Product Details

Hulio

Adalimumab
20 mg/0.4 mL
Solution for Injection
0.4-mL Prefilled Syringe (Preservative-Free)

DIN/PIN/NPN

02502380

Manufacturer

BGP Pharma ULC

Formulary Listing Date

2022-05-31  

Unit Price

235.6350

Amount MOH Pays

235.6350

Coverage Status

Limited Use Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L04AB04

Interchangeable Products

NO  

LU Clinical Criteria

LU Code Auth. Period Clinical Criteria
600 1 year

For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments:

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.)

Maintenance/Renewal:

After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year.

For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect.

Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology.

Approvals will only allow for standard dosing for adalimumab.

The recommended dosing regimen is 40mg every two weeks

601 1 year

For the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/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 should be documented.

Maintenance/Renewal:

After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect.

Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology.

The recommended dosing regimen is for pediatric patients 2 years of age and older:

- 10kg to less than 30kg: 20mg every other week*

- 30kg and greater: 40mg every other week

*a dose of 10mg every other week can be considered for patients weighing 10kg to less than 15kg

It should be noted that some adalimumab products may not be available as 20mg injectables.

Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats

602 1 year

For the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months.

If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required.

Maintenance/Renewal:

After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect.

Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology.

The recommended dosing regimen is 40mg every 2 weeks.

Higher doses may be considered case-by-case through the Exceptional Access Program

603 1 year

For the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with:

- Age of disease onset equal to or younger than 50; AND

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

- 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

- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy.

Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint.

Maintenance/Renewal:

After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect.

Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. 

The recommended dosing regimen is 40mg every 2 weeks.

Higher doses may be considered case-by-case through the Exceptional Access Program.

604 1 year

For the treatment of moderate to severe (luminal) Crohn's Disease in patients who meet the following criteria:

A. Harvey Bradshaw Index (HBI) score greater than or equal to 7; AND

B. Failed to respond to conventional treatment with a corticosteroid equivalent to a daily dose of prednisone 40mg daily for at least 2 weeks OR the patient is stabilized on corticosteroid but cannot be tapered to a corticosteroid dose below prednisone 20mg daily or equivalent; AND

C. Failed to respond to an immunosuppressive agent (azathioprine, 6-mercaptopurine, methotrexate, or cyclosporine) tried for at least 3 months (or where the use of immunosuppressants is contraindicated).

Approvals will only allow for standard dosing for adalimumab.

The recommended dosing regimen is 160mg at week 0; 80mg at week 2; followed by 40mg every two weeks.

Maintenance/Renewal:

Maintenance therapy is funded for patients who meet the Ministry initiation criteria and whose disease is maintained with a 50% reduction in the HBI from pre-treatment measurement, AND improvement of symptoms (e.g., absence of bloody diarrhea, weight is stable or increased), AND no longer using corticosteroids.

For continued funding beyond the first year, the patient must continue to demonstrate benefit and if unable to be discontinued on corticosteroids, the physician may wish to consider other funded alternatives.

Approvals will only allow for standard dosing for adalimumab.

The recommended dosing regimen is 40mg every 2 weeks

605 1 year

For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria:

A. Patient has 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 (e.g., azathioprine or 6-mercaptopurine); AND

B. Harvey Bradshaw Index (HBI) score greater than or equal to 7

Approvals will only allow for standard dosing for adalimumab.

The recommended dosing regimen for induction is 160mg at week 0, followed by 80mg at week 2, then 40mg every other week.

Maintenance/Renewal:

Maintenance therapy is funded for patients who meet the Ministry initiation criteria and achieve and maintain response to therapy.

Approvals will only allow for standard dosing for adalimumab.

The recommended dosing regimen is 40mg every other week

606 1 year

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

1. Moderate disease

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

b. Endoscopic* subscore of 2; AND

c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or a 1-week course of IV equivalent) and 3 months of azathioprine (AZA)/6-mercatopurine (6-MP) (or where the use of immunosuppressants is contraindicated);
OR
Stabilized with 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated).

2. Severe disease

a. Mayo score greater than 10; AND

b. Endoscopy* subscore of greater than or equal to 2; AND

c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or 1 week IV equivalent)
OR
Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid 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 12 months prior to initiation of treatment.

Approvals will only allow for standard dosing for adalimumab.

The recommended dosing regimen for induction is 160mg at week 0, followed by 80mg at week 2, then 40mg every other week.

