CABLIVI (caplacizumab)

CABLIVI (caplacizumab)

OFFICE ADMINISTRATION - IV Bolus

OFFICE ADMINISTRATION / SELF ADMINISTRATION - SQ

Indications for Prior Authorization:

• Indicated in adults with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange and immunosuppressive therapy

Patients must meet the following criteria for the indication(s) above:

• Patient is 18 years of age or older, AND
• Diagnosis of aTTP confirmed by chart note documentation, AND
• Prescribed by or in consultation with a hematologist, AND
• Cablivi® is being used in combination with plasma exchange and immunosuppressive therapy (e.g., systemic corticosteroids, rituximab, cyclosporine, cyclophosphamide, mycophenolate mofetil, hydrochloroquine, Velcade)

Renewal criteria for treatment extension:

• Prescribed by or in consultation with a hematologist, AND
• Cablivi® is being used in combination with plasma exchange and immunosuppressive therapy (e.g., systemic corticosteroids, rituximab, cyclosporine, cyclophosphamide, mycophenolate mofetil, hydrochloroquine, Velcade), AND
• Member is responding positively to therapy as evidence by, including but not limited to, improvement in any of the following: platelet count increase, neurological symptom reduction, organ-damage marker improvement (lactate dehydrogenase, cardiac troponin 1, serum creatinine), AND
• Member has sign(s) of persistent underlying disease such as suppressed ADAMTS13 activity levels remain present, treatment may be extended for a maximum of 28 days, AND
• Discontinue Cablivi® if the patient experiences more than 2 recurrences of aTTP, while on Cablivi®, AND
• The member will not receive more than 58 days of Cablivi® therapy after completion of plasma exchange therapy

Dosing:

• First day of treatment: 11 mg IV bolus at least 15 minutes prior to plasma exchange, then 11 mg SQ after completion of plasma exchange on day 1; IV bolus is given by a healthcare provider
• Subsequent treatment days: 11 mg SQ once daily following plasma exchange; SQ may be self-administered or by a caregiver
• Treatment after plasma exchange period: 11 mg SQ once daily, continuing for 30 days following last daily plasma exchange.  If after initial treatment course, sign(s) of persistent underlying disease such as suppressed ADAMTS13 activity levels remain present, treatment may be extended for a maximum of 28 days
• Withhold Cablivi® treatment 7 days prior to elective surgery, dental procedures, or other invasive interventions

Approval:

• 30 days
• Extension: 28 days
• Maximum: total duration of 58 days post plasma-exchange