Product Details

Rituxan

Rituximab
10 mg/mL
Concentrate for solution for infusion
Single-Use 50-mL Vial (Preservative-Free)

DIN/PIN/NPN

09857407

Manufacturer

Hoffmann-La Roche Limited

Formulary Listing Date

2019-04-30  

Unit Price

2411.5400

Amount MOH Pays

2411.5400

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L01FA01

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Polyarticular Juvenile Idiopathic Arthritis

Abatacept

  • Brand(s): Orencia
  • Dosage Form/Strength: 250 mg/15 mL vial (Note that the SC injection is not approved for this indication)

Infliximab - See formulary for funded biosimilars

  • Brand(s): Avsola, Inflectra, Renflexis Biosimilars); Remicade (Originator)
  • Dosage Form/Strength: 100 mg/vial

Rituximab

  • Brand(s): Riximyo, Ruxience, and Truxima (biosimilar); Rituxan (biologic originator for those meeting biosimilar exemption)
  • Dosage Form/Strength: 10 mg/mL intravenous injection

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:

  1. Patient has active disease (a minimum of 3 (three) swollen joints and a total of 5 active joints); AND

  2. Patient has had an inadequate response to a three-month course of methotrexate administered subcutaneously at a dosage of at least 15 mg/m2 per week for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate the nature of the intolerance or contraindication must be described in detail.; AND

  3. Patient has had an inadequate response to a three-month course of etanercept OR adalimumab OR tociluzumab. If the patient is unable to tolerate or has a contraindication to etanercept OR adalimumab OR tociluzumab, the nature of the intolerance or contraindication must be described in detail.

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:

  • Abatacept refer to the Orencia product monograph for dosing information

  • Infliximab dose up to 6mg/kg/dose at 0, 2 and 6 weeks followed by maintenance of up to 6mg/kg/dose every 8 weeks

EAP Drug Request Form:

Standard Form for EAP Drug Requests
Polyarticular Juvenile Idiopathic Arthritis

Etanercept – see Formulary for funded biosimilars

  • Brand(s): Enbrel
  • Dosage Form/Strength: 25 mg/vial, 25 mg and 50 mg prefilled syringe or pens for subcutaneous injection per formulary listed options

Adalimumab – see Formulary for funded biosimilars

  • Brand(s): Humira and formulary listed biosimilars
  • Dosage Form/Strength: 40 mg/0.8mL prefilled syringe, 40 mg/0.8mL and and 20 mg/0.2 mL prefilled pens for subcutaneous injection

Tociluzumab

  • Brand(s): Actemra
  • Dosage Form/Strength: 80 mg/4 mL Vial, 200 mg/10 mL Vial, 400 mg/20 mL Vial, 162mg/0.9mL Inj (Prefilled syringe), 162mg/0.9mL Auto Injector

Rituximab

  • Brand(s): Riximyo, Ruxience, and Truxima (biosimilar); Rituxan (biologic originator for those meeting biosimilar exemption)
  • Dosage Form/Strength: 10 mg/mL intravenous injection

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:

  • Patient has active disease (≥ 3 swollen joints and ≥ 5 active joints) despite a trial of optimal dose of subcutaneously administered methotrexate (i.e., 15 mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication must be described in detail.

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:
The planned dosing regimen should be provided. The maximum recommended dose is 50mg once weekly.

Recommended dosing for Adalimumab:
- 24 mg/m2 (maximum 40 mg) every two weeks;
OR
- 20 mg every 2 weeks, if the Patient weighs less than 30 kg;
OR
- 40 mg every 2 weeks, if the Patient weighs more than 30 kg.

Recommended dosing for Tocilizumab in combination with Methotrexate:
IV dosing regimen:
- 10 mg/kg every 4 weeks, if the Patient weighs less than 30 kg;
OR
- 8 mg/kg every 4 weeks, if the Patient weighs more than or equal to 30 kg.

SC dosing regimen:
- 162 mg once every 3 weeks if the Patient weighs less than 30 kg
- 162 mg once every 2 weeks if the Patient weighs 30 kg or more

EAP Drug Request Form:

Standard Form for EAP Drug Requests
Rheumatoid Arthritis

Rituximab – See Formulary for funded biosimilars

  • Brand(s): Riximyo, Ruxience, Truxima (Biosimilar); Rituxan (Biologic originator)
  • Dosage Form/Strength: 10 mg/mL intravenous injection

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:

  1. Severe active disease (≥ 5 swollen joints and rheumatoid factor positive and/or radiographic evidence of rheumatoid arthritis); AND

  2. Failure to respond to optimal use of DMARDs or documented intolerance or contraindications to DMARDs (per current EAP reimbursement criteria for anti-TNF agents); AND

  3. Failure to respond to, or the patient has intolerance or contraindications to, an adequate trial of at least ONE anti-TNF agent (e.g., adalimumab, etanercept, infliximab, golimumab, certolizumab pegol)

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:

Standard Form for EAP Drug Requests
Dermatology Drugs

Rituximab – see Formulary for funded biosimilars

  • Brand(s): Riximyo, Ruxience, Truxima (Biosimilars); Rituxan (Originator)
  • Dosage Form/Strength: 10 mg/mL intravenous injection

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. 

