Rituxan. Rituxan (rituximab) Description
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1 Federal Employee Program 1310 G Street, N.W. Washington, D.C Fax Subject: Rituxan Page: 1 of 10 Last Review Date: September 19, 2013 Rituxan Description Rituxan (rituximab) Background Rituxan is a monoclonal antibody that is manufactured through biotechnology methods rather than by the human body s own immune system. The drug works by greatly reducing the number of specific immune cells in the blood, known as B-cells. The drug binds to a particular protein, the CD20 antigen, on the surface of normal and malignant B-cells, making it easier for the patient s immune system to attack the cancer cell as if it were a foreign pathogen. With the targeted mechanism of action of Rituxan to B-cells, it is used in the treatment of chronic lymphocytic leukemia (CLL), a slowly progressing blood and bone marrow cancer, that arises from a group of white blood cells known as B-cells, in the treatment of CD20 positive, Non- Hodgkin s Lymphoma (NHL), which is a type of cancer that occurs in B-cells, and in the treatment of rheumatoid arthritis (RA) which B-cells are believed to play an important role in RA (1,2,4). Rituxan, in combination with glucocorticoids (steroids), is used to treat patients with Wegener s granulomatosis (WG) and microscopic polyangiitis (MPA), two rare disorders that cause blood vessel inflammation (vasculitis). Vasculitis in patients with WG and MPA can lead to tissue damage. WG mostly affects the respiratory tract (sinuses, nose, trachea, and lungs) and kidneys, while MPA commonly affects the kidneys, lungs, nerves, skin, and joints (3).
2 Subject: Rituxan Page: 2 of 10 Regulatory Status FDA approved indications include: (1) Non-Hodgkin s Lymphoma (NHL) Rituxan is indicated for the treatment of 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 Rituxan 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 chemotherapy Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens Chronic lymphocytic leukemia (CLL) Rituxan is indicated, in combination with fludarabine and cyclophosphamide (FC), for the treatment of patients with previously untreated and previously treated CD20-positive CLL. Rheumatoid arthritis (RA) Rituxan in combination with methotrexate is indicated for the treatment of adult patients with moderately- to severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies. Granulomatosis with Polyangiitis (GPA) (Wegener s Granulomatosis) and Microscopic Polyangiitis (MPA) Rituxan in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener s Granulomatosis) and Microscopic Polyangiitis (MPA). Limitations of use: Rituxan is not recommended for use in patients with severe, active infections. Rituxan has several boxed warnings regarding fatal infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions, and progressive multifocal leukoencephalopathy (PML) resulting in death. Rituxan can cause severe, including fatal, infusion reactions. Deaths within 24 hours of Rituxan infusion have been reported. Approximately 80% of fatal infusion reactions occurred in
3 Subject: Rituxan Page: 3 of 10 association with the first infusion. Carefully monitor patients during infusions. Discontinue Rituxan infusion in patients who develop severe (grade 3 or 4) infusion reactions and administer medical treatment (2). Acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia from tumor lysis, some fatal, can occur within hours after the first infusion of Rituxan in patients with non-hodgkin lymphoma (NHL). Patients at high risk for tumor lysis syndrome should be administered aggressive intravenous hydration, anti-hyperuricemic agents, and their renal function should be monitored (2). Mucocutaneous reactions, some with fatal outcome, can occur in patients treated with Rituxan. Rituxan should be discontinued in patients who experience a severe mucocutaneous reaction (2). JC virus infection resulting in PML and death can occur in