Empaveli (pegcetacoplan) — Blue Cross Blue Shield of Montana

Initial criteria

• Diagnosis of Paroxysmal Nocturnal Hemoglobinuria (PNH) confirmed by flow cytometry with at least 2 independent flow cytometry reagents on at least 2 cell lineages demonstrating deficiency in GPI-linked proteins OR the patient has another FDA labeled indication for the requested agent and route of administration
• If the patient has an FDA labeled indication: the patient's age is within FDA labeling for the requested indication OR there is support for using the requested agent for the patient's age for the requested indication
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist) OR the prescriber has consulted with a specialist
• The patient will NOT use Empaveli in combination with Soliris (eculizumab); if switching, Soliris may continue for the first 4 weeks after starting Empaveli then be discontinued
• The patient will NOT use Empaveli in combination with Fabhalta (iptacopan), Ultomiris (ravulizumab-cwvz), or Piasky (crovalimab-akkz)
• The patient does NOT have any FDA labeled contraindications to Empaveli
• For Ohio residents, if the plan is Fully Insured or HIM Shop (SG), Empaveli is also approved when: (1) the patient has no FDA labeled contraindications AND (2) one of the following: (a) patient has another FDA labeled indication and route of administration OR (b) patient has an indication supported in compendia (DrugDex level 1, 2A, 2B; AHFS-DI; NCCN 1, 2A; Clinical Pharmacology; LexiDrugs evidence level A) OR (c) prescriber submitted two peer-reviewed journal articles supporting the proposed use as safe and effective)

Reauthorization criteria

• Patient previously approved for Empaveli through the plan’s Prior Authorization process
• Patient has had improvements or stabilization with Empaveli (e.g., decreased RBC transfusions, stabilization/improvement of hemoglobin, reduction in LDH, improvement/stabilization of symptoms)
• Prescriber is a specialist in the area of the patient’s diagnosis or has consulted one
• Patient will NOT be using Empaveli in combination with Fabhalta, Soliris, Ultomiris, or Piasky
• Patient does NOT have any FDA labeled contraindications to Empaveli

Approval duration

12 months