Coverage Policy Manual
Policy #: 2006016
Category: Pharmacy
Initiated: March 2006
Last Review: March 2018
  Rituximab (Rituxan), Off-label Use

Description:
Rituximab (Rituxan – Genentech), an anti-CD20 monoclonal antibody, was originally approved by the FDA in November 1997 for the treatment of relapsed or refractory low grade or folllicular CD20+ B-cell non-Hodgkin’s lymphoma (NHL).  Since its introduction there have been expanded FDA approved indications, and a number of off-label conditions for which the drug has been investigated.  
 
Rituximab has shown impressive benefit for some conditions, and in addition the drug has been found to have some serious adverse effects for which the FDA has issued "Black Box Warnings."  Fatal infusion reactions may occur within 24 hours of rituximab infusion; approximately 80% of fatal reactions occurred with first infusion. Monitor patients and discontinue rituximab infusion for severe reactions. Acute renal failure requiring dialysis with instances of fatal outcome can occur in the setting of Tumor Lysis Syndrome (TLS) following treatment of rituximab in patients with non-Hodgkin's lymphoma (NHL). Severe and potentially fatal mucocutaneous reactions can occur in patients receiving rituximab. JC virus infection resulting in Progressive Multifocal Leukoencephalopathy (PML) and death can also occur in patients receiving rituximab
 
.Coding
Effective January 01, 2019, there is a specific HCPCS code for Rituximab 10 mg injection and a specific code for rituxan Hycela (rituximab/hyaluronidase):
 
J9312  Injection, rituximab, 10 mg
 
J9311  Injection, rituximab 10 mg and hyaluronidase.

Policy/
Coverage:
Effective March 2018
 
FDA APPROVED INDICATIONS
 
Rituximab meets member benefit certificate Primary Coverage Criteria that there be scientific
evidence of effectiveness for the following indications:
 
· Non-Hodgkin’s Lymphoma, Relapsed or Refractory, Low-grade or Follicular, CD20-
positive, B-cell (FDA approval as orphan drug; Effective, Nov 1997)
· Non-Hodgkin’s Lymphoma, Diffuse, Large B-cell, CD20-positive, in Combination with
CVP or CHOP or other Anthracycline-based Chemotherapy Regimens, as first-line
treatment (FDA approved, 2006; Effective 2006)
· Non-Hodgkin’s Lymphoma, CD20+ B-cell, as a Single Agent, as first line treatment (FDA
approved, 2007; Effective, 2007)
· Non Hodgkin’s Lymphoma, Low-grade, CD20-positive, B-cell, in patients with stable
disease or who achieve a partial or complete response following first-line treatment with
chemotherapy (FDA approved, 2007; Effective, 2007)
· Non-Hodgkin’s Lymphoma, CD20-positive, all types (FDA approved, 2008; Effective, 2008)
(This approval supersedes the previous coverage, as rituximab is now FDA approved for all NHL
patients.
· Mantle Cell Lymphoma, a form of NHL (Effective, 2008)
· Burkitt’s Lymphoma, a form of NHL (Effective, 2008)
· Gastric Malt Lymphoma, a form of NHL (Effective, 2008)
· Non-Gastric Malt Lymphoma, a form of NHL (Effective, 2008)
· Lymphoblastic Lymphoma, (in combination with hyper-CVAD chemotherapy) a form of
NHL (Effective, 2008)
· Post-transplant Lymphoproliferative Disorder, a form of NHL (Effective, 2008)
· Primary Cutaneous B-Cell Lymphoma, a form of NHL (Effective, 2008)
· Splenic Marginal Zone Lymphoma, a form of NHL (Effective, 2008)
· Rheumatoid Arthritis, moderate to severely active, in combination with methotrexate for
patients who have had an inadequate response to one or more TNF antagonist therapies
(FDA approved, Mar 2006; Effective, Mar 2006)
· Rheumatoid Arthritis, in combination with methotrexate, for retreatment of rheumatoid
arthritis at intervals of 16 to 24 weeks depending on response (FDA approved, Sep 2009;
Effective Sep 2009)
· Chronic Lymphocytic Leukemia, CD20-positive, newly diagnosed or relapsed (FDA
approved, Feb 2010; Arkansas BCBS had established off-label coverage for this use in October
2001 based on “external 3rd party review – “expert opinion”)
· Wegener’s Granulomatosis, in Combination with Glucocorticoids (FDA orphan drug
status, Apr 2011; Arkansas BCBS had established off-label coverage for rituximab for Wegener’s
Granulomatosis in Sept 2009, for patients refractory to cyclophosphamide)
· Microscopic Polyangiitis (Anti-Neutrophil Cytoplasmic Antibody Vasculitis) in
Combination with Glucocorticoids (FDA orphan drug status, Apr 2011; Arkansas BCBS had
established off-label coverage for rituximab for ANCA vasculitis in Jul 2010, for patients refractory
to glucocorticoids)
 
OFF-LABEL INDICATIONS
 
For off-label use in malignant diseases, coverage of rituximab is based on the Arkansas state
mandate or coverage of chemotherapy for malignant disease which includes recommendation by the
American Hospital Formulary Service Drug Information (AHFS), Clinical Pharmacology Online (CPO),
or National Comprehensive Cancer Network (NCCN) compendia.
 
For off-label use for non-malignant conditions, rituximab does not meet member certificate of benefit
Primary Coverage Criteria if 1) the use is being studied in phase I, II, or III clinical trials or otherwise
under study to determine effectiveness; 2) if there is lack of scientific evidence of effectiveness; or 3)
the effectiveness of the particular use is in conflict or the subject of debate amongst experts.
 