Rituxan-treated patients with hematologic malignancies or with autoimmune diseases (2). Hepatitis B virus (HBV) reactivation with fulminant hepatitis, hepatic failure, and death can occur in patients treated with Rituxan. Screen patients at high risk of HBV infection before initiation of Rituxan. Closely monitor carriers of hepatitis B for clinical and laboratory signs of active HBV infection for several months following Rituxan therapy. Discontinue Rituxan and any concomitant chemotherapy in patients who develop viral hepatitis, and institute appropriate treatment including antiviral therapy (2). Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of Rituxan-based therapy. Discontinue Rituxan for serious infections and institute appropriate anti-infective therapy (2). Rituxan infusions should be discontinued in patients that develop serious or life-threatening cardiac arrhythmias. Perform cardiac monitoring during and after all infusions of Rituxan for patients who develop clinically significant arrhythmias, or who have a history of arrhythmia or angina (2). The safety of immunization with live viral vaccines following Rituxan therapy has not been studied and vaccination with live virus vaccines is not recommended (2). In patients with lymphoid malignancies, during treatment with Rituxan monotherapy, obtain
4 Subject: Rituxan Page: 4 of 10 complete blood counts (CBC) and platelet counts prior to each Rituxan course. During treatment with Rituxan and chemotherapy, obtain CBC and platelet counts at weekly to monthly intervals and more frequently in patients who develop cytopenias. In patients with rheumatoid arthritis, granulomatosis with polyangiitis (GPA), or microscopic polyangiitis (MPA), obtain CBC and platelet counts at two to four month intervals during Rituxan therapy. The duration of cytopenias caused by Rituxan can extend months beyond the treatment period (2). There are a number of important off-label uses for the use of Rituxan (rituximab) that are supported by the medical literature. The inclusion of the following conditions is based on the studies cited. Burkitt lymphoma 5 MALT lymphoma 6 Mantle cell lymphoma 7 Post-transplant lymphoproliferative disorder 8 Primary cutaneous B-cell lymphoma 9 Splenic marginal zone lymphoma 10 Waldenstrom s macroglobulinemia 11,12 Steroid refractory chronic graft vs. host disease 13 Immune thrombocytopenic purpura 14 Thrombotic thrombocytopenic purpura 17 Refractory autoimmune hemolytic anemia 15 Rituxan as monotherapy or in conjunction with various chemotherapy agents as well as other monoclonal antibodies is supported by clinical trial data and NCCN guideline recommendations (16). The following chemoimmunotherapy regimens are used for either first-line therapy or relapsed/refractory therapy depending on the results of genetic testing and comorbidities in affected patients: Alemtuzumab + Rituxan Bendamustine, Rituxan (BR) CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) + Rituxan HyperCVAD (cyclophosphamide,vincristine,doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine) + Rituxan Dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin) + Rituxan HDMP (high-dose methylpredisolone) + Rituxan Pentostatin, cyclophosphamide, Rituxan) (PCR)
5 Subject: Rituxan Page: 5 of 10 CFAR (cyclophosphamide, fludarabine, alemtuzumab, Rituxan) OFAR (oxaliplatin, fludarabine, cytarabine, Rituxan) Related policies Policy This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims. Rituxan may be considered medically necessary in patients 18 years of age or older for the treatment of Non-Hodgkin s Lymphoma, B-Cell, CD20-Positive, Chronic Lymphocytic Leukemia, moderate-to-severely-active Rheumatoid Arthritis (previously inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies), granulomatosis with polyangiitis (formerly Wegener's granulomatosis) (concurrent with glucocorticoid) or Microscopic Polyangiitis (concurrent with glucocorticoid). Rituxan may also be considered