Hemlibra (emicizumab-kxwh) — Medical Mutual

Initial criteria

• Diagnosis of congenital factor VIII deficiency has been confirmed by blood coagulation testing; AND
• Will NOT be used in combination with another agent used as prophylactic therapy for Hemophilia A (Note: The prophylactic use of factor VIII (FVIII) products may be continued during the first week of emicizumab prophylaxis); AND
• Hemophilia A with inhibitors:
• • Patient has inhibitors to Factor VIII with a current or historical titer of ≥ 5 Bethesda Units (BU); AND
• • Must be used as routine prophylaxis to prevent or reduce the frequency of bleeding episodes; AND
• o Used as primary prophylaxis in patients with severe factor VIII deficiency (factor VIII level of <1%); OR
• o Used as secondary prophylaxis in patients with at least TWO documented episodes of spontaneous bleeding into joints; AND
• • Not used in combination with Immune Tolerance Induction (ITI); AND
• o Patient has had at least two documented episodes of spontaneous bleeding into joints; OR
• o Patient had a documented trial and failure of Immune Tolerance Induction (ITI); OR
• o Patient had a documented trial and failure of, or is currently on, routine prophylaxis with a bypassing agent (i.e., NovoSeven, Feiba)
• Hemophilia A without inhibitors:
• • 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 VIII deficiency (factor VIII level of <1%); OR Secondary prophylaxis in patients with at least TWO documented episodes of spontaneous bleeding into joints; AND
• • Patient is not a suitable candidate for treatment with shorter half-life Factor VIII (recombinant) products at a total weekly dose of 100 IU/kg or less (as attested by the prescribing physician with appropriate clinical rationale)

Reauthorization criteria

• Patient continues to meet the universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Absence of unacceptable toxicity from the drug (examples include thrombotic microangiopathy, thromboembolic events, development of neutralizing antibodies); AND
• Patient has demonstrated a beneficial response to therapy (i.e., the frequency of bleeding episodes has decreased from pre-treatment baseline)

Approval duration

initial 3 months; renewal 12 months