Tavneos — Medical Mutual

Initial criteria

• Patient age ≥ 18 years; AND
• Patient has granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA); AND
• Patient has severe active disease (newly diagnosed or relapsed; not in remission); AND
• Patient is positive for proteinase 3, myeloperoxidase antibodies, or anti-neutrophil cytoplasmic autoantibody (ANCA); AND
• Patient is using Tavneos in combination with at least one immunosuppressant (e.g., cyclophosphamide, rituximab, azathioprine, or mycophenolate mofetil); AND
• Medication is prescribed by or in consultation with a rheumatologist, nephrologist, or immunologist; AND
• Patient meets one of the following: (a) Assessed at baseline by at least one objective measure (eGFR, urinary albumin creatinine ratio, or Birmingham Vasculitis Activity Score [BVAS]); OR (b) At baseline has at least one symptom: joint pain, ulcers, myalgia, persistent cough, abdominal pain, or serious impairment in function or activities of daily living.

Reauthorization criteria

• Patient age ≥ 18 years; AND
• Patient has been established on Tavneos for at least 6 months; AND
• Medication is prescribed by or in consultation with a rheumatologist, nephrologist, or immunologist; AND
• Patient will continue to use Tavneos in combination with standard therapy including glucocorticoids; AND
• Patient meets at least one of the following: (a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (e.g., improvement in eGFR, decrease in urinary albumin creatinine ratio, or improvement in BVAS); OR (b) Compared with baseline, patient experienced improvement in at least one symptom (joint pain, ulcers, myalgia, persistent cough, or abdominal pain) or improvement in function or activities of daily living.

Approval duration

initial 6 months; reauth 1 year