Subject: Rituxan-Ruxience-Truxima-Riabni-Oncology SGM 1704-A P2025

Drug

Rituximab Products Treatment of Hematologic and Oncologic Conditions

RITUXAN®  (rituximab)

RUXIENCE  (rituximab-pvvr)

TRUXIMA  (rituximab-abbs)

RIABNI  (rituximab-arrx)

Policy:

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.

FDA-Approved Indications^1,2,9,10

Rituxan is indicated for the treatment of pediatric patients aged 6 months and older with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy.

Rituxan, Ruxience, Truxima, and Riabni are indicated for:

• Non-Hodgkin’s lymphoma (NHL) in adult patients with:
  • Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent
  • Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy
  • Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL, as a single agent after first-line CVP (cyclophosphamide, vincristine, and prednisone) chemotherapy
  • Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy regimens
• Chronic lymphocytic leukemia (CLL), in combination with fludarabine and cyclophosphamide (FC), for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL.
• Granulomatosis with polyangiitis (Wegener’s Granulomatosis) and microscopic polyangiitis (MPA) in combination with glucocorticoids (Not addressed in this policy – Refer to Rituxan-Ruxience-Truxima-Riabni-RA+Other SGM)
• Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely active RA who have inadequate response to one or more TNF antagonist therapies. (Not addressed in this policy – Refer to Rituxan-Ruxience-Truxima-Riabni-RA+Other SGM)

Rituxan is also indicated for:

• Rituxan is indicated for moderate to severe pemphigus vulgaris in adult patients
  (Not addressed in this policy – Refer to Rituxan-Ruxience-Truxima-Riabni-RA+Other SGM)

Compendial Uses^3-8

• Autoimmune hemolytic anemia⁷
• B-cell acute lymphoblastic leukemia (ALL)⁴
• B-cell lymphomas^4-6
  • Human Immunodeficiency Virus (HIV) Related B-Cell lymphomas⁴
  • B-cell lymphoblastic lymphoma^5,6
  • Burkitt lymphoma⁴
  • Castleman’s disease⁴
  • Diffuse Large B-Cell lymphoma⁴
  • Follicular lymphoma⁴
  • 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)⁴
  • Histological transformation of indolent lymphomas to diffuse large B-cell lymphoma⁴
  • Histological transformation of indolent lymphomas to high-grade B-cell lymphoma with MYC and BCL6 without BCL2 rearrangements⁴
  • Mantle cell lymphoma⁴
  • Marginal zone lymphomas⁴
    • Nodal marginal zone lymphoma
    • Extranodal marginal zone lymphoma (gastric and non-gastric mucosa associated lymphoid tissue {MALT} lymphoma)
    • Splenic marginal zone lymphoma
  • Post-transplant lymphoproliferative disorder (PTLD)⁴
  • Pediatric Aggressive Mature B-Cell Lymphomas⁴
  • Primary Mediastinal Large B-Cell Lymphoma⁴
• Central nervous system (CNS) cancers⁴
  • Leptomeningeal metastases from lymphomas
  • Primary CNS lymphomas
• Chronic graft-versus-host disease (GVHD)⁴
• CLL/Small lymphocytic lymphoma (SLL)⁴
• Hairy cell leukemia⁴
• Rosai-Dorfman disease⁴
• Hodgkin’s lymphoma, nodular lymphocyte-predominant⁴
• Immune checkpoint inhibitor-related toxicities⁴
• Prevention of Epstein-Barr virus (EBV)-related PTLD in high risk patients⁸
• Primary cutaneous B-cell lymphoma⁴
• Relapsed/refractory immune or idiopathic thrombocytopenic purpura (ITP)⁷
• Thrombotic thrombocytopenic purpura⁷
• Waldenström’s macroglobulinemia/lymphoplasmacytic lymphoma (LPL)/ Bing-Neel syndrome⁴
• Allogeneic transplant conditioning⁴
• For other compendial uses, refer to Rituxan-Ruxience-Truxima-Riabni-RA+Other SGM.

All other indications are considered experimental/investigational and not medically necessary.

Documentation

Submission of the following information is necessary to initiate the prior authorization review: Testing or analysis confirming CD20 protein on the surface of the B-cell (if applicable).

