Empaveli (pegcetacoplan) — Blue Cross Blue Shield of Texas

other FDA-labeled indications

Initial criteria

ONE of the following: (A) Diagnosis of Paroxysmal Nocturnal Hemoglobinuria (PNH) confirmed by flow cytometry with at least 2 independent flow cytometry reagents on at least 2 cell lineages (e.g., RBCs and WBCs) demonstrating deficiency in glycosylphosphatidylinositol (GPI)-linked proteins (lab tests required) OR (B) Patient has another FDA-labeled indication for the requested agent and route of administration
If the patient has an FDA-labeled indication, then ONE of the following: (A) Patient’s age is within FDA labeling for the requested indication for the requested agent OR (B) There is support for use of the requested agent for the patient’s age for the requested indication
Prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist) OR has consulted with a specialist
Patient will NOT be using Empaveli in combination with Soliris (eculizumab) for the requested indication (if switching from Soliris, continue Soliris for 4 weeks after starting Empaveli, then discontinue Soliris)
Patient will NOT be using Empaveli in combination with Fabhalta (iptacopan), Ultomiris (ravulizumab-cwvz), or Piasky (crovalimab-akkz)
Patient does NOT have any FDA-labeled contraindications to the requested agent

Patient has been previously approved for Empaveli through the plan’s Prior Authorization process
Patient has had improvements or stabilization with Empaveli (e.g., decreased RBC transfusion requirement, stabilization/improvement of hemoglobin, reduction of LDH, stabilization/improvement of symptoms) (medical records required)
Prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist) OR has consulted with a specialist
Patient will NOT be using Empaveli in combination with Fabhalta (iptacopan), Soliris (eculizumab), Ultomiris (ravulizumab-cwvz), or Piasky (crovalimab-akkz)
Patient does NOT have any FDA-labeled contraindications to the requested agent

12 months