Empaveli (pegcetacoplan) — Medica

Initial criteria

• age ≥ 12 years
• Diagnosis confirmed by biopsy
• Urine protein-to-creatinine ratio ≥ 1.0 g/g
• Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m²
• Patient has been on stable doses of at least ONE of the following for ≥ 12 weeks prior to starting Empaveli: angiotensin converting enzyme inhibitor OR angiotensin receptor blocker OR sodium-glucose transporter-2 inhibitor
• Prescribed by or in consultation with a nephrologist

Reauthorization criteria

• age ≥ 12 years
• Diagnosis confirmed by biopsy
• According to prescriber, patient has had a response to Empaveli (e.g., reduction in urine protein-to-creatinine ratio or proteinuria from baseline)
• Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m²
• Prescribed by or in consultation with a nephrologist

Approval duration

Initial: 6 months; Continuation: 1 year