| Coverage Policy Manual | |
| Policy #: | 2006016 |
| Category: | Pharmacy |
| Initiated: | March 2006 |
| Last Review: | October 2023 |
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| Rituximab (e.g., Rituxan) and Biosimilars- Oncologic Indications | |
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| Description: |
Rituximab, an anti-CD20 monoclonal antibody, was originally approved by the FDA in November 1997 for the treatment of relapsed or refractory low grade or follicular 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 individuals 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 individuals with non-Hodgkin's lymphoma (NHL). Severe and potentially fatal mucocutaneous reactions can occur in individuals receiving rituximab. JC virus infection resulting in Progressive Multifocal Leukoencephalopathy (PML) and death can also occur in individuals receiving rituximab.
Regulatory Status
Rituximab and hyaluronidase human (e.g., Rituxan Hycela), is a combination of rituximab and hyaluronidase human, an endoglycosidase. The FDA approved Rituximab and hyalurondase human (e.g., Rituxan hycela), subcutaneous injection, in June 2017. It is for the treatment of adult individuals with FL, CLL and DLBCL.
On 11/28/2018, the FDA approved Rituximab abbs (e.g., TRUXIMA) for the treatment of adult individuals with:
On 5/23/19 the FDA approved biosimilar, Rituximab abbs (e.g., Truxima), for the adult individuals with:
On July 25, 2019, the Food and Drug Administration approved Rituximab-pvvr (e.g., Ruxience), a biosimilar to Rituximab (e.g., Rituxan) for the treatment of adult individuals with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).
On 12/18/2019 the FDA approved, biosimilar, Rituximab abbs (e.g., Truxima), for the adult individuals with:
On December 17, 2020, the Food and Drug Administration approved Rituximab-arrx (e.g., Riabni), the third biosimilar version of Rituxan for NHL, CLL, GPA, and MPA.
Coding
See CPT/HCPCS Code section below.
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Policy/ Coverage: |
For members of plans that utilize a prescription drug program vendor (i.e., Arkansas State Employees and Public School Employees, Arkansas State Police and Arkansas State University) for preferred products under the medical benefit, the preferred products contained in this policy are NOT applicable. Please contact the member’s prescription drug program vendor.
Effective August 1, 2021, for members of plans that utilize an oncology benefits management program, Prior Approval is required for this service and is managed through the oncology benefits management program.
As of November 1, 2021, please refer policy number 2021034 for Rituximab non-oncological uses.
Effective January 1, 2024, Prior Approval is required for rituximab for oncologic indications.
The Step Therapy Medication Act is applicable to fully insured (Arkansas Blue Cross, Health Advantage, and Exchange) and specified governmental (ASE/PSE and ASP) health plans. The law is not applicable to FEP or self-insured ERISA groups (including but not limited to Walmart or other Blue Advantage groups). Initial approval for exigent request is 28 days. Otherwise, initial approval for standard review is up to 1 year.
Effective January 1, 2024
Select products (e.g., Riabni and Truxima) are preferred where there is an FDA approved indication for the biosimilar product and for all off-label uses of the reference product. According to the United States FDA “a biosimilar is a biological product that has no clinically meaningful differences from the existing FDA-approved reference product. All biosimilar products meet the FDA’s rigorous standards for approval for the indications described in the product labeling. Once a biosimilar has been approved by the FDA, the safety and effectiveness of these products have been established, just as they have been for the reference product.”
Preferred Products:
HCPCS Brand Name Generic Name
Q5115 Truxima Rituximab abbs
Q5123 Riabni Rituximab arrx
Non-preferred Products:
HCPCS Brand Name Generic Name
J9310, J9312 Rituxan Rituximab
J9311 Rituxan Hycela Rituximab and hyaluronidase
Q5119 Ruxience Rituximab pvvr
If the request is for a non-preferred product, one of the following criteria must be met for the non-preferred product to be covered:
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
RITUXIMAB AND HYALURONIDASE (e.g., Rituxan Hycela) (Effective March 2019)
The use of rituximab and hyaluronidase combination meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the treatment for the following indications:
FDA APPROVED INDICATIONS
CONTINUED APPROVAL for up to 12 months:
OFF-LABEL INDICATIONS
The use of this drug is covered if an FDA-approved oncologic indication exists (not listed as an indication above) with the member meeting all the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”) AND/OR a NCCN category 1 or 2A recommendation is recognized in the NCCN Drugs and Biologics Compendium with the member meeting specified criteria (See policy #2000030).
Please see the NCCN Drugs and Biologics Compendium for a complete list of NCCN 1 & 2A indications.
