concizumab-mtci — Blue Cross Blue Shield of New Mexico

Initial criteria

• The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR ALL of the following criteria:
• Diagnosis confirmed by blood coagulation testing with congenital factor VIII or IX deficiency AND inhibitor titer > 5 Bethesda units (BU)
• Requested agent used for primary prophylaxis in severe deficiency (<1%) OR secondary prophylaxis with ≥2 spontaneous joint bleeds
• Patient has had previous prophylaxis therapy
• Patient has tried and had inadequate response to Immune Tolerance Induction (ITI) OR inhibitor level ≥200 BU OR not a candidate for ITI
• If FDA-labeled indication, patient's age within labeling OR there is support for patient’s age for the indication
• Requested agent used as prophylaxis to prevent or reduce bleeding episodes
• Requested agent NOT used for treatment of breakthrough bleeding
• Patient is NOT pregnant
• Prescriber is a hemophilia specialist or has consulted with such specialist
• Requested agent NOT used in combination with clotting factor concentrates, bypassing agents, or Emicizumab for hemophilia A with inhibitors (factor products may be given for breakthrough bleeding)
• Patient does NOT have any FDA labeled contraindications to the requested agent
• Requested dose within FDA labeled dosing
• Alternative approval criteria for MT, NM, or OH members include specific evidence-based medical journal or compendia support as described for off-label or rare indications when no contraindications are present

Reauthorization criteria

• Patient previously approved through plan prior authorization process
• Patient shows improvement or stabilization based on frequency of breakthrough bleeding episodes OR documented support for continued use
• Prescriber is a hemophilia specialist or has consulted with one
• Requested agent NOT used in combination with clotting factor products used as prophylactic therapy (factor products may be used for breakthrough bleeding)
• Absence of unacceptable toxicity (e.g., thromboembolic events, hypersensitivity)
• Plasma concentration of concizumab ≥200 ng/mL
• Patient has no FDA labeled contraindications

Approval duration

3 months (BCBSNM); 12 months (others); 8 weeks (other plans unless otherwise noted)