medically necessary in Burkitt lymphoma, 5 MALT lymphoma, 6 mantle cell lymphoma, 7 post-transplant lymphoproliferative disorder, 8 primary cutaneous B-cell lymphoma, 9 splenic marginal zone lymphoma, 10 Waldenstrom s macroglobulinemia, 11,12 steroid refractory chronic graft vs. host disease, 13 immune thrombocytopenic purpura, 14 thrombotic thrombocytopenic purpura, 18 refractory autoimmune hemolytic anemia, 15 Rituxan may be considered investigational in patients who do not meet the criteria for medical necessity. Prior-Approval Requirements Diagnoses Patient must have ONE of the following: I. Non-Hodgkin lymphoma (NHL), B-Cell, CD20-Positive II. Chronic Lymphocytic Leukemia (CLL), CD20-Positive
6 Subject: Rituxan Page: 6 of 10 III. Rheumatoid arthritis (RA) AND ALL of the following: a. 18 years of age or older b. Moderately- to severely-active RA c. Previously had inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies IV. Microscopic polyangiitis (MPA) AND ALL of the following: a. 18 years of age or older b. Currently taking a glucocorticoid V. Granulomatosis with polyangiitis (formerly Wegener's granulomatosis) AND ALL of the following: a. 18 years of age or older b. Currently taking a glucocorticoid VI. Waldenström s macroglobulinemia VII. Burkitt lymphoma VIII. MALT lymphoma IX. Mantle cell lymphoma X. Post-transplant lymphoproliferative disorder XI. Primary cutaneous B-cell lymphoma XII. Splenic marginal zone lymphoma XIII. Steroid refractory chronic graft vs. host disease XIV. Immune thrombocytopenic purpura XV. Thrombotic thrombocytopenic purpura XVI. Refractory autoimmune hemolytic anemia And ALL of the following:
7 Subject: Rituxan Page: 7 of 10 NOT using a Tumor Necrosis Factor (TNF) antagonist NOT using any of the following: Abatacept (Orencia) Tocilizumab (Actemra) Anakinra (Kineret) Tofacitinib (Xeljanz) NO use of a live vaccines, ( Non-live vaccines should be administered at 4 weeks prior to a course of Rituxan). NO severe, active infections Tumor Necrosis Factor (TNF) antagonists include adalimumab (Humira), etanercept (Enbrel), cerolizumab pegol (Cimzia), golimumab (Simponi), and infliximab (Remicade). Prior Approval Renewal Requirements Same as above Policy Guidelines Pre - PA Allowance None Prior - Approval Limits Duration 1 year Prior Approval Renewal Limits Duration Rationale 1 year Summary Rituxan is a monoclonal antibody that is manufactured through biotechnology methods rather than by the human body s own immune system. The drug works by greatly reducing the number of specific immune cells in the blood, known as B-cells. The drug binds to a particular protein,
8 Subject: Rituxan Page: 8 of 10 the CD20 antigen, on the surface of normal and malignant B-cells, making it easier for the patient s immune system to attack the cancer cell as if it were a foreign pathogen. Rituxan is therefore used to treat diseases which are characterized by excessive numbers of B cells, overactive B cells, or dysfunctional B cells. This includes non-hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), microscopic polyangiitis (MPA), and granulomatosis with polyangiitis (1-4). Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of Rituxan (rituximab) while maintaining optimal therapeutic outcomes. References 1. FDA Resource Pages. Food Drug Administration Website. FDA Approves Rituxan to Treat Chronic Lymphocytic Leukemia Rituxan [package insert]. South San Francisco, CA: Genentech Inc; May FDA Resource Pages. Food Drug Administration Website. FDA approves Rituxan to treat two rare disorders Rituxan Website. About NHL Oriol A, Ribera JM, Bergua J, Giménez Mesa E, Grande C, Esteve J, Brunet S, Moreno MJ, Escoda L, Hernandez-Rivas JM, Hoelzer D. High-dose chemotherapy and immunotherapy in adult Burkitt lymphoma: comparison of results in human immunodeficiency virus-infected and noninfected patients. Cancer Jul 1; 113(1): Conconi A, Martinelli G, Thiéblemont C, Ferreri AJ, Devizzi L, Peccatori F, Ponzoni