Rituximab and biosimilars meet 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:
Dosing and Administration
Dosing per FDA Guidelines
All individuals must receive at least one intravenous infusion of a full dose of a rituximab product due to the higher risk of hypersensitivity and other acute reactions during the first infusion.
Rituximab and hyaluronidase are administered subcutaneously and should only be administered by a healthcare professional with appropriate medical support to manage severe reactions that can be fatal if they occur.
Rituximab and hyaluronidase combination is available as:
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Rituximab and Hyaluronidase (e.g., Rituxan Hycela), for any indication or circumstance not described above, does not meet member benefit primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, rituximab and hyaluronidase, for any indication or circumstance not described above, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
RITUXIMAB (e.g., Rituxan)
The use of rituximab meets member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness for the following indications:
FDA APPROVED INDICATIONS
Note: Individual must not have either of the following:
CONTINUED APPROVAL for up to 12 months:
OFF-LABEL INDICATIONS
The use of this drug is covered if an FDA-approved oncologic indication exists (not listed as an indication above) with the member meeting all the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”) AND/OR a NCCN category 1 or 2A recommendation is recognized in the NCCN Drugs and Biologics Compendium with the member meeting specified criteria (See policy #2000030).
Please see the NCCN Drugs and Biologics Compendium for a complete list of NCCN 1 & 2A indications.
OFF-LABEL
Rituximab meets member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes for the following off-label indications:
Dosage and Administration
Dosing per FDA Guidelines
Administer only as an intravenous infusion.
Rituximab should only be administered by a healthcare professional with appropriate medical support to manage severe reactions that can be fatal if they occur.
Rituximab is available as 100 mg/10 mL (10 mg/mL) and 500 mg/50 mL (10 mg/mL) solution in single-dose vials.
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Rituximab (e.g., Rituxan), for any indication or circumstance not described above, does not meet primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, rituximab, for any indication or circumstance not described above, is considered investigational. Investigational services are specific contract exclusions in member benefit certificates of coverage.
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
RITUXIMAB-PVVR (e.g., Ruxience), RITUXIMAB-ARRX (e.g., Riabni), and RITUXIMAB-ABBS (e.g., Truxima)
The use of rituximab-pvvr (e.g., Ruxience), and rituximab-arrx (e.g., Riabni), and rituximab-abbs (e.g., Truxima) meet member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes for the following indications:
FDA APPROVED INDICATIONS
OFF-LABEL INDICATIONS BIOSIMILARS (e.g., Ruxience, Truxima and Riabni)
The use of these drugs is covered if an FDA-approved oncologic indication exists (not listed as an indication above) with the member meeting all of the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”) AND/OR a NCCN category 1 or 2A recommendation is recognized in the NCCN Drugs and Biologics Compendium with the member meeting specified criteria (See policy #2000030).
Please see the NCCN Drugs and Biologics Compendium for a complete list of NCCN 1 & 2A indications.
Rituximab-pvvr (e.g., Ruxience), and rituximab-arrx (e.g., Riabni), and rituximab-abbs (e.g., Truxima) meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the following off-label indications:
Dosage and Administration
Dosing per FDA Guidelines
Administer only as an intravenous infusion.
Rituximab should only be administered by a healthcare professional with appropriate medical support to manage severe reactions that can be fatal if they occur.
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Rituximab -pvvr (e.g., Ruxience), Rituximab-arrx (e.g., Riabni), and Rituximab-abbs (e.g., Truxima), for any indication or circumstance not described above, does not meet primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, Rituximab -pvvr (e.g., Ruxience), Rituximab-arrx (e.g., Riabni), and Rituximab-abbs (e.g., Truxima), for any indication or circumstance not described above, are considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective November 1, 2021 to December 31, 2023
For members of plans that utilize an oncology benefits management program, Prior Approval is required for this service and is managed through the oncology benefits management program, biosimilar products [Rituximab-arrx (ew.g., Riabni), Rituximab-pvvr (e.g., Ruxience), and Rituximab-abbs (e.g., Truxima) are preferred where there is an FDA approved indication for the biosimilar product and for all off-label uses of the reference product. According to the United States FDA “a biosimilar is a biological product that has no clinically meaningful differences from the existing FDA-approved reference product. All biosimilar products meet the FDA’s rigorous standards for approval for the indications described in the product labeling. Once a biosimilar has been approved by the FDA, the safety and effectiveness of these products have been established, just as they have been for the reference product.”
