Hympavzi (marstacimab-hncq) — Medical Mutual

Initial criteria

• Patient is age ≥ 12 years
• Patient will initiate maintenance therapy at 150 mg every week
• Will not be used for the treatment of breakthrough bleeds (Factor VIII or Factor IX products may be administered as needed for breakthrough bleeds)
• Female patients of reproductive potential are not pregnant prior to initiating therapy
• Will not be used in combination with another agent used as prophylactic therapy for Hemophilia A or B
• Diagnosis of congenital factor VIII deficiency confirmed by blood coagulation testing (Hemophilia A)
• Must be used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes (Hemophilia A)
• Used as treatment in one of the following: primary prophylaxis in patients with severe factor VIII deficiency (factor VIII level <1%) OR secondary prophylaxis in patients with ≥2 documented episodes of spontaneous joint bleeding (Hemophilia A)
• Patient has tried and had inadequate response to emicizumab AND an antihemophilic Factor VIII agent used for prophylaxis, unless contraindicated or not tolerated (Hemophilia A)
• Diagnosis of congenital factor IX deficiency confirmed by blood coagulation testing (Hemophilia B)
• Must be used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes (Hemophilia B)
• Used as treatment in one of the following: primary prophylaxis in patients with severe factor IX deficiency (factor IX level <1%) OR secondary prophylaxis in patients with ≥2 documented episodes of spontaneous joint bleeding (Hemophilia B)
• Patient has tried and had inadequate response to an antihemophilic Factor IX agent used for prophylaxis, unless contraindicated or not tolerated (Hemophilia B)

Reauthorization criteria

• Patient continues to meet the universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy)
• Absence of unacceptable toxicity from the drug (e.g., thromboembolic events, hypersensitivity)
• Patient has demonstrated a beneficial response to therapy (frequency of bleeding episodes has decreased from pre-treatment baseline) OR
• Patient requires dose escalation (up to 300 mg weekly) AND all of the following: patient weighs ≥50 kg, control of bleeding events has been inadequate (≥2 breakthrough bleeds on maintenance lower dose), patient has been fully adherent to therapy for ≥6 months at lower dose

Approval duration

initial 6 months, renewal 12 months