Exceptional Access Program (EAP)

EAP forms are to be completed when applying for MOH funding for drugs for rheumatological diseases through Ontario’s Exceptional Access Program (EAP).

Systemic Juvenile Idiopathic Arthritis (sJIA)

Documents Criteria

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 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

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/m<sup>2</sup> 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:

a) 24 mg/m<sup>2</sup> (maximum 40 mg) every two weeks; OR
b) 20 mg every 2 weeks, if the Patient weighs less than 30 kg; OR
c) 40 mg every 2 weeks, if the Patient weighs more than 30 kg.

Recommended dosing for tocilizumab in combination with methotrexate:

IV dosing regimen:

a) 10 mg/kg every 4 weeks, if the Patient weighs less than 30kg; OR
b) 8 mg/kg every 4 weeks, if the Patient weighs more than or equal to 30kg.

SC dosing regimen:

a) 162 mg once every 3 weeks if the Patient weighs less than 30kg
b) 162 mg once every 2 weeks if the Patient weighs 30kg or more


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 (Only for those approved for biosimilar exemption)
DOSAGE FORM/ STRENGTH:

  • 100 mg/vial

Rituximab -See formulary for funded biosimilars

Brand(s): Riximyo, Ruxience, and Truxima (biosimilar); Rituxan (Only for those approved for biosimilar exemption)
DOSAGE FORM/ STRENGTH:

  • 10 mg/mL intravenous injection

For the treatment of polyarticular-course juvenile idiopathic arthritis in patients meeting the following criteria;

  • Patient has active disease (a minimum of 3 (three) swollen joints and a total of 5 active joints); AND

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  • Patient has had an inadequate response to a three month course of methotrexate administered subcutaneously at a dosage of at least 15 mg/m<sup>2</sup> 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
  • 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 years

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