Preferred Products:
HCPCS Brand Name Generic Name
Q5115 Truxima Rituximab abbs
Q5119 Ruxience Rituximab pvvr
Q5123 Riabni Rituximab arrx
Non-preferred Products:
HCPCS Brand Name Generic Name
J9310, J9312 Rituxan Rituximab
J9311 Rituxan Hycela Rituximab and hyaluronidase
If the request is for a non-preferred product, one of the following criteria must be met for the non-preferred product to be covered:
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
1. RITUXIMAB AND HYALURONIDASE (e.g., Rituxan Hycela) (Effective March 2019)
The use of rituximab and hyaluronidase combination meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the treatment for the following indications:
FDA APPROVED INDICATIONS
OFF-LABEL INDICATIONS
The use of this drug is covered if an FDA-approved oncologic indication exists (not listed as an indication above) with the member meeting all the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”) AND/OR a NCCN category 1 or 2A recommendation is recognized in the NCCN Drugs and Biologics Compendium with the member meeting specified criteria (See policy #2000030).
Rituximab and biosimilars meet 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:
Dosing and Administration
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of RITUXIMAB AND HYALURONIDASE (e.g., Rituxan Hycela) does not meet primary coverage criteria that there be scientific evidence of effectiveness for the treatment of all other indications other than those outlined above.
For members with contracts without primary coverage criteria, the use of rituximab and hyaluronidase is considered investigational.
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
2. RITUXIMAB (e.g., Rituxan)
The use of rituximab meets member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness for the following indications:
FDA APPROVED INDICATIONS
OFF-LABEL INDICATIONS
The use of this drug is covered if an FDA-approved oncologic indication exists (not listed as an indication above) with the member meeting all the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”) AND/OR a NCCN category 1 or 2A recommendation is recognized in the NCCN Drugs and Biologics Compendium with the member meeting specified criteria (See policy #2000030).
The use of rituximab meets member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness for the following off-label indications:
Dosage and administration
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of RITUXIMAB (e.g., Rituxan) does not meet primary coverage criteria that there be scientific evidence of effectiveness for the treatment of any other indication listed above, including the following:
For members with contracts without primary coverage criteria, the use of rituximab is considered investigational. Investigational services are specific contract exclusions in member benefit certificates of coverage.
3. RITUXIMAB-PVVR (e.g., Ruxience), RITUXIMAB-ARRX (e.g., Riabni), and RITUXIMAB-ABBS (e.g., Truxima)
The use of rituximab-pvvr (e.g., Ruxience), and rituximab-arrx (e.g., Riabni), and rituximab-abbs (e.g., Truxima) meet member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness for the following indications:
FDA APPROVED INDICATIONS
OFF-LABEL INDICATIONS BIOSIMILARS (e.g., Ruxience, Truxima and Riabni)
The use of these drugs are covered if an FDA-approved oncologic indication exists (not listed as an indication above) with the member meeting all of the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”) AND/OR a NCCN category 1 or 2A recommendation is recognized in the NCCN Drugs and Biologics Compendium with the member meeting specified criteria (See policy #2000030).
The use of rituximab-pvvr (e.g., Ruxience), and rituximab-arrx (e.g., Riabni), and rituximab-abbs (e.g., Truxima) meet member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness for the following off-label indications:
Dosage and administration for rituximab-pvvr (e.g., Ruxience), and rituximab-arrx (e.g., Riabni), and rituximab-abbs (e.g., Truxima)
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of Rituximab -pvvr (e.g., Ruxience), Rituximab-arrx (e.g., Riabni), and Rituximab-abbs (e.g., Truxima) does not meet primary coverage criteria that there be scientific evidence of effectiveness for the treatment of indications other than those outlined above.
For members with contracts without primary coverage criteria, Rituximab -pvvr (e.g., Ruxience), Rituximab-arrx (e.g., Riabni), and Rituximab-abbs (e.g., Truxima) are considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective August 1, 2021-October 31, 2021
Biosimilar products (Riabni,Ruxience, and Truxima) are preferred where there is an FDA approved indication for the biosimilar product and for all off-label uses of the reference product. According to the United States FDA “a biosimilar is a biological product that has no clinically meaningful differences from the existing FDA-approved reference product. All biosimilar products meet the FDA’s rigorous standards for approval for the indications described in the product labeling. Once a biosimilar has been approved by the FDA, the safety and effectiveness of these products have been established, just as they have been for the reference product.”
