MEDICAL COVERAGE GUIDELINES ORIGINAL EFFECTIVE DATE: 08/19/14 SECTION: DRUGS LAST REVIEW DATE: LAST CRITERIA REVISION DATE: ARCHIVE DATE:

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1 RITUXAN (rituximab) Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Medical Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. The section identified as Description defines or describes a service, procedure, medical device or drug and is in no way intended as a statement of medical necessity and/or coverage. The section identified as Criteria defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or experimental or investigational. State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food and Drug Administration (FDA) may not be considered experimental or investigational and thus the drug, device or biological product may be assessed only on the basis of medical necessity. Medical Coverage Guidelines are subject to change as new information becomes available. For purposes of this Medical Coverage Guideline, the terms "experimental" and "investigational" are considered to be interchangeable. BLUE CROSS, BLUE SHIELD and the Cross and Shield Symbols are registered service marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. All other trademarks and service marks contained in this guideline are the property of their respective owners, which are not affiliated with BCBSAZ. Description: Rituxan is a monoclonal antibody that targets immune cells known as CD20-positive B-cells. It is used to treat non-hodgkin s lymphoma, chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA) and the antineutrophil cytoplasmic antibody-associated vasculitis conditions Wegener s granulomatosis and microscopic polyangiitis. Rituxan has been investigated as a treatment for other conditions. These conditions include, but are not limited to: Churg-Strauss syndrome Congenital/hereditary immune thrombocytopenic purpura Thrombotic thrombocytopenic purpura Systemic Lupus Erythematosus (SLE) O docx Page 1 of 8

2 Definitions: Adult: 18 years of age or older. Immune Thrombocytopenic Purpura (ITP): A hematologic disorder characterized by low platelets with a potential for bleeding episodes. Signs and symptoms are highly variable, ranging from an asymptomatic individual with only mild bruising or mucosal bleeding to frank hemorrhage from any site. The goal of therapy, if needed, is to raise the platelet count high enough to prevent bleeding. ITP may also be referred to as idiopathic thrombocytopenic purpura. Evans Syndrome (ES): A rare autoimmune disorder characterized by the simultaneous or sequential development of autoimmune hemolytic anemia (AIHA) and immune thrombocytopenic purpura (ITP) in the absence of any underlying cause. Typically the disease runs a chronic course with frequent exacerbations and remissions. Autoimmune Hemolytic Anemia (AIHA): A rare disease thought to be mediated by auto-antibodies produced by lymphoid B-cells. As a result of antibody production, there is immunologic destruction of red blood cells resulting in anemia. O docx Page 2 of 8

3 Criteria: For Rituxan for treatment of other cancers, see BCBSAZ Medical Coverage Guideline, Prescription Drugs for the Treatment of Cancer. Review by the clinical pharmacist is required if individual is currently on Kineret or another biologic as defined by Drug Facts & Comparisons. See Resources section for FDA-approved dosage. FDA-approved dosage of Rituxan is considered medically necessary for ANY of the following when results of HBsAg and anti-hbc are documented in the medical records: 1. To treat individuals with B-cell non-hodgkin lymphoma (NHL) in ANY of the following: Follicular lymphoma with ANY of the following: - As first line therapy (as combination therapy or as monotherapy) - As second or subsequent therapy (as combination therapy or as monotherapy) - As single agent maintenance therapy (first or second line) in individuals who achieve a complete or partial response to Rituxan in combination with chemotherapy When used with CHOP or other anthracycline-based chemotherapy as first-line treatment for individuals with diffuse large B-cell lymphoma (DLBCL) For recurrent, aggressive CD20-positive NHL For previously untreated or relapsed/refractory mantle cell lymphoma As combination therapy in previously untreated and previously treated B-cell chronic lymphocytic leukemia (B-CLL) 2. In combination with methotrexate for the treatment of adults with moderately-to severely-active rheumatoid arthritis (RA) who have had an inadequate response to one or more TNF antagonist therapies 3. In combination with glucocorticoids for the treatment of adults with ANY of the following Antineutrophil cytoplasmic antibody-associated vasculitis conditions: Wegener s Granulomatosis (also referred to as Granulomatosis with polyangiitis [GPA]) Microscopic Polyangiitis O docx Page 3 of 8

