Rituximab - PA, NF
Indications for Prior Authorization
Rituxan (rituximab)
-
For diagnosis of Non-Hodgkin’s Lymphoma (NHL)
Indicated for the treatment of patients with:a. Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma as a single agent.
b. Previously untreated follicular, CD20-positive, B-cell non-Hodgkin's lymphoma in combination with first-line chemotherapy and, in patients achieving a complete or partial response to Rituxan in combination with chemotherapy, as a single-agent maintenance therapy.
c. Non-progressing (including stable disease) low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma, as a single agent, after first-line CVP chemotherapy.
d. Previously untreated diffuse large B-cell, CD20-positive non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) or other anthracycline-based chemotherapy regimens.
-
For diagnosis of Pediatric Non-Hodgkin's Lymphoma (NHL)
Indicated for previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy in pediatric patients aged 6 months and older. -
For diagnosis of Chronic Lymphocytic Leukemia (CLL)
Indicated for the treatment of patients with previously untreated and previously treated CD20-positive CLL in combination fludarabine and cyclophosphamide (FC).Limitations of Use: Rituxan is not recommended for use in patients with severe, active infections.
-
For diagnosis of Rheumatoid Arthritis (RA)
In combination with methotrexate, is indicated for the treatment of adult patients with moderately- to severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.Limitation of Use: Rituxan is not recommended for use in patients with severe, active infections.
-
For diagnosis of Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA)
Indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) in adult and pediatric patients 2 years of age and older in combination with glucocorticoids.Limitations of Use: Rituxan is not recommended for use in patients with severe, active infections.
-
For diagnosis of Pemphigus Vulgaris
Indicated for the treatment of moderate to severe Pemphigus Vulgaris (PV) in adult patients. -
For diagnosis of Immune Thrombocytopenic Purpura (ITP)
Has been used for the treatment of immune or idiopathic thrombocytopenic purpura. [1, 2] Overall response rates of 35% to 52% in patients with refractory idiopathic thrombocytopenic purpura. [3, 4] -
For diagnosis of Waldenstrom's Macroglobulinemia
Has been used for the treatment of relapsed/refractory Waldenstrom's macroglobulinemia. Rituximab monotherapy (1 to 8 cycles) has shown efficacy in limited studies. [5-8]
Ruxience (rituximab-pvvr), Truxima (rituximab-abbs)
-
For diagnosis of Non-Hodgkin's Lymphoma (NHL)
Indicated for the treatment of patients with:a. Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma as a single agent.
b. Previously untreated follicular, CD20-positive, B-cell non-Hodgkin's lymphoma in combination with first-line chemotherapy and, in patients achieving a complete or partial response to Rituxan in combination with chemotherapy, as a single-agent maintenance therapy.
c. Non-progressing (including stable disease) low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma, as a single agent, after first-line CVP chemotherapy.
d. Previously untreated diffuse large B-cell, CD20-positive non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) or other anthracycline-based chemotherapy regimens.
-
For diagnosis of Pediatric Non-Hodgkin's Lymphoma (NHL)
Indicated for previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy in pediatric patients aged 6 months and older. [25, C, D] -
For diagnosis of Chronic Lymphocytic Leukemia (CLL)
Indicated for the treatment of patients with previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC). -
For diagnosis of Rheumatoid Arthritis (RA)
In combination with methotrexate, is indicated for the treatment of adult patients with moderately- to severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies. -
For diagnosis of Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA)
Indicated for the treatment of adults with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) in combination with glucocorticoids.
Riabni (rituximab-arrx)
-
For diagnosis of Non-Hodgkin's Lymphoma (NHL)
Indicated for the treatment of patients with:a. Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma as a single agent.
b. Previously untreated follicular, CD20-positive, B-cell non-Hodgkin's lymphoma in combination with first-line chemotherapy and, in patients achieving a complete or partial response to Rituxan in combination with chemotherapy, as a single-agent maintenance therapy.
c. Non-progressing (including stable disease) low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma, as a single agent, after first-line CVP chemotherapy.
d. Previously untreated diffuse large B-cell, CD20-positive non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) or other anthracycline-based chemotherapy regimens.
