danicopan — Blue Cross Blue Shield of Montana

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 using at least 2 independent reagents on at least 2 cell lineages demonstrating GPI-linked protein deficiency (lab tests required) AND (2) Clinically significant extravascular hemolysis as indicated by BOTH: (A) Hemoglobin ≤ 9.5 g/dL (lab test required) AND (B) Absolute reticulocyte count ≥ 120 x 10^9/L with or without transfusion support (lab test required) AND (3) BOTH of the following: (A) 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 requested agent will be used 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 use for the patient’s age
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist) or has consulted with a specialist
• 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 approval for Ohio residents with Fully Insured or HIM Shop (SG) plans when: (a) No FDA labeled contraindications AND (b) ONE of: (i) Another FDA labeled indication and route of administration OR (ii) Compendia-supported indication OR (iii) TWO peer-reviewed journal articles showing safety and efficacy per acceptable study design

Reauthorization criteria

• The patient was 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 a specialist
• 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 months (12 months for BCBSIL/BCBSTX); renewal: 12 months