PiaSky™ (crovalimab-akkz)

Covered: PiaSky (crovalimab-akkz) is authorized for treatment of PNH only in patients ≥13 years old and ≥40 kg; patients younger than 13, weighing <40 kg, lacking peripheral blood flow cytometry confirmation of GPI‑anchored protein deficiency on ≥2 lineages, or without hematologist prescribing/consultation are excluded. Key requirements: initial approval is 6 months (with specified IV loading and weight‑based subcutaneous loading/maintenance dosing), renewals (12 months) require documentation of age/weight, flow cytometry results, hematology involvement, adherence to the recommended dosing schedule, and evidence of ongoing clinical benefit (e.g., improved/stable hemoglobin, reduced transfusions or hemolysis).

"Treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adult and pediatric patients 13 years of age or older with body weight of at least 40 kg (FDA-approved indication)."