Pharmacy Prior Authorization Criteria

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
• Diagnosis is confirmed 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
• Prescribed by or in consultation with one of the following:
• 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
• Prescribed by or in consultation with one of the following:
• Nephrologist
• Pulmonologist
• Rheumatologist

Tavneos

Non Formulary

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
• Diagnosis is confirmed 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
• Prescribed by or in consultation with one of the following:
• Nephrologist
• Pulmonologist
• Rheumatologist

P & T Revisions

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

References

1. Tavneos Prescribing Information. ChemoCentryx, Inc. San Carlos, CA. October 2021.
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.

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Revision History

• 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

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