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Effective October 1, 2023: the permanent J-code for SYFOVRE is J27811
The CMS-assigned permanent J-code for SYFOVRE, J2781, will replace any miscellaneous or temporary codes and is recognized by government and commercial payers in all sites of care. Please see resources below for additional information.
FDA Approval Letter
Product Ordering Guide
Preparation for Administration Brochure
Billing and Coding Guide
Access and Reimbursement Guide
Sample Letter of Medical Necessity
Sample Letter of Appeals
ApellisAssist® Enrollment Form
Spanish ApellisAssist Enrollment Form
Enrollment Form Guide
J-code and Utilization Postcard
SYFOVRE Attributes Flashcard
SYFOVRE Patient Brochure
Patient Amsler Grid
CMS=Centers for Medicare & Medicaid Services.
Reference: 1. CMS HCPCS Level II Coding Decisions: Narrative Summary. Accessed 07/24/2023. https://www.cms.gov/files/document/2023-hcpcs-application-summary-quarter-2-2023-drugs-and-biologicals.pdf.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
SYFOVRE® (pegcetacoplan injection) is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Please see full Prescribing Information for more information.
*Defined as patients with study-eye investigator-determined new-onset nAMD.
AMD=age-related macular degeneration; CNV=choroidal neovascularization; FA=fluorescein angiography; IOP=intraocular pressure; IVT=intravitreal; nAMD=neovascular age-related macular degeneration; VEGF=vascular endothelial growth factor.
*This group does not include the 10 patients from Phase 1b Study 103 who were included in the GALE safety set.
AE=adverse event; EOM=every other month; IE=infectious endophthalmitis; IOI=intraocular inflammation.
†Total includes 1 incident of endophthalmitis with negative vitreous culture results in the EOM group that appeared to be associated with an impurity in the drug product lots at the beginning of the study, which has been successfully removed by optimization of the manufacturing process.2
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firstname.lastname@example.org 5th AvenueWaltham, MA 02451
October 10th, 2023
To the Retina Community,
As part of our commitment to keep you informed, we are writing to provide a SYFOVRE update on long-term and real-world safety and how cases are evaluated and reported.
On October 5, we announced that more than 100,000 commercial and sample vials have been shipped to physician practices since FDA approval, with approximately 37,000 commercial vials and 10,000 samples distributed in the third quarter.
Long-term and real-world safety
How are cases evaluated and reported
As shared with Retina Today, Drug Safety and Pharmacovigilance is an integral part of Apellis’ process and culture, safeguarding patient safety at all times. Apellis’ Safety & Medical Team reviews all post-market events reported with SYFOVRE. Any new suspected events of IOI, including retinal vasculitis, are systematically assessed and adjudicated based on all available information. Where information is missing, targeted follow-up (i.e., specific questionnaire, collection of imaging) is performed by internal Apellis team members. Requested data includes baseline patient characteristics, imaging (angiography, OCT, fundus photography) and long-term visual outcomes. All suspected retinal vasculitis cases are also independently evaluated and adjudicated by two external sources: a panel of four retina and uveitis experts, and an independent reading center, Digital Angiography Reading Center (DARC).
Apellis submits all reported adverse events to the FDA and other applicable Regulatory Agencies consistent with reporting guidelines and regulations for drug manufacturers. Apellis and the American Society of Retina Specialists (ASRS) Research and Safety in Therapeutics (ReST) Committee are in close communication regarding reported cases of retinal vasculitis following SYFOVRE treatment. While the adjudication of vasculitis may differ between ASRS and Apellis, the visual outcomes are most important, and are monitored closely by both parties.
Patient safety is our top priority. We are committed to making a meaningful difference in the lives of people impacted by geographic atrophy and will continue to provide you with the information you need to make the best treatment decisions for patients.