Rituximab meets member benefit certificate Primary Coverage Criteria that there be scientific
evidence of effectiveness in improving health outcomes for off-label use for treatment of the following
conditions:
 
· Acute Lymphocytic Leukemia, CD20-Positive, in combination with Hyper-CVAD
chemotherapy (Effective, Apr 2011 – Recommended by CPO)
· Autoimmune Hemolytic Anemia (AIHA) in patients that have failed to respond to
corticosteroid therapy (Effective, Aug 2007)
· Catastrophic Antiphospholipid antibody Syndrome (CAPS) (Effective, Mar 2010)
· Cryoglobulinemic vasculitis associated with Hepatitis C virus infection (Effective, March
2010)
· Ebstein-Barr Virus infection in patients with X-linked Immunodeficiency (Effective, Mar
2010)
· Evan’s Syndrome, pediatric and adult, who are unresponsive to, or unable to tolerate
corticosteroids (Effective, Mar 2010)
· Graft vs. Host Disease, Chronic, for treatment of corticosteroid-refractory disease
(Effective, Mar 2010)
· Hairy Cell Leukemia (Effective, Jan 2008)
· HIV-associated Multicentric Castleman Disease (Effective, Dec 2007)
· Hodgkin Disease, Lymphocyte-Predominant Hodgkin’s Lymphoma (LPHL) in relapsed
disease or patients who cannot receive chemotherapy. (Effective, Aug 2008)
·ITP, in children with ITP who have significant ongoing bleeding and/or have a need for improved quality of life despite conventional treatment. Also may be considered as an alternative to splenectomy in children with chronic ITP or as therapy in those who have failed splenectomy. (Effective, March 2018)
·ITP, in adults at risk of bleeding who have failed one line of therapy such as corticosteroids, IVIg, or  splenectomy. (Effective, March 2018)
· Leukemic Reticuloendotheliosis (Hairy-cell Leukemia) for patients with relapsed or
refractory disease or for patients who cannot take pentostatin or interferon. (Effective, Nov
2001)
·  Lupus Erythematosus, Systemic, as second or third line therapy, for Hispanics or
African Americans (Effective, Jul 2010)
· Mantle Cell Lymphoma, as maintenance post Autologous Stem Cell Transplantation
· Membranous Glomerulonephropathy for patients refractory to, or cannot take alkylating
agents or calcineurin inhibitors (Effective, Jan 2011)
· Monoclonal Gammopathy of Unknown Significance with Polyneuropathy (with or without
anti-MAG antibodies in patients refractory to standard therapy (Effective, Mar 2010)
· Multifocal Motor Neuropathy for patients who have become refractory to IVIg (Effective,
Mar 2010)
· Multiple Myeloma in Patients with CD20+ antigen plasma cells in patients with disease
refractory to drugs that are FDA approved for treatment of myeloma (Effective, Mar 2010)
· Neuromyelitis Optica for patients with disease refractory to immunosuppressive drugs
and/or plasmapheresis (Effective, Mar 2010)
· Pemphigus Vulgaris and Pemphigus Foliaceus, unresponsive to conventional
therapy(e.g., systemic corticosteroids and immunosuppressive agents) or in those
patients in whom these drugs would not be tolerated (Effective, Aug 2007)
· Multiple Sclerosis, Relapsing Remitting (Effective, Feb 2008)
· Post-transplant Lymphoproliferative Disorder as first and second-line therapy, and as
maintenance therapy (Effective, April 2011). From March 2010 to April 2011, rituximab was
covered for patients refractory to standard therapy (Effective, Mar 2010)
· Rheumatoid arthritis, as a single agent in patients who have failed DMARDs, and antitumor
necrosis alfa drugs, and who have been shown to be intolerant of methotrexate
(Effective, Jan 2007)
· Sjögren’s Syndrome (Effective, Mar 2010)
· Thrombotic Thrombocytopenic Purpura, Acquired, due to ADAMTS13 deficiency, and to Gemcitabine induced TTP (Effective, Mar 2010)
· Transplant, Heart, Acute Graft Rejection due to Antibody Mediated Disease, in patients
refractory to plasmapheresis/IVIG (Effective, Mar 2010)
· Transplant, Kidney, Desensitization of ABO Incompatible Patients on Renal Transplant
Waiting List, when used in conjunction with IVIG (Effective, Jan 2008)
· Transplant, Kidney, Desensitization of Panel Reactive Antibodies on Renal Transplant
Waiting List (Effective, Mar 2010)
· Transplant, Kidney, Acute Graft Rejection due to Antibody Mediated Disease, when used
as second-line therapy (Effective, Mar 2010)
· Transplant, Lung, Acute Humoral Antibody Mediated Disease (Effective, Mar 2010)
· Transplant, Heart, Desensitization of Panel Reactive Antibodies in Patients on Cardiac
Transplant Waiting List (Effective, Mar 2010)
· Waldenström's Macroglobulinemia, for 1st or 2nd line therapy (Effective, Jan 2002)
 
Rituximab does not meet member benefit Primary Coverage Criteria that there be scientific evidence
of effectiveness in improving health outcomes and for contract without primary coverage criteria is
considered investigational for the following conditions:
 
· Atopic Eczema
· Autoimmune Neutropenia
· Autoimmune Retinopathy
· Chronic Fatigue Syndrome
· Chronic Inflammatory Demyelinating Polyneuropathy
· Cryoglobulinemia for any indication except the use described under covered conditions
· Dermatomyositis
· Desensitization of HLA Incompatible Patients on liver transplant waiting list
· Desensitization of HLA Incompatible Patients on renal transplant waiting list when used
as a single agent
· Ebstein-Barr Virus infection in any condition other than X-linked immunodeficiency
· Encephalitis, including Rasmussen
· Glomerulosclerosis, Focal Segmental
· Graft-Versus-Host Disease, Acute for treatment of active disease
· Graft-Versus-Host Disease, Acute, as a preventative agent
· Graft-Versus-Host Disease, Acute, for steroid-refractory disease
· Graft-Versus-Host Disease, Chronic, as initial, (first-line) therapy
· Graft-Versus-Host Disease, Chronic, as preventative therapy
· Graves’ Ophthalmopathy
· Fibrillary Glomerulonephritis· Hemophilia A, treatment to eradicate or suppress autoimmune anti-factor VIII antibodies
· IgA Nephropathy
· Lupus Erythematosus, Systemic
· Multiple Myeloma, for Primary, Recurrent, Relapsed, or Refractory Disease in patients
with absence of CD20+ antigen plasma cells
· Multiple Sclerosis, Primary Progressive
· Myasthenia Gravis
· Polymyositis
· Pemphigus Vulgaris and Pemphigus Foliaceous, when administered concomitantly (or
sequentially) with immune globulin
· Primary Biliary Cirrhosis
· Red Cell Aplasia or Diamond Blackfan Anemia
· Rheumatoid arthritis, when administered concomitantly (or within the same month) with
anti-tumor necrosis alpha drugs
· Transplant, Heart, Desensitization of ABO Incompatible Patients on Transplant Waiting
List
· Transplant, Kidney, Desensitization of HLA Panel Reactive Antibodies developing in
kidney transplant recipients to prevent potential rejection
· Transplant, Kidney, as Induction Given Prior to Transplant
· Transplant, Liver, Desensitization of ABO Incompatible Patients on Transplant Waiting
List
· Transplant, Liver, Rejection
· Transplant, Lung, Acute Rejection due to Cellular Vascular Rejection
· Transplant, Lung, Desensitization of ABO Incompatible Patients on Transplant Waiting
List
· Systemic Sclerosis, for Any Use, Including Treatment of Pulmonary Hypertension
· Urticaria, Chronic
 
