Product Details
Riximyo
Rituximab10 mg/mL
Solution for Injection
Vial (Preservative-Free)
DIN/PIN/NPN
02498316
Manufacturer
Sandoz Canada Inc.
Formulary Listing Date
2020-07-31
Unit Price
29.7000
Amount MOH Pays
29.7000
Coverage Status
Limited Use Product
ODB Formulary Therapeutic Classification
Therapeutic Note
NO
ATC Code
L01FA01
Interchangeable Products
NOLU Clinical Criteria
LU Code | Auth. Period | Clinical Criteria |
---|---|---|
581 | 3 months | For the treatment of adults with severe active rheumatoid arthritis (RA) (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or anti-CCP positive, and radiographic evidence of rheumatoid arthritis) who meet ALL the following criteria. 1. Patient has experienced failure to respond, documented intolerance, or contraindication to optimal use of one of the following disease-modifying antirheumatic (DMARD) regimens: A) i) Methotrexate (20mg/week) for at least 3 months, AND B) i) Methotrexate (20mg/week) for at least 3 months, AND C) i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine(400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) 2. Patient has experienced failure to respond, documented intolerance, or contraindication to an adequate trial of at least ONE anti-TNF agent (e.g., adalimumab, etanercept, infliximab, golimumab, certolizumab pegol). 3. Patient is not using rituximab in a maintenance setting. 4. Patient is not using a treatment course of rituximab earlier than 6 months after the completion of a prior course of rituximab. 5. Rituximab is not used in combination with another biologic to treat the patient's RA. 6. Treatment must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. One course of treatment is 1000mg followed two weeks later by the second 1000mg dose. |
582 | 3 months | For the re-treatment of patients with severe active rheumatoid arthritis (RA) (greater than or equal to 5 swollen joints, and rheumatoid factor positive and/or anti-CCP positive, and radiographic evidence of rheumatoid arthritis) who meet ALL the following criteria: 1. Patient has met the initiation criteria for rituximab in accordance with RFU 581; 2. Patient has experienced loss of effect after having responded to the prior treatment course of rituximab (Response is defined as a 20% reduction in the swollen joint count compared to the joint count prior to the first, pre-treatment course evaluated at 3 to 4 months following the administered course AND improvement in 2 swollen joints); AND 3. Patient is not using rituximab in a maintenance setting; AND 4. Patient is not using a treatment course of rituximab earlier than 6 months after the completion of a prior course of rituximab; AND 5. Rituximab is not used in combination with another biologic to treat the patient's RA. 6. Treatment must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. One course of re-treatment is 1000mg followed two weeks later by the second 1000mg dose. |
616 | 1 month (1 treatment course) | Rituximab is used in combination with glucocorticoids for the induction of remission in patients with severely active Granulomatosis with Polyangiitis [(GPA), also known as Wegener's Granulomatosis (WG)] OR microscopic polyangiitis (MPA), for patients who meet all of the following criteria: 1. The patient must have severe active disease that is life- or organ-threatening as supported by laboratory and/or imaging reports. AND 2. There is a positive serum assay for either proteinase 3-ANCA (anti-neutrophil cytoplasmic autoantibodies) or myeloperoxidase-ANCA. AND 3. Cyclophosphamide cannot be used by the patient for one of the following reasons: a. The patient has failed a minimum of six IV pulses of cyclophosphamide; OR 4. The request is from a prescriber experienced in the diagnosis and management of GPA, MPA, and vasculitis. Exclusion criteria: The patient should not have received a course of rituximab in the prior 6 months. The recommended dosing regimen for the initial treatment would be a once weekly infusion dosed at 375 milligrams per square metre x 4 weeks. Case-by-case considerations for patients not meeting the LU criteria may be considered through the Exceptional Access Program. |
617 | 1 year | Rituximab (Riximyo) treatment will be used for patients with severely active Granulomatosis with Polyangiitis [(GPA), also known as Wegener's Granulomatosis (WG)] OR microscopic polyangiitis (MPA) who have achieved disease remission. Patient must meet all of the following criteria: 1. The patient must have severe active disease that is life- or organ-threatening as supported by laboratory and/or imaging reports. 2. There is a positive serum assay for either proteinase 3-ANCA (anti-neutrophil cytoplasmic autoantibodies) or myeloperoxidase-ANCA. A copy of the laboratory report must be provided. 3. Stabilization of the condition with induction doses of cyclophosphamide (injectable or oral doses are acceptable) and a glucocorticoid as combination over 4 to 6 months until disease remission prior to initiation of rituximab. 4. The request is from a prescriber experienced in the diagnosis and management of GPA, MPA, and vasculitis. Exclusion criteria: The patient should not have received a dose of rituximab in the prior 6 months. Doses of rituximab administered at intervals more frequently than every 6 months are not funded. The recommended dosing regimen: A fixed dose regimen of Rituximab of 500mg IV every 6 months. Case-by-case considerations for patients not meeting the LU criteria may be considered through the Exceptional Access Program. |
