Product Details

Remicade

Infliximab
10 mg/mL
Powder for Injection
10-mL Vial Pack

DIN/PIN/NPN

02244016

Manufacturer

Janssen Inc.

Formulary Listing Date

2014-01-30  

Unit Price

987.5600

Amount MOH Pays

987.5600

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L04AB02

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
Rheumatoid Arthritis

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 20 mg/0.2 mL prefilled pens for subcutaneous injection

Anakinra

  • Brand(s): Kineret
  • Dosage Form/Strength: 100 mg /0.67 mL subcutaneous injection

Certolizumab pegol

  • Brand(s): Cimzia
  • Dosage Form/Strength: 200 mg/mL prefilled syringe and autoinjector

Etanercept – see Formulary for funded biosimilars

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

Golimumab

  • Brand(s): Simponi
  • Dosage Form/Strength: 50 mg/0.5 mL prefilled syringe and autoinjector

Infliximab – see Formulary for funded biosimilars

  • Brand(s): Remicade
  • Dosage Form/Strength: 100 mg/vial intravenous infusion

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 rheumatoid arthritis in patients who have:

  1. Severe active disease (≥ 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) despite the optimal use of various formulary disease-modifying anti-rheumatic drugs (DMARDs)*.

    *Optimal use of DMARDs include:

  • Methotrexate (20 mg/week) for at least 3 months and leflunomide (20 mg/day) for at least 3 months in addition to an adequate trial (3 months) of at least one combination of DMARDs;

    OR

  • Methotrexate (20 mg/week) for at least 3 months and leflunomide in combination with methotrexate for at least 3 months.

    Note: If the patient could not receive adequate trial(s) of methotrexate and/or leflunomide due to contraindication(s) or intolerance(s), the nature of contraindication(s) or intolerance(s) must be provided along with details of trials of other DMARDs or clear rationale why other DMARDs cannot be considered.

    OR

  • Methotrexate (20mg/week), sulfasalazine (2 GM/day) and hydroxychloroquine (400mg/day)* for at least 3 months. If the patient could not receive an adequate trial of methotrexate, sulfasalazine and hydroxychloroquine due to intolerance, then the above DMARD trial criteria must be met.

    *Hydroxychloroquine is based by weight up to 400 mg per day

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.

The planned dosing regimen for the requested biologic should be provided.

The recommended doses for the treatment of rheumatoid arthritis are as follows:

  • Adalimumab 40mg every two weeks

  • Anakinra 100mg per day

  • Certolizumab pegol 400mg at 0, 2 and 4 weeks followed by maintenance therapy of 200 mg every 2 weeks. For maintenance dosing, 400mg every 4 weeks may be considered

  • Etanercept 25mg twice weekly or 50mg once weekly

  • Golimumab 50mg once a month

  • Infliximab 3mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 3mg/kg/dose every 8 weeks up to a maximum of six maintenance doses per year

Duration of Approval:
- First Renewal: 1 Year
- Subsequent Renewals: 5 Years

EAP Drug Request Form:

Standard Form for EAP Drug Requests
Ankylosing Spondylitis Drugs

Adalimumab – See Formulary for funded biosimilars

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

Certolizumab

  • Brand(s): Cimzia
  • Dosage Form/Strength: 200 mg/mL prefilled syringe and autoinjector

Etanercept – See Formulary for funded biosimilars

  • Brand(s): Enbrel and formulary listed biosimilars
  • Dosage Form/Strength: 25mg/vial and 50mg prefilled syringe for subcutaneous injection

Golimumab

  • Brand(s): Simponi
  • Dosage Form/Strength: 50 mg/0.5 ml prefilled syringe and autoinjector

Infliximab- See Formulary for funded biosimilars

  • Brand(s): Remicade and formulary listed biosimilars
  • Dosage Form/Strength: 100mg/10mL intravenous infusion

Secukinumab

  • Brand(s): Cosentyx
  • Dosage Form/Strength: 150 mg/mL prefilled syringe and 150 mg/mL prefilled pen

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 ankylosing spondylitis (AS) OR psoriatic spondylitis (PS) in patients who have severe active disease with:

  1. Age of disease onset 50 years of age or younger; AND 

  2. Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND 

  3. Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND

  4. BASDAI score of ≥ 4 for at least 4 weeks while on standard therapy; AND

  5. A list of current concomitant medications related to the AS/PS, including pain medications (if relevant) with dosing regimens provided. 

