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    PiaSky™

    Drug - PiaSky™ (crovalimab-akkz) [Genentech, Inc.]

    March 2025

    Therapeutic Area - Paroxysmal Nocturnal Hemoglobinuria (PNH)

    Initial approval criteria

    • The patient must have ONE of the following:
      • The patient has a diagnosis of Paroxysmal Nocturnal Hemoglobinuria (PNH) as confirmed by flow cytometry with at least 2 independent flow cytometry reagents on at least 2 cell lineages (e.g., RBCs and WBCs) demonstrating that the patient’s peripheral blood cells are deficient in glycosylphosphatidylinositol (GPI) – linked proteins (lab tests required) OR
      • The patient has another FDA labeled indication for the requested agent and route of administration AND
    • If the patient has an FDA labeled indication, then ONE of the following:
      • The patient’s age is within FDA labeling for the requested indication for the requested agent OR
      • There is compendial support for using the requested agent for the patient’s age for the requested indication AND
    • The prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
    • The patient will NOT be using the requested agent in combination with Soliris (eculizumab), Ultomiris (ravulizumab-cwvz), Fabhalta (iptacopan), or Empaveli (pegcetacoplan) for the requested indication AND
    • The patient does NOT have any FDA labeled contraindications to the requested agent AND
    • Initial approval is for 6 months 

    Renewal criteria

    • The patient was previously approved for the requested agent AND
    • The patient has had improvements or stabilization with the requested agent (e.g., decreased requirement of RBC transfusions, stabilization/improvement of hemoglobin, reduction of lactate dehydrogenase (LDH), stabilization/improvement of symptoms) (medical records required) AND
    • The prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
    • The patient will NOT be using the requested agent in combination with Soliris (eculizumab), Ultomiris (ravulizumab-cwvz), Fabhalta (iptacopan), or Empaveli (pegcetacoplan) for the requested indication AND
    • The patient does NOT have any FDA labeled contraindications to the requested agent AND
    • Renewal approval is for 12 months

    Quantity limits

    • The requested quantity (dose) is within FDA labeled dosing for the requested indication 
    • Patient’s body weight (in kg) must be submitted at time of request

    Billing for PiaSky

    PiaSky must be billed as a medical claim.

    Questions

    Provider Call Center (844) 575-7887

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