EAP Criteria
Therapeutic Class | Reimbursement Criteria |
---|---|
Polyarticular Juvenile Idiopathic Arthritis | Abatacept
Infliximab - See formulary for funded biosimilars
Rituximab
Originator biologics (e.g., Enbrel®, Humira®, Remicade®, and Rituxan®) with a provincially funded biosimilar are only considered for provincial funding in patients who are treatment experienced and stable on the reference biologic or those with existing EAP approvals. Prescribers should refer to the ODB formulary for biosimilars and their funded conditions. It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on a originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, may be expected to be provided ongoing access of the reference biologic through the patient support program or to use a biosimilar upon meeting specified criteria. The Ministry will only consider funding of Originator biologics with a funded biosimilar version in those who are treatment experienced and stabilized on the product prior to transitioning to the ODB program or in patients with an existing EAP approval. Refer to the Executive Officer Communications on the Ministry website for Frequently asked questions and notifications of funded biosimilars at http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions (see below). In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 of this document) For the treatment of polyarticular-course juvenile idiopathic arthritis in patients meeting the following criteria:
Duration of Approval: 1 Year Renewals will be considered for patients with objective evidence of at least a 20% reduction in swollen joint count. For renewals beyond the second year, objective evidence of preservation of treatment effect should be provided. (i.e., the current joint count should be compared to the count prior to initiating treatment with the biologic agent) Duration of Approval: 5 Year Approved Dose:
EAP Drug Request Form: |
Polyarticular Juvenile Idiopathic Arthritis | Etanercept – see Formulary for funded biosimilars
Adalimumab – see Formulary for funded biosimilars
Tociluzumab
Rituximab
Originator biologics (e.g., Enbrel®, Humira®, Remicade®, and Rituxan®) with a provincially funded biosimilar are only considered for provincial funding in patients who are treatment experienced and stable on the reference biologic or those with existing EAP approvals. Prescribers should refer to the ODB formulary for biosimilars and their funded conditions. It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on a originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, may be expected to be provided ongoing access of the reference biologic through the patient support program or to use a biosimilar upon meeting specified criteria. The Ministry will only consider funding of Originator biologics with a funded biosimilar version in those who are treatment experienced and stabilized on the product prior to transitioning to the ODB program or in patients with an existing EAP approval. Refer to the Executive Officer Communications on the Ministry website for Frequently asked questions and notifications of funded biosimilars at http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions (see below). In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 of this document) Patients with pJIA who are unable to use Erelzi or Brenzys to accommodate weight-based dosing as a result of the syringe format and ability to measure partial syringe doses may request an exemption for Enbrel. For the first-line treatment of polyarticular-course juvenile idiopathic arthritis in patients meeting the following criteria:
Duration of Approval: 1 Year Renewal will be considered for patients with objective evidence of at least a 20% reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. Duration of Approval: 5 Year Dosing for Etanercept: Recommended dosing for Adalimumab: Recommended dosing for Tocilizumab in combination with Methotrexate: SC dosing regimen: EAP Drug Request Form: |
Rheumatoid Arthritis | Rituximab – See Formulary for funded biosimilars
Originator biologics (e.g., Enbrel®, Humira®, Remicade®, and Rituxan®) with a provincially funded biosimilar are only considered for provincial funding in patients who are treatment experienced and stable on the reference biologic or those with existing EAP approvals. Prescribers should refer to the ODB formulary for biosimilars and their funded conditions. It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on a originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, may be expected to be provided ongoing access of the reference biologic through the patient support program or to use a biosimilar upon meeting specified criteria. The Ministry will only consider funding of Originator biologics with a funded biosimilar version in those who are treatment experienced and stabilized on the product prior to transitioning to the ODB program or in patients with an existing EAP approval. Refer to the Executive Officer Communications on the Ministry website for Frequently asked questions and notifications of funded biosimilars at http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions (see below). In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 of this document) First course of Rituximab for the treatment of rheumatoid arthritis in adult patients with:
