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    Actemra

    Drug - Actemra® (tocilizumab) [Genentech]

    September 2019

    Therapeutic area - Auto-inflammatory diseases

    Giant Cell Arteritis (GCA)

    Initial approval criteria

    • Patient is at least 18 years of age AND
    • Patient has a diagnosis of giant cell arteritis (GCA) AND
    • Patient has negative tuberculin test or, if positive, therapy with isoniazid was initiated at least 1 month prior to request AND
    • Patient does not have an active infection or a history of recurring infections AND
    • Patient is not on a concurrent TNF antagonist AND
    • Patient does not have positive HBV or HCV serology AND
    • Patient has an absolute neutrophil count (ANC) above 2000 per mm3, platelet count above 100,000 per mm3, or who have ALT or AST below 1.5 times the upper limit of normal (ULN) AND
    • Patient has tried a systemic corticosteroid taper for at least 6 months, unless contraindicated

    Renewal criteria

    • Patient continues to meet initial approval criteria AND
    • Patient has the following lab values:
      • Less than 5 times ULN AND
      • ANC greater than 500 cells per mm3 AND
      • Platelet count greater than 50,000 cells per mm3

    Systemic Juvenile Idiopathic Arthritis (SJIA)

    Initial approval criteria

    • Patient is at least 2 years of age AND
    • Patient has a diagnosis of systemic juvenile idiopathic arthritis (SJIA) AND
    • Patient has negative tuberculin test or, if positive, therapy with isoniazid was initiated at least 1 month prior to request AND
    • Patient does not have an active infection or a history of recurring infections AND
    • Patient is not on a concurrent TNF antagonist AND
    • Patient does not have positive HBV or HCV serology AND
    • Patient has an absolute neutrophil count (ANC) above 2000 per mm3, platelet count above 100,000 per mm3, or who have ALT or AST below 1.5 times the upper limit of normal (ULN)

    Renewal criteria

    • Patient continues to meet initial approval criteria
    • Patient has the following lab values:
      • Less than 5 times ULN AND
      • ANC greater than 500 cells per mm3 AND
      • Platelet count greater than 50,000 cells per mm3

    CAR-T cell therapy-induced Cytokine Release Syndrome (CRS)

    FDA-approved REMS for specific CAR-T cell therapy provides guideline for the management of CRS including hospitalization. Reimbursement for the dispensing of Actemra in an outpatient setting for CRS indication is not available.

    Other Diagnoses

    Refer to the PA criteria sheet, “Immunomodulators,” if the patient has one of the following diagnoses:

    • Rheumatoid Arthritis (RA) OR
    • Polyarticular Juvenile Idiopathic Arthritis (PJIA)

    Quantity limit

    Patient’s current weight to be reported at time of submission.

    Quantity limits depend on patient’s diagnosis.

    • Patients with GCA:
      • 162 mg SC every week
    • Patients with SJIA:
      • IV
        • Patient weight < 30 kg: 12 mg/kg every 2 weeks
        • Patient weight ≥ 30 kg: 8 mg/kg every 2 weeks
      • SC
        • Patient weight < 30 kg: 162 mg every 2 weeks
        • Patient weight ≥ 30 kg: 162 mg every week

    Questions?

    MHCP Provider Call Center 651-431-2700 or 800-366-5411

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