-
For diagnosis of Pediatric Non-Hodgkin's Lymphoma (NHL)
Indicated for previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy in pediatric patients aged 6 months and older. [25, C, D] -
For diagnosis of Chronic Lymphocytic Leukemia (CLL)
Indicated for the treatment of patients with previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC). -
For diagnosis of Rheumatoid Arthritis (RA)
Indicated in combination with methotrexate for the treatment of adult patients with moderately- to severely- active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies. -
For diagnosis of Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA)
Indicated for the treatment of adults with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) in combination with glucocorticoids.
Criteria
Rituxan, Truxima, Riabni
*Includes attestation that a total of two TNF inhibitors have already been tried in the past, and the patient should not be made to try a third TNF inhibitor. ** For review process only: Refer to the table in the Background section for carrier-specific formulary adalimumab products
Prior Authorization (Initial Authorization)
Length of Approval: 1 Month(s)
For diagnosis of Rheumatoid Arthritis (RA)
- Diagnosis of moderately- to severely-active rheumatoid arthritis AND
- Minimum duration of a 3-month trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses [26, 27]:
- methotrexate
- leflunomide
- sulfasalazine
- Used in combination with methotrexate [A] AND
- One of the following:
- Both of the following:
- Trial and failure, contraindication, or intolerance to TWO of the following, or attestation demonstrating a trial may be inappropriate*
- Cimzia (certolizumab)
- Enbrel (etanercept)
- One formulary adalimumab product**
- Simponi (golimumab)
- Rinvoq (upadacitinib)
- Xeljanz/XR (tofacitinib/ER)
- Trial and failure, contraindication, or intolerance to BOTH of the following:
- Actemra (tocilizumab)
- Orencia (abatacept)
- For continuation of prior therapy, defined as no more than a 45-day gap in therapy
- Trial and failure or intolerance to Ruxience
Ruxience
*Includes attestation that a total of two TNF inhibitors have already been tried in the past, and the patient should not be made to try a third TNF inhibitor. ** For review process only: Refer to the table in the Background section for carrier-specific formulary adalimumab products
Prior Authorization (Initial Authorization)
Length of Approval: 1 Month(s)
For diagnosis of Rheumatoid Arthritis (RA)
- Diagnosis of moderately- to severely-active rheumatoid arthritis AND
- Minimum duration of a 3-month trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses [26, 27]:
- methotrexate
- leflunomide
- sulfasalazine
- Used in combination with methotrexate [A] AND
- One of the following:
- Trial and failure, contraindication, or intolerance to TWO of the following, or attestation demonstrating a trial may be inappropriate*
- Cimzia (certolizumab)
- Enbrel (etanercept)
- One formulary adalimumab product**
- Simponi (golimumab)
- Rinvoq (upadacitinib)
- Xeljanz/XR (tofacitinib/ER)
- For continuation of prior therapy, defined as no more than a 45-day gap in therapy
Rituxan, Ruxience, Truxima, Riabni
Prior Authorization (Reauthorization)
Length of Approval: 1 Month(s)
For diagnosis of Rheumatoid Arthritis (RA)
- Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [10, 26, 27]:
- Reduction in the total active (swollen and tender) joint count from baseline
- Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline
- At least 16 weeks have elapsed since last course of therapy [B]
Riabni, Truxima
*Includes attestation that a total of two TNF inhibitors have already been tried in the past, and the patient should not be made to try a third TNF inhibitor. ** For review process only: Refer to the table in the Background section for carrier-specific formulary adalimumab products
Non Formulary
Length of Approval: 1 Month(s)
For diagnosis of Rheumatoid Arthritis (RA)
- Diagnosis of moderately- to severely-active rheumatoid arthritis AND
- Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 3-month trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses [26, 27]:
- methotrexate
- leflunomide
- sulfasalazine
- Paid claims or submission of medical records (e.g., chart notes) confirming that medication is used in combination with methotrexate [A] AND
- One of the following:
- Both of the following:
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to TWO of the following, or attestation demonstrating a trial may be inappropriate*
- Cimzia (certolizumab)
- Enbrel (etanercept)
- One formulary adalimumab product**
- Simponi (golimumab)
- Rinvoq (upadacitinib)
- Xeljanz/XR (tofacitinib/ER)
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to BOTH of the following:
- Actemra (tocilizumab)
- Orencia (abatacept)
- Both of the following:
- Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy AND
- Documentation of positive clinical response to therapy as evidenced by at least one of the following [10, 26, 27]:
- Reduction in the total active (swollen and tender) joint count from baseline
- Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to Ruxience
Ruxience
Prior Authorization
Length of Approval: 12 Month(s)
For diagnosis of Non-Hodgkin’s Lymphoma
- One of the following:
- Both of the following: [10]
- Diagnosis of diffuse large B-cell, CD20-positive, non-Hodgkin’s lymphoma
- Used as first-line treatment in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) or other anthracycline-based chemotherapy regimens
- Both of the following:
- Diagnosis of follicular, CD20-positive, B-cell non-Hodgkin's lymphoma
- Used as first-line treatment in combination with chemotherapy
- All of the following:
- Diagnosis of follicular, CD20-positive, B-cell non-Hodgkin's lymphoma
- Patient achieved a complete or partial response to a rituximab product in combination with chemotherapy
- Followed by rituximab used as monotherapy for maintenance therapy
- Both of the following: [1]
- Diagnosis of low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma AND
- One of the following:
- Patient has stable disease following first-line treatment with CVP (cyclophosphamide, vincristine, prednisolone/ prednisone) chemotherapy
- Patient achieved a partial or complete response following first-line treatment with CVP (cyclophosphamide, vincristine, prednisolone/ prednisone) chemotherapy
- Diagnosis of relapsed or refractory, low grade or follicular CD20-positive, B-cell non-Hodgkin’s lymphoma. OR
- All of the following (off-label) [25, C, D]
- Diagnosis of one of the following previously untreated, advanced stage indications:
- CD-20-positive diffuse large B-cell lymphoma (DLBCL)
- Burkitt lymphoma (BL)
- Burkitt-like lymphoma (BLL)
- Mature B-cell acute leukemia (B-AL)
- Patient is 6 months of age or older AND
- Used in combination with chemotherapy
Riabni, Rituxan, Truxima
Prior Authorization
Length of Approval: 12 Month(s)
For diagnosis of Non-Hodgkin’s Lymphoma
- One of the following:
- Both of the following: [10]
- Diagnosis of diffuse large B-cell, CD20-positive, non-Hodgkin’s lymphoma
- Used as first-line treatment in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) or other anthracycline-based chemotherapy regimens
- Both of the following:
- Diagnosis of follicular, CD20-positive, B-cell non-Hodgkin's lymphoma
- Used as first-line treatment in combination with chemotherapy
- All of the following:
- Diagnosis of follicular, CD20-positive, B-cell non-Hodgkin's lymphoma
- Patient achieved a complete or partial response to a rituximab product in combination with chemotherapy
- Followed by rituximab used as monotherapy for maintenance therapy
- Both of the following: [1]
- Diagnosis of low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma AND
- One of the following:
- Patient has stable disease following first-line treatment with CVP (cyclophosphamide, vincristine, prednisolone/ prednisone) chemotherapy
- Patient achieved a partial or complete response following first-line treatment with CVP (cyclophosphamide, vincristine, prednisolone/ prednisone) chemotherapy
- Diagnosis of relapsed or refractory, low grade or follicular CD20-positive, B-cell non-Hodgkin’s lymphoma. OR
- All of the following (off-label for Riabni, Truxima) [25, C, D]:
- Diagnosis of one of the following previously untreated, advanced stage indications:
- CD-20-positive diffuse large B-cell lymphoma (DLBCL)
- Burkitt lymphoma (BL)
- Burkitt-like lymphoma (BLL)
- Mature B-cell acute leukemia (B-AL)
- Patient is 6 months of age or older AND
- Used in combination with chemotherapy
- One of the following:
- Trial and failure, or intolerance to Ruxience OR
- Continuation of therapy for patients currently in the midst of an ongoing prescribed treatment regimen
Riabni, Truxima
Non Formulary
Length of Approval: 12 Month(s)
For diagnosis of Non-Hodgkin’s Lymphoma
- One of the following:
- Both of the following: [10]
- Diagnosis of diffuse large B-cell, CD20-positive, non-Hodgkin’s lymphoma
- Used as first-line treatment in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) or other anthracycline-based chemotherapy regimens
- Both of the following:
- Diagnosis of follicular, CD20-positive, B-cell non-Hodgkin's lymphoma
- Used as first-line treatment in combination with chemotherapy
- All of the following:
- Diagnosis of follicular, CD20-positive, B-cell non-Hodgkin's lymphoma
- Patient achieved a complete or partial response to a rituximab product in combination with chemotherapy
- Followed by rituximab used as monotherapy for maintenance therapy
- Both of the following: [1]
- Diagnosis of low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma AND
- One of the following:
- Patient has stable disease following first-line treatment with CVP (cyclophosphamide, vincristine, prednisolone/ prednisone) chemotherapy
- Patient achieved a partial or complete response following first-line treatment with CVP (cyclophosphamide, vincristine, prednisolone/ prednisone) chemotherapy
