Exceptional Access Program (EAP)

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/0.8 mL prefilled syringe
  • 40 mg/0.8 mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection

Tocilizumab

• Brand(s): Actemra
• Dosage Form/Strength:
  • 80 mg/4 mL Vial
  • 200 mg/10 mL Vial
  • 400 mg/20 mL Vial
  • 162 mg/0.9 mL Inj (Prefilled syringe)
  • 162 mg/0.9 mL Auto Injector

Abatacept

• Brand(s): Orencia
• Dosage Form/Strength:
  • 250 mg/15 mL vial (Note: 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 (biosimilars); Rituxan (Only for those approved for biosimilar exemption)
• Dosage Form/Strength:
  • 10 mg/mL intravenous injection

Indications for Treatment

For the first-line treatment of polyarticular-course juvenile idiopathic arthritis (JIA) in patients meeting the following criteria:

• 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.

Approval Duration

• Initial Approval: 1 Year
• Renewals:
  • Duration of Approval: 5 Years
  • Criteria for Renewal:
    • Patients with objective evidence of at least a 20% reduction in swollen joint count.
    • 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 (i.e., the current joint count should be compared to the count prior to initiating treatment with the biologic agent).

Renewal Criteria

• For Renewals Beyond the Second Year:
  • Objective evidence of preservation of treatment effect.
• General Renewal Requirements:
  • Patients must demonstrate at least a 20% reduction in swollen joint count.
  • Improvement in the number of swollen joints.
  • The planned dosing regimen for the requested biologic should be provided.

Recommended Dosing Regimens

Etanercept:

• The planned dosing regimen should be provided.
• Maximum Recommended Dose: 50 mg once weekly.

Adalimumab:

• a) 24 mg/m² (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.

Tocilizumab in Combination with Methotrexate:

• IV Dosing Regimen:
  • a) 10 mg/kg every 4 weeks, if the patient weighs less than 30 kg; OR
  • b) 8 mg/kg every 4 weeks, if the patient weighs ≥ 30 kg.
• SC Dosing Regimen:
  • a) 162 mg once every 3 weeks, if the patient weighs less than 30 kg
  • b) 162 mg once every 2 weeks, if the patient weighs ≥ 30 kg