Subject: Tavneos 5019-A SGM P2023
Policy:
I. 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 Indication
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.
II. DOCUMENTATION
Submission of the following information is necessary to initiate
the prior authorization review:
A. Initial requests:
1. Chart notes or medical records showing a history of
positive serum assay for anti-proteinase-3 (anti-PR3) or
anti-myeloperoxidase (anti-MPO) antibody
2. 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)
B. 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)
III. CRITERIA FOR INITIAL APPROVAL
Anti-neutrophil cytoplasmic autoantibody (ANCA)-
associated vasculitis (granulomatosis with polyangiitis
[GPA] and microscopic polyangiitis [MPA])
Authorization of 12 months may be granted for treatment of
severe active ANCA-associated vasculitis (GPA and MPA) when
all of the following are met:
A. Tavneos will be used in combination with standard therapy
(e.g., rituximab, cyclophosphamide, methotrexate,
azathioprine, mycophenolate mofetil)
B. The member has a history of testing positive for anti-PR3 or
anti-MPO antibody
C. Documentation of pretreatment objective assessment of the
most impactful aspects of the member’s ANCA-associated
vasculitis (e.g., renal, pulmonary, neurologic)
IV. 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:
- Tavneos [package insert]. Cincinnati, OH: ChemoCentryx, Inc.; October 2021.
- 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.
- Geetha D, Jefferson JA. ANCA-Associated vasculitis: Core curriculum 2020. Am J Kidney Dis. 75(1):124-137.
- 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.
June 11, 2023