Coverage Criteria

Oncologic Indications^1-6,9,19

Authorization of 12 months may be granted for treatment of any of the following oncologic disorders that are CD20-positive as confirmed by testing or analysis:

• B-cell acute lymphoblastic leukemia (ALL)
• B-cell lymphomas:
  • HIV-Related B-Cell Lymphomas
  • B-cell lymphoblastic lymphoma
  • Burkitt lymphoma
  • Castleman’s disease
  • Diffuse large B-cell lymphoma
  • Follicular lymphoma
  • 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)
  • Histological transformation of indolent lymphomas to diffuse large B-cell lymphoma
  • Histological transformation of indolent lymphomas to high-grade B-cell lymphoma with MYC and BCL6 without BCL2 rearrangements
  • Mantle cell lymphoma
  • Marginal zone lymphomas
    • Nodal marginal zone lymphoma
    • Extranodal marginal zone lymphoma (gastric and non-gastric MALT lymphoma)
    • Splenic marginal zone lymphoma
  • Post-transplant lymphoproliferative disorder (PTLD)
  • Pediatric Aggressive Mature B-Cell Lymphomas
  • Primary Mediastinal Large B-Cell Lymphoma
• Central nervous system (CNS) cancers:
  • Leptomeningeal metastases from lymphomas
  • Primary CNS lymphoma
• CLL/Small lymphocytic lymphoma (SLL)
• Hairy cell leukemia
• Rosai-Dorfman disease
• Hodgkin’s lymphoma, nodular lymphocyte-predominant
• Primary cutaneous B-cell lymphoma
• Waldenström’s macroglobulinemia/lymphoplasmacytic lymphoma (LPL)/Bing-Neel syndrome

Hematologic Indications^3,7,8

Authorization of 12 months may be granted for treatment of any of the following indications:

• Refractory immune or idiopathic thrombocytopenic purpura (ITP)
• Autoimmune hemolytic anemia
• Thrombotic thrombocytopenic purpura
• Chronic graft-versus-host disease (GVHD)
• Prevention of Epstein-Barr virus (EBV)-related PTLD
• As part of a non-myeloablative conditioning regimen for allogeneic transplant

Immune Checkpoint Inhibitor-Related Toxicities⁴

Authorization of 3 months may be granted for treatment of immune checkpoint inhibitor-related toxicities.

Continuation of Therapy

Oncologic indications

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an oncologic indication listed in coverage criteria section when there is no evidence of unacceptable toxicity.

Immune checkpoint inhibitor-related toxicities

Authorization of 3 months may be granted for continued treatment in members requesting reauthorization for treatment of immune checkpoint inhibitor-related toxicities who are experiencing benefit from therapy.

All other indications

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section who are experiencing benefit from therapy.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Rituxan [package insert]. South San Francisco, CA: Genentech, Inc.; December 2021.
2. Truxima [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc.: February 2022.
3. Micromedex Solutions [database online]. Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com/. Accessed April 15, 2025.
4. The NCCN Drugs & Biologics Compendium® © 2025 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed April 15, 2025.
5. Arber D, Orazi A, Vardiman J, et al. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. May 19, 2016;127(20):2391-2405.
6. The NCCN Clinical Practice Guidelines in Oncology® Acute Lymphoblastic Leukemia (Version 3.2024). © 2025 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed April 15, 2025.
7. Lexicomp Online®, AHFS® Drug Information, Hudson, Ohio: Wolters Kluwer Clinical Drug Information, Inc.; http://online.lexi.com [available with subscription]. Accessed April 15, 2025.
8. Tomblyn M, Chiller T, Einsele H, et al. Guidelines for preventing infectious complications among hematopoietic cell transplantation recipients: a global perspective. Biol Blood Marrow Transplant. 2009; 15(10):1143-1238. URL: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3103296/pdf/nihms205400.pdf. Accessed April 30, 2019.
9. Ruxience [package insert]. NY, NY: Pfizer Inc; October 2023.
10. Riabni [package insert]. Thousand Oaks, CA: Amgen Inc.; February 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.

October 12, 2025