Rituximab does not meet member benefit certificate primary coverage criteria that there be scientific
evidence of effectiveness in improving health outcomes for any other use of rituximab that is not listed
as a covered indication. Requests for coverage of any of the conditions on the Non-Covered list, or
for any condition not listed in the policy will require submission of data on effectiveness which will be
reviewed to determine if the proposed indication meets member certificate of benefit coverage
criteria.
 
For contracts without primary coverage criteria, any other use of rituximab that is not listed as a
covered indication is considered to be investigational. Investigational services are specific contract
exclusions in most member benefit certificates of coverage.
 
Effective prior to March 2018
 
FDA APPROVED INDICATIONS
 
Rituximab meets member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness for the following indications:
 
    • Non-Hodgkin’s Lymphoma, Relapsed or Refractory, Low-grade or Follicular, CD20-positive, B-cell (FDA approval as orphan drug; Effective, Nov 1997)
    • Non-Hodgkin’s Lymphoma, Diffuse, Large B-cell, CD20-positive, in Combination with CVP or CHOP or other Anthracycline-based Chemotherapy Regimens, as first-line treatment (FDA approved, 2006; Effective 2006)
    • Non-Hodgkin’s Lymphoma, CD20+ B-cell, as a Single Agent, as first line treatment (FDA approved, 2007; Effective, 2007)
    • Non Hodgkin’s Lymphoma, Low-grade, CD20-positive, B-cell, in patients with stable disease or who achieve a partial or complete response following first-line treatment with chemotherapy (FDA approved, 2007; Effective, 2007)
    • Non-Hodgkin’s Lymphoma, CD20-positive, all types (FDA approved, 2008; Effective, 2008)(This approval supersedes the previous coverage, as rituximab is now FDA approved for all NHL patients.
    • Mantle Cell Lymphoma, a form of NHL (Effective, 2008)
    • Burkitt’s Lymphoma, a form of NHL (Effective, 2008)
    • Gastric Malt Lymphoma, a form of NHL (Effective, 2008)
    • Non-Gastric Malt Lymphoma, a form of NHL (Effective, 2008)
    • Lymphoblastic Lymphoma, (in combination with hyper-CVAD chemotherapy) a form of NHL (Effective, 2008)
    • Post-transplant Lymphoproliferative Disorder, a form of NHL (Effective, 2008)
    • Primary Cutaneous B-Cell Lymphoma, a form of NHL (Effective, 2008)
    • Splenic Marginal Zone Lymphoma, a form of NHL (Effective, 2008)
    • Rheumatoid Arthritis, moderate to severely active, in combination with methotrexate for patients who have had an inadequate response to one or more TNF antagonist therapies (FDA approved, Mar 2006; Effective, Mar 2006)
    • Rheumatoid Arthritis, in combination with methotrexate, for retreatment of rheumatoid arthritis at intervals of 16 to 24 weeks depending on response (FDA approved, Sep 2009; Effective Sep 2009)
    • Chronic Lymphocytic Leukemia, CD20-positive, newly diagnosed or relapsed (FDA approved, Feb 2010; Arkansas BCBS had established off-label coverage for this use in October 2001 based on “external 3rd party review – “expert opinion”)
    • Wegener’s Granulomatosis, in Combination with Glucocorticoids (FDA orphan drug status, Apr 2011; Arkansas BCBS had established off-label coverage for rituximab for Wegener’s Granulomatosis in Sept 2009, for patients refractory to cyclophosphamide)
    • Microscopic Polyangiitis (Anti-Neutrophil Cytoplasmic Antibody Vasculitis) in Combination with Glucocorticoids (FDA orphan drug status, Apr 2011; Arkansas BCBS had established off-label coverage for rituximab for ANCA vasculitis in Jul 2010, for patients refractory to glucocorticoids)  
 
OFF-LABEL INDICATIONS
 
For off-label use in malignant diseases, coverage of rituximab is based on the Arkansas state mandate or coverage of chemotherapy for malignant disease which includes recommendation by the American Hospital Formulary Service Drug Information (AHFS), Clinical Pharmacology Online (CPO), or National Comprehensive Cancer Network (NCCN) compendia.
 
For off-label use for non-malignant conditions, rituximab does not meet member certificate of benefit Primary Coverage Criteria if 1) the use is being studied in phase I, II, or III clinical trials or otherwise under study to determine effectiveness; 2) if there is lack of scientific evidence of effectiveness; or 3) the effectiveness of the particular use is in conflict or the subject of debate amongst experts.  
 
