Subject: Imbruvica 1997-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 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 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. 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
4. Waldenström’s macroglobulinemia/lymphoplasmacytic lymphoma (WM/LPL)
5. Primary central nervous system lymphoma
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 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.
3. 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 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. 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. AIDS-related B-cell lymphomas
Authorization of 12 months may be granted for single agent subsequent treatment of AIDS-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; August 2022.
- The NCCN Drugs & Biologics Compendium® © 2022 National Comprehensive Cancer Network. The NCCN Drugs & Biologics Compendium. http://www.nccn.org. Accessed May 25, 2022.
- 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.
January 28, 2023
