Subject: Brukinsa 3411-A SGM P2022a
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.
A. FDA-Approved Indication
Brukinsa is a kinase inhibitor indicated for the treatment of
adult patients with:
1. Mantle cell lymphoma (MCL) who have received at least
one prior therapy.
2. Waldenstrom’s macroglobulinemia (WM).
3. Relapsed or refractory marginal zone lymphoma (MZL)
who have received at least one anti-CD20-based regimen.
4. Chronic lymphocytic leukemia (CLL) or small lymphocytic
lymphoma (SLL)
B. Compendial Use
1. Chronic Lymphocytic Leukemia/Small Lymphocytic
Lymphoma
2. Gastric MALT Lymphoma (Extranodal Marginal Zone
Lymphoma of the Stomach)/Non-gastric MALT Lymphoma
(Extranodal Marginal Zone Lymphoma of Nongastric
Sites)
3. Nodal Marginal Zone Lymphoma
4. Splenic Marginal Zone Lymphoma
5. Waldenstrom Macroglobulinemia/Lymphoplasmacytic
lymphoma/Bing-Neel Syndrome
All other indications are considered experimental/investigational
and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
A. Mantle Cell Lymphoma
Authorization of 12 months may be granted for treatment of
mantle cell lymphoma as a single agent when the member
has received at least one prior therapy.
B. Chronic Lymphocytic Leukemia (CLL)/Small
Lymphocytic Lymphoma (SLL)
Authorization of 12 months may be granted for treatment of
CLL/SLL when used as a single agent.
C. Marginal Zone Lymphoma
Authorization of 12 months may be granted for treatment of
marginal zone lymphoma, including gastric MALT lymphoma
(extranodal marginal zone lymphoma of the stomach), non-
gastric MALT lymphoma (extranodal marginal zone
lymphoma of nongastric sites), nodal marginal zone
lymphoma and splenic marginal zone lymphoma, when used
as subsequent therapy for members who have received an
anti-CD20 based-regimen (e.g., rituximab or obinutuzumab).
D. Waldenstrom Macroglobulinemia/Lymphoplasmacytic
Lymphoma/Bing-Neel Syndrome
Authorization of 12 months may be granted for treatment of
Waldenstrom macroglobulinemia/Lymphoplasmacytic
lymphoma when used as a single agent or for the treatment
of Bing-Neel syndrome when used as a single agent or in
combination with rituximab.
III. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued
treatment in members requesting reauthorization for an
indication listed in Section II when there is no evidence of
unacceptable toxicity or disease progression while on the current
regimen.
Place of Service:
Outpatient
The above policy is based on the following references:
- Brukinsa [package insert]. San Mateo, CA: BeiGene USA, Inc.; April 2023.
- The NCCN Drugs & Biologics Compendium ® © 2023 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed June 2, 2023.
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, 2023
