Alhemo (concizumab-mtci) — Medical Mutual

Initial criteria

• Patient is at least 12 years of age; AND
• Will not be used for the treatment of breakthrough bleeds; AND
• Female patients of reproductive potential are not pregnant prior to initiating therapy with concizumab; AND
• Will NOT be used in combination with another agent used as prophylactic therapy for Hemophilia A or B; AND
• Diagnosis of congenital factor VIII deficiency has been confirmed by blood coagulation testing (for Hemophilia A); AND
• Patient has inhibitors to Factor VIII with a current or historical titer of ≥ 5 Bethesda Units (BU) (for Hemophilia A); AND
• Must be used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes (for Hemophilia A); AND
• Used as treatment in one of the following (for Hemophilia A): 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 has had previous prophylaxis therapy (for Hemophilia A); AND
• Diagnosis of congenital factor IX deficiency has been confirmed by blood coagulation testing (for Hemophilia B); AND
• Patient has inhibitors to Factor IX with a current or historical titer of ≥ 5 Bethesda Units (BU) (for Hemophilia B); AND
• Must be used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes (for Hemophilia B); AND
• Used as treatment in one of the following (for Hemophilia B): Primary prophylaxis in patients with severe factor IX deficiency (factor IX level of <1%) OR Secondary prophylaxis in patients with at least TWO documented episodes of spontaneous bleeding into joints; AND
• Patient has had previous prophylaxis therapy (for Hemophilia B)

Reauthorization criteria

• Patient continues to meet the universal and other indication-specific relevant criteria such as concomitant therapy requirements, performance status, etc.; AND
• Absence of unacceptable toxicity from the drug (examples: thromboembolic events, hypersensitivity, etc.); AND
• Patient has demonstrated a beneficial response to therapy (i.e., the frequency of bleeding episodes has decreased from pre-treatment baseline); AND
• Patient measurement of concizumab plasma concentrations at least 200 ng/mL

Approval duration

initial 8 weeks, renewal 12 months