- Diagnosis of relapsed or refractory, low grade or follicular CD20-positive, B-cell non-Hodgkin’s lymphoma. OR
- All of the following (off-label) [25, C, D]:
- Diagnosis of one of the following previously untreated, advanced stage indications:
- CD-20-positive diffuse large B-cell lymphoma (DLBCL)
- Burkitt lymphoma (BL)
- Burkitt-like lymphoma (BLL)
- Mature B-cell acute leukemia (B-AL)
- Patient is 6 months of age or older AND
- Used in combination with chemotherapy
- One of the following:
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, or intolerance to Ruxience OR
- Paid claims or submission of medical records (e.g., chart notes) confirming continuation of therapy for patients currently in the midst of an ongoing prescribed treatment regimen, defined as no more than a 45-day gap in therapy
Ruxience
Prior Authorization
Length of Approval: 12 Month(s)
For diagnosis of Chronic Lymphocytic Leukemia
- Diagnosis of chronic lymphocytic leukemia [2, 12, 15-19] AND
- Used in combination with fludarabine and cyclophosphamide
Riabni, Rituxan, Truxima
Prior Authorization
Length of Approval: 12 Month(s)
For diagnosis of Chronic Lymphocytic Leukemia
- Diagnosis of chronic lymphocytic leukemia [2, 12, 15-19] AND
- Used in combination with fludarabine and cyclophosphamide AND
- One of the following:
- Trial and failure, or intolerance to Ruxience OR
- Continuation of therapy for patients currently in the midst of an ongoing prescribed treatment regimen
Riabni, Truxima
Non Formulary
Length of Approval: 12 Month(s)
For diagnosis of Chronic Lymphocytic Leukemia
- Diagnosis of chronic lymphocytic leukemia [2, 12, 15-19] AND
- Used in combination with fludarabine and cyclophosphamide AND
- One of the following:
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, or intolerance to Ruxience OR
- Paid claims or submission of medical records (e.g., chart notes) confirming continuation of therapy for patients currently in the midst of an ongoing prescribed treatment regimen, defined as no more than a 45-day gap in therapy
Rituxan
Prior Authorization
Length of Approval: 12 Month(s)
For diagnosis of Immune or Idiopathic Thrombocytopenic Purpura [1, 2] (Off-Label)
- Diagnosis of immune or idiopathic thrombocytopenic purpura (off-label) [3, 4, 11] AND
- Trial and failure, contraindication, or intolerance to at least ONE of the following: [12]
- Glucocorticoids (e.g., prednisone, methylprednisolone)
- Immunoglobulins (e.g., IVIg)
- Splenectomy
- Documented platelet count of less than 50 x 10^9 / L [11]
Rituxan
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Pemphigus Vulgaris
- Diagnosis of moderate to severe Pemphigus Vulgaris
Rituxan
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Pemphigus Vulgaris
- Patient demonstrates positive clinical response to therapy
Rituxan
Prior Authorization
Length of Approval: 12 Month(s)
For diagnosis of Waldenstrom’s macroglobulinemia
- Diagnosis of relapsed/refractory Waldenstrom’s macroglobulinemia (off-label) [1, 2, 5-8]
Ruxience
Prior Authorization
Length of Approval: 3 Month(s)
For diagnosis of Wegener’s Granulomatosis and Microscopic Polyangiitis
- One of the following diagnoses:
- Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis)
- Microscopic Polyangiitis
- Used in combination with glucocorticoids (e.g., prednisone)
Riabni, Rituxan, Truxima
Prior Authorization
Length of Approval: 3 Month(s)
For diagnosis of Wegener’s Granulomatosis and Microscopic Polyangiitis
- One of the following diagnoses:
- Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis)
- Microscopic Polyangiitis
- Used in combination with glucocorticoids (e.g., prednisone) AND
- One of the following:
- Trial and failure, or intolerance to Ruxience OR
- Continuation of therapy for patients currently in the midst of an ongoing prescribed treatment regimen
Riabni, Truxima
Non Formulary
Length of Approval: 3 Month(s)
For diagnosis of Wegener’s Granulomatosis and Microscopic Polyangiitis
- One of the following diagnoses:
- Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis)
- Microscopic Polyangiitis
- Paid claims or submission of medical records (e.g., chart notes) confirming medication is used in combination with glucocorticoids (e.g., prednisone) AND
- One of the following:
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, or intolerance to Ruxience OR
- Paid claims or submission of medical records (e.g., chart notes) confirming continuation of therapy for patients currently in the midst of an ongoing prescribed treatment regimen, defined as no more than a 45-day gap in therapy
P & T Revisions
2024-12-02, 2024-06-24, 2024-05-30, 2024-04-24, 2024-03-06, 2024-01-23, 2023-11-16, 2023-07-27, 2023-06-15, 2023-01-31, 2022-10-23, 2022-07-21, 2022-02-22, 2022-01-05, 2021-12-01, 2021-09-17, 2021-07-01, 2021-06-24, 2021-05-21, 2021-04-14, 2021-02-03, 2020-09-18, 2020-03-04, 2020-01-16, 2020-01-16, 2019-12-13, 2019-11-27, 2019-11-13
References
- DRUGDEX Information System [Internet database]. Greenwood Village, Colorado: Thomson Micromedex. Accessed January 18, 2024.
