Subject: Tavneos SGM 5019-A P2026

Drug

TAVNEOS  (avacopan)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-approved Indications¹

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.

All other indications are considered experimental/investigational and not covered benefits.

Documentation

Submission of the following information is necessary to initiate the prior authorization review:

Initial requests

·        Chart notes or medical record documentation showing a history of positive serum assay for anti-proteinase-3 (anti-PR3) or anti-myeloperoxidase (anti-MPO) antibody

·        Chart notes or medical records of pre-treatment objective assessment of the most impactful aspects of the member’s ANCA-associated vasculitis (e.g., renal, pulmonary, neurologic)

Continuation requests

Chart notes or medical records showing stabilization or improvement in the most impactful aspects of the member’s ANCA-associated vasculitis (e.g., renal, pulmonary, neurologic)

Prescriber Specialties

This medication must be prescribed by or in consultation with a nephrologist, pulmonologist, rheumatologist, or a specialist in the treatment of ANCA-associated vasculitis (GPA and MPA).

Coverage Criteria

Anti-Neutrophil Cytoplasmic Autoantibody (ANCA)-Associated Vasculitis (Granulomatosis with Polyangiitis [GPA] and Microscopic Polyangiitis [MPA])^1-4

Authorization of 12 months may be granted for treatment of severe active ANCA-associated vasculitis (GPA and MPA) in members 18 years of age or older when all of the following criteria are met:

·        Tavneos will be used in combination with standard therapy (e.g., rituximab, cyclophosphamide, methotrexate, azathioprine, mycophenolate mofetil)

·        The member has a history of testing positive for anti-PR3 or anti-MPO antibody

·        Documentation of pretreatment objective assessment of the most impactful aspects of the member’s ANCA-associated vasculitis (e.g., renal, pulmonary, neurologic)

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment for severe active ANCA-associated vasculitis (GPA and MPA) in members who achieve or maintain a positive clinical response as evidenced by stabilization or improvement in the most impactful aspects of the member’s ANCA-associated vasculitis (e.g., renal, pulmonary, neurologic).

Place of Service:

Outpatient

The above policy is based on the following references:

1.      Tavneos [package insert]. Thousand Oaks, CA: ChemoCentryx, Inc.; June 2024.

2.     Chung SA, Langford CA, Maz M, et al. 2021 American college of rheumatology/vasculitis foundation guideline for the management of antineutrophil cytoplasmic antibody-associated vasculitis. Arthritis Rheumatol. 2021 Aug;73(8):1366-1383.

3.     Geetha D, Jefferson JA. ANCA-Associated vasculitis: Core curriculum 2020. Am J Kidney Dis. 75(1):124-137.

4.     Jayne DRW, Merkel PA, Schall TJ, Bekker Pl. Avacopan for the treatment of ANCA-associated vasculitis [supplemental appendix]. N Engl J Med. 2021; 384:599-609. doi: 10.1056/NEJMoa2023386.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

July 29, 2026