Voydeya — Blue Cross Blue Shield of Oklahoma

Initial criteria

• ONE of the following: (A) The patient has a diagnosis of paroxysmal nocturnal hemoglobinuria (PNH) AND ALL of the following: 1. Diagnosis confirmed by flow cytometry with ≥2 independent reagents on ≥2 cell lineages showing GPI-linked protein deficiency (lab tests required) AND 2. Clinically significant extravascular hemolysis (EVH) indicated by BOTH: (A) Hemoglobin ≤9.5 g/dL AND (B) Absolute reticulocyte count ≥120 x 10^9/L with or without transfusion support AND 3. BOTH of the following: (A) Patient treated on stable dose of Soliris (eculizumab) or Ultomiris (ravulizumab-cwvz) for ≥6 months AND (B) Will use 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 patient has an FDA labeled indication: ONE of the following: (A) Patient’s age is within FDA labeling for the requested indication and agent OR (B) There is support for use of the requested agent at the patient’s age for the indication.
• Prescriber is a specialist in the diagnosis area (e.g., hematologist) OR has consulted with such specialist.
• Patient will NOT use the requested agent with Empaveli (pegcetacoplan), Fabhalta (iptacopan), or Piasky (crovalimab-akkz).
• Patient does NOT have any FDA labeled contraindications.
• Alternative pathway (Ohio only): 1. Member resides in Ohio AND 2. Plan is Fully Insured or HIM Shop (SG) AND BOTH: (a) Patient does NOT have any FDA labeled contraindications AND (b) ONE of: (i) Patient has another FDA labeled indication for the agent and route OR (ii) Patient has a compendia supported indication OR (iii) Prescriber provides ≥2 peer-reviewed journal articles supporting proposed use. Accepted compendia include: Non-oncology: DrugDex level 1, 2A, or 2B; AHFS-DI (supportive narrative). Oncology: NCCN 1 or 2A; AHFS-DI (supportive narrative); DrugDex level 1, 2A, or 2B; Clinical Pharmacology (supportive narrative); LexiDrugs evidence level A; peer-reviewed literature.

Reauthorization criteria

• Patient previously approved through plan’s prior authorization process (new patients require initial review).
• Patient has demonstrated clinical benefit with requested agent.
• Prescriber is a specialist in the diagnosis area (e.g., hematologist) OR has consulted with such specialist.
• Patient will continue using the requested agent as add-on therapy to Soliris (eculizumab) or Ultomiris (ravulizumab-cwvz).
• Patient will NOT use the requested agent in combination with Empaveli (pegcetacoplan), Fabhalta (iptacopan), or Piasky (crovalimab-akkz).
• Patient does NOT have any FDA labeled contraindications.

Approval duration

initial: 3 months (12 months for BCBSIL/BCBSTX); renewal: 12 months