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).

Psoriatic Arthritis (PsA)

Documents

Adalimumab

  • See Formulary for funded biosimilars
  • Brand(s): Humira (Only for those approved for biosimilar exemption)
  • 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

Certolizumab

  • Brand(s): Cimzia
  • Dosage Form/Strength:
    • 200 mg/mL prefilled syringe and autoinjector

Etanercept

  • See Formulary for funded biosimilars
  • Brand(s): Enbrel (Only for those approved for biosimilar exemption)
  • Dosage Form/Strength:
    • 25 mg/vial
    • 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

Guselkumab

  • Brand(s): Tremfya
  • Dosage Form/Strength:
    • 100 mg/mL prefilled syringe
    • Patient-controlled injector (AI)
  • Effective Date: November 27, 2023

Secukinumab

  • Brand(s): Cosentyx
  • Dosage Form/Strength:
    • 150 mg/mL prefilled syringe
    • 150 mg/mL prefilled Pen

Ixekizumab

  • Brand(s): Taltz
  • Dosage Form/Strength:
    • 80 mg/mL Autoinjector
    • 80 mg/mL Syringe for subcutaneous injection
  • Effective Date: March 4, 2019

Upadacitinib

  • Brand(s): Rinvoq
  • Dosage Form/Strength:
    • 15 mg tablet
  • Effective Date:
    • November 16, 2022 (PsA)
    • October 31, 2023 (AD)

Indications for Treatment

For the treatment of psoriatic arthritis (PsA) in patients who have:

  • Severe active disease (≥ 5 swollen joints and radiographic evidence of psoriatic arthritis)
    • Despite treatment with methotrexate (20 mg/week) for at least 3 months and one of leflunomide (20 mg/day) or sulfasalazine (1 g twice daily) for at least 3 months.
    • If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20 mg/day) or sulfasalazine (1 g twice daily) for at least 3 months is required.
    • Details of contraindications and intolerances must also be provided.

Approval Duration

  • Initial Approval of Initials: 1 Year
  • Renewals:
    • Duration of Approval:
      • First Renewal: 1 Year
      • Second and Subsequent Renewals: 5 Years
    • Criteria for Renewal:
      • 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 (i.e., the current joint count should be compared to the count prior to initiating treatment with the biologic agent).

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.

Certolizumab:

  • 400 mg at week 0, 2, 4
  • Then maintenance doses of 200 mg every 2 weeks or 400 mg every 4 weeks

Etanercept:

  • 25 mg twice weekly or 50 mg once weekly

Golimumab:

  • 50 mg once a month

Guselkumab:

  • 100 mg subcutaneously at week 0 and 4
  • Then maintenance dose of 100 mg every 8 weeks thereafter.
    • Guselkumab may be used alone or in combination with a conventional DMARD (e.g., methotrexate).

Secukinumab:

  • 150 mg SC at weeks 0, 1, 2, and 3
  • Followed by monthly maintenance dosing starting at week 4.
    • If a patient is an anti-TNFα inadequate responder and continues to have active psoriatic arthritis, consider using the 300 mg SC dose.
    • For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, use the dosing and administration recommendations for plaque psoriasis (i.e., 300 mg SC at weeks 0, 1, 2, and 3, followed by monthly maintenance dosing starting at week 4).

Ixekizumab:

  • For psoriatic arthritis (PsA) patients or those with PsA and coexistent mild plaque psoriasis:
    • 160 mg (two 80 mg injections) SC at Week 0
    • Followed by 80 mg every 4 weeks.
  • For psoriatic arthritis patients with coexistent moderate-to severe plaque psoriasis:
    • 160 mg by subcutaneous injection (two 80 mg injections) at Week 0
    • Followed by 80 mg every 2 weeks for 6 doses (i.e., weeks 2, 4, 6, 8, 10, and 12)
    • Then 80 mg every 4 weeks thereafter.
    • Ixekizumab may be used alone or in combination with a conventional DMARD (e.g., methotrexate).

Upadacitinib:

  • Recommended Dose: 15 mg once daily.
Biosimilars

 

Biosimilar

LU Code20mg/0.2ml20mg/0.4ml40mg/0.4ml40mg/0.8ml80mg/0.8ml

Abrilada

Manufacturer: Pfizer

View LU CodesPen Syringe

Amgevita

Manufacturer: Amgen

View LU CodesSyringe Pen Syringe

Hadlima

Manufacturer: Organon

View LU CodesPen Syringe Pen Syringe

Hulio

Manufacturer: Biocon (BGP)

View LU CodesSyringe Pen Syringe

Hyrimoz

Manufacturer: Sandoz

View LU CodesSyringe Pen Syringe

Idacio

Manufacturer: Fresenius Kabi

View LU CodesPen Syringe

Simlandi

Manufacturer: Jamp Pharma

View LU CodesPen Syringe Syringe

Yuflyma

Manufacturer: Celltrion

View LU CodesPen Syringe Pen Syringe

LU Code25mg/0.5ml50mg/1ml

Brenzys

Manufacturer: Organon

View LU CodesPen Syringe

Erelzi

Manufacturer: Sandoz

View LU CodesSyringe Pen Syringe

Rymti

Manufacturer: Sandoz

View LU CodesPen Syringe

LU Code

Avsola

Manufacturer: Amgen

View LU Codes

Inflectra

Manufacturer: Pfizer

View LU Codes

Renflexis

Manufacturer: Organon

View LU Codes

Remsima

Manufacturer: Celltrion

View LU Codes

LU Code45mg/0.5mL90mg/0.9mL

Jamteki

Manufacturer: Jamp Pharma Corp

View LU CodesSyringe Syringe

Wezlana Amgen

Manufacturer: Amgen

View LU CodesSyringe Syringe
Originators
  • Certolizumab
  • Golimumab
  • Guselkumab
  • Ixekizumab
  • Secukinumab
  • Upadacitinib