Initial approval: One year: One course of treatment is 1000 mg followed two weeks later by the second 1000mg dose. Two courses will be approved each year (courses should be at least 6 months apart with second course being given only AFTER loss of effect as noted in the re-treatment guidelines below). Second course is not approved for “maintenance” therapy. Renewal criteria: A joint count at 3-4 months indicating at least a 20% reduction in swollen joint count and a minimum of improvement in 2 swollen joints, should be recorded to indicate a response, and then re-treatment can be given after an interval of at least 6 months AND after a loss of effect. Details of all courses given and the subsequent response should be provided in the renewal request. Renewal approval: 1 year (2 courses). One course of treatment is 1000 mg followed two weeks later by the second 1000mg dose. Repeated courses are not approved for maintenance therapy. Note: Rituximab should not be used concomitantly with other anti-TNF agents. EAP Drug Request Form: |
Dermatology Drugs | Rituximab – see Formulary for funded biosimilars
Originator biologics (e.g., Enbrel®, Humira®, Remicade®, and Rituxan®) with a provincially funded biosimilar are only considered for provincial funding in patients who are treatment experienced and stable on the reference biologic or those with existing EAP approvals. Prescribers should refer to the ODB formulary for biosimilars and their funded conditions. It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on a originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, may be expected to be provided ongoing access of the reference biologic through the patient support program or to use a biosimilar upon meeting specified criteria. The Ministry will only consider funding of Originator biologics with a funded biosimilar version in those who are treatment experienced and stabilized on the product prior to transitioning to the ODB program or in patients with an existing EAP approval. Refer to the Executive Officer Communications on the Ministry website for Frequently asked questions and notifications of funded biosimilars at http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions (see below). In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 of this document) For the treatment of severe pemphigus vulgaris in patients who meet the following criteria.
1Patients must have used a steroid dose equivalent to a 1 mg/kg prednisone dose equivalent (or a minimum of 60 mg/day for patients > 60 kg) for at least 4 to 6 weeks before attempting to taper to a lower dose. 2Patients must try at least one of the following at therapeutic doses: azathioprine, mycophenolate, cyclophosphamide, or methotrexate (in combination with a steroid). Dose: ONE course of treatment with rituximab is considered
Re-treatment may be provided if the patient responded to rituximab therapy then experiences disease flare, as long as the request is made no less than 6 months after the last dose of the patient’s last treatment course/cycle with rituximab. Rejection Criteria:
Duration of Approval: 1 year Maintenance Treatment is not funded. First Renewal: 1 year Subsequent Renewals after first renewal: 2 years (Rituximab is funded for course of therapy to be given at an interval of at least 6 months only upon flare of the condition.) EAP Drug Request Form: |
Granulomatosis with Polyangiitis or Microscopic Polyangiitis | Rituximab -See Formulary for funded biosimilars
Originator biologics (e.g., Enbrel®, Humira®, Remicade®, and Rituxan®) with a provincially funded biosimilar are only considered for provincial funding in patients who are treatment experienced and stable on the reference biologic or those with existing EAP approvals. Prescribers should refer to the ODB formulary for biosimilars and their funded conditions. It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on a originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, may be expected to be provided ongoing access of the reference biologic through the patient support program or to use a biosimilar upon meeting specified criteria. The Ministry will only consider funding of Originator biologics with a funded biosimilar version in those who are treatment experienced and stabilized on the product prior to transitioning to the ODB program or in patients with an existing EAP approval. Refer to the Executive Officer Communications on the Ministry website for Frequently asked questions and notifications of funded biosimilars at http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions (see below). In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 of this document) For the induction of remission of severely active Granulomatosis with Polyangiitis (GPA) OR microscopic polyangiitis (MPA) as combination treatment with glucocorticoids, in patients who meet all of the following criteria:
The initial treatment would be a once weekly infusion dosed at 375 mg/m2 x 4 weeks. The physician must confirm that the treatment would not be a maintenance infusion as maintenance infusions will not be funded. Renewals will be considered provided that, the patient meets the same criteria for initial approval and the request for retreatment is made no less than 6 months after the last dose of the patient’s last treatment cycle with rituximab. First Renewal: 1year Subsequent Renewals after first renewal: 2 years (Rituximab is funded for course of therapy to be given at an interval of at least 6 months only upon flare of the condition.) Rituximab will be funded as maintenance therapy for patients with severely active Granulomatosis with Polyangiitis [(GPA), also known as Wegener’s Granulomatosis (WG)] OR microscopic polyangiitis (MPA). Patient must meet all of the following criteria:
