Subject: lenalidomide-Revlimid 2232-A SGM P2023
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REVLIMID
(lenalidomide)
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lenalidomide
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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
Revlimid is indicated for the treatment of adult patients with:
1. Multiple myeloma (MM) in combination with dexamethasone.
2. Multiple myeloma (MM), as maintenance therapy following autologous hematopoietic
stem cell transplantation (auto-HSCT).
3. Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic
syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without
additional cytogenetic abnormalities.
4. Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior
therapies, one of which included bortezomib.
5. Previously treated follicular lymphoma (FL), in combination with a rituximab product.
6. Previously treated marginal zone lymphoma (MZL), in combination with a rituximab
product.
B. Compendial Uses
1. Multiple myeloma
2. Systemic light chain amyloidosis
3. Classic Hodgkin lymphoma
4. Myelodysplastic syndrome without the 5q deletion cytogenetic abnormality
5. Myelofibrosis-associated anemia
6. POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin
changes) syndrome
7. Myelodysplastic syndrome/myeloproliferative neoplasms
8. T-cell Lymphomas
a. Peripheral T-Cell Lymphomas not otherwise specified
b. Angioimmunoblastic T-cell lymphoma
c. Enteropathy-associated T-cell lymphoma
d. Monomorphic epitheliotropic intestinal T-cell lymphoma
e. Nodal peripheral T-cell lymphoma with TFH phenotype
f. Follicular T-cell lymphoma
g. Adult T-cell leukemia/lymphoma
h. Hepatosplenic T-cell lymphoma
9. Primary central nervous system (CNS) lymphoma
10. Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)
11. B-Cell Lymphomas
a. HIV-related B-Cell lymphomas, including non-germinal center diffuse large B-cell
lymphoma, HIV-related diffuse large B-cell lymphoma, primary effusion lymphoma,
HHV8+ diffuse large B-cell lymphoma, and HIV-related plasmablastic lymphoma
b. Monomorphic post-transplant lymphoproliferative disorder
c. Diffuse large B-cell lymphoma
d. Follicular lymphoma
e. Marginal zone lymphoma with any of the following subtypes: Extranodal
(Nongastric/Gastric mucosa associated lymphoid tissue {MALT}), splenic ornodal
marginal zone lymphoma
f. Multicentric Castleman disease
g. High-grade B-cell lymphomas
h. Histologic transformation of indolent lymphomas to diffuse large B-cell lymphoma
i. Mantle cell lymphoma
12. Kaposi Sarcoma
13. Smoldering myeloma
14. Histiocytic Neoplasms
All other indications are considered experimental/investigational and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
A. Multiple myeloma
Authorization of 12 months may be granted for treatment of multiple myeloma.
B. T-cell Lymphomas
Authorization of 12 months may be granted for treatment of T-cell lymphoma, as a single
agent, with any of the following subtypes:
1. Peripheral T-Cell Lymphomas not otherwise specified as initial palliative therapy or
subsequent therapy.
2. Angioimmunoblastic T-cell lymphoma as initial palliative therapy or subsequent therapy.
3. Enteropathy-associated T-cell lymphoma as initial palliative therapy or subsequent
therapy.
4. Monomorphic epitheliotropic intestinal T-cell lymphoma as initial palliative therapy or
subsequent therapy.
5. Nodal peripheral T-cell lymphoma with TFH phenotype as initial palliative therapy or
subsequent therapy.
6. Follicular T-cell lymphoma as initial palliative therapy or subsequent therapy.
7. Adult T-cell leukemia/lymphoma as subsequent therapy.
8. Hepatosplenic T-cell lymphoma as subsequent therapy.
C. Primary central nervous system (CNS) lymphoma
Authorization of 12 months may be granted for treatment of primary central nervous system
(CNS) lymphoma as a single agent or in combination with rituximab.
D. Chronic lymphocytic leukemia (CLL)/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.
E. B-Cell Lymphomas
Authorization of 12 months may be granted for treatment of B-cell lymphoma with any of the
following subtypes:
1. HIV-related B-Cell lymphomas, including non-germinal center diffuse large B-cell
lymphoma, HIV-related diffuse large B-cell lymphoma, primary effusion lymphoma,
HHV8+ diffuse large B-cell lymphoma, and HIV-related plasmablastic lymphoma, as
subsequent therapy.
2. Monomorphic post-transplant lymphoproliferative disorder as subsequent therapy.
3. Diffuse large B-cell lymphoma as subsequent therapy.
4. Follicular lymphoma.
5. Marginal zone lymphoma with any of the following subtypes: Extranodal
(Nongastric/Gastric mucosa-associated lymphoid tissue {MALT}), splenic, ornodal
marginal zone lymphoma, as subsequent therapy.
6. Multicentric Castleman disease as subsequent therapy.
7. High-grade B-cell lymphomas as subsequent therapy.
8. Histologic transformation of indolent lymphomas to diffuse large B-cell lymphoma as
subsequent therapy.
9. Mantle cell lymphoma.
F. Myelodysplastic syndrome
Authorization of 12 months may be granted for treatment of lower risk myelodysplastic
syndrome (defined as Revised International Prognostic Scoring System (IPSS-R) (Very
Low, Low, Intermediate), International Prognostic Scoring System (IPSS)
(Low/Intermediate-1), WHO classification-based Prognostic Scoring System (WPSS) (Very
Low, Low, Intermediate)) for those with symptomatic anemia.
G. Myelofibrosis-associated anemia
Authorization of 12 months may be granted for treatment of myelofibrosis-associated
anemia when all of the following criteria are met:
1. The requested medication will be given as a single agent or in combination with
prednisone.
2. The member has serum erythropoietin (EPO) levels of either of the following:
a. 500 mU/mL or greater
b. Less than 500 mU/mL and no response or loss of response to erythropoiesis-
stimulating agents
H. Systemic light chain amyloidosis
Authorization of 12 months may be granted for treatment of systemic light chain
amyloidosis.
I. Classic Hodgkin lymphoma
Authorization of 12 months may be granted for treatment of classic Hodgkin lymphoma that
is refractory to at least 3 prior lines of therapy, as a single agent.
J. POEMS Syndrome
Authorization of 12 months may be granted for treatment of POEMS syndrome in
combination with dexamethasone.
K. Myelodysplastic/myeloproliferative neoplasms
Authorization of 12 months may be granted for treatment of
myelodysplastic/myeloproliferative neoplasms, as a single agent or in combination with a
hypomethylating agent.
L. Kaposi Sarcoma
Authorization of 12 months may be granted for treatment of Kaposi sarcoma as subsequent
therapy.
M. Smoldering Myeloma
Authorization of 12 months may be granted for treatment of asymptomatic high-risk
smoldering myeloma.
N. Histiocytic Neoplasms
Authorization of 12 months may be granted for treatment of histiocytic neoplasms, including
Langerhans cell histiocytosis and Rosai-Dorfman disease, 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:
- Revlimid [package insert]. Summit, NJ: Celgene Corporation; March 2023.
- Lenalidomide [package insert]. Parsippany, NJ: Teva Pharmaceuticals; May 2022.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed October 6, 2023.
- Lexicomp Online®, Lexi-Drugs. Waltham, MA: UpToDate, Inc.; Updated October 2, 2023. http://online.lexi.com [available with subscription]. Accessed October 6, 2023.
- DRUGDEX® System (electronic version). Micromedex Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com. Accessed October 6, 2023.
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 17, 2024
