Subject: lenalidomide-Revlimid 2232-A SGM P2022

Drug

REVLIMID  (lenalidomide)

lenalidomide

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 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.  AIDS-related B-Cell lymphomas, including non-
                         germinal center diffuse large B-cell lymphoma, AIDS-
                         related diffuse large B-cell lymphoma, primary
                         effusion lymphoma, HHV8+ diffuse large B-cell
                         lymphoma, and AIDS-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: Nongastric/Gastric mucosa associated
                         lymphoid tissue (MALT) lymphoma, splenic/nodal
                         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.  Langerhans cell histiocytosis

          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.  AIDS-related B-Cell lymphomas, including non-germinal
                    center diffuse large B-cell lymphoma, AIDS-related
                    diffuse large B-cell lymphoma, primary effusion
                    lymphoma, HHV8+ diffuse large B-cell lymphoma, and
                    AIDS-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: Nongastric/Gastric mucosa-associated
                    lymphoid tissue (MALT) lymphoma, splenic/nodal
                    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 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.  Langerhans Cell Histiocytosis
               Authorization of 12 months may be granted for treatment of
               Langerhans cell histiocytosis 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:

1. Revlimid [package insert]. Summit, NJ: Celgene Corporation; May 2022.
2. Lenalidomide [package insert]. Parsippany, NJ: Teva Pharmaceuticals; May 2022.
3. The NCCN Drugs & Biologics Compendium^® © 2022 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed October 6, 2022.
4. Lexicomp Online®, Lexi-Drugs. Waltham, MA: UpToDate, Inc.; Updated October 4, 2022. http://online.lexi.com [available with subscription]. Accessed October 6, 2022.
5. DRUGDEX^® System (electronic version). Micromedex Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com. Accessed October 6, 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.

May 15, 2023