Rituxan (Rituximab) Policy

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1 Policy Number 2015D0003B Annual Approval Date Rituxan (Rituximab) Policy 1/27/2014 Approved By UnitedHealthcare National Pharmacy & Therapeutics Committee United HealthCare Community & State Payment Policy Committee IMPORTANT NOTE ABOUT THIS REIMBURSEMENT POLICY You are responsible for submission of accurate claims. This reimbursement policy is intended to ensure that you are reimbursed based on the code or codes that correctly describe the health care services provided. UnitedHealthcare Community Plan reimbursement policies uses Current Procedural Terminology (CPT *), Centers for Medicare and Medicaid Services (CMS) or other coding guidelines. References to CPT or other sources are for definitional purposes only and do not imply any right to reimbursement. This reimbursement policy applies to all health care services billed on CMS 1500 forms and, when specified, to those billed on UB04 forms. Coding methodology, industry-standard reimbursement logic, regulatory requirements, benefits design and other factors are considered in developing reimbursement policy. This information is intended to serve only as a general reference resource regarding UnitedHealthcare Community Plan s reimbursement policy for the services described and is not intended to address every aspect of a reimbursement situation. Accordingly, UnitedHealthcare Community Plan may use reasonable discretion in interpreting and applying this policy to health care services provided in a particular case. Further, the policy does not address all issues related to reimbursement for health care services provided to UnitedHealthcare Community Plan enrollees. Other factors affecting reimbursement supplement, modify or, in some cases, supersede this policy. These factors include, but are not limited to: federal &/or state regulatory requirements, the physician or other provider contracts, the enrollee s benefit coverage documents, and/or other reimbursement, medical or drug policies. Finally, this policy may not be implemented exactly the same way on the different electronic claims processing systems used by UnitedHealthcare Community Plan due to programming or other constraints; however, UnitedHealthcare Community Plan strives to minimize these variations. UnitedHealthcare Community Plan may modify this reimbursement policy at any time by publishing a new version of the policy on this Website. However, the information presented in this policy is accurate and current as of the date of publication. UnitedHealthcare Community Plan uses a customized version of the Optum Claims Editing System known as ices Clearinghouse to process claims in accordance with UnitedHealthcare Community Plan reimbursement policies. *CPT is a registered trademark of the American Medical Association Proprietary information of UnitedHealthcare Community and State Copyright 2015 United HealthCare Services, Inc. Application This drug policy applies to UnitedHealthcare Community Plan Medicaid and Medicare products. This reimbursement policy applies to services reported using the 1500 Health Insurance Claim Form (a/k/a ) or its electronic equivalent or its successor form. This policy applies to all products and all network and non-network physicians and other qualified health care professionals, including, but not limited to, non-network authorized and percent of charge contract physicians and other qualified health care professionals. Payment Policies for Medicare & Retirement and Employer & Individual please use this link. Medicare & Retirement Policies are listed under Medicare Advantage Reimbursement Policies. Employer & Individual are listed under Reimbursement Policies-Commercial.

