Voydeya — Blue Cross Blue Shield of Texas

Initial criteria

• ONE of the following: (A) The patient has a diagnosis of paroxysmal nocturnal hemoglobinuria (PNH) AND ALL of the following: 1. The diagnosis was confirmed by flow cytometry with at least 2 independent flow cytometry reagents on at least 2 cell lineages demonstrating deficiency in GPI-linked proteins (lab tests required); 2. The patient has clinically significant extravascular hemolysis (EVH) as indicated by BOTH of the following: (A) Hemoglobin ≤ 9.5 g/dL AND (B) Absolute reticulocyte count ≥ 120 x 10^9/L with or without transfusion support (lab tests required); 3. BOTH of the following: (A) The patient has been treated on a stable dose of Soliris (eculizumab) or Ultomiris (ravulizumab-cwvz) for at least the previous 6 months AND (B) The patient will be using the requested agent as add-on therapy to Soliris or Ultomiris 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 has consulted with one
• The patient will NOT be using the requested agent in combination with Empaveli (pegcetacoplan), Fabhalta (iptacopan), or Piasky (crovalimab-akkz)
• The patient does NOT have any FDA labeled contraindications to the requested agent
• Alternate Ohio fully insured/HIM Shop (SG) 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: (i) patient has other FDA labeled indication, (ii) compendia-supported indication, (iii) prescriber submitted TWO peer-reviewed journal articles showing safety and efficacy; compendia accepted: DrugDex level 1/2A/2B, AHFS-DI supportive text (non-oncology); NCCN 1 or 2A, AHFS-DI, DrugDex level 1/2A/2B, Clinical Pharmacology, LexiDrugs (oncology)

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• The patient has had clinical benefit with the requested agent
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist) or has consulted with one
• The patient will be using the requested agent as add-on therapy to Soliris (eculizumab) or Ultomiris (ravulizumab-cwvz)
• The patient will NOT be using the requested agent in combination with Empaveli (pegcetacoplan), Fabhalta (iptacopan), or Piasky (crovalimab-akkz)
• The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

initial 3–12 months; renewal 12 months