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    Tavneos®

    Drug - Tavneos® (avacopan) [ChemoCentryx, Inc.]

    October 2022

    Therapeutic area - Immunosuppressives, Oral

    Initial approval criteria

    • Patient is at least 18 years old AND
    • Patient has severe active antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis AND
      • Patient has autoantibodies for proteinase 3 (PR3) or myeloperoxidase (MPO), as detected using indirect immunofluorescence (IIF) assay or antigen-specific enzymelinked immunosorbent assays (ELISAs) OR
      • Disease is confirmed by tissue biopsy at the site of active disease AND
    • Patient has been evaluated and screened for the presence of hepatitis B virus (HBV) prior to initiating treatment AND
    • Physician has assessed disease severity utilizing an objective measure/tool (e.g., Birmingham Vasculitis Activity Score [BVAS]) AND
    • Patient does NOT have an active infection, including clinically important localized infections AND
    • Patient does NOT have severe hepatic impairment (e.g., Child-Pugh C) or active, untreated, and/or uncontrolled chronic liver disease (e.g., chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis, cirrhosis) AND
    • Patient will avoid concomitant therapy with strong and moderate CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John’s wort) AND
    • Patient will avoid concomitant therapy with CYP3A4 inhibitors (e.g., ketoconazole, itraconazole), or if therapy is unavoidable, the patient will be monitored closely for adverse reaction and/or dose modifications will be implemented AND
    • Patient has failed on 1 of the following regimens (if failure occurred during induction) OR patient failed on both of the following regimens (if failure occurred during maintenance) [Note: may be used with or without glucocorticoids]: 
      • Patient has failed immunosuppressant therapy (e.g., cyclophosphamide, azathioprine, methotrexate, mycophenolate), unless contraindicated or not tolerated
      • Patient has failed on anti-CD20 monoclonal antibody therapy (e.g., rituximab), unless contraindicated or not tolerated AND
    • Avacopan (Tavneos) will be used as adjunctive therapy in combination with standard therapy (e.g., corticosteroids, cyclophosphamide, azathioprine, mycophenolate, rituximab)
    • Initial approval is for 6 months

    Renewal criteria

    • Patient must continue to meet the above criteria AND
    • Disease response from pre-treatment baseline as indicated by the following:
      • Absence of new symptoms AND
      • Minimal glucocorticoid requirement (e.g., < 5 mg of prednisone or equivalent) AND
      • One or more of the following:
        • Decrease in relapses/flares and/or ANCA levels OR
        • Improvement in organ manifestations (e.g., those with pulmonary-renal syndrome should improve in PFTs, proteinuria, creatinine) OR
        • Remission (defined as a composite scoring index of 0 on the BVAS) AND
    • Patient has NOT experienced any treatment-restricting adverse effects (e.g., hepatoxicity, severe hypersensitivity reactions, serious infections)
    • Renewal approval is for 6 months

    Quantity limits

    • 180 capsules per 30 days (60 mg daily)

    Questions?

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

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