Veopoz (pozelimab-bbfg) — Medica

Initial criteria

• age ≥ 1 year
• has had a genetic test confirming the diagnosis of CHAPLE disease with a biallelic CD55 loss-of-function pathogenic variant [documentation required]
• has a serum albumin level ≤ 3.2 g/dL [documentation required]
• according to the prescribing physician, the patient has active disease and is experiencing one or more signs or symptoms within the last 6 months (e.g., abdominal pain, diarrhea, vomiting, peripheral edema, facial edema)
• medication is prescribed by a physician with expertise in managing CHAPLE disease

Reauthorization criteria

• age ≥ 1 year
• has had a genetic test confirming the diagnosis of CHAPLE disease with a biallelic CD55 loss-of-function pathogenic variant [documentation required]
• medication is prescribed by a physician with expertise in managing CHAPLE disease
• patient had experienced a response to therapy [documentation required] (e.g., increased or maintained serum albumin levels, reduction in albumin transfusions, improved protein/immunoglobulin levels, improved clinical outcomes, reduced hospitalizations, improved growth percentiles, reduced corticosteroid use)

Approval duration

initial: 3 months; reauthorization: 1 year