SYFOVRE (pegcetacoplan)

SYFOVRE (pegcetacoplan)

Medical Administration – injectable

Coverage Criteria:

• Diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) as confirmed by one of the following: 
  • Fundus photography (e.g. fundus autofluorescence [FAF])
  • Optical coherence tomography (OCT) 
  • Fluorescein angiography, AND
• GA is not secondary to any other conditions (e.g., Stargardt disease, cone rod dystrophy, toxic maculopathies), AND
• Prescribed by or in consultation with an ophthalmologist

Reauthorization Criteria:

• Documentation of positive clinical response to therapy (e.g., reduction in growth rate of GA lesion)

Dosing: 

• The recommended dose for SYFOVRE is 15 mg (0.1 mL of 150 mg/mL solution) administered by intravitreal injection to each affected eye once every 25 to 60 days.

Coverage Duration: 

• Initial: 12 months
• Reauthorization: 12 months

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Pegcetacoplan is indicated for the treatment of GA secondary to AMD.
• Warnings and precautions of pegcetacoplan include the risks of endophthalmitis and retinal detachment incurred with the IVT route of injection, increased rates of neovascular AMD (nAMD) or choroidal neovascularization (CNV), intraocular inflammation, and increased intraocular pressure.

Policy Updates:

•    08/15/2023 – New policy approved by P&T.

References:

1. Syfovre Prescribing Information. Apellis Pharmaceuticals, Inc. Waltham, MA. February 2023.