Alhemo®

Drug - Alhemo® (concizumab-mtci) [Novo Nordisk, Inc.]

July 2025

Therapeutic Area - Hemophilia treatments

Initial approval criteria

  • Patient is ≥ 12 years of age; AND
  • Must be used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; AND
  • Patient has hemophilia A (congenital factor VIII deficiency) with inhibitors; AND
    • Diagnosis of congenital factor VIII deficiency has been confirmed by blood coagulation testing; AND
    • Patient has inhibitors to factor VIII with a current or historical titer of ≥ 5 Bethesda Units (BU)*; 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 ≥ 2 documented episodes of spontaneous bleeding into joints; OR
  • Patient has hemophilia B (congenital factor IX deficiency, also known as Christmas Disease) with inhibitors; AND: 
    • Diagnosis of congenital factor IX deficiency has been confirmed by blood coagulation testing; AND
    • Patient has inhibitors to factor IX with a current or historical titer of ≥ 5 Bethesda Units (BU)*; AND
    • Used as treatment in one of the following:
      • Primary prophylaxis in patients with severe factor IX deficiency (factor IX level of <1%); OR
      • Secondary prophylaxis in patients with ≥ 2 documented episodes of spontaneous bleeding into joints; AND
  • Patient has not previously received treatment with a gene therapy product (e.g., Hemgenix, Roctavian) for the treatment of hemophilia A or B; AND
  • Patient does NOT have a history of known serious hypersensitivity to Alhemo or its components or the inactive ingredient; AND
  • Will NOT be used for the treatment of breakthrough bleeds (Note: bypassing agents [e.g., recombinant activated factor VII (rFVIIa) or activated prothrombin complex concentrate (aPCC)] may be administered on an as needed basis for the treatment of breakthrough bleeds in patients being treated with concizumab); AND
  • Will NOT be used in combination with any of the following (Note: factor VIII or factor IX products can be administered for the treatment of breakthrough bleeds while receiving concizumab):
    • Hemophilia bypassing agents (e.g., factor VIIa or anti-inhibitor coagulant complex); AND
    • Immune tolerance induction in combination with clotting factor products (e.g., factor VIII or factor IX concentrates) as prophylactic therapy; AND
    • Emicizumab-kxwh (Hemlibra) for hemophilia A with inhibitors;AND
  • Patients of reproductive potential are NOT pregnant prior to initiating therapy with concizumab and will use a highly effective form of contraception during treatment with Alhemo and for 7 weeks after ending treatment
  • Initial approval is for 8 weeks

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 measurement of concizumab plasma concentrations is ≥ 200 ng/mL**; AND
  • Patient has NOT experienced any treatment-restricting adverse effects (e.g., thromboembolic events, hypersensitivity). 
  • Renewal approval is for 12 months

*Note: Patients with inhibitor titer levels > 0.6 BU to < 5 BU who are not responding to or are not a candidate for standard factor replacement, will be evaluated on a case-by-case basis.
**Note: Requests for patients with measurements of concizumab plasma concentrations that remain < 200 ng/mL at 2 consecutive measurements, will be reviewed on a case-by-case basis.

Quantity limits

  • Loading dose and maintenance dose will NOT exceed those recommended in the FDA-approved label
  • Patient’s weight (in kg) will be submitted at time of request

Questions

Provider Call Center (844) 575-7887