Preferred Products:
HCPCS Brand Name Generic Name
Q5115 Truxima Rituximab abbs
Q5119 Ruxience Rituximab pvvr
C9399, J3490, J3590, J9999 Riabni Rituximab arrx
Non-preferred Products:
HCPCS Brand Name Generic Name
J9310, J93112 Rituxan Rituximab
J9311 Rituxan Hycela Rituximab and hyaluronidase
If the request is for a non-preferred product, one of the following criteria must be met for the non-preferred product to be covered:
1. RITUXAN HYCELA (Effective March 2019)
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Rituxan Hycela meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:
Dosing and Administration
Follow FDA guidelines regarding dosing.
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Rituxan Hycela does not meet primary coverage criteria and is not covered for any other indications including non-malignant indications.
2. RITUXIMAB
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Rituximab meets member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness for the following indications:
FDA APPROVED INDICATIONS
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.
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:
Dosage and administration
Per FDA label guidelines.
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
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:
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 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.
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.
3. RUXIENCE (Rituximab-pvvr) and RIABNI (rituximab-arrx)
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Ruxience and Riabni meets member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness for the following indications:
FDA APPROVED INDICATIONS
Dosage and administration
Per FDA label guidelines.
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Ruxience and Riabni do not meet primary coverage criteria and is not covered for any other indications not listed above.
4. TRUXIMA (Rituximab-abbs)
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Truxima meets member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness for the following indications:
FDA APPROVED INDICATIONS
Dosage and administration
Per FDA label guidelines.
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Truxima does not meet primary coverage criteria and is not covered for any other indications not listed above.
Due to the detail of the policy statement, the document containing the coverage statements for dates prior to August 2021 are not online. If you would like a hardcopy print, please email: codespecificinquiry@arkbluecross.com
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| Rationale: |
Due to the detail of the rationale, it is not online. If you would like a hardcopy print, please email : codespecificinquiry@arkbluecross.com
June 2019 Update
Part one of the two-part SAWYER study predicted that subcutaneous rituximab 1600 mg would achieve trough serum concentrations that were non-inferior to those achieved with intravenous rituximab 500 mg/m(2) in patients with chronic lymphocytic leukaemia. In part two of the study, the aim was to confirm the pharmacokinetic non-inferiority of subcutaneous rituximab, and investigate its safety and efficacy.
A phase 1b, open-label, randomised controlled non-inferiority study at 68 centres in 19 countries in Europe, North America, South America, and Australasia was done. Patients aged 18 years or older with untreated chronic lymphocytic leukaemia were randomly assigned, via an interactive voice-response system with a permuted block randomisation scheme (block size of ten), to receive subcutaneous rituximab 1600 mg or intravenous rituximab 500 mg/m(2) plus fludarabine and cyclophosphamide every 4 weeks for up to six cycles. In cycle one, all patients received intravenous rituximab 375 mg/m(2). Randomisation was stratified by Binet stage and fludarabine and cyclophosphamide administration route (oral vs intravenous). Study investigators and patients were not masked to group allocation, but allocation was concealed from the statistician, clinical scientist, and clinical pharmacologist. The primary endpoint was trough serum concentration at cycle five, with a non-inferiority margin of 0·8 for the adjusted geometric mean ratio of the subcutaneous to the intravenous dose. Primary analysis in patients in the intention-to-treat population with complete pharmacokinetic data (pharmacokinetic population) was done. This trial is registered with ClinicalTrials.gov, number NCT01292603, and is ongoing, although the treatment stage is now complete.
Between Aug 20, 2012, and June 17, 2013, 176 patients were randomly assigned to receive subcutaneous rituximab (n=88) or intravenous rituximab (n=88); 134 (76%) patients comprised the pharmacokinetic population. As of May 7, 2014, median follow-up was 13·9 months (IQR 11·9-16·0) for patients in the subcutaneous group and 14·1 months (11·6-16·5) for patients in the intravenous group. At cycle five, the geometric mean trough serum concentration in patients given subcutaneous rituximab was non-inferior to that in patients given intravenous rituximab (97·5 μg/mL vs 61·5 μg/mL), with an adjusted geometric mean ratio of 1·53 (90% CI 1·27-1·85). In the safety analysis, the proportion of patients reporting adverse events was similar between the subcutaneous and intravenous groups (all grades: 82 [96%] of 85 patients and 81 [91%] of 89 patients; serious adverse events: 25 [29%] and 29 [33%] patients; grade ≥3: 59 [69%] and 63 [71%] patients, respectively). The most common adverse event of grade 3 or higher was neutropenia (48 [56%] patients in the subcutaneous group and 46 [52%] patients in the intravenous group); the most common serious adverse event was febrile neutropenia (n=9 [11%] and n=4 [4%], respectively). Administration-related reactions were recorded in 37 (44%) patients given subcutaneous rituximab and 40 (45%) patients given the intravenous dose, with differences between administration routes for injection-site erythema (n=10 [12%] and n=0, respectively) and nausea (n=2 [2%] and n=11 [12%], respectively). More patients reported local cutaneous reactions after subcutaneous rituximab (n=36 [42%]) than after intravenous rituximab (n=2 [2%]); most of these reactions were grade 1 or 2.