Rituximab meets member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes for off-label use for treatment of the following conditions:
 
    • Acute Lymphocytic Leukemia, CD20-Positive, in combination with Hyper-CVAD chemotherapy (Effective, Apr 2011 – Recommended by CPO)   
    • Autoimmune Hemolytic Anemia (AIHA) in patients that have failed to respond to corticosteroid therapy (Effective, Aug 2007)
    • Catastrophic Antiphospholipid antibody Syndrome (CAPS) (Effective, Mar 2010)
    • Cryoglobulinemic vasculitis associated with Hepatitis C virus infection (Effective, March 2010)
    • Ebstein-Barr Virus infection in patients with X-linked Immunodeficiency (Effective, Mar 2010)
    • Evan’s Syndrome, pediatric and adult, who are unresponsive to, or unable to tolerate corticosteroids  (Effective, Mar 2010)
    • Graft vs. Host Disease, Chronic, for treatment of corticosteroid-refractory disease (Effective, Mar 2010)
    • Hairy Cell Leukemia (Effective, Jan 2008)
    • HIV-associated Multicentric Castleman Disease (Effective, Dec 2007)
    • Hodgkin Disease, Lymphocyte-Predominant Hodgkin’s Lymphoma (LPHL) in relapsed disease or patients who cannot receive chemotherapy. (Effective, Aug 2008)
    • Idiopathic/Immune Thrombocytopenic Purpura, in patients that have failed to respond to conventional therapy, including IVIG (Effective, Jan 2002)
    • Leukemic Reticuloendotheliosis (Hairy-cell Leukemia) for patients with relapsed or refractory disease or for patients who cannot take pentostatin or interferon. (Effective, Nov 2001)  
    •  Lupus Erythematosus, Systemic, as second or third line therapy, for Hispanics or African Americans (Effective, Jul 2010)  
    • Membranous Glomerulonephropathy for patients refractory to, or cannot take alkylating agents or calcineurin inhibitors (Effective, Jan 2011)
    • Monoclonal Gammopathy of Unknown Significance with Polyneuropathy (with or without anti-MAG antibodies in patients refractory to standard therapy (Effective, Mar 2010)
    • Multifocal Motor Neuropathy for patients who have become refractory to IVIg (Effective, Mar 2010)
    • Multiple Myeloma in Patients with CD20+ antigen plasma cells in patients with disease refractory to drugs that are FDA approved for treatment of myeloma (Effective, Mar 2010)
    • Neuromyelitis Optica for patients with disease refractory to immunosuppressive drugs and/or plasmapheresis (Effective, Mar 2010)
    • Pemphigus Vulgaris and Pemphigus Foliaceus, unresponsive to conventional therapy(e.g., systemic corticosteroids and immunosuppressive agents) or in those patients in whom these drugs would not be tolerated (Effective, Aug 2007)
    • Multiple Sclerosis, Relapsing Remitting (Effective, Feb 2008)
    • Post-transplant Lymphoproliferative Disorder as first and second-line therapy, and as maintenance therapy (Effective, April 2011).  From March 2010 to April 2011, rituximab was covered for patients refractory to standard therapy (Effective, Mar 2010)
    • Rheumatoid arthritis, as a single agent in patients who have failed DMARDs, and anti-tumor necrosis alfa drugs, and who have been shown to be intolerant of methotrexate (Effective, Jan 2007)
    • Sjögren’s Syndrome (Effective, Mar 2010)
    • Thrombotic Thrombocytopenic Purpura, Acquired, due to ADAMTS13 deficiency, and to Gemcitabine induced TTP (Effective, Mar 2010)
    • Transplant, Heart, Acute Graft Rejection due to Antibody Mediated Disease, in patients refractory to plasmapheresis/IVIG (Effective, Mar 2010)
    • Transplant, Kidney, Desensitization of ABO Incompatible Patients on Renal Transplant Waiting List, when used in conjunction with IVIG (Effective, Jan 2008)
    • Transplant, Kidney, Desensitization of Panel Reactive Antibodies on Renal Transplant Waiting List (Effective, Mar 2010)
    • Transplant, Kidney, Acute Graft Rejection due to Antibody Mediated Disease, when used as second-line therapy (Effective, Mar 2010)
    • Transplant, Lung, Acute Humoral Antibody Mediated Disease (Effective, Mar 2010)
    • Transplant, Heart, Desensitization of Panel Reactive Antibodies in Patients on Cardiac Transplant Waiting List (Effective, Mar 2010)
    • Waldenström's Macroglobulinemia, for 1st or 2nd line therapy (Effective, Jan 2002)
 
 
Rituximab does not meet member benefit Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes and for contract without primary coverage criteria is considered investigational for the following conditions:
 
    • Atopic Eczema
    • Autoimmune Neutropenia
    • Autoimmune Retinopathy
    • Chronic Fatigue Syndrome
    • Chronic Inflammatory Demyelinating Polyneuropathy
    • Cryoglobulinemia for any indication except the use described under covered conditions
    • Dermatomyositis
    • Desensitization of HLA Incompatible Patients on liver transplant waiting list
    • Desensitization of HLA Incompatible Patients on renal transplant waiting list when used as a single agent
    • Ebstein-Barr Virus infection in any condition other than X-linked immunodeficiency
    • Encephalitis, including Rasmussen
    • Glomerulosclerosis, Focal Segmental
    • Graft-Versus-Host Disease, Acute for treatment of active disease
    • Graft-Versus-Host Disease, Acute, as a preventative agent
    • Graft-Versus-Host Disease, Acute, for steroid-refractory disease
    • Graft-Versus-Host Disease, Chronic, as initial, (first-line) therapy
    • Graft-Versus-Host Disease, Chronic, as preventative therapy
    • Graves’ Ophthalmopathy
    • Fibrillary Glomerulonephritis
    • Hemophilia A, treatment to eradicate or suppress autoimmune anti-factor VIII antibodies
    • IgA Nephropathy
    • Lupus Erythematosus, Systemic
    • Multiple Myeloma, for Primary, Recurrent, Relapsed, or Refractory Disease in patients with absence of CD20+ antigen plasma cells
    • Multiple Sclerosis, Primary Progressive
    • Myasthenia Gravis
    • Polymyositis
    • Pemphigus Vulgaris and Pemphigus Foliaceous, when administered concomitantly (or sequentially) with immune globulin
    • Primary Biliary Cirrhosis
    • Red Cell Aplasia or Diamond Blackfan Anemia
    • Rheumatoid arthritis, when administered concomitantly (or within the same month) with anti-tumor necrosis alpha drugs
    • Transplant, Heart, Desensitization of ABO Incompatible Patients on Transplant Waiting List
    • Transplant, Kidney, Desensitization of HLA Panel Reactive Antibodies developing in kidney transplant recipients to prevent potential rejection
    • Transplant, Kidney, as Induction Given Prior to Transplant
    • Transplant, Liver, Desensitization of ABO Incompatible Patients on Transplant Waiting List  
    • Transplant, Liver, Rejection
    • Transplant, Lung, Acute Rejection due to Cellular Vascular Rejection
    • Transplant, Lung, Desensitization of ABO Incompatible Patients on Transplant Waiting List
    • Systemic Sclerosis, for Any Use, Including Treatment of Pulmonary Hypertension
    • Urticaria, Chronic
 
Rituximab does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for any other use of rituximab that is not listed as a covered indication.  Requests for coverage of any of the conditions on the Non-Covered list, or for any condition not listed in the policy will require submission of data on effectiveness which will be reviewed to determine if the proposed indication meets member certificate of benefit coverage criteria.
 