- AHFS Drug Information (Adult and Pediatric) [Internet database]. Hudson, Ohio: Lexicomp. Accessed January 18, 2024.
- Stasi R, Pagano A, Stipa E, et al. Rituximab chimeric anti-CD20 monoclonal antibody treatment for adults with chronic idiopathic thrombocytopenic purpura. Blood. 2001;98:952-7.
- Saleh MN, Moore M, Feinberg B, et al. A pilot study of anti-CD20 MoAB rituximab in patients with refractory immune thrombocytopenic purpura (ITP). Blood. 2001;96:521a.
- Dimopoulos MA, Kiamouris C, Karkantaris C, et al. Prospective evaluation of rituximab for the treatment of waldenstrom's macroglobulinemia. Blood. 2000;96:169a.
- Treon SP, Agus DB, Link B, et al. Rituximab is an active agent in waldenstrom's macroglobulinemia (WM).Proc Am Soc Clin Oncol. 2000;19:6a.
- Weide R, Heymanns J, & Koppler H. The polyneuropathy associated with Waldenstrom's macroglobulinaemia can be treated effectively with chemotherapy and the anti-CD20 monoclonal antibody rituximab. Br J Haematol. 2000;109:838-841.
- Byrd JC, White CA, Link B, et al. Rituximab therapy in Waldenstrom's macroglobulinemia: preliminary evidence of clinical activity. Ann Oncol. 1999;10:1525-7.
- American College of Rheumatology 2008 Recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum. 2008;59(6):762-784.
- Rituxan Prescribing Information. Genentech, Inc. South San Francisco, CA. December 2021.
- Gudbrandsdottir S, Birgens HS, Frederiksen H, et al. Rituximab and dexamethasone vs dexamethasone monotherapy in newly diagnosed patients with primary immune thrombocytopenia. Blood. 2013;121(11):1976-81.
- George JN, Woolf SH, Raskob GE, et al. Idiopathic thrombocytopenic purpura: a practice guideline developed by explicit methods for the American Society of Hematology. Blood. 1996;88:3-40.
- Stone JH, Merkel PA, Spiera R, et al. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010;363:221-32.
- Per clinical consult with rheumatologist. March 10, 2014.
- Byrd JC, Murphy T, Howard RS, et al. Rituximab using a thrice weekly dosing schedule in B-cell chronic lymphocytic leukemia and small lymphocytic lymphoma demonstrates clinical activity and acceptable toxicity. J Clin Oncol. 2001;19:2153-2164.
- Byrd JC, Peterson BL, Morrison VA, et al. Randomized phase II study of fludarabine with concurrent versus sequential treatment with rituximab in symptomatic, untreated patients with B-cell chronic lymphocytic leukemia: results from Cancer and Leukemia Group B 9712 (CALGB 9712). Blood. 2003;101:6-14.
- Schulz H, Klein SK, Rehwald U, et al. Phase 2 study of a combined immunochemotherapy using rituxumab and fludarabine in patients with chronic lymphocytic leukemia. Blood. 2002;100:3115-3120.
- Keating MJ, O'Brien S, Albitar M, et al. Early results of a chemoimmunotherapy regimen of fludarabine, cyclophosphamide, and rituxumab as initial therapy for chronic lymphocytic leukemia. J Clin Oncol. 2005;23:4079-4088.
