Pegcetacoplan (Syfovre™)

Restricted Product(s):

• pegcetacoplan (Syfovre™) intravitreal injection for administration by a healthcare professional

FDA Approved Use:

• For treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)

Criteria for Medical Necessity:

The restricted product(s) may be considered medically necessary when the following criteria are met:

Initial Criteria for Approval:

1. The patient is 50 years of age or older; AND
2. The patient has a diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD); AND
3. The patient has a best corrected visual acuity (BCVA) of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts OR approximately 20/320 Snellen equivalent if using the Snellen chart [medical record documentation required]; AND
4. The patient has GA lesions with the total GA area measuring between 2.5 mm2 and 17.5 mm2 in size [medical record documentation required]; AND
   1. If the patient has multifocal lesions, at least one focal GA lesion measures 1.25 mm2 or larger in size [medical record documentation required]; AND
5. The patient does NOT have a diagnosis of GA secondary to a condition other than AMD in either eye (e.g., Stargardt disease, cone rod dystrophy, or toxic maculopathies like hydroxychloroquine-induced maculopathy); AND
6. The patient does NOT have a history of or active choroidal neovascularization (CNV) in the treatment eye(s), associated with AMD or any other cause, including the presence of retinal pigment epithelial (RPE) tear; AND
7. The patient does NOT have any contraindications to treatment with the requested agent (i.e., ocular or periocular infection, active intraocular inflammation); AND
8. The patient will NOT use the requested agent in combination with other intravitreal complement inhibitor therapies (i.e., avacincaptad pegol [Izervay]); AND
9. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., ophthalmology specialist) or has consulted with a specialist in the area of the patient’s diagnosis; AND
10. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below)

Duration of Approval:

365 days (1 year)

Continuation Criteria for Approval:

1. The patient was approved through Blue Cross NC initial criteria for approval; OR
2. The patient would have met initial criteria for approval at the time they started therapy; AND
3. The patient has demonstrated clinical benefit since initiating therapy (e.g., decrease in total area of GA lesion, reduction in mean rate of GA lesion growth) [medical record documentation required]; AND
4. The patient does NOT have a history of or active choroidal neovascularization (CNV) in the treatment eye(s), associated with AMD or any other cause, including the presence of retinal pigment epithelial (RPE) tear; AND
5. The patient does NOT have any contraindications to treatment with the requested agent (i.e., ocular or periocular infection, active intraocular inflammation); AND
6. The patient will NOT use the requested agent in combination with other intravitreal complement inhibitor therapies (i.e., avacincaptad pegol [Izervay]); AND
7. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., ophthalmology specialist) or has consulted with a specialist in the area of the patient’s diagnosis; AND
8. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below)

Duration of Approval:

365 days (1 year)

FDA Label Reference

*Maximum units allowed for duration of approval

References:

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q4 annually.

November 2023: Criteria change: Updated age requirement to 50 years of age or older. Added requirement for no use in combination with new to market product Izervay, another intravitreal complement inhibitor therapy.

October 2023: Coding change: Added HCPCS code J2781 to dosing reference table effective 10/1/2023; deleted C9151, J3490, and J3590 termed 9/30/2023.

July 2023: Coding change: Added HCPCS code C9151 to dosing reference table effective 7/1/2023; deleted C9399 termed 6/30/2023.

May 2023: Original medical policy criteria issued.