Fabhalta (iptacopan) — CareFirst (Caremark)

Initial criteria

• Diagnosis of PNH confirmed by detecting deficiency of glycosylphosphatidylinositol-anchored proteins (GPI-APs) (e.g., at least 5% PNH cells, at least 51% of GPI-AP deficient polymorphonuclear cells)
• Flow cytometry used to demonstrate GPI-APs deficiency
• Member has and exhibits clinical manifestations of disease (e.g., LDH > 1.5 × ULN, thrombosis, renal dysfunction, pulmonary hypertension, dysphagia)
• Requested medication will not be used in combination with another complement inhibitor (e.g., Empaveli, Piasky, Soliris, Ultomiris) for the treatment of PNH

Reauthorization criteria

• No evidence of unacceptable toxicity or disease progression while on the current regimen
• Member demonstrates a positive response to therapy (e.g., improvement in hemoglobin levels, normalization of lactate dehydrogenase [LDH] levels)
• Requested medication will not be used in combination with another complement inhibitor (e.g., Empaveli, Piasky, Soliris, Ultomiris) for the treatment of PNH

Approval duration

Initial: 6 months; Reauthorization: 12 months