally administered into each affected eye once every 25 to 60 days.
Click here for a rundown of how it works.
How did it perform in clinical trials?
The formulation’s safety and efficacy were demonstrated in two phase 3 clinical trials: DERBY and OAKS. See here for post-hoc analysis results.
In August 2023, data from a 30-month extension study supported Syfovre’s extended use. Read our coverage here.
OK .. now back to this J-code. What is it?
As part of the Healthcare Common Procedure Coding System (HCPCS)—which standardizes claims for medical services and supplies—a J-code is a permanent reimbursement, HCPCS Level II code used to designate non-orally administered drugs and other medical devices.
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 is this different from other HCPCS codes?
The following codes are often used in ophthalmology:
- 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.
And Syfovre’s new code?
J2781, according to CMS.
See it here (scroll to page 9).
When is this effective?
October 1, 2023.