*NSAIDs include coxibs; use of DMARDS instead of NSAIDs not acceptable.

The information submitted with the request must include the following: 

  • A list of current concomitant medications related to the AS/PS, including pain medications (if relevant). Please include dosing regimens. 

  • Details of review of radiographic reports for severe active disease.
    o     X-ray or CT scan report stating the presence of “SI joint fusion” or “SI joint erosion”
    OR
    o     MRI report stating the presence of “inflammation” or “edema” of the SI joint
    o     Actual radiographic reports must be submitted with the request. If the radiographic reports do not specify the above, the request will be reviewed by external medical experts.

Additional information that should be provided if applicable:

  • Schober measurement and chest expansion measurement 

  • Evidence of restricted spinal mobility 

  • If the patient has AS/PS with predominantly peripheral joint involvement, additional information pertaining to trials of DMARDs must be provided, and these requests will be reviewed by external medical experts. 

Duration of Approval: 1 year

Renewal will be considered for patients with objective evidence of at least a 50% reduction in BASDAI score or ≥ 2 absolute point reduction in BASDAI score. Please provide an update on concomitant medications for AS/PS and whether there has been a reduction in pain medication for AS/PS since initiating the biologic (if applicable).

For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided.

The planned dosing regimen for the requested biologic should be provided. The recommended doses for the treatment of AS/PS are:

  • Adalimumab 40 mg every two weeks

  • Certolizumab 400mg at 0, 2, and 4 weeks followed by maintenance therapy of 200 mg every 2 weeks or 400 mg every 4 weeks.

  • Etanercept 25 mg twice weekly or 50 mg once weekly

  • Golimumab 50mg once a month

  • Infliximab 3-5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of up to 5mg/kg/dose every 6 to 8 weeks

  • Secukinumab 150 mg SC at weeks 0, 1, 2, and 3 followed by monthly maintenance dosing starting at week 4.

Duration of Approval: First renewal: 1 year; Second and subsequent renewals: 5 years

EAP Drug Request Form:

Standard Form for EAP Drug Requests
Inflammatory Bowel Diseases

Infliximab - See formulary for funded biosimilars

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

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)

The below criteria are for Infliximab as Remicade. Refer to the ODB formulary for the Limited Use Criteria for Infliximab biosimilars which was updated with the January 2023 ODB Formulary Update.

Treatment of moderate to severe (luminal) Crohn’s Disease in patients who have: 

  1. HBI (Harvey Bradshaw Index) score ≥ 7*; AND 

  2. Failed to respond to conventional treatment with glucocorticoids (prednisone 40mg/day or equivalent for at least 2 weeks or dose cannot be tapered to below prednisone 20 mg/day or equivalent); AND

  3. Failed to respond to an immunosuppressive agent (azathioprine, 6-mercaptopurine, methotrexate, or cyclosporine) tried for at least 3 months. 

Note: Any intolerance(s) or contraindication(s) to treatment with required alternative(s) must be described in detail.

*If the patient has HBI below 7, the request will be reviewed by external medical experts when the following information is provided: bloodwork (with hematocrit, hemoglobin, C reactive protein, ESR, platelets, and ferritin levels); supporting endoscopy; details of weight loss; and a list of narcotic analgesics being used.

Duration of Approval: 6 months

Renewal will be considered for patients with 50% reduction in HBI from pre-treatment as well as improvement of symptoms (e.g., absence of bloody diarrhea and weight stabilization or increase) and no longer using steroids. Biochemical improvements may also be required. 

The planned dosing regimen for the requested biologic should be provided.

Recommended dose:
Infliximab: 5 mg/kg/dose at 0, 2 and 6 weeks followed by 5mg/kg/dose every 8 weeks 

Requests for higher doses of infliximab must provide a description of symptoms and HBI score on standard dosing and may include laboratory support of infliximab levels for consideration of case-by-case consideration.

Duration of Approval:
- First renewal: 1 year
- Second and subsequent renewals: 2 years

Pediatric patients will be considered case-by-case.

