Fabhalta — Medical Mutual

Initial criteria

• Patient is age ≥ 18 years; AND
• Paroxysmal nocturnal hemoglobinuria diagnosis was confirmed by peripheral blood flow cytometry results showing the absence or deficiency of glycosylphosphatidylinositol-anchored proteins on at least two cell lineages; AND
• Patient has a mean hemoglobin level < 10 g/dL; AND
• Patient has an LDH level of 1.5 times the upper limit of the normal range; AND
• Patient has complete or updated vaccinations for encapsulated bacteria (Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae) at least 2 weeks prior to the first dose of Fabhalta; AND
• Medication is prescribed by or in consultation with a hematologist

Reauthorization criteria

• Patient is age ≥ 18 years; AND
• Patient is continuing to derive benefit from Fabhalta according to the prescriber (examples: increase in or stabilization of hemoglobin levels, decreased transfusion requirements or transfusion independence, reductions in hemolysis); AND
• Medication is prescribed by or in consultation with a hematologist

Approval duration

initial 6 months; reauth 1 year