Voydeya (danicopan) — CareFirst (Caremark)

Initial criteria

• Diagnosis of PNH confirmed by detecting a deficiency of glycosylphosphatidylinositol-anchored proteins (GPI-APs) as demonstrated by either of the following: at least 5% PNH cells OR at least 51% of GPI-AP deficient polymorphonuclear cells
• Flow cytometry used to demonstrate GPI-APs deficiency
• Member has clinically significant extravascular hemolysis while on ravulizumab or eculizumab as evidenced by BOTH of the following: hemoglobin ≤ 9.5 g/dL AND absolute reticulocyte count ≥ 120 x 10^9/L
• The requested medication will be used concomitantly with ravulizumab or eculizumab

Reauthorization criteria

• No evidence of unacceptable toxicity or disease progression while on the current regimen
• Member demonstrates a positive response to therapy (e.g., improvement in hemoglobin levels, normalization of lactate dehydrogenase [LDH] levels)
• Requested medication will be used concomitantly with ravulizumab or eculizumab

Approval duration

Initial: 6 months; Reauthorization: 12 months