WHA
 

Tavneos (avacopan) - PA, NF

Indications for Prior Authorization

Tavneos (avacopan)
  • For diagnosis of Anti-Neutrophil Cytoplasmic Autoantibody (ANCA)-Associated Vasculitis
    Indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. Tavneos does not eliminate glucocorticoid use.

Criteria

Tavneos

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

  • Diagnosis of one of the following types of severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis:
    • Granulomatosis with polyangiitis (GPA)
    • Microscopic polyangiitis (MPA)
    AND
  • Submission of medical records (e.g., chart notes) confirming diagnosis by one of the following: [4]
    • ANCA test positive for proteinase 3 (PR3) antigen
    • ANCA test positive for myeloperoxidase (MPO) antigen
    • Tissue biopsy
    AND
  • Patient is receiving concurrent immunosuppressant therapy with one of the following: [1-3]
    • cyclophosphamide
    • rituximab
    AND
  • One of the following:
    • Patient is concurrently on glucocorticoids (e.g., prednisone)
      • OR
    • History of contraindication or intolerance to glucocorticoids (e.g., prednisone)
    AND
  • Provider attests that liver function (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP], and total bilirubin) will be measured before initiation, every 4 weeks after start of therapy for the first 6 months of treatment and as clinically indicated thereafter [A]
    • AND
  • Prescribed by or in consultation with one of the following with shared decision-making regarding treatment risks:
    • Nephrologist
    • Pulmonologist
    • Rheumatologist
Tavneos

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

  • Patient does not show evidence of progressive disease while on therapy
    • AND
  • Patient is receiving concurrent immunosuppressant therapy (e.g., azathioprine, cyclophosphamide, methotrexate, rituximab)
    • AND
  • Provider continues to monitor liver function (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP], and total bilirubin)
    • AND
  • Prescribed by or in consultation with one of the following with shared decision-making regarding treatment risks:
    • Nephrologist
    • Pulmonologist
    • Rheumatologist
Tavneos

Non Formulary

Length of Approval: 12 Month(s)

  • Submission of medical records (e.g., chart notes) confirming diagnosis of one of the following types of severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis:
    • Granulomatosis with polyangiitis (GPA)
    • Microscopic polyangiitis (MPA)
    AND
  • Submission of medical records (e.g., chart notes) confirming diagnosis by one of the following: [4]
    • ANCA test positive for proteinase 3 (PR3) antigen
    • ANCA test positive for myeloperoxidase (MPO) antigen
    • Tissue biopsy
    AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming patient is receiving concurrent immunosuppressant therapy with one of the following: [1-3]
    • cyclophosphamide
    • rituximab
    AND
  • One of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming patient is concurrently on glucocorticoids (e.g., prednisone)
      • OR
    • Paid claims or submission of medical records (e.g., chart notes) confirming contraindication or intolerance to glucocorticoids (e.g., prednisone)
    AND
  • Submission of medical records (e.g., chart notes) confirming that liver function (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP], and total bilirubin) will be measured before initiation, every 4 weeks after start of therapy for the first 6 months of treatment and as clinically indicated thereafter [A]
    • AND
  • Prescribed by or in consultation with one of the following with shared decision-making regarding treatment risks:
    • Nephrologist
    • Pulmonologist
    • Rheumatologist

  • Guideline ID
    GL-636212

  • Formulary
    Premium

  • Effective date
    Jul 1, 2026

  • P&T approval date
    Dec 15, 2021

P & T Revisions

2026-06-10, 2025-12-02, 2024-10-01, 2023-10-05, 2022-10-14, 2022-10-13, 2022-04-07, 2022-01-27, 2021-12-08

  1. Tavneos Prescribing Information. ChemoCentryx, Inc. Thousand Oaks. May 2026.
  2. Jayne DRW, Merkel PA, Schall TJ, Bekker P; ADVOCATE Study Group. Avacopan for the Treatment of ANCA-Associated Vasculitis. N Engl J Med. 2021;384(7):599-609. doi:10.1056/NEJMoa2023386
  3. Per clinical consult with rheumatologist November 17, 2021.
  4. Falk RJ, Merkel PA, King TE. Granulomatosis with polyangiitis and microscopic polyangiitis: clinical manifestations and diagnosis. In: Post T, ed. UpToDate 2022. Accessed October 9, 2022.
  5. Merkel PA, Kaplan AA. Granulomatosis with polyangiitis and microscopic polyangiitis: Induction and maintenance therapy. UpToDate 2022. Accessed October 9, 2022.
  1. Serious cases of hepatic injury have been observed in patients taking TAVNEOS. During controlled trials, the TAVNEOS treatment group had a higher incidence of transaminase elevations and hepatobiliary events, including serious and life-threatening events. In the postmarketing setting, vanishing bile duct syndrome (VBDS) as a consequence of liver injury, including cases with a fatal outcome, has been reported. These events occurred predominantly in Japan in patients aged 65 years and older, but VBDS may affect patients of any age or ethnicity who are receiving TAVNEOS. Obtain liver test panel (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP], and total bilirubin) before initiating TAVNEOS, every 4 weeks after start of therapy for the first 6 months of treatment and as clinically indicated thereafter. For patients of Japanese descent, consider more frequent laboratory testing: every 2 weeks after the start of therapy for the first 3 months, followed by laboratory testing every 4 weeks for the next 3 months of treatment, and as clinically indicated thereafter. If a patient receiving treatment with TAVNEOS presents with an elevation in ALT or AST to >3 times the upper limit of normal, evaluate promptly and consider pausing treatment as clinically indicated. If AST or ALT is > 5 times the upper limit of normal (ULN), or ALT or AST > 3 times the ULN with total bilirubin > 2 times the ULN, or ALP ≥ 2 times the ULN, or if the patient has clinical symptoms such as jaundice or pruritus, discontinue TAVNEOS until TAVNEOS-induced liver injury is ruled out. Immediately and permanently discontinue TAVNEOS if VBDS is suspected.
  • 2026-06-10: Added criteria to monitor liver function and updated prescriber criteria to add in shared decision making regarding treatment risks.
  • 2025-12-02: 2025 Annual Review. No criteria changes, updated references
  • 2024-10-01: 2024 Annual Review
  • 2023-10-05: 2023 Annual Review
  • 2022-10-14: 2022 Annual Review
  • 2022-10-13: GPI Reclassification
  • 2022-04-07: Update Guideline
  • 2022-01-27: New Program
  • 2021-12-08: New Program