For contracts without primary coverage criteria, any other use of rituximab that is not listed as a covered indication is considered to be investigational.  Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 

Rationale:
Due to the detail of the rationale, it is not online. If you would like a hardcopy print, please email : codespecificinquiry@arkbluecross.com
 
2012 Update: Rituximab for treatment of SLE meets Primary Coverage Criteria as second line therapy for Hispanics or African Americans; otherwise, Rituximab for treatment of systemic lupus erythematosus does not meet Primary Coverage Criteria, as the drug showed no benefit over placebo, except as second or third line treatment for Hispanic or African-American patients, as demonstrated in the 2 largest controlled trials to date; a third trial was terminated due to safety concerns.
 
2015 Update
A literature search conducted through July 2015 did not reveal any new information that would prompt a change in the coverage statement.  The key identified literature is summarized below.
 
Recent editorials discussed an alternative to maintenance rituximab in patients with rituximab-responsive, low tumor burden FL (Friedberg, 2014; Barton. 2015). Two trials compared maintenance rituximab with a watch-and-wait, treat-at-progression strategy and found no difference in PFS or OS (Ardeshna, 2014; Kahl, 2014).  However, patients who received maintenance therapy sustained their first disease remission longer, and median response durations for patients in the watch-and-wait groups progressively declined, from 34 months after induction to 12 months after second retreatment. Low tumor burden FL was defined as “no mass measuring greater than 7 cm, fewer than 3 masses measuring more than 3 cm, no systemic or B symptoms, no splenomegaly measuring greater than 16 cm, no organ compromise, no leukemic phase greater than 5000/mL circulating lymphocytes, and no cytopenias (Friedberg, 2014).”
 
Jaeger and colleagues  conducted an international, open-label RCT in 683 adults (median age, 58 years) with previously untreated CD20+, aggressive NHL (Jaeger, 2015). Patients with DLBCL (n=662) or grade 3b FL (n=21) were randomized 1:1 to rituximab maintenance after first (confirmed or unconfirmed) complete remission or to observation for 2 years. Patients completed first-line therapy (8 infusions of rituximab [375 mg/m2] plus 4-8 cycles of CHOP-like chemotherapy) 12 to 14 weeks before trial start. For patients randomized to rituximab maintenance, rituximab 375 mg/m2 was administered every 2 months. Assessments in both groups occurred every 8 weeks. The primary outcome was EFS by intention-to-treat analysis, with events defined as progressive disease, death from any cause, initiation of new anticancer treatment, secondary malignancy, or unacceptable toxicity). PFS and OS also were assessed. At median follow-up of 45 months, estimated 3-year EFS was 80.1% in the rituximab maintenance group versus 76.5% in the observation group (HR=0.79 [95% CI, 0.57 to 1.08]; p=0.143). Similarly, in intention-to-treat analysis, 3- year PFS and 3-year OS estimates did not differ statistically between treatment groups.
 
Aviles and colleagues conducted an RCT of rituximab consolidation therapy in 325 adults (median age, 63 years) with previously untreated, advanced stage DLBCL and poor prognostic factors, who were in CR after dose-dense chemotherapy (CHOP-14) (Aviles, 2015). Patients were randomized 1:1 to rituximab consolidation (375 mg/m2 weekly x 4 weeks at 3 and 9 months after chemotherapy) or no consolidation (observation). Assessments occurred every 3 months for 2 years, then every 6 months for 2 years, and then annually until relapse, death, or last follow-up. At median follow-up of 43 months, estimated 5-year PFS was 51% in the rituximab consolidation group versus 53% in the observation group (p=0.8). Similarly, estimated 5- year OS did not differ statistically between groups (65% vs 66%, respectively; p=0.78).
 
Several single-arm studies have examined chemo immunotherapy regimens with rituximab for relapsed or refractory DLBCL. Merchionne and colleagues reported on one such study (Merchionne, 2014): retrospective analysis study of Bendamustine plus rituximab for relapsed or refractory diffuse large B cell lymphoma. Patients were transplant ineligible, relapsed/refractory DLBCL. Treatment included up to 6 (median, 5) 28 day cycles of rituximab375 mg/m2 on daty 1 plus bendamustine 90-120 (mean, 90) mg/m2 IV on days 1 & 2; the resulting in a complete response 39% Partial response 11% and progressive-free survival  8 months.
 
Posttransplant Lymphoproliferative Disorders
Posttransplant lymphoproliferative disorders (PTLD) are characterized by lymphoid proliferations that occur in patients receiving immunosuppressive therapy after solid organ or allogeneic stem cell transplantation. The majority of PTLDs are B-cell proliferations that develop 12 to 24 months after transplant with Epstein-Barr virus (EBV) detected in up to 70% of cases. EBV-negative PTLD typically has a later onset (>24 months after transplant). Risk factors for PTLD after solid organ transplant include EBV mismatch (positive donor/negative recipient), augmented immunosuppression (eg, with antilymphocyte antibodies), and type of organ transplant (incidence ranges from 􀁼1% in kidney recipients to 􀁼10% in small bowel or multiorgan recipients). The World Health Organization defines 4 categories of PTLD: (a) early lesions (reactive plasmacytic hyperplasia and infectious mononucleosis-like); (b) polymorphic PTLD; (c) monomorphic B-cell and T-cell PTLD; and (d) Hodgkin lymphoma (HL) and HL-like PTLD (Harris, 2008). Early lesions and some polymorphic lesions may be found incidentally; more advanced disease, such as monomorphic PTLD, typically presents with bulky, extranodal lymphadenopathy. Nonhealing ulcers of the gastrointestinal tract, bowel perforation, or pulmonary manifestations can occur. A primary goal of treatment is to save the transplanted organ (Blaes, 2010; Jagadeesh, 2012; Nassi, 2015; Lucey, 2013).
 
