Subject: Brukinsa 3411-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.
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.
B. Compendial Use
1. Chronic Lymphocytic Leukemia/Small Lymphocytic
Lymphoma
2. Gastric MALT Lymphoma/Non-gastric MALT Lymphoma
3. Nodal Marginal Zone Lymphoma
4. Splenic Marginal Zone Lymphoma
5. Waldenstrom Macroglobulinemia/Lymphoplasmacytic
lymphoma
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,
non-gastric MALT lymphoma, nodal marginal zone
lymphoma and splenic marginal zone lymphoma, when used
as subsequent therapy for members who are intolerant or
have contraindications to ibrutinib or for members who have
received an anti-CD20 based-regimen (e.g., rituximab or
obinutuzumab).
D. Waldenstrom Macroglobulinemia/Lymphoplasmacytic
Lymphoma
Authorization of 12 months may be granted for treatment
of Waldenstrom macroglobulinemia/Lymphoplasmacytic
lymphoma when used as a single agent.
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.; September 2021.
- National Comprehensive Cancer Network. The NCCN Drugs & Biologics Compendium. http://www.nccn.org. Accessed June 2, 2022.
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.
December 29, 2022