4 Criteria: (cont.) Immune Thrombocytopenic Purpura (ITP): Rituxan is considered medically necessary for individuals 18 years of age or older with immune thrombocytopenic purpura with documentation of ALL of the following: 1. Bleeding symptoms or platelet count less than 30 x 10 9 /L 2. Individual has failed ANY of the following therapies: Corticosteroids Intravenous immune globulin Anti-D immunoglobulin 3. Splenectomy has failed or is otherwise determined by the treating provider that surgery poses a greater risk to the individual than medical treatment with Rituxan 4. Results of HBsAg and anti-hbc are documented in the medical records 5. Dosage is no greater than 375 mg/m 2 given as an intravenous infusion once weekly for 4 doses Rituxan is considered medically necessary for individuals 18 years of age or older with Evans syndrome with documentation of ALL of the following: 1. Individual has failed ANY of the following therapies: Corticosteroids Intravenous immune globulin Other immunosuppressants such as Cyclosporine or Mycophenolate or Vincristine or Cyclophosphamide 2. Splenectomy has failed or is otherwise determined by the treating provider that surgery poses a greater risk to the individual than medical treatment with Rituxan 3. Results of HBsAg and anti-hbc are documented in the medical records 4. Dosage is no greater than 375 mg/m 2 given as an intravenous (IV) infusion once weekly for 4 doses. O docx Page 4 of 8

5 Criteria: (cont.) Autoimmune Hemolytic Anemia (AIHA): Rituxan is considered medically necessary for individuals 18 years of age or older with autoimmune hemolytic anemia with documentation of ALL of the following: 1. Individual has failed ANY of the following therapies: Corticosteroids Intravenous immune globulin Other immunosuppressants such as Azathioprine or Cyclosporine 2. Splenectomy has failed or is otherwise determined by the treating provider that surgery poses a greater risk to the individual than medical treatment with Rituxan 3. Results of HBsAg and anti-hbc are documented in the medical records 4. Dosage is no greater than 375 mg/m 2 given as an intravenous infusion once weekly for 4 doses Churg-Strauss Syndrome: Rituxan for treatment of Churg-Strauss syndrome is considered experimental or investigational based upon: 1. Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes, and 2. Insufficient evidence to support improvement of the net health outcome, and 3. Insufficient evidence to support improvement outside the investigational setting. Thrombotic Thrombocytopenic Purpura: Rituxan for treatment of thrombotic thrombocytopenic purpura is considered experimental or investigational based upon: 1. Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes, and 2. Insufficient evidence to support improvement of the net health outcome, and 3. Insufficient evidence to support improvement outside the investigational setting. O docx Page 5 of 8

6 Criteria: (cont.) Other: Rituxan for all other indications not previously listed or if above criteria not met is considered experimental or investigational based upon: 1. Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes, and 2. Insufficient evidence to support improvement of the net health outcome, and 3. Insufficient evidence to support improvement of the net health outcome as much as, or more than, established alternatives, and 4. Insufficient evidence to support improvement outside the investigational setting. These indications include, but are not limited to: Systemic Lupus Erythematosus (SLE) Anti-myelin-associated glycoprotein neuropathy Congenital/hereditary immune thrombocytopenic purpura Resources: Resources published prior to 2008 may be requested from the BCBSAZ Medical Policy and Technology Research Department BCBS Association Medical Policy Reference Manual. Uses of Monoclonal Antibodies for the Treatment of Non-Hodgkin Lymphoma, including Chronic Lymphocytic Leukemia, and Acute Myeloid Leukemia in the Non-Stem-Cell Transplant Setting. Re-issue date 07/10/2014, issue date 10/10/ American College of Rheumatology, van Vollenhoven R, Emery P, et al. Long-term Safety of Rituximab: Long-term Follow-up of the RA Clinical Trials and Retreatment Population. Arthritis Rheum. 2009;60(10 suppl). 3. Burzynski, J. New options after first-line therapy for chronic immune thrombocytopenic purpura. Am J Health Syst Pharm Jan 15;66(2 Suppl 2):S Genentech. Rituxan Package Insert. 04/2011, Rec'd 04/20/ Genentech., Tat S. Letter Regarding Rituxan in Rheumatoid Arthritis to K. Kelley, PharmD. 07/30/ Godeau B, Bierling P. [Treatment of idiopathic thrombocytopenic purpura in adults]. Presse Med Sep;37(9): O docx Page 6 of 8

