PiaSky (crovalimab-akkz) — Medica

Initial criteria

• age ≥ 13 years
• weight ≥ 40 kg
• diagnosis confirmed by peripheral blood flow cytometry showing absence or deficiency of glycosylphosphatidylinositol (GPI)-anchored proteins on at least two cell lineages
• prescribed by or in consultation with a hematologist

Reauthorization criteria

• age ≥ 13 years
• weight ≥ 40 kg
• according to the prescriber, patient is continuing to derive benefit from PiaSky (e.g., increase or stabilization of hemoglobin levels, decreased transfusion requirements or transfusion independence, reductions in hemolysis, improvement in FACIT-Fatigue score)
• prescribed by or in consultation with a hematologist

Approval duration

initial: 6 months; reauthorization: 1 year