Fabhalta — Medica

Initial criteria

• age ≥ 18 years
• Diagnosis confirmed by biopsy
• Patient is at high risk of disease progression defined by BOTH of the following: (a) proteinuria ≥ 0.5 g/day OR urine protein-to-creatinine ratio ≥ 1.5 g/g; AND (b) patient has received the maximum or maximally tolerated dose of an angiotensin converting enzyme inhibitor OR angiotensin receptor blocker for ≥ 12 weeks prior to starting Fabhalta
• According to the prescriber, patient has received ≥ 3 months of optimized supportive care including blood pressure management, lifestyle modification, and cardiovascular risk modification
• Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2
• 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 from baseline, reduction in proteinuria from baseline)
• Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2
• Prescribed by or on consultation with a nephrologist

Approval duration

9 months initial, 1 year reauthorization