Empaveli — Blue Cross Blue Shield of Oklahoma

Initial criteria

• ONE of the following: (A) The 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 demonstrating deficiency in glycosylphosphatidylinositol (GPI)–linked proteins (lab tests required) OR (B) The 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) The patient’s age is within FDA labeling for the requested indication for the requested agent OR (B) 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 in the area of the patient’s diagnosis
• The patient will NOT be using the requested agent in combination with Soliris (eculizumab) for the requested indication (NOTE: if the patient is switching from Soliris, Soliris should be continued for the first 4 weeks after starting the requested agent and then Soliris should be discontinued)
• The patient will NOT be using the requested agent in combination with Fabhalta (iptacopan), Ultomiris (ravulizumab-cwvz), or Piasky (crovalimab-akkz) for the requested indication
• The patient does NOT have any FDA labeled contraindications to the requested agent
• Alternate approval: The member resides in Ohio AND The plan is Fully Insured or HIM Shop (SG) AND BOTH of the following: (A) The patient does NOT have any FDA labeled contraindications to the requested agent AND (B) ONE of the following: (1) The patient has another FDA labeled indication for the requested agent and route of administration OR (2) The patient has another indication that is supported in compendia for the requested agent and route of administration OR (3) The prescriber has submitted TWO articles from major peer-reviewed professional medical journals supporting the proposed use(s) as generally safe and effective

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• The patient has had improvements or stabilization with the requested agent (e.g., decreased requirement of RBC transfusions, stabilization/improvement of hemoglobin, reduction of lactate dehydrogenase (LDH), stabilization/improvement of symptoms) (medical records required)
• 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
• The patient will NOT be using the requested agent in combination with Fabhalta (iptacopan), Soliris (eculizumab), Ultomiris (ravulizumab-cwvz), or Piasky (crovalimab-akkz) for the requested indication
• The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months