The below criteria are for Infliximab as Remicade. Refer to the ODB formulary for the Limited Use Criteria for Infliximab biosimilars which was updated with the January 2023 ODB Formulary Update.

Remicade for fistulizing Crohn's disease: 

Actively draining perianal or enterocutaneous fistula(e) that have recurred or persist despite a course of: 

  • appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole); AND 

  • immunosuppressive therapy (azathioprine or 6-mercaptopurine therapy). 

Recommended dose:
Infliximab 3 doses of 5mg/kg/dose, administered at 0, 2 and 6 weeks. 

Duration of Approval: 6 months

If the patient has been using a higher dosing regimen over the past year, the requesting MD must provide the rationale for this dose by comparing the patient’s symptoms on standard dosing and the current dosing. Then the request should be sent for external review. 

Renewal of funding of patients using Remicade for the treatment of fistulizing Crohn’s Disease will be considered for patients with resolution of fistulae. 

The planned dosing regimen for the requested biologic should be provided. The recommended dose for the treatment of Crohn’s Disease is 5 mg/kg/dose at 0, 2 and 6 weeks followed by 5mg/kg/dose every 8 weeks with up to 10 mg/kg/dose every 8 weeks being considered on a case-by-case basis. 

Approval duration of first renewal: 6 months to 1 year pending fistula(e) resolution 

Approval duration of second and subsequent renewals: 2 years with complete resolution; case-by-case duration with partial resolution

Initial induction requests for infliximab for patients with mild Ulcerative Colitis (Mayo score below 6) may be considered for Infliximab as Inflectra on a case-by-case basis through EAP but the submission must include the rationale for coverage. 

Patients treatment experienced to Remicade and transitioning to public funding must meet the initiation (induction) criteria before consideration of funding of maintenance under renewal criteria will be applied.

For the treatment of ulcerative colitis disease in patients who meet the following criteria:

Induction (Initiation) Criteria:

Moderate disease:

  1. Mayo score between 6 and 10 (inclusive); AND 

  2. *Endoscopic subscore of 2; AND 

  3. Failed 2 weeks of oral prednisone ≥ 40mg (or IV equivalent for at least 1 week) AND 3 months of azathioprine (AZA)/ 6-mercaptopurine (6-MP) (or where the use of immunosuppressants is contraindicated**)
    OR
    Stabilized with 2 weeks of oral prednisone ≥40mg (or a 1-week course of IV equivalent) but the prednisone dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated**)

*The endoscopy procedure must be done within the last year but does not have to be full endoscopy. 

**Contraindication to Aza/6MP includes pancreatitis, allergic reaction [fever and/or rash and arthritis], malaise, diarrhea and hepatitis 

Approved Dose:
Infliximab: 5mg/kg/dose at 0, 2 and 6 weeks followed by 5mg/kg/dose every 8 weeks. 

Approval duration: 6 months

Severe disease:

  1. Mayo score >10; AND 

  2. Endoscopy* subscore of 2 or more; AND

  3. Failed 2 weeks of oral prednisone ≥40mg (or 1 week IV equivalent)
    OR
    Stabilized with 2 weeks of oral prednisone ≥40mg (or 1 week of IV equivalent) but the prednisone dose cannot be tapered despite 3 months of Aza/6MP (or where the use of immunosuppressants is contraindicated**)

*The endoscopy procedure must be done within the last year but does not have to be full endoscopy.

**Contraindication to Aza/6MP includes pancreatitis, allergic reaction [fever and/or rash and arthritis], malaise, diarrhea and hepatitis

Approval duration: 6 months 

Dose:
Remicade: 5mg/kg/dose at 0, 2 and 6 weeks followed by 5mg/kg/dose every 8 weeks.

Maintenance (Renewal) Criteria for first renewal:

After 3 loading doses of Remicade, if Mayo score below 6 AND 50% reduction in prednisone from the starting dose

Approval duration: 6 months

If After 3 loading doses of Remicade if Mayo score below6 AND patient is no longer on prednisone

Approval duration: 12 months

Approved Dose:
Infliximab 5mg/kg/dose up to every 6 weeks

Maintenance (Renewal) Criteria for second and subsequent renewals:

  1. Mayo score below 6* AND 

  1. Must be off steroids

Patients who remain on steroids will be considered on a case-by-case basis.

