Subject: Imbruvica 1997-A SGM P2021a
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. Mantle Cell Lymphoma (MCL)
Imbruvica is indicated for the treatment of adult patients with
MCL who have received at least one prior therapy.
2. 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.
3. Waldenström’s Macroglobulinemia (WM)
Imbruvica is indicated for the treatment of adult patients with
WM.
4. Marginal Zone Lymphoma (MZL)
Imbruvica is indicated for the treatment of adult patients with
MZL who require systemic therapy and have received at least one
prior anti-CD20-based therapy.
5. Chronic Graft versus Host Disease (cGVHD)
Imbruvica is indicated for the treatment of adult patients with
cGVHD after failure of one or more lines of systemic therapy.
B. Compendial Use
1. Mantle cell lymphoma
2. Marginal zone lymphomas
a. Gastric mucosa associated lymphoid tissue (MALT) lymphoma
b. Nongastric MALT lymphoma
c. Nodal marginal zone lymphoma
d. Splenic marginal zone lymphoma
3. Hairy cell leukemia, for progression
4. Lymphoplasmacytic lymphoma (LPL)
5. Primary central nervous system lymphoma, for relapsed or
refractory disease or induction therapy
6. Follicular lymphoma, second-line or subsequent therapy
7. Histologic transformation of nodal marginal zone lymphoma to
diffuse large B-cell lymphoma in members who have received
prior chemoimmunotherapy
8. Histologic transformation of follicular lymphoma to diffuse large
B-cell lymphoma
9. Diffuse large B-cell lymphoma, second-line or subsequent
therapy
10. 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), second-line or subsequent therapy
11. AIDS-related B-cell lymphoma, for second-line or subsequent
therapy for relapsed disease
12. Post-transplant lymphoproliferative disorders, subsequent
therapy for members with partial response, persistent, or
progressive disease after receiving chemoimmunotherapy
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 the 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.
B. Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic
Lymphoma (SLL)
Authorization of 12 months may be granted for the treatment of
CLL/SLL as a single agent or in combination with rituximab or
obinutuzumab.
C. Waldenström’s Macroglobulinemia/lymphoplasmacytic
lymphoma (WM/LPL)
Authorization of 12 months may be granted for the 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 the treatment of
MZL, such as gastric or non-gastric MALT 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 the 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 the treatment of
hairy cell leukemia when the requested medication is used as a
single agent for disease progression.
G. Primary central nervous system lymphoma
Authorization of 12 months may be granted for treatment of primary
central nervous system lymphoma 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.
2. The requested medication is used for induction therapy as a single
agent.
H. Follicular lymphoma (FL)
Authorization of 12 months may be granted for the treatment of
follicular lymphoma when the requested medication is used as a
single agent, as second line or subsequent therapy.
I. Histologic transformation of follicular lymphoma to diffuse
large B-cell lymphoma
Authorization of 12 months may be granted to members with
histologic transformation of follicular lymphoma to diffuse large B-cell
lymphoma in members who have received prior
chemoimmunotherapy as a single agent.
J. Histologic transformation of nodal marginal zone lymphoma to
diffuse large B-cell lymphoma
Authorization of 12 months may be granted to members with
histologic transformation of nodal marginal zone lymphoma to diffuse
large B-cell lymphoma in members who have received prior
chemoimmunotherapy.
K. Diffuse large B-cell lymphoma
Authorization of 12 months may be granted for the treatment of
diffuse large B-cell lymphoma when the requested medication is used
as second-line or subsequent therapy.
L. 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 the 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)
when the requested medication is used as second-line or subsequent
therapy.
M. AIDS-related B-cell lymphoma
Authorization of 12 months may be granted for the treatment of
relapsed AIDS-related B-cell lymphoma when the requested
medication is used as a single agent and as second-line or
subsequent therapy.
N. Post-transplant lymphoproliferative disorders
Authorization of 12 months may be granted for the treatment of post-
transplant lymphoproliferative disorders in members who have
received prior chemoimmunotherapy.
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]. Sunnyvale, CA: Pharmacyclics LLC; December 2020.
- The NCCN Drugs & Biologics Compendium® © 2022 National Comprehensive Cancer Network. The NCCN Drugs & Biologics Compendium. http://www.nccn.org. Accessed March 16, 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.
April 16, 2022