2 Policy Overview This policy provides information about Rituxan (rituximab) and its recommended use. Rituxan is a monoclonal antibody that targets normal and malignant B-lymphocytes, and is used in the treatment of oncological and non-oncological conditions. Rituxan is U.S. Food and Drug Administration (FDA) approved for the treatment of chronic lymphocytic leukemia, Non-Hodgkin lymphoma, and rheumatoid arthritis. Scientific evidence in the literature also supports its use for other, un-labeled indications. Reimbursement Guidelines Oncology Indications This policy provides parameters for coverage of Rituxan (rituximab) based upon the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium. The Compendium lists the appropriate drugs and biologics for specific cancers using FDA-approved disease indications and specific NCCN panel recommendations. Each commendation is supported by a level of evidence category. UnitedHealthcare recognizes indications and uses of injectable oncology medications listed in the NCCN Drugs and Biologics Compendium with Categories of Evidence and Consensus of 1, 2A, and 2B as proven and Categories of Evidence and Consensus of 3 as unproven. NCCN Categories of Evidence and Consensus: Category 1: The recommendation is based on high-level evidence (i.e., high-powered randomized clinical trials or meta-analyses), and the panel has reached uniform consensus that the recommendation is indicated. In this context, uniform means near unanimous positive support with some possible neutral positions. Category 2A: The recommendation is based on lower level evidence, but despite the absence of higher level studies, there is uniform consensus that the recommendation is appropriate. Lower level evidence is interpreted broadly, and runs the gamut from phase II to large cohort studies to case series to individual practitioner experience. Importantly, in many instances, the retrospective studies are derived from clinical experience of treating large numbers of patients at a member institution, so panel members have firsthand knowledge of the data. Inevitably, some recommendations must address clinical situations for which limited or no data exist. In these instances the congruence of experience-based opinions provides an informed if not confirmed direction for optimizing patient care. These recommendations carry the implicit recognition that they may be superseded as higher level evidence becomes available or as outcomesbased information becomes more prevalent. Category 2B: The recommendation is based on lower level evidence, and there is nonuniform consensus that the recommendation should be made. In these instances, because the evidence is not conclusive, institutions take different approaches to the management of a particular clinical scenario. This nonuniform consensus does not represent a major disagreement, rather it recognizes that given imperfect information, institutions may adopt different approaches. A Category 2B designation should signal to the user that more than one approach can be inferred from the existing data. Category 3: The recommendation has engendered a major disagreement among the panel members. Several circumstances can cause major disagreements. For example, if substantial data exist about two interventions but they have never been directly compared in a randomized trial, adherents to one set of data may not accept the interpretation of the other side's results. Another situation resulting in a Category 3 designation is when experts disagree about how trial data can be generalized. A Category 3 designation alerts users to a major interpretation issue in the data and directs them to the manuscript for an explanation of the controversy. Additional Information: The NCCN Clinical Practice Guidelines in Oncology are a comprehensive set of guidelines documenting patient management recommendations for the malignancies that affect about 97% of all patients with cancer. They also address supportive care issues. The guidelines are developed and updated by 44 individual panels, composed of more than 800 clinicians and oncology researchers from

3 the 21 NCCN member institutions and their affiliates. DRUG POLICY Non-Oncology Indications Rituximab is proven for the treatment of: 1) Idiopathic thrombocytopenic purpura; 2) Autoimmune mucocutaneous blistering diseases; 3) Wegener's granulomatosis; 4) Autoimmune hemolytic anemia, including chronic cold agglutinin disease; and 5) Rheumatoid arthritis. Rituximab is unproven for the treatment of: 1) Anti-GM1 antibody-related neuropathies; 2) Post-transplant B-lymphoproliferative disorder; 3) Kaposi sarcoma-associated herpes virus-related multicentric Castleman disease; 4) Idiopathic autoimmune thrombocytopenia and neutropenia (ITN); 5) Pure red cell aplasia; 6) Systemic lupus erythematosus; 7) Acquired factor VIII inhibitors; 8) Polyneuropathy associated with anti-mag antibodies; 9) Idiopathic membranous nephropathy; 10) Chronic graft-versus-host disease; 11) Reduction of anti-hla antibodies in patients awaiting renal transplant; and 12) Multiple sclerosis While a beneficial effect of rituximab has been reported in some of these conditions, none of them have been studied in large, controlled clinical trials. Additional Information: Clinical evidence supports the use of rituximab for Wegener s granulomatosis that is refractory to conventional immunosuppressive therapy. State Exceptions Kansas Kansas is exempt from this policy Codes HCPCS code section J9310 Rituxan (rituximab) - Injection, rituximab, 100 mg Attachments 2015A United Healthcare Community Plan Approved ICD-9 Codes for HCPCS Code J9310 Approved Diagnosis Codes for Rituxan Resources

