Pharmacy Prior Authorization Criteria

Piasky (crovalimab)

Indications for Prior Authorization

Piasky (crovalimab)

• For diagnosis of Paroxysmal nocturnal hemoglobinuria (PNH)
  Indicated for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg.

Criteria

Piasky

For state-mandated plans in Illinois or other states where applicable: Step therapy requirements do NOT apply. Beginning January 1, 2026, step therapy requirements or use of the authorization of alternative covered medications in a manner that effectively creates a step therapy requirement will not be imposed.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH)
AND
• Patient is 13 years of age or older
AND
• Patient weighs at least 40 kg
AND
• Trial and failure, contraindication, or intolerance to one of the following:
• Epysqli (eculizumab-aagh)
• Ultomiris (ravulizumab)
AND
• Prescribed by or in consultation with a hematologist/oncologist

Piasky

For state-mandated plans in Illinois or other states where applicable: Step therapy requirements do NOT apply. Beginning January 1, 2026, step therapy requirements or use of the authorization of alternative covered medications in a manner that effectively creates a step therapy requirement will not be imposed.

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., hemoglobin stabilization, decrease in the number of red blood cell transfusions)
AND
• Trial and failure, contraindication, or intolerance to one of the following:
• Epysqli (eculizumab-aagh)
• Ultomiris (ravulizumab)

Piasky

Non Formulary

Length of Approval: 12 Month(s)

• Submission of medical records (e.g., chart notes) confirming a diagnosis of paroxysmal nocturnal hemoglobinuria (PNH)
AND
• Patient is 13 years of age or older
AND
• Patient weighs at least 40 kg
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to one of the following:
• Epysqli (eculizumab-aagh)
• Ultomiris (ravulizumab)
AND
• Prescribed by or in consultation with a hematologist/oncologist

P & T Revisions

1970-01-01, 2025-12-18, 2025-10-22, 2025-02-05, 2024-10-11, 2024-09-03, 2024-09-03, 2024-09-03

References

1. Piasky Prescribing Information. Genentech, Inc. San Francisco, CA. June 2024.

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Revision History

• 1970-01-01: No criteria changes
• 2025-12-18: no criteria changes, added IL statute operational note
• 2025-10-22: 2025 Annual Review. Replaced Soliris (eculizumab) with Epysqli (eculizumab-aagh) as alternative. Epysqli is the preferred eculizumab product.
• 2025-02-05: Addition of NF criteria to guideline
• 2024-10-11: Removal of step through Empaveli or Fabhalta
• 2024-09-03: New Program for Piasky
• 2024-09-03: New Program for Piasky
• 2024-09-03: New Program for Piasky

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