Intravenous rituximab is the standard of care in B-cell non-Hodgkin lymphoma, and is administered over 1·5-6 h. A subcutaneous formulation could reduce patients' treatment burden and improve resource utilisation in health care. The SABRINA study aimed to show the pharmacokinetic non-inferiority of subcutaneous rituximab to intravenous rituximab in follicular lymphoma and to provide efficacy and safety data.
SABRINA is a two-stage, randomised, open-label phase 3 study at 113 centres in 30 countries. Eligible patients were aged 18 years or older and had histologically confirmed, previously untreated, CD20-positive grade 1, 2, or 3a follicular lymphoma; Eastern Co-operative Oncology Group performance statuses of 0-2; bidimensionally measurable disease (by CT or MRI); life expectancy of 6 months or more; adequate haematological function for 28 days or more; and one or more symptoms requiring treatment according to the Groupe d'Etudes des Lymphomes Folliculaires criteria. Patients were randomly assigned (1:1) by investigators or members of the research team via a dynamic randomisation algorithm to 375 mg/m2 intravenous rituximab or 1400 mg subcutaneous rituximab, plus chemotherapy (six-to-eight cycle
Update August 2019
Granulomatosis with polyangiitis (formerly called Wegener’s granulomatosis), microscopic polyangiitis, and renal-limited antineutrophil cytoplasm antibody (ANCA)–associated vasculitides are the main ANCA-associated vasculitis variants. The combination of cyclophosphamide and glucocorticoids leads to remission in most patients with antineutrophil cytoplasm antibody (ANCA)-associated vasculitides. However, even when patients receive maintenance treatment with azathioprine or methotrexate, the relapse rate remains high. Rituximab may help to maintain remission.
In this study, patients with newly diagnosed or relapsing granulomatosis with polyangiitis, microscopic polyangiitis, or renal-limited ANCA-associated vasculitis in complete remission after a cyclophosphamide-glucocorticoid regimen were randomly assigned to receive either 500 mg of rituximab on days 0 and 14 and at months 6, 12, and 18 after study entry or daily azathioprine until month 22. The primary end point at month 28 was the rate of major relapse (the reappearance of disease activity or worsening, with a Birmingham Vasculitis Activity Score>0, and involvement of one or more major organs, disease-related life-threatening events, or both).
115 enrolled patients (87 with granulomatosis with polyangiitis, 23 with microscopic polyangiitis, and 5 with renal-limited ANCA-associated vasculitis) received azathioprine (58 patients) or rituximab (57 patients). At month 28, major relapse had occurred in 17 patients in the azathioprine group (29%) and in 3 patients in the rituximab group (5%) (hazard ratio for relapse, 6.61; 95% confidence interval, 1.56 to 27.96; P=0.002). The frequencies of severe adverse events were similar in the two groups. Twenty-five patients in each group (P=0.92) had severe adverse events; there were 44 events in the azathioprine group and 45 in the rituximab group. Eight patients in the azathioprine group and 11 in the rituximab group had severe infections, and cancer developed in 2 patients in the azathioprine group and 1 in the rituximab group. Two patients in the azathioprine group died (1 from sepsis and 1 from pancreatic cancer) (Guillevin L, et al 2014).
In conclusion, the between-group differences in relapse rate observed at month 28 in this trial showed that 500-mg rituximab infusions administered every 6 months were superior to azathioprine as maintenance therapy for ANCA-associated vasculitides, at least for patients positive for anti–proteinase 3 ANCA. Rituximab use for maintenance in those patients was found to have a clear clinical benefit in our study. Further studies are warranted for patients with antimyeloperoxidase ANCA–positive vasculitis. (Funded by the French Ministry of Health; MAINRITSAN ClinicalTrials.gov number, NCT00748644; EudraCT number, 2008-002846-51.).
