Subject: Brukinsa 3411-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.
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. Mantle Cell Lymphoma
2. Chronic Lymphocytic Leukemia/Small Lymphocytic
Lymphoma
3. Gastric MALT Lymphoma (Extranodal Marginal Zone
Lymphoma of the Stomach)/Non-gastric MALT
Lymphoma (Extranodal Marginal Zone Lymphoma of
Nongastric Sites)
4. Nodal Marginal Zone Lymphoma
5. Splenic Marginal Zone Lymphoma
6. Waldenstrom Macroglobulinemia/Lymphoplasmacytic
lymphoma/Bing-Neel Syndrome
All other indications are considered
experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to
initiate the prior authorization review:
Test results confirming TP53 mutation, where applicable
III. CRITERIA FOR INITIAL APPROVAL
A. Mantle Cell Lymphoma
Authorization of 12 months may be granted for
treatment of mantle cell lymphoma when any of the
following criteria are met:
1. The requested medication will be used as a single
agent when the member has received at least one
prior therapy.
2. The requested medication will be used as a
component of TRIANGLE regimen for members with
TP53 mutations for induction therapy.
TRIANGLE regimen = alternating RCHOP (rituximab,
cyclophosphamide, doxorubicin, vincristine, and
prednisone) + Brukinsa/RDHAP (rituximab,
dexamethasone, and cytarabine) + platinum
(carboplatin, cisplatin, or oxaliplatin) regimen
3. The requested medication will be used in combination
with rituximab for maintenance 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.
IV. 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.
- Eskelund CW, Dahl C, Hansen JW, et al. TP53 mutations identify younger mantle cell lymphoma patients who do not benefit from intensive chemoimmunotherapy. 2017;130(17):1903-1910.
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 09, 2023
