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