Subject: Tavneos 5019-A SGM P2022
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 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)5
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)5
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., cyclophosphamide, azathioprine,
mycophenolate, rituximab)
B. The member is positive for anti-PR3 or anti-MPO antibody
C. Documentation of pre-treatment 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 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.
- American College of Rheumatology. 2021 American college of rheumatology/vasculitis foundation guideline for the management of antineutrophil cytoplasmic antibody-associated vasculitis. Arthritis & Rheumatology. Https://www.vasculitisfoundation.org/wp-content/uploads/2021/07/2021-ACR-VF-Guideline-for-Management-of-ANCA-Associated-Vasculitis.pdf. Accessed January 13, 2022.
- Geetha D, Jefferson JA. ANCA-Associated vasculitis: Core curriculum 2020. Am J Kidney Dis. 75(1): 124-137.
- Jayne DRW, Merkel PA, Schall TJ et al. Avacopan for the treatment of ANCA-associated vasculitis [supplemental appendix]. N Engl J Med. 2021; 384:599-609. DOI: 10.1056/NEJMoa2023386. https://www.nejm.org/doi/suppl/10.1056/NEJMoa2023386/suppl_file/nejmoa2023386_appendix.pdf. Accessed October 28, 2021.
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 03, 2022
