Background

Syfovre is the first drug therapy to be approved for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). It is administered via intravitreal injection to each affected eye once every 25 to 60 days. Syfovre contains the active ingredient, pegcetacoplan, a complement C3 inhibitor that is the same ingredient in Empaveli™, but the indication, dosage form, dose, and route of administration are different than Empaveli. Both drugs work by blocking C3 and downregulating the complement system. For Syfovre, this is thought to decrease the pathogenesis and progression of GA. Clinical trials found an increased incidence of neovascular AMD in the Syfovre group compared to the sham group, so the FDA labeling suggests monitoring of patients for signs of neovascular AMD. Additionally, patients with ocular history of or active choroidal neovascularization were excluded from the pivotal trials of Syfovre.

AMD is a chronic, multifactorial, progressive central retinal disease that is the leading cause of irreversible blindness in the elderly population. It is divided into two types: exudative or neovascular (“wet”) and nonexudative (“dry”). GA is caused by the gradual breakdown of light-sensitive cells in the macula, resulting in the growth of irreversible lesions in the retinal pigment epithelium that can lead to impaired vision or blindness. It has several potential causes, but can be caused by dry age AMD (intermediate and advanced stages of disease). At this time, there are no other medical therapies for GA.

Policy

The use of Syfovre is considered investigational/unproven therefore is considered NOT MEDICALLY NECESSARY for all indications including treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

References

1. Syfovre [package insert]. Apellis Pharmaceuticals, Inc. Waltham, MA. Updated Feb 2023.
2. Syfovre Drug Evaluation. Express Scripts. Updated March 2023.
3. New Drug Review, Syfovre (pegcetacoplan injection). IPD Analytics. February 2023. Accessed July 20, 2023 Subscription required.

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

History From 2024 Forward