Granulomatosis with polyangiitis (GPA) is a systemic necrotizing vasculitis, typically engaging the upper airways, kidneys and lungs and often associated with circulating anti-neutrophil cytoplasmic antibodies (ANCA) directed against proteinase 3 (PR3). The well-established standard treatment for remission induction in GPA has been cyclophosphamide (CY), in combination with corticosteroids (CS) [Hoffman GS, et al. 1992 and Mukhtyar C, et al. 2009]. This treatment regimen, introduced in the 1970s, has dramatically improved the outcome for GPA patients but with a risk of considerable side effects, including infections, sterility and bladder cancer [Knight A, et al. 2004]. Maintenance treatment is usually given with methotrexate (MTX), azathioprine (AZA) or mycophenolate mofetil (MMF), but as at least 50 % of patients have one or several relapses, repeated induction treatment is often necessary with the risk of high cumulative doses of CY [Jayne D et al 2003 and Pagnoux C, et al. 2008].
Recently, rituximab (RTX) has been approved by the FDA and the European Medicines Agency (EMA) for induction treatment of GPA and microscopic polyangiitis (MPA) in combination with CS, using the lymphoma protocol of 375 mg/m2 once weekly for 4 weeks. However, the efficacy and safety of repeated RTX courses as maintenance treatment has not yet been established.
The study includes 12 patients (seven females, five males) with relapsing GPA treated with repeated cycles of RTX from January 2003 through February 2013. Of the 12 included patients, all with a positive proteinase 3–anti-neutrophil cytoplasmic antibodies, generalised disease and a median disease duration of 35 months (21–270), 92% (11/12) achieved sustainable remission during a median follow-up time of 32 months (range 21–111) from first RTX treatment. Concomitant immunosuppressants were reduced. Infections were the most common adverse events, but infections were an issue also before the start of RTX. RTX administered every 6 months seems to be an effective maintenance treatment in a population with severe, relapsing long-standing GPA. Granulomatous as well as vasculitic manifestations responded equally well. Infections are a problem in this patient group but no new safety problems were identified [Knight A, et al. 2014].
Update October 2019
The study design consisted of an initial 6-month remission induction phase, and a minimum 12month follow-up phase up to a maximum of 54 months (4.5 years) in pediatric patients 2 years to 17 years of age with GPA and MPA. Patients were to receive a minimum of 3 doses of intravenous methylprednisolone (30 mg/kg/day, not exceeding 1g/day) prior to the first RITUXAN or non-U.S.licensed rituximab intravenous infusion. The remission induction regimen consisted of four once weekly intravenous infusions of RITUXAN or non-U.S.-licensed rituximab at a dose of 375 mg/m2 BSA, on study days 1, 8, 15 and 22 in combination with oral prednisolone or prednisone at 1 mg/kg/day (max 60 mg/day) tapered to 0.2 mg/kg/day minimum (max 10 mg/day) by Month 6. After the remission induction phase, patients could receive subsequent RITUXAN or non-U.S.licensed rituximab intravenous infusions on or after Month 6 to maintain remission and control disease activity. The primary objectives of this study were to evaluate safety and PK parameters in pediatric GPA and MPA patients (2 years to 17 years of age). The efficacy objectives of the study were exploratory and principally assessed using the Pediatric Vasculitis Activity Score (PVAS).
A total of 25 pediatric patients 6 years to 17 years of age with active GPA and MPA were treated with RITUXAN or non-U.S.-licensed rituximab in a multicenter, open-label, single-arm, uncontrolled study (NCT01750697). The median age of patients in the study was 14 years and the majority of patients (20/25 [80%]) were female.
All 25 patients completed all four once weekly intravenous infusions for the 6-month remission induction phase. A total of 24 out of 25 patients completed at least 18 months from Day 1 (baseline). After the 6-month remission induction phase, patients who had not achieved remission or who had progressive disease or flare that could not be controlled by glucocorticoids alone received additional treatment for GPA and MPA, that could include RITUXAN or non-U.S.-licensed rituximab and/or other therapies, at the discretion of the investigator. Planned follow-up was until Month 18 (from Day 1).
Fourteen out of 25 patients (56%) received additional RITUXAN or non-U.S.-licensed rituximab treatment at or post Month 6, up to Month 18. Five of these patients received four once weekly doses of intravenous RITUXAN or non-U.S.-licensed rituximab approximately every 6 months; 5 of these patients received a single dose of RITUXAN or non-U.S.licensed rituximab every 6 months, and 4 of these patients received various other RITUXAN or non-U.S.-licensed rituximab doses/regimens according to investigator. Of the 14 patients who received follow-up treatment between Month 6 and Month 18, 4 patients first achieved remission between Months 6 and 12 and 1 patient first achieved remission between Months 12 and 18. Nine of these 14 patients achieved PVAS remission by Month 6 but required additional follow-up treatment after Month 6.
December 2019 Update
A study was conducted to retrospectively evaluate the efficacy and safety of rituximab (Rtx) treatment in patients with anti-synthetase syndrome (ASS) and severe interstitial lung disease (ILD).
