Subject: Imbruvica 1997-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 Indications
1. Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic
Lymphoma (SLL)
i. Imbruvica is indicated for the treatment of adult
patients with CLL/SLL.
ii. Imbruvica is indicated for the treatment of adult
patients with CLL/SLL with 17p deletion.
2. Waldenström’s Macroglobulinemia (WM)
Imbruvica is indicated for the treatment of adult patients
with WM.
3. Chronic Graft versus Host Disease (cGVHD)
Imbruvica is indicated for the treatment of adult and
pediatric patients age 1 year and older with cGVHD after
failure of one or more lines of systemic therapy.
B. Compendial Use
1. Mantle cell lymphoma
2. Marginal zone lymphomas
a. Extranodal (gastric and nongastric MALT) marginal
zone lymphoma
b. Nodal marginal zone lymphoma
c. Splenic marginal zone lymphoma
3. Hairy cell leukemia
4. Waldenström’s macroglobulinemia/lymphoplasmacytic
lymphoma (WM/LPL)
5. Central nervous system cancers
6. Diffuse large B-cell lymphoma
7. High-grade B-cell lymphoma (including high-grade B-cell
lymphoma with translocations of MYC and BCL2 and/or
BCL6 [double/triple hit lymphoma], high-grade B-cell
lymphoma, not otherwise specified)
8. AIDS-related B-cell lymphoma
9. Monomorphic post-transplant lymphoproliferative
disorders (PTLD)
10. Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic
Lymphoma (SLL)
All other indications are considered experimental/investigational
and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
A. Mantle Cell Lymphoma (MCL)
Authorization of 12 months may be granted for treatment of
MCL when any of the following criteria is met:
1. The member has received at least one prior therapy when
the requested medication is used as a single agent or in
combination with rituximab or venetoclax.
2. The requested medication will be used in combination
with rituximab as pretreatment to induction therapy with
RHyperCVAD (rituximab, cyclophosphamide, vincristine,
doxorubicin, and dexamethasone) regimen.
3. The requested medication will be used as aggressive
induction therapy as a component of TRIANGLE regimen:
alternating RCHOP (rituximab, cyclophosphamide,
doxorubicin, vincristine, and prednisone) + covalent
Bruton tyrosine kinase inhibitor (ibrutinib)/RDHA
(rituximab, dexamethasone, and cytarabine) +
carboplatin regimen.
4. The requested medication will be used in combination
with rituximab for members aged 65 years and older.
B. Chronic Lymphocytic Leukemia (CLL) and Small
Lymphocytic Lymphoma (SLL)
Authorization of 12 months may be granted for treatment of
CLL/SLL as a single agent or in combination with rituximab or
obinutuzumab.
C. Waldenström’s Macroglobulinemia/lymphoplasmacytic
lymphoma (WM/LPL)/ Bing-Neel syndrome
Authorization of 12 months may be granted for treatment of
WM/LPL when the requested medication is used as a single
agent or in combination with rituximab.
D. Marginal Zone Lymphoma (MZL)
Authorization of 12 months may be granted for treatment of
MZL, such as extranodal (gastric or non-gastric MALT
lymphoma) marginal zone lymphoma, nodal marginal zone
lymphoma, or splenic marginal zone lymphoma, when the
member has received at least one prior therapy.
E. Chronic Graft-Versus-Host Disease (cGVHD)
Authorization of 12 months may be granted for treatment of
cGVHD when the member has failed one or more lines of
therapy.
F. Hairy Cell Leukemia
Authorization of 12 months may be granted for treatment of
relapsed/refractory hairy cell leukemia when the requested
medication is used as a single agent for disease progression.
G. Central Nervous System Cancers
Authorization of 12 months may be granted for treatment of
central nervous system cancers when any of the following
criteria is met:
1. The requested medication is used for relapsed or
refractory disease as either a single agent, or in
combination with high-dose methotrexate and rituximab
for primary central nervous system lymphoma.
2. The requested medication is used for induction therapy as
a single agent for primary central nervous system
lymphoma.
3. The requested medication is used as a single agent for
brain metastases in lymphoma
H. Diffuse large B-cell lymphoma
Authorization of 12 months may be granted for single agent
subsequent treatment of diffuse large B-cell lymphoma in
members who are non-candidates for transplant.
I. High-grade B-cell lymphoma (including high-grade B-
cell lymphoma with translocations of MYC and BCL2
and/or BCL6 [double/triple hit lymphoma], high-grade
B-cell lymphoma, not otherwise specified)
Authorization of 12 months may be granted for single agent
subsequent treatment of high-grade B-cell lymphoma
(including high-grade B-cell lymphoma with translocations of
MYC and BCL2 and/or BCL6 [double/triple hit lymphoma],
high-grade B-cell lymphoma, not otherwise specified) in
members who are non-candidates for transplant.
J. HIV-related B-cell lymphomas
Authorization of 12 months may be granted for single agent
subsequent treatment of HIV-related B-cell lymphomas in
members who are non-candidates for transplant.
K. Monomorphic post-transplant lymphoproliferative
disorders
Authorization of 12 months may be granted for single agent
subsequent treatment of monomorphic post-transplant
lymphoproliferative disorders in members who are non-
candidates for transplant.
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:
- Imbruvica [package insert]. South San Francisco, CA: Pharmacyclics LLC; May 2023.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network. The NCCN Drugs & Biologics Compendium. http://www.nccn.org. Accessed June 6, 2023.
- Jain P, Zhao S, Lee HJ, et al Ibrutinib with rituximab in first-line treatment of older patients with mantle cell lymphoma. J Clin Oncol. 2022;40(2):202-212.
- Wang ML, Jurczak W, Jerkeman M, et al. Ibrutinib plus bendamustine and rituximab in untreated mantle-cell lymphoma. N Engl J Med. 2022;386:2482-2494.
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.
February 06, 2024
