Empaveli (pegcetacoplan) — Blue Cross Blue Shield of Alabama

Initial criteria

• 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 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: patient’s age is within FDA labeling for the requested indication for the requested agent OR there is 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