Empaveli (pegcetacoplan) — Blue Cross Blue Shield of New Mexico

Initial criteria

• 1. 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 peripheral blood cells deficient in glycosylphosphatidylinositol (GPI)–linked proteins (lab tests required) OR B. Patient has another FDA labeled indication for the requested agent and route of administration
• 2. If patient has an FDA labeled indication, ONE of the following: A. Patient age is within FDA labeling for the requested indication OR B. There is support for using the requested agent for patient's age for the requested indication
• 3. Prescriber is a specialist in the area of patient's diagnosis (e.g., hematologist) or has consulted with a specialist
• 4. Patient will NOT be using the requested agent in combination with Soliris (eculizumab) for the requested indication (NOTE: if switching from Soliris, it should be continued for the first 4 weeks after starting the requested agent and then discontinued)
• 5. Patient will NOT be using the requested agent in combination with Fabhalta (iptacopan), Ultomiris (ravulizumab-cwvz), or Piasky (crovalimab-akkz) for the requested indication
• 6. Patient does NOT have any FDA labeled contraindications to the requested agent
• Alternative approval path: Member resides in Ohio AND plan is Fully Insured or HIM Shop (SG) AND BOTH (A) No FDA labeled contraindications AND (B) ONE of: (1) another FDA labeled indication and route OR (2) another indication supported in compendia OR (3) prescriber submitted two peer-reviewed journal articles supporting proposed use. Compendia sources allowed: Non-oncology: DrugDex level 1, 2A or 2B, AHFS-DI supportive. Oncology: NCCN 1 or 2A, AHFS-DI supportive, DrugDex level 1, 2A or 2B, Clinical Pharmacology supportive, LexiDrugs level A, or peer-reviewed medical literature

Reauthorization criteria

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

Approval duration

12 months