Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Pegcetacoplan (Empaveli) Initial Criteria
Pegcetacoplan (Empaveli) may be considered medically necessary when an individual meets ALL of the following criteria:
Paroxysmal Nocturnal Hemoglobinuria (PNH)
- The individual 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 individual’s peripheral blood cells are deficient in glycosylphosphatidylinositol (GPI) – linked proteins (lab tests required); and
- The individual is 18 years of age or older; and
- The prescriber is a specialist in the area of the individual’s diagnosis (e.g., hematologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- The individual will NOT be using pegcetacoplan (Empaveli) in combination with Soliris (eculizumab) (NOTE: if the individual is switching from Soliris, Soliris should be continued for the first 4 weeks after starting the requested agent and then Soliris should be discontinued); and
- The individual will NOT be using pegcetacoplan (Empaveli) in combination with Ultomiris (ravulizumab-cwvz); and
- The individual does NOT have any FDA labeled contraindications to pegcetacoplan (Empaveli).
Pegcetacoplan (Empaveli) for any other indication not listed within this policy will be considered experimental/investigational and, therefore, non-covered. Scientific evidence does not support its efficacy or safety for any other indications.