Fabhalta (iptacopan) — Medica

Initial criteria

• age ≥ 18 years
• diagnosis confirmed by biopsy
• urine protein-to-creatinine ratio ≥ 1.0 g/g
• estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2
• received the maximum or maximally tolerated dose of at least ONE of the following for ≥ 12 weeks prior to starting Fabhalta: angiotensin converting enzyme inhibitor OR angiotensin receptor blocker
• prescribed by or in consultation with a nephrologist

Reauthorization criteria

• age ≥ 18 years
• diagnosis confirmed by biopsy
• according to the prescriber, patient has had a response to Fabhalta (e.g., reduction in urine protein-to-creatinine ratio or reduction in 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; Reauthorization: 1 year