  • Patient has failed combination therapy with high-dose systemic steroids1 and a steroid-sparing immunosuppressant2 trialed in combination for a minimum of 3 months. 

  • The request must be made by a dermatologist/specialist familiar with the management of pemphigus vulgaris and with the use of rituximab in this condition.

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

  • 375 mg/m2 administered weekly for 4 weeks (for a total of 4 doses), OR

  • 1000 mg of rituximab administered at week 0 and week 2 (for a total of 2 doses) 

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: 

  • Other dermatology diagnoses, such as pemphigus foliaceus and bullous pemphigoid 

  • Maintenance infusions (i.e., regular maintenance doses to keep disease in remission) 

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:

Standard Form for EAP Drug Requests
Granulomatosis with Polyangiitis or Microscopic Polyangiitis

Rituximab -See Formulary for funded biosimilars

  • Brand(s): Riximyo, Ruxience, Truxima (biosimilars); Rituxan (Originator)
  • Dosage Form/Strength: 10 mg/mL intravenous injection

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: 

  1. The patient must have severe active disease that is life- or organ-threatening. At least one supporting laboratory and/or imaging report must be provided. The organ(s) and how the organ(s) is (are) threatened must be specified. 

  1. There is a positive serum assays for either proteinase 3-ANCA (anti-neutrophil cytoplasmic autoantibodies) or myeloperoxidase-ANCA. A copy of the laboratory report must be provided. 

  1. Cyclophosphamide cannot be used for the patient for at least ONE of the following reasons:
    i) The patient has failed a minimum of six IV pulses of cyclophosphamide;
    OR
    ii) The patient has failed three months of oral cyclophosphamide therapy;
    OR
    iii)     The patient has a severe intolerance or an allergy to cyclophosphamide;
    OR
    iv)     Cyclophosphamide is contraindicated;
    OR
    v)     The patient has received a cumulative lifetime dose of at least 25 g of cyclophosphamide;
    OR
    vi)     The patient wishes to preserve ovarian/testicular function for fertility. 

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: 

  1. The patient must have severe active disease that is life- or organ-threatening. At least one supporting laboratory and/or imaging report must be provided. The organ(s) and how the organ(s). is(are) threatened must be specified. 

  1. 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. 

  1. Stabilization of the condition with induction doses of cyclophosphamide (IV or PO doses) and a glucocorticoid as combination over 4 to 6 months until disease remission followed by rituximab at 500mg doses every 6 months. Cyclophosphamide dosing to align with MAINRITSAN studies1. 

After remission (typically within a month of remission), rituximab will be administered as one of the following: 

  • A fixed dose regimen of Rituximab consisting of 500 mg dosed at days 0 and 14 followed by fixed doses of 500 mg at 6, 12, and 18 months, used in combination with low-dose prednisone of another glucocorticoid; x 18 months duration of funding OR 

  • A tailored dose regimen of Rituximab based on CD19 and ANCA monitoring. Dose of Rituximab funded is 500 mg on day 0 followed by a dose as early as every 3 months if CD19 exceeds 0/mm3 or if ANCA reappears or if there is a titre increase x 18 months duration of funding. 

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:
Renewals will be considered case-by-case. Requests should include information pertaining to the number of disease flares during the period of funding and a description of symptoms during flares. The dosing interval of use must be maintained as every 6 months and should be specified.

