Orencia (Preservative Free)

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

Abatacept

• Brand(s): Orencia
• Dosage Form/Strength: 250 mg/15 mL intravenous injection, 125 mg/mL pre-filled syringe for subcutaneous injection

For the treatment of adult patients with severe active rheumatoid arthritis who meet the following criteria:

The Patient has severe active disease as demonstrated by:

• ≥5 swollen joints; AND

• rheumatoid factor positive; AND/OR

• having radiographic evidence of rheumatoid arthritis

Despite the optimal* use of various disease-modifying anti-rheumatic drugs (“DMARDs”).

*For the purpose of the criteria, the optimal use of DMARDs is defined as:

• use of methotrexate (dosed at 20 mg per week) for at least 3 months; AND

• use of leflunomide (dosed at 20 mg per day) for at least 3 months; AND

• an adequate trial (3 months) of at least one combination of DMARDs;

  OR

• use of methotrexate (dosed at 20 mg per week) for at least 3 months; AND

• leflunomide in combination with methotrexate for at least 3 months.

Note: If the patient cannot be treated with 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 why other DMARDs cannot be considered.

For patients who have failed treatment with an anti-TNF therapy due to lack of efficacy or toxicity, prescribers should consider use of a biologic with a different mechanism of action.

Approved Dosing:

IV use: The initial dose is administered at 0, 2, and 4 weeks then every 4 weeks thereafter. Note that funding for higher doses will not be considered.
Doses based on body weight:
- Less than 60 kg, 500 mg
- 60-100 kg, 750 mg
- >100 kg, 1 gram

SC use: 125 mg SC weekly. Note that an IV loading dose of 750 mg may be given prior to initiating the weekly SC dosing. (Please refer to the Orencia product monograph for further details.)

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

Renewals will be considered in patients with objective evidence of at least a twenty percent (20%) reduction in swollen joint count and a minimum of improvement in two (2) swollen joints over the previous year.

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

EAP Drug Request Form:

Standard Form for EAP Drug Requests