Reduction of immunosuppression is the first step in treatment of PTLD. Several studies have investigated rituximab for patients who have an inadequate response to reduction in immunosuppression (see list below). Overall response rates were 59% to 90%. Two retrospective comparative studies showed that PFS and OS were increased with rituximab-containing regimens, including monotherapy, compared with rituximab-free regimens (Evens, 2010) and that chemotherapy added to rituximab did not improve PFS and OS (Elsrom, 2006) although both studies were small (N=80 and 35, respectively).
 
Studies of Rituximab Chemoimmunotherapy for PTLD (Post Transplant Lymphoproliferative Disorders) After Solid Organ Transplant
 
(Trappe, 2012) CD20-pos patients with PTLD (HK (Hodgkin Lymphoma), polymorphic, monomorphic) unresponsive to RI (reduction in immunosuppression); 59 patients; treatment Rituximab 375 mg/m2 weekly x 4 wk (median, 4 doses) followed by 4 cycles of CHOP (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 to maximum 2 mg, and prednisone 100 mg/day x 5 days, repeated every 21 days as tolerated;) (median, 4 cycles); results complete response 68%; partial response 22%.
 
(Evens ,2010) EBV-pos, -neg, or unknown PTLD after RI; median time from transplant to PTLD, 48 month; 80 patients; treatment Rituximab ± chemotherapy (various regimens; n=59); results 3-y progression-free survival 21%; 3-y overall survival 33%.
 
(Gonzalez-Barca, 2007) PTLD after RI; 38 assessable patients; Rituximab 375 mg/m2 weekly x 4 wk, repeated x 1 in patients not achieving CR; results complete response 61%, partial results 18%.
 
(Choquet, 2006) B-cell PTLD unresponsive to RI; 46 patients; treatment Rituximab 375 mg/m2 weekly x 4 wk; results complete response 26%, 1-y overall survival 67%.
 
(Elstrom, 2006) PTLD unresponsive to or relapsed after RI; 35 patients; treatment Rituximab 375 mg/m2 weekly x 4 wk (n=22); results complete response 59%, partial response 9%, overall survival median 31 months; CHOP chemotherapy ± rituximab up to 6 cycles (n=23); results complete response 57%, partial response 17%; overall survival median 42 months.
 
(Blaes, 2005)  CD20-pos patients with PTLD (HL, polymorphic) after RI; median time from transplant to PTLD, 9 months; 11 patients; treatment Rituximab 375 mg/m2 weekly x 4 wk, repeated every 6 mo for 2 y in responding patients; results complete response 55%, partial response 17%, overall survival median 42 months.
 
(Oretel, 2005) PTLD (HL, HL-like, polymorphic) 17 patients; treatment Rituximab 375 gm/m2  weekly x 4 weeks; results complete response 53%; partial response 6% and overall survival median 37 months.
 
Ongoing and Unpublished Clinical Trials
A search of the online site ClinicalTrials.gov in July 2015 identified several randomized trials on that migh influence this policy:
 
Ongoing
 
(NCT01724021).  A Randomized, Open-label, Multicenter Study to Evaluate Patient Preference With Subcutaneous Administration of Rituximab Versus Intravenous Rituximab in Previously Untreated Patients With CD20+ Diffuse Large B-cell  Lymphoma or CD20+ Follicular Non-Hodgkin's Lymphoma Grades 1, 2 or 3a an industry-sponsored or cosponsored trial; planned enrollment 900; expected completion date March 2017.
 
(NCT01595048) Intergroup Trial for Children or Adolescents with B-Cell NHL or BAL: Evaluation of Rituximab Efficacy and Safety in High Risk Patients; planned enrollment 640; expected completion date December 2020.
 
(NCT01516580) Intergroup Trial for Children or Adolescents With B-Cell Non Hodgkin Lymphoma or B-Acute Leukemia: Evaluation of Rituximab Efficacy and Safety in High Risk Patients - Phase III Trial; planned enrollment 600; expected completion date December 2021.
 
(NCT00645606) Single-agent Rituximab as Maintenance Treatment Versus Observation After Combined Induction Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab (FCR) in Patients Older Than 65 Years With Previously Untreated B-cell Chronic Lymphocytic Leukemia (B-CLL): a Phase III Intergroup Trial of the GOELAMS and the FCGCLL/WM Groups an industry-sponsored or cosponsored trial; planned enrollment 542; expected completion date August 2019.
 
(NCT01996865)  A Phase 3B Randomized Study of Lenalidomide (CC-5013) Plus Rituximab Maintenance Therapy Followed by Lenalidomide Single- Agent Maintenance Versus Rituximab Maintenance in Subjects With Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma an industry-sponsored or cosponsored trial; planned enrollment 500; expected completion date July 2022.
 
(NCT02128061) Sub-cutaneous Rituximab-miniCHOP Versus Sub-cutaneous Rituximab-mini CHOP + enalidomide (R2-miniCHOP) in Diffuse Large B Cell Lymphoma for Patients of 80 Years Old or More. A Multicentric Phase III Study of the LYSA Association; planned enrollment 250; expected completion date February 2019.
 
(NCT01889069) A Single Arm, Multicenter, Phase IIIb Study to Evaluate Safety, Efficacy and Pharmacokinetic (PK) of Subcutaneous (SC) Rituximab Administered During Induction Phase or Maintenance in Previously Untreated Patients With CD20+ Diffuse Large B Cell Lymphoma (DLBCL) or Follicular Lymphoma (FL) an industry-sponsored or cosponsored trial; planned enrollment 161; expected completion date June 2019.
 
(NCT01987505) Open-Label, Single-Arm, Phase IIIb Clinical Trial to Evaluate the Safety of Switching from Intravenous Rituximab to Subcutaneous Rituximab during First Line Treatment for CD20+ Non-Hodgkin’s Follicular Lymphoma and Diffuse Large B-Cell Lymphoma an industry-sponsored or cosponsored trial; planned enrollment 140; expected completion date May 2017.
 