4 Individual state Medicaid regulations, manuals & fee schedules DRUG POLICY American Medical Association, Current Procedural Terminology ( CPT ) Professional Edition and associated publications and services Centers for Medicare and Medicaid Services, CMS Manual System and other CMS publications and services Centers for Medicare and Medicaid Services, Healthcare Common Procedure Coding System, HCPCS Release and Code Sets National Uniform Claim Committee (NUCC) References 1. The NCCN Drugs and Biologics Compendium (NCCN Compendium ) The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ) Rituxan prescribing information. Genentech, Inc. South San Francisco, CA. February Saleh MN, Gutheil J, Moore M, et al. A pilot study of the anti-cd20 monoclonal antibody rituximab in patients with refractory immune thrombocytopenia. Semin Oncol 2000;27(suppl 12): Stasi R, Pagano A, Stipa E, Amadori S. Rituximab chimeric anti-cd20 monoclonal antibody treatment for adults with chronic idiopathic thrombocytopenic purpura. Blood 2001;98: Quartier P, Brethon B, Philippet P, et al. Treatment of childhood autoimmune haemolytic anaemia with rituximab. Lancet 2001;358: Berentsen S, Tjonnfjord GE, Brudevold R, et al. Favourable response to therapy with the anti-cd20 monoclonal antibody rituximab in primary chronic cold agglutinin disease. Br J Haematol 2001;115: Hertl M, Zillikens D, Borradori L, et al. Recommendations for the use of rituximab (anti-cd20 antibody) in the treatment of autoimmune bullous skin diseases. JDDG (5): Delgado J, Bustos JG, Jimenez-Yuste V, Hernandez-Navarro F. Anti-CD20 monoclonal antibody therapy in refractory immune thrombocytopenic purpura. Haematologica 2002;87: Zaja F, Iacona I, Masolini P, et al. B-cell depletion with rituximab as treatment for immune hemolytic anemia and chronic thrombocytopenia. Haematologica 2002;87: Specks U, Fervenza FC, McDonald TJ, Hogan MC. Response of Wegener's granulomatosis to anti-cd20 chimeric monoclonal antibody therapy. Arthritis Rheum 2001;44: Giagounidis AAN, Anhuf J, Schneider P, et al. Treatment of relapsed idiopathic thrombocytopenic purpura with the anti-cd20 monoclonal antibody rituximab: a pilot study. Eur J Haematol 2002;69: Gupta N, Kavuru S, Patel D, et al. Rituximab-based chemotherapy for steroid-refractory autoimmune hemolytic anemia of chronic lymphocytic leukemia. Leukemia 2002;16: Salopek TG, Logsetty S, Tredget EE. Anti-CD20 chimeric monoclonal antibody (rituximab) for the treatment of recalcitrant, life-threatening pemphigus vulgaris with implications in the pathogenesis of the disorder. J Am Acad Dermatol 2002;47: Dupuy A, Viguier M, Bedane C, et al. Treatment of refractory pemphigus vulgaris with rituximab (anti-cd20 monoclonal antibody). Arch Dermatol 2004;140: Cooper N, Stasi R, Cunningham-Rundles S, et al. The efficacy and safety of B-cell depletion with anti-cd20 monoclonal antibody in adults with chronic immune thrombocytopenic purpura. Br J Haematol 2004;125: Keogh KA, Ytterberg SR et al. Rituximab for refractory Wegener's granulomatosis: report of a prospective, openlabel pilot trial. Am J Respir. Crit. Med Jan 15:173(2):180-7.