M, Pedrinis E, Dell'Oro S, Pruneri G, Filipazzi V, Dietrich PY, Gianni AM, Coiffier B, Cavalli F, Zucca E. Clinical activity of rituximab in extranodal marginal zone B-cell lymphoma of MALT type. Blood Oct 15; 102(8): Forstpointner R, Unterhalt M, Dreyling M, Böck HP, Repp R, Wandt H, Pott C, Seymour JF,Metzner B, Hänel A, Lehmann T, Hartmann F, Einsele H, Hiddemann W; German Low Grade Lymphoma Study Group (GLSG). Maintenance therapy with rituximab leads to a significant prolongation of response duration after salvage therapy with a combination of rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) in patients with recurring and refractory follicular and mantle cell lymphomas: Results of a prospective randomized study of the German Low Grade Lymphoma Study Group (GLSG). Blood Dec 15;108(13): Choquet S, Leblond V, Herbrecht R, Socié G, Stoppa AM, Vandenberghe P, Fischer A, Morschhauser F, Salles G, Feremans W, Vilmer E, Peraldi MN, Lang P, Lebranchu Y,
9 Subject: Rituxan Page: 9 of 10 Oksenhendler E, Garnier JL, Lamy T, Jaccard A, Ferrant A, Offner F, Hermine O, Moreau A, Fafi-Kremer S, Morand P, Chatenoud L, Berriot-Varoqueaux N, Bergougnoux L, Milpied N.Efficacy and safety of rituximab in B-cell post-transplantation lymphoproliferative disorders: results of a prospective multicenter phase 2 study. Blood Apr 15; 107(8): Heinzerling LM, Urbanek M, Funk JO, Peker S, Bleck O, Neuber K, Burg G, von Den Driesch P, Dummer R. Reduction of tumor burden and stabilization of disease by systemic therapy with anti-cd20 antibody (rituximab) in patients with primary cutaneous B-cell lymphoma. Cancer.2000 Oct 15; 89(8): Tsimberidou AM, Catovsky D, Schlette E, et al. Outcomes in patients with splenic marginal zone lymphoma and marginal zone lymphoma treated with rituximab with or without chemotherapy or chemotherapy alone. Cancer 2006; 107: NCCN Drugs and Biologics Compendium 12. NCCN Guidelines (NCCN Guidelines Waldenström s Macroglobulinemia / Lymphoplasmacytic Lymphoma, page WMPLP-2) 13. Zaja F, Bacigalupo A, Patriarca F, Stanzani M, Van Lint MT, Fili C, Scime R, Milone G, Falda M, Vener C, Laszlo D, Alessandrino PE, Narni F, Sica S, Olivieri A, Sperotto A, Bosi A, Bonifazi F, Fanin R; GITMO (Gruppo Italiano Trapianto Midollo Osseo). Treatment of refractory chronic GVHD with rituximab: a GITMO study. 14. Bone Marrow Transplant Aug; 40(3):273-7). Medeot M, Zaja F, Vianelli N,Battista M, Baccarani M, Patriarca F, Soldano F, Isola M, De Luca S, Fanin R. Rituximab therapy in adult patients with relapsed or refractory ITP: long term follow-up results. Eur J Haematol May Bader-Meunier B, Aladjidi N, Bellmann F, Monpoux F, Nelken B, Robert A, Armari-Alla C, Picard C, Ledeist F, Munzer M, Yacouben K, Bertrand Y, Pariente A, Chaussé A, Perel Y, Leverger G. Rituximab therapy for childhood Evans syndrome. Haematologica Dec;92(12):1691-4) 16. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology Non- Hodgkin s Lymphomas Last accessed September 04, Rituximab for refractory and or relapsing thrombotic thrombocytopenic purpura. Elliott, et al; Eur j Haematol Oct; 83(4): Policy History Date February 2012 Action Added Methotrexate (MTX) is required unless there is intolerance to MTX, contraindication to MTX or failure on MTX.
10 Subject: Rituxan Page: 10 of 10 September 2012 December 2012 March 2013 September 2013 Annual editorial and reference update Deleted requirement of concurrent fludarabine and cyclophosphamide therapy for CLL (NCCN guidelines include many other concurrent therapies) Added indication for thrombotic thrombocytopenic purpura. Added exclusion of concomitant TNFI therapy or other biologic DMARD Added exclusion of live vaccine within two weeks. Annual editorial review and reference update Keywords This policy was approved by the FEP Pharmacy and Medical Policy Committee on September 19, 2013 and is effective October 1, Signature on File Deborah M. Smith, MD, MPH
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