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Qfitlia (fitusiran) — CareFirst (Caremark)

Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged ≥12 years with hemophilia A or B with or without factor VIII or IX inhibitors

Initial criteria

  • Member is aged ≥12 years
  • Member has severe factor VIII deficiency (factor VIII level <1%) or severe factor IX deficiency (factor IX level ≤2%)
  • Member is using the requested medication for routine prophylaxis to prevent or reduce the frequency of bleeding episodes
  • Member will not use the requested medication to treat breakthrough bleeding
  • Member does not have co-existing coagulation disorders (other than hemophilia A or B)
  • Member does not have a history of arterial or venous thromboembolism, significant valvular disease or atrial fibrillation, or co-existing thrombophilic disorder (e.g., Factor V Leiden mutation)
  • Member does not have a history of symptomatic gallbladder disease
  • Member does not have a history of or is planning to undergo immune tolerance treatment
  • Member does not have baseline antithrombin (AT) activity <60%
  • Member does not have baseline alanine transaminase (ALT) and/or aspartate aminotransferase (AST) >1.5 × ULN
  • Member does not have clinically significant liver disease
  • Member will not use the requested medication in combination with Alhemo, Hemlibra, or Hympavzi
  • Member has not previously received treatment with a gene therapy product (e.g., Beqvez, Hemgenix, Roctavian) for the treatment of hemophilia A or B
  • Prophylactic use of bypassing agents, factor VIII products, and factor IX products will be discontinued no later than 7 days after the initial dose of Qfitlia
  • Provider attests that AT activity and liver enzymes will be monitored per the protocol outlined in the prescribing information
  • Medication must be prescribed by or in consultation with a hematologist

Reauthorization criteria

  • Member is experiencing benefit from therapy (e.g., reduced frequency or severity of bleeds)
  • Member is not using the requested medication in combination with bypassing agents, factor VIII products (e.g., Advate, Adynovate, Eloctate), or factor IX products (e.g., Alprolix, Ixinity, Rebinyn) for prophylactic use

Approval duration

12 months