Fabhalta — Cigna
Primary Immunoglobulin A Nephropathy
Initial criteria
- Patient is age ≥ 18 years
- Diagnosis has been confirmed by biopsy
- Patient is at high risk of disease progression, defined by meeting 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 ONE of the following for ≥ 12 weeks prior to starting Fabhalta: angiotensin converting enzyme inhibitor OR angiotensin receptor blocker
- According to the prescriber, patient has received ≥ 3 months of optimized supportive care, including blood pressure management, lifestyle modification, and cardiovascular risk modification
- Patient has an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2
- The medication is prescribed by or in consultation with a nephrologist
Reauthorization criteria
- Patient is age ≥ 18 years
- Diagnosis has been 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)
- Patient has an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2
- The medication is prescribed by or in consultation with a nephrologist
Approval duration
initial: 9 months; reauth: 1 year