Maintenance/Renewal:

Maintenance therapy is funded for patients who meet the Ministry initiation criteria and whose disease is maintained at Mayo score less than 6 AND who demonstrate at least 50% reduction in the dose of prednisone compared with the starting dose following the first 6 months of treatment with adalimumab or be off corticosteroids after the first year of treatment.

Approvals will only allow for standard dosing for adalimumab.

The recommended dosing regimen is 40mg every other week

607 1 year

For the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following:

A. A total abscess and nodule count of 3 or greater; AND

B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND

C. Experienced an inadequate response to a 90-day trial of oral antibiotics.

Therapy must be prescribed by a practitioner with expertise in the management of patients with HS.

The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter.

The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response.

If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment.

Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.

Maintenance/Renewal:

Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline.

Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab).

The recommended maintenance dose is 40mg weekly.

Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats

609 1 year

For the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**.

Claims for the first 6 months must be written by a dermatologist.

Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required.

Patients not responding adequately at 12 weeks should have treatment discontinued.

*Definition of severe plaque psoriasis:

Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND

Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND

Dermatology Life Quality Index (DLQI) score of at least 10.

**Definition of failure, intolerance or contraindication to adequate trials of standard therapies:

6-month trial of at least 3 topical agents including vitamin D analogues and steroids

12-week trial of phototherapy (unless not accessible)

6-month trial of at least 2 systemic, oral agents used alone or in combination

- Methotrexate 15-30mg per week
- Acitretin (could have been used with phototherapy)
- Cyclosporine

Maintenance/Renewal:

After 3 months of therapy, patients who respond to therapy should have:

- at least a 50% reduction in PASI, AND
- at least a 50% reduction in BSA involvement, AND
- at least a 5-point reduction in DLQI score

Approvals will only allow for standard dosing for adalimumab.

The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada.

If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent

611 1 year

For the treatment of severe uveitis in patients meeting the following criteria:

A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND

B. Treatment must be prescribed by an ophthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases.

Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program.

The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subsubcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses.

The recommended dose for pediatric patients (2 years of age and older) with anterior uveitis is:

Less than 30kg: 20mg every other week in combination with methotrexate

30kg or greater: 40mg every other week in combination with methotrexate

For patients 6 years of age or older and less than 30kg, an optional loading dose of 40mg at week 0 may be administered before starting maintenance therapy.

For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy.

It should be noted that some adalimumab products may not be available as 20mg injectables.

Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.

Maintenance/Renewals:

Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g., reduction or control of ocular inflammation)

 

EAP Criteria

Therapeutic Class Reimbursement Criteria
Polyarticular Juvenile Idiopathic Arthritis

Etanerceptsee 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

Adalimumabsee 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

Adalimumabsee 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

Etanerceptsee 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

Infliximabsee 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

AdalimumabSee 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

EtanerceptSee 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

Dermatology Drugs

AdalimumabSee 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

For the treatment of adult patients with active moderate to severe hidradenitis suppurativa who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: 

  • A total abscess and nodule count of 3 or greater 

  • Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III 

  • An inadequate response to a 90-day trial of oral antibiotics 

  • Prescribed by a practitioner with expertise in the management of patients with HS 

  • Note: Treatment with adalimumab should be discontinued if there is no improvement after 12 weeks of treatment 

First renewal: 

  • Requests for renewal should provide objective evidence of a treatment response, defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline at week 12. 

Subsequent renewal: 

  • For renewals beyond the second year, objective evidence of the preservation of treatment effect should be provided (i.e., the current AN (abscess and inflammatory nodule) count and draining fistula count should be compared to the count prior to initiating treatment with adalimumab). 

Approval duration: 

  • Initial approval: 3 months 

  • First renewals: 1 year 

  • Subsequent renewals: 2 years

Recommended dose: 

  • The recommended dose is 160 mg initially (week 0), followed by 80 mg at week 2, then 40 mg at week 4, and 40 mg weekly thereafter

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Inflammatory Bowel Diseases

AdalimumabSee 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

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 Adalimumab as Humira. Refer to the ODB formulary for the Limited Use Criteria for Adalimumab biosimilars which was updated with the January 2023 ODB Formulary Update. 

For the treatment of fistulising Crohn’s disease with concomitant luminal disease in patients who meet the following criteria:

  1. Patient with 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 (e.g. azathioprine or 6-mercaptopurine) AND 

  2. Harvey Bradshaw Index (HBI) score 7 

The dose that will be considered is Adalimumab 160 mg at week zero, 80 mg at week two, followed by 40 mg every two weeks.

Duration of Approval: 3 months 

Renewal will be considered based on the response to therapy. 

