BlueCross BlueShield of Tennessee Medical Policy Manual

Rituximab

DESCRIPTION

Rituximab is a genetically engineered monoclonal antibody which binds specifically to the human CD20 antigen. The CD20 antigen is expressed on greater than 90% of B-cell non-Hodgkin’s lymphomas and is found on the abnormal B-cells of chronic lymphocytic leukemia (CLL).  Additionally, B-cells expressing the CD20 antigen are believed to play a role in the pathogenesis of rheumatoid arthritis.

POLICY

• Rituximab for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met: (See Medical Appropriateness below.)

• • Acute lymphoblastic leukemia (ALL)

  • Autoimmune Hemolytic Anemia (AIHA)

  • Central nervous system cancers

  • Chronic graft-versus-host disease

  • Chronic lymphocytic leukemia (CLL) / Small lymphocytic lymphoma (SLL)

  • Hodgkin’s lymphoma

  • Idiopathic/immune thrombocytopenic purpura (ITP)

  • Idiopathic inflammatory myopathy (e.g., myositis, dermatomyositis, polymyositis)

  • Neuromyelitis optica / neuromyelitis optica spectrum disease (NMO/NMOSD)

  • Non-Hodgkin’s lymphomas (NHL), including, but not limited to:

  • • AIDS-related B-Cell Lymphoma

    • Burkitt Lymphoma

    • Castleman’s Disease

    • Diffuse Large B-Cell Lymphoma

    • Low-grade or Follicular Lymphoma

    • Gastric & Non-gastric Malt Lymphoma

    • Hairy Cell Leukemia

    • Mantle Cell Lymphoma

    • Nodal Marginal Zone Lymphoma

    • Post-transplant lymphoproliferative disorder (PTLD) after solid organ transplant or allogeneic hematopoietic stem cell transplantation

    • Primary Cutaneous B-Cell Lymphomas

    • Splenic Marginal Zone Lymphoma

  • Pemphigus vulgaris

  • Rheumatoid arthritis (RA)

  • Thrombotic Thrombocytopenic Purpura (TTP)

  • Waldenström's macroglobulinemia / lymphoplasmacytic lymphoma

  • Wegener’s granulomatosis (WG) / microscopic polyangiitis (MP)

• Rituximab for the treatment of other conditions/diseases is considered investigational.

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

• Rituximab is considered medically appropriate if ALL of the following criteria are met:

• • Individual must be screened for HBV infection (i.e., HBsAg and anti-HBc) prior to initiating therapy

  • For an oncology indication the individual must be CD20-positive

  • Diagnosis of ANY ONE of the following:

  • • Acute lymphocytic/lymphoblastic leukemia (ALL) if individual is 15 years of age or older and ANY ONE of the following:

    • • Treatment is for induction with ALL of the following:

      • • Disease is Philadelphia chromosome-negative (Ph-)

        • Used in combination with an anthracycline, cyclophosphamide and vincristine based regimen

      • Treatment is Relapsed-Refractory disease if ALL of the following:

      • • Used as a component of MOpAD regimen (methotrexate, vincristine, pegaspargase, dexamethasone)

        • Disease is Philadelphia chromosome-negative (Ph-) or Philadelphia chromosome-positive (Ph+) and refractory to tyrosine kinase inhibitors (e.g.; omacetaxine, imatinib, bosutinib, ponatinib, nilotinib, etc.)

    • Autoimmune Hemolytic Anemia if ANY ONE of the following:

    • • Individual has warm-reactive disease refractory to or dependent on glucocorticoids

      • Individual has cold agglutinin disease with symptomatic anemia, transfusion-dependence, and/or disabling circulatory symptoms

    • Central nervous system cancer of ANY ONE of the following:

    • • Leptomeningeal metastases from lymphomas and rituximab will be administered intrathecally

      • Primary CNS lymphoma  as ANY ONE of the following:

      • • As a component of induction therapy and/or consolidation therapy for with a complete response to induction therapy

        • Relapsed or refractory disease and will receive rituximab as a single agent or in combination with temozolomide

