Qfitlia (fitusiran) — Medica

Hemophilia B without Factor IX inhibitors

Initial criteria

age ≥ 12 years
using Qfitlia for routine prophylaxis to prevent or reduce the frequency of bleeding episodes
moderately severe to severe hemophilia B evidenced by baseline Factor IX level ≤ 2% without Factor IX replacement therapy
EITHER (a) Factor IX inhibitor titer testing performed within past 30 days AND no positive test ≥ 1.0 Bethesda units/mL OR (b) has not received Factor IX therapy in the past
prescriber will discontinue prophylactic use of Factor IX products no later than 7 days following the initial Qfitlia dose (use of Factor IX products for treatment of breakthrough bleeding is permitted)
prescribed by or in consultation with a hemophilia specialist

using Qfitlia for routine prophylaxis to prevent or reduce the frequency of bleeding episodes
prophylactic use of Factor IX products will not occur while receiving Qfitlia (use for breakthrough bleeding is permitted)
prescribed by or in consultation with a hemophilia specialist
beneficial response to therapy (e.g., reduction in bleeding events or severity, fewer bleeds requiring treatment, and/or fewer spontaneous bleeds)

1 year