EAP Drug Request Form:

Standard Form for EAP Drug Requests
Nephrology Treatments

Rituximab

  • Brand(s): Riximyo, Ruxience, and Truxima (biosimilar); Rituxan (biologic originator)
  • Dosage Form/Strength: 10 mg/mL intravenous injection
  • Effective date: July 29, 2022

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:

  1. Patient is 18 years of age or older (see Note 3): AND 

  1. Prescribed by a nephrologist with expertise in the diagnosis and treatment of (PMN); AND 

  1. Patient meets one of the following clinical circumstances:
    a)     Has documented proteinuria greater than 5 g per day despite 6 months of therapy with an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) (Note that a shorter period of observation may be provided for patients with documented proteinuria greater than 8 g per day or high anti-PLA2R titres greater than 50 or eGFR less than 60 mL/min/1.73m2);
    OR
    b)     Has documented proteinuria greater than 3.5 g per day with life- or organ- threatening complication(s) of nephrotic syndrome (i.e., venous thrombosis, arterial thrombosis, infection, or rapid decline in kidney function not otherwise explained);
    OR
    c)     Has biopsy-proven or serology(anti-PLA2R)-proven recurrence in a patient who has received a kidney transplant and has proteinuria greater than 3.5 g per day. 

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: 

  1. Rituximab can be discontinued in patients who have achieved complete remission. 

  1. Rituximab can be discontinued in non-responders. Retreatment of non-responders is not recommended. 

  1. Pediatric patients 17 years of age and younger may be considered on a case-by-case basis through external review. Please include relevant laboratory results, consult notes, and medications that have been used to manage the patient’s condition. 

  1. Definitions:

    Complete remission: Proteinuria less than 0.3 g per day or protein-creatinine ratio less than 30 mg/mmoL

    Partial remission: Reduction in proteinuria of at least 50% from baseline and final proteinuria between 0.3 g and 3.5 g per day

    Relapse: Recurrence of proteinuria (as per the initiation criteria) accompanied by a decrease in serum albumin to less than 30 g/L in patients who have achieved a complete or partial remission following prior rituximab treatment.

    Nonresponse: Lower than 25 per cent reduction in proteinuria by 6 months after initial treatment course

EAP Drug Request Form:

Standard Form for EAP Drug Requests
Ocular Treatments

Rituximab

  • Brand(s): Riximyo, Ruxience, and Truxima (biosimilar); Rituxan (biologic originator for those meeting biosimilar exemption)
  • Dosage Form/Strength: 10 mg/mL intravenous injection
  • Effective date: August 11, 2015

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:

  1. Experienced failure, intolerance, or contraindication to oral corticosteroid (or topical corticosteroid for anterior uveitis) and failure or intolerance to at least one immunosuppressive therapy; OR 

  2. For the treatment of chronic Juvenile Idiopathic Arthritis (JIA)-associated uveitis after failure or intolerance to a first-line immunosuppressive agent; OR 

  3. For patients who have immediately vision-threatening OID and do not meet the above criteria, where consultation notes/ letter from an ophthalmologist expert
    •     specializing in OIDs (who may be the requesting physician) confirm the severity of the patient’s condition and indicate detailed rationale for an immediate biologic therapy (e.g., ocular inflammation associated with Behcet’s disease; severe non- necrotizing scleritis; necrotizing scleritis; etc.);
    AND
    •     Patient must be followed by a uveitis specialist, a retina specialist familiar with ocular inflammatory diseases, or a pediatric ophthalmologist.

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; 

  • Consultation notes or a letter is provided by the requesting physician to confirm that treatment has resulted in improvement/stability of vision and other treatment goals (e.g., remission from/control of ocular inflammation) have been met; AND

  • Patients must also have demonstrated subsequent deterioration of symptoms, at least 6 months from the last dose of rituximab. 

Duration of Approval: 2 years

Rituximab

  • Brand(s): Riximyo, Ruxience, and Truxima (biosimilar); Rituxan ((biologic originator for those meeting biosimilar exemption)
  • Dosage Form/Strength: 10 mg/mL intravenous injection
  • Effective date: July 29, 2022

Neuromyelitis Optica Spectrum Disorder (NMOSD) 

Initiation Criteria: 

For the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) in patients meeting the following criteria:

  1. NMOSD diagnosis meets international diagnostic criteria; AND 

  1. Patient is seropositive for the aquaporin-4 (AQP-4) antibody OR patient is AQP-4 antibody negative, but has had more than one attack within a 6-month timeframe while on azathioprine/mycophenolate with or without corticosteroids (i.e., aggressive disease); AND 

  1. The prescriber is a neurologist with expertise in the diagnosis and treatment of NMOSD. 

Notes: 

  1. Rituximab should not be initiated during an acute episode of NMOSD. 

  1. Patients to be re-evaluated every 12 months.

Exclusion:
Rituximab will not be funded in combination with other biologics for NMOSD

Dosage:
- Induction with 1,000mg IV x 2 doses 2 weeks apart for adults (4 weekly treatments of 375 mg/m2 for children)
- Repeat every 6 months 

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. 

Renewals: 2 years

EAP Drug Request Form:

Standard Form for EAP Drug Requests

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