    • Chronic graft-versus-host disease (cGVHD) if individual is post allogeneic stem cell transplant with  glucocorticoid-refractory disease

    • Chronic lymphocytic leukemia (CLL) / Small lymphocytic lymphoma (SLL)

    • Hodgkin lymphoma that is nodular lymphocyte-predominant disease

    • Idiopathic inflammatory myopathy (e.g., dermatomyositis, myositis, polymyositis, inclusion body myositis) if intolerant to or inadequate response to prior treatment with ALL of the following:

    • • Glucocorticoids

      • Minimum of one other immunosuppressive or immunomodulatory agent (e.g. azathioprine, methotrexate, mycophenolate, mofetil, cyclosporine, tacrolimus, cyclophosphamide, leflunomide or IVIg)

    • Neuromyelitis optica / neuromyelitis optica spectrum disease (NMO/NMOSD) for ANY ONE of the following:

    • • Treatment-naïve individual with high disease activity as first-line  therapy

      • Individual who relapsed or was refractory to one or more prior treatment including previous immunosuppressive therapy (e.g., azathioprine)

    • Non-Hodgkin lymphoma (NHL) including but not limited to, the following:

    • • AIDS-related B-Cell Lymphoma

      • Burkitt Lymphoma

      • Castleman’s Disease

      • Diffuse Large B-Cell Lymphoma

      • Low-grade or Follicular Lymphoma

      • Gastric & Non-gastric Malt Lymphoma

      • Hairy Cell Leukemia

      • Mantle Cell Lymphoma

      • Nodal Marginal Zone Lymphoma

      • Post-transplant lymphoproliferative disorder (PTLD) after solid organ transplant or allogeneic hematopoietic stem cell transplantation

      • Primary Cutaneous B-Cell Lymphomas

      • Splenic Marginal Zone Lymphoma

    • Pemphigus vulgaris if disease is refractory to previous conventional therapy with corticosteroids and/or azathioprine

    • Rheumatoid arthritis if ALL of the following:

    • • Individual is 18 years of age or older

      • Disease is moderately- to severely-active

      • Used in combination with methotrexate (MTX) unless individual has a contraindication or intolerance

      • Individual tried and failed a minimum 3 month trial with ONE oral disease modifying anti-rheumatic agent (DMARD) (e.g., methotrexate, Imuran, Ridaura, Plaquenil, Cuprimine, Azulfidine, Arava, etc.)

      • Previous failure/inadequate response with one or more preferred tumor necrosis factor (TNF) antagonist therapies, at least one of which should be a self-injectable

      • Individual has NOT had treatment with rituximab in the previous 4 months

    • Thrombocytopenic purpura if ANY ONE of the following:

    • • Primary thrombocytopenia

      • Idiopathic (Immune) thrombocytopenia purpura (ITP)

      • Evan’s syndrome

      • Congenital and hereditary thrombocytopenic purpura

      • Thrombotic thrombocytopenic purpura in patients with ADAMTS13-deficiency

    • Waldenström's macroglobulinemia / lymphoplasmacytic lymphoma

    • Wegener’s granulomatosis (WG), microscopic polyangiitis (MP) and granulomatosis with polyangiitis (GPA) in an individual 18 years of age if treatment is in combination with glucocorticoids

RENEWAL CRITERIA

• Rituximab is considered medically appropriate for renewal if ALL of the following criteria are met:

• • Individual continues to meet initial approval criteria

  • Absence of unacceptable toxicity from the drug such as severe infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions, progressive multifocal leukoencephalopathy (PML), viral hepatitis, serious bacterial, fungal, or viral infections, cardiac arrhythmias, renal toxicity, bowel obstruction or perforation

  • Diagnosis of ANY ONE of the following:

  • • Oncological applications of Non-Hodgkin’s lymphoma (NHL); CNS Lymphoma; Hodgkin’s lymphoma; Chronic lymphocytic leukemia (CLL); Small lymphocytic lymphoma; Waldenström’s macroglobulinemia; Castleman’s Disease; Post-transplant lymphoproliferative disorder (PTLD) with ALL of the following:

    • • Tumor response with stabilization of disease or decrease in size of tumor or tumor spread

      • Individual has not exceeded dosing limits

    • Non-oncological limits of ANY ONE of the following:

    • • Autoimmune hemolytic anemia (AIHA) with disease response as indicated by improvement in anemia signs and symptoms (e.g., dyspnea, fatigue, etc.) as well as: improvement in laboratory values (Hb/Hct), reduced transfusion needs, and/or reduced glucocorticoid use

      • Chronic graft-versus-host disease (cGVHD) with disease response as indicated by improvement in patient-reported symptoms or clinician assessments (e.g., manifestations of disease to the skin, oral cavity, musculoskeletal system, etc.)

