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).

Ankylosing Spondylitis (AS)/Spondyloarthropathy (SpA)

Documents Criteria

Ankylosing Spondylitis Drugs

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

Certolizumab

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

Etanercept

  • See Formulary for funded biosimilars
  • Brand(s): Enbrel and formulary listed biosimilars
  • Dosage Form/Strength:
    • 25 mg/vial
    • 50 mg prefilled syringe for subcutaneous injection

Golimumab

  • Brand(s): Simponi
  • Dosage Form/Strength:
    • 50 mg/0.5 mL prefilled syringe and autoinjector

Infliximab

  • See Formulary for funded biosimilars
  • Brand(s): Remicade and formulary listed biosimilars
  • Dosage Form/Strength:
    • 100 mg/10 mL intravenous infusion

Secukinumab

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

Indications for Treatment

For the treatment of ankylosing spondylitis (AS) OR psoriatic spondylitis (PS) in patients who have severe active disease with:

  • Age of disease onset: 50 years of age or younger; AND
  • Low back pain and stiffness: For greater than 3 months that improves with exercise and not relieved by rest; AND
  • Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND
  • BASDAI score: ≥ 4 for at least 4 weeks while on standard therapy; AND
  • A list of current concomitant medications related to the AS/PS, including pain medications (if relevant) with dosing regimens provided.

Note: NSAIDs include coxibs; use of DMARDS instead of NSAIDs not acceptable.

Submission Requirements

The information submitted with the request must include the following:

  • Current Concomitant Medications:
    • Related to AS/PS, including pain medications (if relevant).
    • Include dosing regimens.
  • Details of Review of Radiographic Reports for Severe Active Disease:
    • X-ray or CT scan report stating the presence of “SI joint fusion” or “SI joint erosion” OR
    • MRI report stating the presence of “inflammation” or “edema” of the SI joint.
    • Actual radiographic reports must be submitted with the request. If the radiographic reports do not specify the above, the request will be reviewed by external medical experts.
  • Additional Information (if applicable):
    • Schober measurement and chest expansion measurement.
    • Evidence of restricted spinal mobility.
    • If the patient has AS/PS with predominantly peripheral joint involvement, additional information pertaining to trials of DMARDs must be provided, and these requests will be reviewed by external medical experts.

Duration of Approval

  • Initial Approval: 1 year
  • Renewals:
    • First Renewal: 1 year
    • Second and Subsequent Renewals: 5 years

Renewal Criteria:

  • For Renewals Beyond the Second Year:
    • Objective evidence of preservation of treatment effect.
  • General Renewal Requirements:
    • For patients with objective evidence of at least a 50% reduction in BASDAI score or ≥ 2 absolute point reduction in BASDAI score.
    • Provide an update on concomitant medications for AS/PS and whether there has been a reduction in pain medication for AS/PS since initiating the biologic (if applicable).
    • The planned dosing regimen for the requested biologic should be provided.

Recommended Dosing Regimens for AS/PS

  • Adalimumab:
    • 40 mg every two weeks.
  • Certolizumab:
    • 400 mg at weeks 0, 2, and 4.
    • Followed by maintenance therapy 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.
  • Infliximab:
    • 3-5 mg/kg/dose at weeks 0, 2, and 6.
    • Followed by maintenance therapy of up to 5 mg/kg/dose every 6 to 8 weeks.
  • Secukinumab:
    • 150 mg subcutaneously at weeks 0, 1, 2, and 3.
    • Followed by monthly maintenance dosing starting at week 4.
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Biosimilars

 

Biosimilar

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

(Humira)

Manufacturer: AbbVie

No LU CodesSyringe Pen Syringe

LU Code25mg/0.5ml50mg/1ml

Brenzys

Manufacturer: Organon

View LU CodesPen Syringe

Erelzi

Manufacturer: Sandoz

View LU CodesSyringe Pen Syringe

Erelzi

Manufacturer:

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 
  • Secukinumab 
  • Upadacitinib