Voydeya (danicopan) — Highmark
Paroxysmal nocturnal hemoglobinuria (PNH) with clinically significant extravascular hemolysis (EVH)
Initial criteria
- age ≥ 18 years
- prescribed by or in consultation with a hematologist who specializes in the treatment of PNH
- diagnosis of PNH (ICD-10: D59.5)
- clinically significant extravascular hemolysis (EVH) demonstrated by one of the following: hemoglobin ≤ 9.5 gm/dL OR absolute reticulocyte count (ARC) ≥ 120 x 10^9/L
- Voydeya will be used in combination with ravulizumab or eculizumab for the treatment of PNH
- member has been receiving ravulizumab or eculizumab for ≥ 6 months
Reauthorization criteria
- positive clinical response to therapy evidenced by one of the following: increased or stabilization of hemoglobin levels OR reduction in transfusions OR improvement in hemolysis OR decrease in LDH OR decreased reticulocyte count
- continues to receive Voydeya in combination with ravulizumab or eculizumab
Approval duration
initial: 6 months; reauthorization: 12 months