After remission (typically within a month of remission), rituximab will be administered as one of the following:
1Remission-induction therapy included prednisone (starting at 1 mg per kilogram of body weight per day, followed by gradual tapering), preceded in some patients by methylprednisolone “pulses” (500 to 1000 mg daily for 1 to 3 consecutive days), and “pulse” cyclophosphamide (0.6 g per square meter of body-surface area on days 0, 14, and 28, then 0.7 g per square meter every 3 weeks for three to six additional pulses) until remission was attained, after 4 to 6 months. At that time, and within a maximum of 1 month after the last cyclophosphamide pulse, we have also accepted oral dosing (an example of oral cyclophosphamide dosing that has been used by clinicians is 150 mg daily). Approval duration: 18 months Renewals: EAP Drug Request Form: |
Nephrology Treatments | Rituximab
Originator biologics (e.g., Enbrel®, Humira®, Remicade®, and Rituxan®) with a provincially funded biosimilar are only considered for provincial funding in patients who are treatment experienced and stable on the reference biologic or those with existing EAP approvals. Prescribers should refer to the ODB formulary for biosimilars and their funded conditions. It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on a originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, may be expected to be provided ongoing access of the reference biologic through the patient support program or to use a biosimilar upon meeting specified criteria. The Ministry will only consider funding of Originator biologics with a funded biosimilar version in those who are treatment experienced and stabilized on the product prior to transitioning to the ODB program or in patients with an existing EAP approval. Refer to the Executive Officer Communications on the Ministry website for Frequently asked questions and notifications of funded biosimilars at http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions (see below). In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 of this document) Initiation Criteria: For the treatment of adult patients with primary membranous nephropathy (PMN) who are at moderate to high risk of developing progressive kidney injury or complications of nephrotic syndrome meeting the following criteria:
Approved dosage: 1,000 mg IV on day 0 and day 15 (i.e., 1,000 mg IV administered two weeks apart) No additional doses are required in patients who demonstrate complete remission. An additional course of rituximab may be administered at the above dosage after a minimum of 6 months has elapsed from the prior treatment course, if treatment with rituximab has resulted in a reduction in proteinuria from baseline by at least 25 per cent without complete remission OR if the patient relapses following complete remission. Approval duration of initial criteria: 12 months Notes:
EAP Drug Request Form: |
Ocular Treatments | Rituximab
Originator biologics (e.g., Enbrel®, Humira®, Remicade®, and Rituxan®) with a provincially funded biosimilar are only considered for provincial funding in patients who are treatment experienced and stable on the reference biologic or those with existing EAP approvals. Prescribers should refer to the ODB formulary for biosimilars and their funded conditions. It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on a originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, may be expected to be provided ongoing access of the reference biologic through the patient support program or to use a biosimilar upon meeting specified criteria. The Ministry will only consider funding of Originator biologics with a funded biosimilar version in those who are treatment experienced and stabilized on the product prior to transitioning to the ODB program or in patients with an existing EAP approval. Refer to the Executive Officer Communications on the Ministry website for Frequently asked questions and notifications of funded biosimilars at http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions (see below). In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 of this document) For the treatment of severe non-infectious ocular inflammatory disease (OID) in patients failed or did not tolerate treatment with infliximab or adalimumab; OR has contraindication to anti-TNF therapy AND who meet one of the following criteria:
Approved Dose: Rituximab up to 1000 mg IV per infusion at days 1 & 15 and 3rd infusion at 6–12 months. Note that maintenance rituximab infusions are not funded. Duration of Approval: 1 year Renewals will be considered for requests where;
Duration of Approval: 2 years Rituximab
Neuromyelitis Optica Spectrum Disorder (NMOSD) Initiation Criteria: For the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) in patients meeting the following criteria:
Notes:
Exclusion: Dosage: Approval duration of initial criteria: 12 months Renewal criteria: Renewal of funding will be considered in patients who have not experienced a relapse of NMOSD or unacceptable toxicities from rituximab. Consideration of funding in patients who have experienced a relapse will require a description of the relapse, including any associated bloodwork to support the ongoing efficacy and safety of rituximab. Please submit relevant consult notes to support the request. |