- National Comprehensive Cancer Network. Practice Guidelines in Oncology - v. 1.2024. Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/cll.pdf. Accessed January 18, 2024.
- Truxima Prescribing Information. Teva Pharmaceuticals USA, Inc. North Wales, PA. November 2022.
- Ruxience Prescribing Information. Pfizer Ireland Pharmaceuticals USA, Inc. Cork, Ireland. October 2023.
- U.S. Food and Drug Administration (FDA). Biosimilar and Interchangeable Products. Silver Spring, MD: FDA; December 13, 2022. Available at: https://www.fda.gov/drugs/biosimilars/review-and-approval. Accessed January 18, 2024.
- National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. B-Cell Lymphomas. v.6.2023. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf. Accessed January 18, 2024.
- Riabni Prescribing Information. Amgen, Inc. Thousand Oaks, CA. June 2022.
- National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Pediatric Aggressive Mature B-Cell Lymphomas. v.1.2023. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/ped_b-cell.pdf. Accessed January 18, 2024.
- Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res. 2015;68(1):1-25.
- Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. 2021;73(7):924-939.
End Notes
- Aggressive, continuous and early treatment with DMARDs may slow the destructive processes in RA by preventing or delaying cartilage and bone destruction. [11] Often used in combination, the most commonly prescribed DMARDs include hydroxychloroquine, sulfasalazine, leflunomide and methotrexate, with methotrexate being the gold standard.
- An open-label extension analysis of RA patients previously treated with Rituxan was conducted. Patients were eligible for the second course if they demonstrated a greater than or equal to 20% reduction in both swollen joint count and the tender joint count at any visit 16 weeks after initial treatment or later and had active disease (swollen joint count greater than or equal to 8 and tender joint count greater than or equal to 8). Repeat courses of treatment were administered at the investigator’s discretion, with a minimum interval between treatment courses of 16 weeks. [15]
- The FDA defines biosimilar as a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product. [22]
- An FDA-approved biosimilar is an appropriate substitute for rituximab. [23, 25]
Revision History
- 2024-12-02: Update to remove manufacturer information from "one formulary adalimumab product"; updated background table
- 2024-06-24: No criteria changes; updated background table to specify BI manufacturer for adalimumab-adbm
- 2024-05-30: Updated background table to include CalPERS formulary; no criteria changes
- 2024-04-24: Updated verbiage in the RA step to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products
- 2024-03-06: Updated verbiage in the RA step to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products
- 2024-01-23: 2024 Annual Review. No changes to clinical criteria. Updated references.
- 2023-11-16: Program update to standard reauthorization language. No changes to clinical intent
- 2023-07-27: Removed oncology specialist requirement; Addition of Cyltezo, Hyrimoz, and brand Adalimumab-adaz as preferred step options for RA
- 2023-06-15: Removed specialist requirement
- 2023-01-31: Modified criteria to read "used in combination with methotrexate" and "used in combination with glucocorticoids" to align with labeling. Updated references.
- 2022-10-23: Addition of Enbrel as another preferred step option for RA; further clinical detail added for RA
- 2022-07-21: Added criteria for new RA indication for Riabni. Updated background and references.
- 2022-02-22: Added new pediatric indication for NHL. Added additional criteria for Truxima in NF RA section. Updated references.
- 2022-01-05: Addition of RA indication and criteria for Ruxience; addition of Ruxience step to RA criteria for Rituxan and Truxima
- 2021-12-01: Added NF sections for Riabni.
- 2021-09-17: Update to Truxima NF criteria for RA.
- 2021-07-01: Added Truxima NF criteria.
- 2021-06-24: Update to add Truxima NF guideline type.
- 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
- 2021-04-14: GPI Replication. Specified 'Initial auth' therapy stage for Pemphigus Vulgaris/Rituxan.
- 2021-02-03: Added new biosimilar Riabni. Updated background and references.
- 2020-09-18: Formulary strategy update to remove Simponi Aria as a preferred step option for RA
- 2020-03-04: Added Ruxience to guideline, changed guideline name to Rituximab.
- 2020-01-16: Revised to include new indications for Truxima
- 2020-01-16: 2020 Annual Review, no changes to criteria.
- 2019-12-13: 2020 Annual Review, no changes to criteria.
- 2019-11-27: Re-added Rinvoq as a first-line step option for RA. Previously approved at October P&T.
- 2019-11-13: Guideline updated for November 2019 P&T.
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