Patients with severe ILD and>12 months follow-up post-Rtx were identified from the Oslo University Hospital ASS cohort (n = 112). Clinical data, including pulmonary function tests (PFTs), were retrospectively collected from medical reports. Extent of ILD pre-, and post-Rtx was scored on thin-section high-resolution CT (HRCT) images and expressed as a percentage of total lung volume. Muscle strength was evaluated by manual muscle testing of eight muscle groups (MMT8).
Altogether, 34/112 ASS patients had received Rtx; 24/34 had severe ILD and>12 months follow-up post-Rtx (median 52 months). In these 24 patients, the median percentage of predicted forced vital capacity, forced expiratory volume in 1 s (FEV1) and diffusing capacity of the lungs for carbon monoxide (DLCO) increased by 24%, 22% and 17%, respectively, post-Rtx. Seven patients (allwith disease duration<12 months and/or acute onset/exacerbation of ILD) had>30% improvement in all three PFTs. HRCT analysis showed a median 34% reduction in ILD extent post-Rtx. MMT8 score increased post-Rtx. During follow-up, 7/34 (21%) Rtx-treated ASS patients died; 6/7 deaths were related to infections. The mortality rate in the Rtx-treated group was comparable to that of the remaining ASS cohort (25/78 deceased; 32%).
In conclusion, this study, which included 24 Rtx-treated ASS patients with severe ILD, reports improved PFTs after a median 52 months follow-up post-Rtx. The best outcome was observed in patients with a disease duration<12 months and/or acute onset/exacerbation of ILD. The study indicates that Rtx could be a treatment option for selected ASS patients, but infections should be given attention.
A study was conducted to assess the efficacy of rituximab (RTX) in SSc.
Fourteen patients with SSc were evaluated. Eight patients were randomized to receive two cycles of RTX at baseline and 24 weeks [each cycle consisted of four weekly RTX infusions (375 mg/m(2))]in addition to standard treatment, whereas six patients (control group) received standard treatment alone. Lung involvement was assessed by pulmonary function tests (PFTs) and chest high-resolution CT (HRCT). Skin involvement was assessed both clinically and histologically.
There was a significant increase of forced vital capacity (FVC) in the RTX group compared with baseline (mean +/- s.d.: 68.13 +/- 19.69 vs 75.63 +/- 19.73, at baseline vs 1-year, respectively, P = 0.0018). The median percentage of improvement of FVC in the RTX group was 10.25%, whereas that of deterioration in the controls was 5.04% (P = 0.002). Similarly, diffusing capacity of carbon monoxide (DL(CO)) increased significantly in the RTX group compared with baseline (mean +/- s.d.: 52.25 +/- 20.71 vs 62 +/- 23.21, at baseline vs 1-year respectively, P = 0.017). The median percentage of improvement of DL(CO) in the RTX group was 19.46%, whereas that of deterioration in the control group was 7.5% (P = 0.023). Skin thickening, assessed with the Modified Rodnan Skin Score (MRSS), improved significantly in the RTX group compared with the baseline score (mean +/- s.d.: 13.5 +/- 6.84 vs 8.37 +/- 6.45 at baseline vs 1-year, respectively, P<0.001).
In conclusion, results indicate that RTX may improve lung function in patients with SSc. To confirm the results, a proposal of a larger scale, multi-center study with longer evaluation periods is needed. Patients’ with refractory interstitial lung disease, which had previously failed to respond to prednisone and/or other cytotoxic drugs, experiences using rituximab as therapy for refractory antisynthetase syndrome (ASS)-associated interstitial lung disease were assessed retrospectively.
All patients (7) received rituximab therapy. Data on pulmonary symptoms, pulmonary function tests and high resolution computed tomography (HRCT) scan of the lungs were collected: (1) before rituximab initiation; and (2) at 6-month and one-year follow-up after the first infusion of rituximab.
At one-year follow-up, ASS patients had resolution or improvement of pulmonary clinical manifestations. Patients also exhibited significant improvement of interstitial lung disease parameters: 1) on pulmonary function tests: FVC (p = 0.03) and DLCO (p = 2×10(-5)); 2) and HRCT-scan of the lungs. Due to clinical resolution/improvement of interstitial lung disease, the median daily dose of oral prednisone could be reduced in these 7 ASS patients at one-year follow-up, compared with baseline.
These findings suggest that rituximab may be a helpful therapy for refractory interstitial lung disease in patients with ASS.
