Truxima

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
   ii) Leflunomide (20mg/day) for at least 3 months, in addition to 
   iii) An adequate trial of at least one combination of DMARDs for 3 months;
   OR
B. i) Methotrexate (20mg/week) for at least 3 months, AND
   ii) Leflunomide in combination with methotrexate for at least 3 months; OR

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.

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 575;

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.

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
b. The patient has failed three months of oral cyclophosphamide therapy; OR
c. The patient has a severe intolerance or an allergy to cyclophosphamide; OR
d. Cyclophosphamide is contraindicated; OR
e. The patient has received a cumulative lifetime dose of at least 25g of cyclophosphamide; OR
f. The patient wishes to preserve ovarian/testicular function for fertility.

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.

Rituximab (Truxima) 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.

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

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

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

Rituximab – see Formulary for funded biosimilars

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

Rituximab -See Formulary for funded biosimilars

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

Rituximab

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

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