(NCT01200758) Risk-stratified Sequential Treatment of Post-transplant SC Followed by 4 Courses of Rituximab SC, 4 Courses of Lymphoproliferative Disease (PTLD) With 4 Courses of Rituximab Rituximab SC Combined With CHOP-21 or 6 Courses of Rituximab SC Combined With Alternating CHOP-21 and DHAOx: The PTLD-2 Trial ) an industry-sponsored or cosponsored trial; planned enrollment 90; expected completion date September 2019.
 
Rituximab
Randomized trials did not show benefit of rituximab consolidation or maintenance therapy in patients with DLBCL in first complete remission.
 
Evidence for use of rituximab as monotherapy or in chemoimmunotherapy regimens for posttransplant lymphoproliferative disorders (PTLD) comprises small cohort studies and retrospective comparative studies. One study showed improved PFS and OS in patients receiving rituximab-containing regimens, including monotherapy, compared with rituximab-free regimens. This evidence is considered sufficient to demonstrate improved health outcomes in patients with PTLD and an inadequate response to reduction in mmunosuppression, particularly because treatment options for these patients are limited.
 
2016 Update
A literature search conducted through August 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Araki and colleagues have designed a study to investigate the safety and efficacy of anti-CD20 monoclonal antibodies (rituximab) in high-risk RTx recipients. Major eligibility criteria include: 1) major and minor ABO blood group mismatch, 2) positive DSA. Thirty-five patients will receive 200 mg/body of rituximab. The primary endpoint is the incidence of B cell depletion. This study will clarify whether rituximab is efficacious in improving graft survival in high-risk RTx recipients (Araki, 2016).

CPT/HCPCS:
96413Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug
96415Chemotherapy administration, intravenous infusion technique; each additional hour (List separately in addition to code for primary procedure)
J9310Injection, rituximab, 100 mg
J9311Injection, rituximab 10 mg and hyaluronidase
J9312Injection, rituximab, 10 mg

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Collins M, Navaneethan SD, Chung M, et al.(2008) Rituximab treatment of fibrillary glomerulonephritis. Am J Kidney Dis, 2008; 52:1158-1162.

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Dass S, Bowman SJ, Vital EM, et al.(2008) Reduction of fatigue in Sjogren syndrome with rituximab: results of a randomized, double-blind, placebo-controlled pilot study. Ann Rheum Dis, 2008; 67:1541-1544.

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Diaz LA.(2007) Rituximab and pemphigus - a therapeutic advance. New Engl J Med, 2007; 357:605-607.

Dimopoulos MA, Anagnostopoulos Z, et al.(2005) Predictive factors for response to rituximab in Waldenstrom’s macroglobulinemia. Clin Lymphoma, 2005; 5:270-2.

Dimopoulos MA, Merlini G, et al.(2005) How we treat Waldenstrom’s macroglobulinemia. Hematologica, 2005; 90:117-125.

Dungarwalla M, Marsh C, Tooze A, et al.(2007) Lack of clinical efficacy of rituximab in the treatment of autoimmune neutropenia and pure red cell aplasia: implications for their pathophysiology. Ann Hematol,2007; 86:191-197.

Dupond JL, Essaimi L, Gil H, et al.(2010) ). Rituximab treatment of stiff-person syndrome in a patient with thymoma, diabetes mellitus and autoimmune thyroiditis. J Clin Neurosci, 2010; 17:389-391.

Edwards J, Szczepanski L, et al.(2004) Efficacy of B-cell-targeted therapy with rituximab in patients with rheumatoid arthritis. NEJM 2004; 350:2572-81.

Egawa H, Termukai S, Haga H, et al.(2008) Present status of ABO-incompatible living donor liver transplantation in Japan. Hepatology, 2008; 47:11-13.

El Fassi D, Nielsen CH, Nonnema S, et al.(2007) B lymphocyte depletion with the monoclonal antibody rituximab in Graves’ disease: a controlled pilot study. J Clin Endocrinol Metab, 2007; 92:1769-1772.

El Fassi D, Nielsen CH, Nonnema S, et al.(2009) B lymphocyte depletion with the monoclonal antibody rituximab in Graves’ disease: a controlled pilot study. . J Clin Endocrinol Metab, 2007; 92:1769-1772.

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El Tal KA, Posner MR, et al.(2006) Rituximab: a monoclonal antibody to CD20 used in the treatment of pemphigus vulgaris. J Am Acad Dermatol, 2006; 44:449-59.

Eleftheriou D, Melo M, Marks SD, et al.(2009) Biologic therapy in primary systemic vasculitis of the young. Rheumatology (Oxford), 2009; 48:978-986.

Eleftheriou D, Melo M, Marks SD, et al.(2009) Biologic therapy in primary systemic vasculitis of the young. Rheumatology (Oxford), 2009; 48:978-986.

Elstrom RL, Andreadis C, Aqui NA, et al.(2006) Treatment of PTLD with rituximab or chemotherapy. . Am J Transplant. Mar 2006;6(3):569-576. PMID 16468968

Engelhardt M, Jakob A, Ruter B, et al.(2002) Severe cold hemagglutinin disease (CHD) successfully treated with rituximab. Blood, 2002; 100:1922-1923.

Erikkson P.(2005) Nine patients with anti-neutrophil cytoplasmic antibody-positive vasculitis successfully treated with rituximab. J Intern Med, 2005; 257:540-548.

Erre GL, Pardini S, Faedda R, et al.(2008) Effect of rituximab on clinical and laboratory features of antiphospholipid syndrome: A case report and review of literature. Lupus, 2008; 17:50-55.

Evans RS, Takahashi K, Duane RT.(1951) Primary thrombocytopenic purpura and acquired hemolytic anemia. Arch Int Med, 1951; 87: 48-65.

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Fervenza FC, Abraham RS, Erickson SB, et al.(2010) Rituximab therapy in idiopathic membranous nephropathy: a 2-year study. Clin J Am Soc Nephrol, 2010; 5:2188-2198

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Hawker K, O’Connor P, Freedman MS, et al.(2009) Rituximab in patients with primary progressive multiple sclerosis. Results of a randomized double-blind placebo-controlled multicenter trial. Ann Neurol, 2009; 66:460-461.