Patients’ with refractory interstitial lung disease, which had previously failed to respond to prednisone and/or other cytotoxic drugs, experiences using rituximab as therapy for refractory antisynthetase syndrome (ASS)-associated interstitial lung disease were assessed retrospectively.
All patients (7) received rituximab therapy. Data on pulmonary symptoms, pulmonary function tests and high resolution computed tomography (HRCT) scan of the lungs were collected: (1) before rituximab initiation; and (2) at 6-month and one-year follow-up after the first infusion of rituximab.
At one-year follow-up, ASS patients had resolution or improvement of pulmonary clinical manifestations. Patients also exhibited significant improvement of interstitial lung disease parameters: 1) on pulmonary function tests: FVC (p = 0.03) and DLCO (p = 2×10(-5)); 2) and HRCT-scan of the lungs. Due to clinical resolution/improvement of interstitial lung disease, the median daily dose of oral prednisone could be reduced in these 7 ASS patients at one-year follow-up, compared with baseline.
These findings suggest that rituximab may be a helpful therapy for refractory interstitial lung disease in patients with ASS.
2020 Update
In a randomized phase 3 trial, Shanafelt et al (2019) compared efficacy of treatment with ibrutinib plus rituximab with standard chemoimmunotherapy for patients with previously untreated CLL. Investigators randomly assigned 529 patients ≤70 years of age to one of two groups: group 1 (n=354) received either ibrutinib and rituximab for 6 cycles (following a single cycle of ibrutinib alone), then only ibrutinib until disease progression; group 2 (n=175) received 6 cycles of chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab. PFS at the median follow-up of 33.6 months favored the ibrutinib-rituximab combination over chemoimmunotherapy (89.4% vs 72.9% at 3 years; hazard ratio [HR] for progression or death, 0.35; 95% CI, 0.22 to 0.56; p<.001). Ibrutinib-rituximab was also superior to chemoimmunotherapy for overall survival (98.8% vs 91.5% at 3 y; HR for death, 0.17; 95% CI, 0.05 to 0.54; p<.001). The occurrence of adverse events of grade 3 or higher was similar in the two groups (80.1% for ibrutinib-rituximab; 79.7% for chemoimmunotherapy). However, infectious complications of grade 3 or higher were fewer in the ibrutinib-rituximab group (10.5%) vs the chemoimmunotherapy group (20.3%). Although the ibrutinib-rituximab regimen is superior for PFS and overall survival at 3 years in CLL patients aged ≤70 years, there is potential for long-term toxic effects and an increased risk of developing drug resistance with indefinite use of ibrutinib therapy.
March 2021 Update
B-cell anomalies play a role in the pathogenesis of membranous nephropathy. B-cell depletion with rituximab may therefore be noninferior to treatment with cyclosporine for inducing and maintaining a complete or partial remission of proteinuria in patients with this condition.
Patients were randomly assigned who had membranous nephropathy, proteinuria of at least 5 g per 24 hours, and a quantified creatinine clearance of at least 40 ml per minute per 1.73 m2 of body-surface area and had been receiving angiotensin-system blockade for at least 3 months to receive intravenous rituximab (two infusions, 1000 mg each, administered 14 days apart; repeated at 6 months in case of partial response) or oral cyclosporine (starting at a dose of 3.5 mg per kilogram of body weight per day for 12 months). Patients were followed for 24 months. The primary outcome was a composite of complete or partial remission of proteinuria at 24 months. Laboratory variables and safety were also assessed.
A total of 130 patients underwent randomization. At 12 months, 39 of 65 patients (60%) in the rituximab group and 34 of 65 (52%) in the cyclosporine group had a complete or partial remission (risk difference, 8 percentage points; 95% confidence interval [CI], -9 to 25; P = 0.004 for noninferiority). At 24 months, 39 patients (60%) in the rituximab group and 13 (20%) in the cyclosporine group had a complete or partial remission (risk difference, 40 percentage points; 95% CI, 25 to 55; P<0.001 for both noninferiority and superiority). Among patients in remission who tested positive for anti-phospholipase A2 receptor (PLA2R) antibodies, the decline in autoantibodies to anti-PLA2R was faster and of greater magnitude and duration in the rituximab group than in the cyclosporine group. Serious adverse events occurred in 11 patients (17%) in the rituximab group and in 20 (31%) in the cyclosporine group (P = 0.06).
Rituximab was noninferior to cyclosporine in inducing complete or partial remission of proteinuria at 12 months and was superior in maintaining proteinuria remission up to 24 months. (Fervenza FC, Appel GB, Barbour SJ, et.al., 2019)
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2022. No new literature was identified that would prompt a change in the coverage statement.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2023.
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