Fabhalta (iptacopan) — CareFirst (Caremark)

Initial criteria

• Diagnosis of complement 3 glomerulopathy (C3G) confirmed by kidney biopsy
• Either proteinuria ≥ 1 g/day OR UPCR ≥ 1.0 g/g
• Member has reduced serum C3 (< 0.85 × lower limit of normal per reference range) at baseline
• Member has received a stable dose of maximally tolerated RAS inhibitor therapy (e.g., ACEI or ARB) for at least 3 months prior to initiation OR has intolerance or contraindication to RAS inhibitors

Reauthorization criteria

• No evidence of unacceptable toxicity or disease progression while on the current regimen
• Member is experiencing benefit from therapy as evidenced by decreased proteinuria or decrease in UPCR from baseline

Approval duration

Initial: 12 months; Reauthorization: 12 months