Erelzi

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.

The recommended dosing regimen is 50mg per week or 25mg twice weekly."

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 50mg per week or 25mg twice weekly.

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 for pediatric patients ages 4 to 17 years with active pJIA is 0.8mg/kg per week (up to a maximum of 50mg per week).

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

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 treatment with methotrexate (20mg/week) for at least 3 months and one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months.

Maintenance/Renewal:

After 12 months of treatment, maintenance therapy is funded 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, 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 50mg per week or 25mg twice weekly.

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

For the treatment of severe* plaque psoriasis in patients 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%, 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, AND

12 week trial of phototherapy (unless not accessible), AND

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 etanercept: 

The recommended dose is 50mg subcutaneous twice weekly for 12 weeks followed by maintenance therapy at 25-50mg subcutaneous once weekly 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.

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

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

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

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

Adalimumab – See 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

Etanercept – see 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

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