Alhemo — CareFirst (Caremark)

Initial criteria

• Member is 12 years of age or older
• Member is > 25 kg
• Member has documented history of factor VIII or factor IX inhibitors (≥ 0.6 Bethesda units [BU])
• Member must be using the requested medication for routine prophylaxis to prevent or reduce the frequency of bleeding episodes
• Member has been prescribed, or in need of, treatment with a bypassing agent within the past 6 months (e.g., FEIBA, NovoSeven)
• Member does not have a history, current signs or symptoms, or is at high risk of thromboembolic events
• Member is not currently undergoing or is planning to undergo immune tolerance treatment
• Member does not have baseline laboratory abnormalities: platelets less than 100,000 cells/microL; ALT or AST greater than 3 times ULN; total bilirubin greater than 1.5 times ULN (unless Gilbert’s Syndrome and otherwise stable); fibrinogen below the laboratory lower limit of normal; eGFR ≤ 30 mL/min/1.73 m2
• Member will not use the requested medication in combination with Hemlibra
• Member has not previously received treatment with a gene therapy product (e.g., Beqvez, Hemgenix, Roctavian) for the treatment of hemophilia A or B
• Prophylactic use of bypassing agents, factor VIII products (e.g., Advate, Adynovate, Eloctate), and factor IX products (e.g., Alprolix, Ixinity, Rebinyn) will be discontinued prior to starting therapy with the requested medication
• Provider attests that concizumab-mtci plasma concentrations will be monitored per the protocol outlined in the prescribing information
• Medication must be prescribed by or in consultation with a hematologist

Reauthorization criteria

• Member is experiencing benefit from therapy (e.g., reduced frequency or severity of bleeds)
• Member is not using the requested medication in combination with bypassing agents, factor VIII products (e.g., Advate, Adynovate, Eloctate) or factor IX products (e.g., Alprolix, Ixinity, Rebinyn) for prophylactic use

Approval duration

12 months