5 18. Zecca M, Nobili B, Ramenghi U, et al. Rituximab for the treatment of refractory autoimmune hemolytic anemia in children. Blood. 2003;101(10): D'Arena G, Califano C, Annunziata M, et al. Rituximab for warm-type idiopathic autoimmune hemolytic anemia: a retrospective study of 11 adult patients. Eur J Haematol 2007 July;79(1): Faurschou A, Gniadecki R. Two courses of rituximab (anti-cd20 monoclonal antibody) for recalcitrant pemphigus vulgaris. Int J Dermatol Mar;47(3): Barrera MV, Mendiola MV, Bosch RJ, Herrera E. Prolonged treatment with rituximab in patients with refractory pemphigus vulgaris. J Dermatolog Treat. 2007;18(5): Seo P, Specks U, Keogh KA. Efficacy of rituximab in limited Wegener's granulomatosis with refractory granulomatous manifestations. J Rheumatol Oct;35(10): Roccatello D, Baldovino S, Alpa M, et al. Effects of anti-cd20 monoclonal antibody as a rescue treatment for ANCA-associated idiopathic systemic vasculitis with or without overt renal involvement. Clin Exp Rheumatol May-Jun;26(3Suppl 49):S Stasi R, Stipa E, Del Poeta G, et al. Long-term observation of patients with anti-neutrophil cytoplasmic antibodyassociated vasculitis treated with rituximab. Rheumatology (Oxford). 2006;45(11): Blood Aug 15;112(4): 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. 2008;112(4): Garcia-Chavez J, Majluf-Cruz, Montiel-Cervantes L, et al. Rituximab therapy for chronic and refractory immune thrombocytopenic purpura: a long-term follow-up analysis. Ann Hematol. 2007;86(12): Mueller BU, Bennett CM, Feldman HA, et al. One year follow-up of children and adolescents with chronic immune thrombocytopenic purpura (ITP) treated with rituximab. Pediatr Blood Cancer Feb;52(2): Wang W, Yu Qh, Zhang HY et al. [Rituximab treatment for adults with steroid-resistant idiopathic thrombocytopenic purpura]. Zhonghua Nei Ke Za Zhi Mar;47(3): Provan D, Butler T, Evangelista ML, et al. Activity and safety profile of low-dose rituximab for the treatment of autoimmune cytopenias in adults. Haematologica Dec;92(12): Narang M, Penner JA, Williams D. Refractory autoimmune thrombocytopenic purpura: responses to treatment with a recombinant antibody to lymphocyte membrane antigen CD20 (rituximab). Am J Hematol Dec;74(4): Meo P, Stipa E, La Presa M, et al. [Rituximab treatment of chronic idiopathic thrombocytopenic purpura. Results of a phase II study]. Recenti Prog Med Jul-Aug;93(7-8): Joly P, Mouquet H, Roujea JC. A Single cycle of Rituximab for the Treatment of Severe Pemphigus. N Eng J Med (6): Ahmed AR, Spigelman Z, Cavacini LA. Treatment of Pemphigus Vulgaris with Rituximab and Intravenous Immune Globulin. N Eng J Med (17): Esposito, M, Capriotti E, Giunta A, et al. Long-lasting remission of pemphigus vulgaris treated with rituximab. Acta Dermato-Venereologica (1): Wenzel J, Bauer R, Bieber T, Tuting T. Successful rituximab treatment of severe pemphigus vulgaris resistant to multiple immunosuppressants. Acta Dermato-Venereologica (2): Schmidt E, Herzog S, Brocker EB, et al. Long-standing remission of recalcitrant juvenile pemphigus vulgaris after adjuvant therapy with rituximab. British Journal of Dermatology (2): Schöllkopf C, Kjeldsen L, Bjerrum OW, et al. Rituximab in chronic cold agglutinin disease: a prospective study of 20 patients. Leuk Lymphoma Feb;47(2):

6 38. Rao A, Kelly M, Musselman M, et al. Safety, efficacy, and immune reconstitution after rituximab therapy in pediatric patients with chronic or refractory hematologic autoimmune cytopenias. Pediatr Blood Cancer. 2007;50(4): Shanafelt TD, Madueme HL, Wolf RC, Tefferi A. Rituximab for immune cytopenia in adults: idiopathic thrombocytopenic purura, autoimmune hemolytic anemia, and Evan syndrome. Mayo Clin Proc. 2003;78(11): History 4/1/2015 Policy Retired Effective 4/1/ /1/2015 Application Section: Application Section: Removed reference to location of policy for Mississippi Chip 1/1/2015 Annual Version Change History Section: Entries prior to 1/1/13 archived. 8/4/2014 Application Section: Removed Florida Medicaid and Rhode Island Medicaid, added including, but not limited to verbiage, and added verbiage stating this policy applies to UnitedHealthcare Community Plan Medicaid and Medicare products. State Exceptions Section: Added exception for Kansas 3/31/2014 Disclaimer: Revised 2/15/2014 Annual Version Change Policy List Change: Required ICD-9 Codes with HCPCS Code J9310 updated 1/27/2014 Annual renewal of policy approved by United HealthCare Community & State Payment Policy Committee 4/9/2013 Annual renewal of policy approved by UnitedHealthcare National Pharmacy & Therapeutics Committee 10/3/2005 Policy implemented for the following plans: AZ, MD, NE, NJ, NY, PA, TX, and WI. 2015A United Healthcare Community Plan Approved ICD-9 Codes for Rituxan; HCPCS Code J

7 2015A United Healthcare Community Plan Approved ICD-9 Codes for Rituxan; HCPCS Code J Back To Top

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