The dose that will be considered on renewals is Adalimumab 40 mg every two weeks. All requests for higher doses will not be approved. 

Duration of Approval: 3 months to 1 year pending fistula(e) resolution

Second Renewal:

  • 2 years for 2nd renewal of requests with complete resolution
  • Case-by-case duration for renewal of requests with partial resolution.

Pediatric patients will be considered case-by-case.


The below criteria are for Adalimumab as Humira. Refer to the ODB formulary for the Limited Use Criteria for Adalimumab 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. 

The recommended dose:
Adalimumab: 160mg at week 0; 80mg at week 2; followed by 40mg every two weeks

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 Adalimumab as Humira. Refer to the ODB formulary for the Limited Use Criteria for Adalimumab biosimilars which was updated with the January 2023 ODB Formulary Update. 

For the treatment of ulcerative colitis disease in adult patients1 who meet the following criteria:

Induction Criteria:

Mild disease:

  1. Mayo score below 6; AND 

  1. Patients with mild disease will be considered on a case-by-case basis BUT submission must include the rationale for coverage 

Moderate disease:

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

  1. Endoscopic* subscore of 2; AND 

  1. Failed 2 weeks of oral prednisone at daily doses ≥40mg (or a 1-week course of IV equivalent) AND 3 months of azathioprine (AZA)/ 6-mercaptopurine (6MP) (or where the use of immunosuppressants is contraindicated);
    OR

    Stabilized with 2 weeks of oral prednisone at daily dose 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) 

Severe disease:

  1. Mayo score > 10; AND 

  1. Endoscopic* subscore of ≥ 2; AND 

  1. Failed 2 weeks of oral prednisone at daily dose 40mg (or 1 week IV equivalent);
    OR
    Stabilized with 2 weeks 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)

Initial Approval: 6 months at 160 mg initially administered at week 0, followed by 80mg at week 2, then 40 mg every other week thereafter. 

*The endoscopy procedure must be done within the 12 months prior to initiation of treatment.

Maintenance Criteria:

After 8 weeks of adalimumab therapy: 

  1. Mayo score below 6; AND 

  1. 50% reduction in prednisone from the starting dose

Approval: 6 months at 40mg every other week. 

If patient is completely off steroids:

Approval: 12 months at 40 mg every other week.

Subsequent renewals:

  1. Mayo score below 6; AND 

  1. Must be completely off steroids

Approval: 2 years at 40mg every other week.
(
Patients who remain on steroids will be considered on a case-by-case basis)
 

1Pediatric patients will be considered case-by-case.

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Ocular Treatments

AdalimumabSee 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

InfliximabSee 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

Psoriatic Arthritis Treatments

AdalimumabSee Formulary for funded biosimilars

  • Brand(s): Humira and formulary listed biosimilars
  • Dosage Form/Strength: 40 mg/0.8 mL prefilled syringe, 40 mg/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

Etanerceptsee Formulary for funded biosimilars

  • Brand(s): Enbrel and formulary listed biosimilars
  • Dosage Form/Strength: 25 mg/vial and 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

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 psoriatic arthritis in patients who have:

  • Severe active disease (≥ 5 swollen joints and radiographic evidence of psoriatic arthritis) despite treatment with methotrexate (20 mg/week) for at least 3 months and one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. 

If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20 mg/day) or sulfasalazine (1 g twice daily) for at least 3 months is required. Details of contraindications and intolerances must also be provided. 

Duration of Approval of initials: 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 of first renewal: 1 Year 

The planned dosing regimen for the requested biologic should be provided. The recommended doses for the treatment of psoriatic arthritis are as follows: 

  • Adalimumab 40mg every two weeks 

  • Certolizumab 400 mg at week 0, 2, 4 then maintenance doses of 200 mg every 2 weeks or 400 mg every 4weeks 

  • Etanercept 25 mg twice weekly or 50mg once weekly 

  • Golimumab 50 mg once a month 

  • Secukinumab 150mg SC at weeks 0, 1, 2, and 3 followed by monthly maintenance dosing starting at week 4. If a patient is an anti-TNF-alpha inadequate responder and continues to have active psoriatic arthritis, consider using the 300 mg SC dose.

For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, use the dosing and administration recommendations for plaque psoriasis (i.e., 300 mg SC at weeks 0, 1, 2, and 3, followed by monthly maintenance dosing starting at week 4) 

Duration of Approval of second and subsequent renewals: 5 years

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Juvenile Spondyloarthritis or Enthesitis-Related Arthritis

Adalimumabsee 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

Etanerceptsee Formulary for funded biosimilars

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

Infliximabsee 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