Actemra

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

Tocilizumab

• 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

For the treatment of rheumatoid arthritis in adult patients with:

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

2. Failure to respond to optimal use¹ of DMARDs or with documented intolerance to DMARDs (per current EAP reimbursement criteria for anti-TNF agents).

¹Optimal use of DMARDs (hydroxychloroquine, methotrexate, sulfasalazine, leflunomide, cyclosporine, azathioprine, penicillamine, chloroquine and gold compounds) defined as:

• 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 the contraindication(s) or intolerance(s) must be provided along with details of trials of other DMARDs or clear rationale as to why other DMARDs cannot be considered.

  OR

• Methotrexate (20 mg/week), sulfasalazine (2 G/day) and hydroxychloroquine (400 mg/day)² for at least 3 months.
  Note: 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.

²Hydroxychloroquine is based by weight up to 400 mg per day

The requesting physician is required to provide the planned dosing regimen on the request.

The following are the recommended doses for tocilizumab (Actemra) IV and SC for rheumatoid arthritis:

IV recommended dose:
Approval for 4mg/kg/dose once every 4 weeks followed by an increase to 8mg/kg/dose based on clinical response; even for individuals whose body weight is more than 100kg, doses exceeding 800mg per infusion are not recommended

SC recommended dose:
- For patients less than 100 kg weight, starting dose of 162 mg every other week, followed by an increase to every week based on clinical response.
- For patients at or above 100 kg weight, 162 mg every week.

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 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

Duration of Second and Subsequent Renewals – 5 Years

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Tocilizumab

• Brand(s): Actemra
• Dosage Form/Strength: 162 mg/0.9 mL inj (PFS), 162mg/0.9mL Auto Inj.

Tocilizumab

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