PiaSky™ (crovalimab-akkz)

PiaSky (crovalimab-akkz) is covered only for FDA‑approved use in PNH patients aged ≥13 years and weighing ≥40 kg; patients <13 years, <40 kg, and off‑label indications are excluded. Coverage requires peripheral blood flow cytometry confirming GPI‑anchored protein absence/deficiency on ≥2 cell lineages, prescription or consultation by a hematologist, initiation of the specified weight‑based loading (IV Day 1; subcutaneous Days 2, 8, 15, 22) and maintenance (Day 29 then every 4 weeks) regimen, initial approval of 6 months (renewals 12 months), and documented clinical benefit for reauthorization.

"Weight limitation: patients weighing less than 40 kg are not eligible under these coverage guidelines."

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