Hympavzi™

Drug - Hympavzi™ (marstacimab-hncq) [Pfizer, Inc.]

July 2025

Therapeutic Area - Hemophilia treatments

Initial approval criteria

  • Age ≥ 12 years; AND
  • ONE of the following:
    • Diagnosis of hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors confirmed by blood coagulation testing, OR
    • Diagnosis of hemophilia B (congenital factor IX deficiency, Christmas disease) without factor IX inhibitors confirmed by blood coagulation testing; AND
  • ONE of the following:
    • Severe hemophilia (factor activity < 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
  • Hympavzi must be used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; AND
  • Hympavzi will NOT be used in combination with prophylactic factor replacement therapy (e.g., factor VIII or factor IX inhibitors); therapy can be initiated at any time after discontinuing clotting factor concentrates (note: factor VIII or factor IX products can be administered for the treatment of breakthrough bleeds during Hympavzi treatment); AND
  • Patient will initiate maintenance therapy at the lower range of dosing (150 mg weekly); AND
  • Hympavzi will NOT be used for treatment of breakthrough bleeds (note: factor VIII or factor IX products may be administered on an as-needed basis for treatment of breakthrough bleeds in patients being treated with Hympavzi); AND
  • Patient of reproductive potential must have a negative pregnancy test prior to initiation of Hympavzi and must use effective 
  • contraception during treatment and for 2 months after the last dose.
  • 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., frequency of bleeding episodes has decreased from pre-treatment baseline); OR
  • Patient requires dose escalation* (up to the maximum dose and frequency specified below) provided that the patient meets ALL of the following criteria:
    • Body weight ≥ 50 kg
    • Inadequate control of bleeding events (e.g., patient has experienced ≥ 2 breakthrough bleeds while on maintenance therapy at the lower dose)
    • Full adherence to maintenance therapy for ≥ 6 months at the lower dose; AND
  • Patient has NOT experienced any treatment-restricting adverse effects (e.g., thromboembolic events, severe hypersensitivity reactions).
  • Renewal approval is for 12 months

Quantity limits

  • 8 prefilled 150 mg/mL single-dose syringes or pens/28 days
  • Max dose: 300 mg SC weekly

Questions

Provider Call Center (844) 575-7887