Approval duration: 12 months to up to 2 years for those off steroids

Approved Dose: 5 mg/kg/dose up to every 6 weeks

1Note that the endoscopy procedure must be done within the last year but does not have to be full endoscopy. 

Pediatric patients will be considered case-by-case.

EAP Drug Request Form:

Standard Form for EAP Drug Requests
Ocular Treatments

Adalimumab – See Formulary for funded biosimilars

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

Infliximab – See formulary for funded biosimilars

  • Brand(s): Remicade and formulary listed biosimilars
  • Dosage Form/Strength: 100 mg/Vial Injection for infusion

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 meeting 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

  4. Patient must be followed by a uveitis specialist, a retina specialist familiar with ocular inflammatory diseases, or a pediatric ophthalmologist.

Approved Dose: 

Adalimumab 40 mg subcutaneous every 1 to 2 weeks. 

Infliximab 5-10 mg/kg IV at weeks 0, 2, 6 and maintenance every 4-8 weeks 

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. 

Duration of Approval: 2 years

EAP Drug Request Form:

Standard Form for EAP Drug Requests
Juvenile Spondyloarthritis or Enthesitis-Related Arthritis

Adalimumab – see Formulary for funded biosimilars

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

Etanercept – see Formulary for funded biosimilars

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

Infliximab – see Formulary for funded biosimilars

  • Brand(s): Remicade and formulary listed biosimilars
  • Dosage Form/Strength: 100 mg/vial

Updated: March 29, 2021

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 juvenile spondyloarthritis (JSpA) or enthesitis-related arthritis (ERA) in patients who meet the following criteria for either axial or peripheral disease: 

Axial Disease 

  1. Age of disease onset ≤ 16 years; AND 

  2. Low back pain and stiffness for > 3 months that improve with exercise and not relieved by rest; AND 

  3. Failure to respond to or documented intolerance to adequate trials of 2 nonsteroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND 

  4. BASDAI score of ≥ 4 after at least 4 weeks of standard NSAID therapy; AND 

  5. Imaging evidence of severe active disease by X-ray, CT scan or MRI 

The details of imaging reports for severe active disease must provide the following:

  • X-ray or CT scan report stating the presence of “SI joint fusion” or “SI joint erosion” OR 

  • MRI report stating the presence of “inflammation” or “edema” or “erosion” of the SI joint. 

Actual imaging reports must be submitted with the request. If the imaging reports do not specify the above findings, the request will be reviewed by external medical experts. The imaging interpretation report from the radiologist or rheumatologist may be submitted along with radiographic report.

Renewal will be considered for patients with objective evidence of at least a 50% reduction in BASDAI score or ≥ 2 absolute point reduction in BASDAI score. 

For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. 

Peripheral Disease 

  1. Age of disease onset ≤ 16 years; AND

  2. ≥ 5 active sites of inflammation attained by a combination of swollen/active joints and/or enthesitis sites (tenderness or swelling at entheseal insertion)

  3. Failure or intolerance to at least one DMARD (sulfasalazine 50 mg/kg/day- maximum 2 grams, or methotrexate 15 mg/m2/week-maximum 25 mg per week) for at least 3 months. 

Renewals will be considered for patients with objective evidence of at least a 20% reduction in active sites over the previous year. There should also be an improvement in number of enthesitis sites. 

For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. Requests that do not meet these criteria will undergo external review. 

The planned dosing regimen for the requested biologic should be provided.

The recommended dose for the treatment of JSpA/ERA is as follows: 

  • Etanercept 0.4mg/kg (max 25 mg) twice weekly or 0.8mg/kg (max 50 mg) once weekly

  • Infliximab 5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of up to 5mg/kg/dose every 6-8 weeks 

  • Adalimumab:
    - If Less than 30 kg, 20 mg SC every 2 weeks
    - If Greater than or equal to 30 kg, 40 mg SC every 2 weeks

Requests for higher doses will be considered on a case-by-case basis.

Duration of Approval of Initials and Renewals: 1 Year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

View Monograph