Qfitlia™

Drug - Qfitlia™ (fitusiran) [Genzyme Corporation]

January 2026

Therapeutic Area - Hemophilia treatments

Initial approval criteria

  • Patient is ≥ 12 years of age; AND
  • Patient has a diagnosis of severe hemophilia A (congenital factor VIII deficiency) or hemophilia B (congenital factor IX deficiency; also known as Christmas Disease)
  • Must be used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; AND
  • Used as treatment in one of the following:
    • Primary prophylaxis in patients with severe factor deficiency; OR
    • Secondary prophylaxis in patients with at least ONE documented episode of spontaneous bleeding; AND
  • Will NOT be used for the treatment of breakthrough bleeds (Note: on-demand clotting factor concentrates [CFC] or bypassing agents [BPA] may be administered, with a reduced dose and frequency when occurring > 7 days after initiation of Qfitlia, on an as-needed basis for the treatment of breakthrough bleeds in patients being treated with Qfitlia); AND
  • Patient has an antithrombin (AT) activity level of ≥ 60% prior to start of therapy and AT activity will be monitored periodically, as outlined in the prescribing information, throughout therapy; AND
  • Patient does NOT have a co-existing thrombophilic disorder or a history of, or risk factors predisposing to, thrombosis; AND
  • Provider will consider alternative treatments in patients with a history of symptomatic gallbladder disease, or interruption/discontinuation of therapy in patients with acute/recurrent gallbladder disease; AND
  • Patient does NOT have hepatic impairment (Child-Pugh Class A, B and C); AND
  • Will NOT be used in combination with any of the following (Note: patient may continue their prior CFC or BPA prophylaxis for the first 7 days of Qfitlia treatment; discontinue CFC or BPA prophylaxis no later than 7 days after the initial dose of Qfitlia):
    • Hemophilia BPA prophylaxis (e.g., factor VIIa, anti-inhibitor coagulant complex); OR
    • Immune tolerance induction with clotting factor products (e.g., factor VIII or factor IX concentrates) as prophylactic therapy; OR
    • Emicizumab-kxwh (Hemlibra) for hemophilia A with inhibitors.
  • Initial approval is for 6 months

Renewal criteria

  • Patient must continue to meet the above criteria; AND
  • Patient has demonstrated a beneficial response to therapy (e.g., the frequency of bleeding episodes has decreased from pre-treatment baseline); AND
  • Patient’s latest AT activity result is categorized as one of the following:*
    • Less than 15%; AND
      • Reduction in dose according to package labeling (Note: patient is already receiving 10 mg every 2 months must discontinue therapy); OR
    • 15% to 35%; AND
      • Continue at the current dosage; OR
  • Patient has NOT achieved satisfactory bleed control compared to baseline or the patient’s latest AT activity result is categorized as > 35% after ≥ 6 months*; AND
    • Escalation in dose and frequency according to package labeling; AND
  • Absence of unacceptable toxicity from the drug (e.g., severe hepatotoxicity, thromboembolic events, severe gallbladder disease).
  • Renewal approval is for 12 months

* Note: Patient AT activity should be monitored at prescribed times following the initiation of therapy and after any dose modifications using an FDA-cleared test

Quantity limits

  • 50 mg every month

Questions

Provider Call Center: (844) 575-7887