7 Resources: (cont.) 7. Godeau B, Porcher R, Fain O, et al. Rituximab efficacy and safety in adult splenectomy candidates with chronic immune thrombocytopenic purpura: results of a prospective multicenter phase 2 study. Blood Aug 15;112(4): Leger JM, Viala K, Nicolas G, et al. Placebo-controlled trial of rituximab in IgM anti-myelinassociated glycoprotein neuropathy. Neurology. Jun ;80(24): Medeot M, Zaja F, Vianelli N, et al. Rituximab therapy in adult patients with relapsed or refractory immune thrombocytopenic purpura: long-term follow-up results. Eur J Haematol Sep;81(3): Merrill JT, Neuwelt CM, Wallace DJ, et al. Efficacy and safety of rituximab in moderately-toseverely active systemic lupus erythematosus: the randomized, double-blind, phase II/III systemic lupus erythematosus evaluation of rituximab trial. Arthritis Rheum. Jan 2010;62(1): Michel, M. [Characteristics of warm autoimmune hemolytic anemia and Evans syndrome in adults]. Presse Med Sep;37(9): Michel M, Chanet V, Dechartres A, et al. The spectrum of Evans syndrome in adults: new insight into the disease based on the analysis of 68 cases. Blood Oct 8;114(15): Palombi M, Niscola P, et al. Long-lasting Remission Induced by Rituximab in Two Cases of Refractory Autoimmune Haemolytic Anaemia Due to Cold Agglutinins. Blood Transfus. 2009;7: Panzer, S. New therapeutic options for adult chronic immune thrombocytopenic purpura: a brief review. Vox Sang Jan;94(1): Rodeghiero, F. First-line therapies for immune thrombocytopenic purpura: re-evaluating the need to treat. Eur J Haematol Suppl Feb (69): Rovin BH, Furie R, Latinis K, et al. Efficacy and safety of rituximab in patients with active proliferative lupus nephritis: the Lupus Nephritis Assessment with Rituximab study. Arthritis Rheum. Apr 2012;64(4): Steck AJ, Stalder AK, Renaud S. Anti-myelin-associated glycoprotein neuropathy. Curr Opin Neurol. Oct 2006;19(5): O docx Page 7 of 8

8 Resources: (cont.) FDA Product Approval Information for Rituxan (Rituximab): FDA-approved indication and dosage: Indication Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell, non- Hodgkin s lymphoma (NHL) Retreatment for relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL Previously untreated follicular, CD20- positive, B-cell NHL Non-progressing, low-grade, CD20- positive, B-cell NHL, after first-line CVP chemotherapy Diffuse large B-cell NHL Recommended Dose 375 mg/m 2 as an intravenous (IV) infusion once weekly for 4 or 8 doses 375 mg/m 2 as an IV infusion once weekly for 4 doses 375 mg/m 2 as an IV infusion on day 1 of each cycle of chemotherapy, for up to 8 doses. In patients with complete or partial response, initiate Rituxan maintenance 8 weeks following completion of Rituxan in combination with chemotherapy. Administer Rituxan as a single-agent every 8 weeks for 12 doses. Following completion of 6-8 cycles of CVP chemotherapy, 375 mg/m 2 as an IV infusion once weekly for 4 doses at 6- month intervals to a maximum of 16 doses 375 mg/m 2 as an IV infusion on day 1 of each cycle of chemotherapy, for up to 8 infusions Chronic Lymphocytic Leukemia (CLL) 375 mg/m 2 the day prior to the initiation of FC chemotherapy, then 500 mg/m 2 on day 1 of cycles 2-6 (every 28 days) Rheumatoid Arthritis Two-1000 mg IV infusions separated by 2 weeks Subsequent courses should be administered every 24 weeks or based on clinical evaluation, but not sooner than every 16 weeks Rituxan is given in combination with methotrexate Glucocorticoids administered as methylprednisolone 100 mg IV or its equivalent 30 minutes prior to each infusion are recommended to reduce the incidence and severity of infusion reactions Wegener s Granulomatosis (also referred to as Granulomatosis with polyangiitis [GPA]) Microscopic Polyangiitis 375 mg/m 2 as an intravenous (IV) infusion once weekly for 4 weeks Glucocorticoids administered as methylprednisolone 1000 mg intravenously per day for 1 to 3 days followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day and tapered per clinical need) are recommended to treat severe vasculitis symptoms. This regimen should begin within 14 days prior to or with the initiation of Rituxan and may continue during and after the 4 week course of Rituximab treatment. Safety and efficacy of treatment with subsequent courses of Rituxan have not been established. O docx Page 8 of 8