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Jacob A, Weinshenker BG, Violich I, et al.(2008) Treatment of neuromyelitis optica with rituximab. Retrospective analysis of 25 patients. Arch Neurol, 2008; 65:1443-1448

Jaeger U, Trneny M, Melzer H, et al.(2015) Rituximab maintenance for patients with aggressive B-cell lymphoma in first remission: results of the randomized NHL13 trial. Haematologica. Apr 24 2015. PMID 25911553

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Joly P, Mouquet H, Roujeau J-C.(2007) A single cycle of rituximab for the treatment of severe pemphigus. New Engl J Med, 2007; 357:545-552.

Jones RB, Ferraro AJ, Chaudhry AN, et al.(2009) A multicenter survey of rituximab therapy for refractory antineutrophil cytoplasmic antibody-associated vasculitis. Arthritis & Rheumatism, 2009; 60:2156-2168

Jones RB, Tervaert JWC, Hauser T, et al for the European Vasculitis Study Group.(2010) Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis. New Engl J Med, 2010; 361:211-220.

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Kahl BS, Hong F, Williams ME, et al.(2014) Rituximab extended schedule or re-treatment trial for low-tumor burden follicular lymphoma: eastern cooperative oncology group protocol e4402. J Clin Oncol. Oct 1 2014;32(28):3096-3102. PMID 25154829

Kapoor, PT Greipp, WG Morice, et al.(2008) Anti-CD20 monoclonal antibody therapy in multiple myeloma. British J of Hematology, 2008.

Katoh N, Matsuda M, Ishii W, et al.(2010) Successful treatment with rituximab in a patient with stiff-person syndrome complicated by dysthyroid ophthalmopathy. Intern Med, 2010; 49:237-241

Katoh N, Matsuda M, Ishii W, et al.(2010) Successful treatment with rituximab in a patient with stiff-person syndrome complicated by dysthyroid ophthalmopathy. Intern Med, 2010; 49:237-241

Kavuru MS, Malur A, Marshall I, et al.(2011) An open-label trial of rituximab therapy in pulmonary alveolar proteinosis. Eur Respir J, 2011, Epub ahead of print, Apr 8 2011.

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Keogh KA, Ytterberg SR, Specks U., et al.(2006) Rituximab for refractory Wegener’s granulomatosis. Am J Respir Crit Care Med, 2006; 173:180-187

Keren A, Hayes HM, O’Driscoll G.(2006) Late humoral rejection in a cardiac transplant recipient treated with the anti-CD20 monoclonal antibody rituximab. Transplant Proc, 2006; 38:1520-1522

Keren A, Hayes HM, O’Driscoll G.(2006) Late humoral rejection in a cardiac transplant recipient treated with the anti-CD20 monoclonal antibody rituximab. Transplant Proc, 2006; 38:1520-1522.

Kharfan-Dabaja MA, Mhaskar AR, Djulbegovic B, et al.(2009) Efficacy of rituximab in the setting of steroid-refractory chronic graft-versus-host disease: a systematic review and meta-analysis. Biol Blood Marrow Transplant, 2009; 15:1005-1113

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Kotani T, Takeuchi T, Kawasaki Y, et al.(2006) Successful treatment of cold agglutinin disease with anti-CD20 antibody (rituximab) in a patient with systemic lupus erythematosus. Lupus, 2006; 15:683-685.

Krug P, Schleiermacher G, Michon J, et al.(2010) Opsoclonus-myoclonus in children associated or not with neuroblastoma. Eur J Paediatric Neurol, 2010 Jan 26 (Epub ahead of print)

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Lamprecht P, Lerin-Lozano C, Merz H, et al.(2003) Rituximab induces remission in refractory HCV associated cryoglobulinemic vasculitis. Ann Rheum Dis, 2003; 62:1230-1233

Lee A, LaCasce AS.(2009) Nodular lymphocyte predominant Hodgkin lymphoma. Oncologist, 2009; 14:739-751

Lee PC, Terasaki PI, Takemoto SK, et al.(2002) All chronic reaction failures in kidney transplants were preceded by the development of HLA antibodies. Transplantation, 2002; 74:1192-1194

Leen WG, Weemaes CM, Verbeek MM, et al.(2008) Rituximab and intravenous immunoglobulins for relapsing postinfectious opsoclonus-myoclonus syndrome. Pediatric Neurol, 2008; 39:213-217

Lekharaju V, Chattopadhyay C.(2008) Efficacy of rituximab in Felty’s syndrome. Ann Rheum Dis, 2008; 67:1352

Lekharaju V, Chattopadhyay C.(2008) Efficacy of rituximab in Felty’s syndrome. Ann Rheum Dis, 2008; 67:1352.

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Lovric S, Erdbruegger U, Kumpers P, et al.(2009) Rituximab as rescue therapy in anti-neutrophil cytoplasmic antibody-associated vasculitis: a single-centre experience with 15 patients. Nephrol Dial Transplant, 2009; 23:179-185

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Lucey MR, Terrault N, Ojo L, et al.(2013) Long-term management of the successful adult liver transplant: 2012 practice guideline by the American Association for the Study of Liver Diseases and the American Society of Transplantation. Liver Transpl. Jan 2013;19(1):3-26. PMID 23281277

Maeda LS, Advani RH.(2009) The emerging role of rituximab in the treatment of nodular lymphocyte predominant Hodgkin lymphoma. Current Opinion Oncol, 2009; 21:397-400

Malloy ES, Cabrese LH.(2008) Progressive multifocal leukoencephalopathy in patients with rheumatic diseases: are patients with systemic lupus erythematosus at particular risk:. Autoimmun Rev, Aug 2008.

Markatseli TE, Kaltsonoudis ES, Voulgari PV, et al.(2009) Induction of psoriatic skin lesions in a patient with rheumatoid arthritis treated with rituximab. Clin Exp Rheumatol, 2009; 27:996-998

Martinez-Calle N, Alfonso A, Rifon J, et al.(2017) First-line use of rituximab correlates with increased overall survival in late post-transplant lymphoproliferative disorders: retrospective, single-centre study. Eur J Haematol. 2017 Jan;98(1):38-43. doi: 10.1111/ejh.12782. Epub 2016 Jun 28.

Martinu T, Chen, D-F, Palmer SM.(2010) Acute cellular rejection and humoral sensitization in lung transplant recipients. Semin Respir Crit Care Med, 2010; 31:179-188,

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