      • Idiopathic inflammatory myopathy with disease response as indicated by improvement in signs and symptoms of condition compared to baseline

      • Neuromyelitis optica / neuromyelitis optica spectrum disease (NMO/NMOSD) with disease response as indicated by improvement in signs and symptoms of condition compared to baseline

      • Pemphigus vulgaris, Granulomatosis with Polyangiitis (GPA) (Wegener’s granulomatosis) and Microscopic polyangiitis (MPA) with disease response as indicated by improvement in signs and symptoms of condition compared to baseline

      • Rheumatoid arthritis (RA) with disease response as indicated by improvement in signs and compared to baseline such as the number of tender and swollen joint counts.

      • Thrombocytopenic purpura with disease response as indicated by the achievement and maintenance of a platelet count of at least 50 × 109/L as necessary to reduce the risk for bleeding

      • Thrombotic thrombocytopenic purpura (TTP) with disease response as indicated by an increase in ADAMTS13 activity with a reduction in thrombosis risk

LENGTH OF AUTHORIZATION

Coverage will be provided for an authorization period of 6 months, with renewals not to exceed 2 years, other than for acute lymphoblastic leukemia (ALL), which is NOT eligible for renewal.

Click to see DOSAGE LIMITS

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

No controlled studies were found in the published literature that validate the use of rituximab for the treatment or prevention of other conditions or diseases.

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2017). Nononcologic uses of rituximab (5.01.24). Retrieved December 11, 2017 from BlueWeb.

BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2017). Uses of monoclonal antibodies for the treatment of non-Hodgkin’s lymphoma and acute myeloid leukemia in the non-stem cell transplant setting (2.03.05). Retrieved December 11, 2017 from BlueWeb.

Joly, B. S., Coppo, P., Veyradier, A. (2017, May). Thrombotic thrombocytopenic purpura. Blood, 129 (21), 2836-2846.

Lexi-Comp Online. (2017). AHFS DI. Rituximab. Retrieved December 13, 2017 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2017, October). Rituximab. Retrieved December 13, 2017 from MICROMEDEX Healthcare Series.

Moghadam-Kia, S., Aggarwal, S., Oddis, C. V. (2015). Treatment of inflammatory myopathy: emerging therapies and therapeutic targets. Expert Review of Clinical Immunology. (11)11, 1265-1275.

National Comprehensive Cancer Network. (2017). NCCN Drugs & Biologics Compendium™. Rituximab. Retrieved December 13, 2017 from the National Comprehensive Cancer Network.

Oddis, C. V., Reed, A. M., Aggarwal, R., Rider, L. G., Ascherman, D. P., Levesque, M. C., et al. (2013, February). Rituximab in the treatment of refractory adult and juvenile dermatomyositis and adult polymyositis: A randomized, placebo-phase trial. Arthritis Rheumatology, 65 (2), 314-324.

Trebst, C., Jarius, S., Berthele, A., Paul, F., Schippling, S., Wildemann, B., et al. (2013). Update on the diagnosis and treatment of neuromyelitis optica: Recommendations of the Neuromyelitis Optica Study Group (NEMOS). Journal of Neurology. (2014) 261, 1-16.

U. S. Food and Drug Administration. (2014, August). Center for Drug Evaluation and Research. Rituxan® (rituximab) injection for intravenous use. Retrieved December 13, 2017 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103705s5432lbl.pdf.

ORIGINAL EFFECTIVE DATE:  2/26/2003

MOST RECENT REVIEW DATE:  2/16/2018

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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.