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).

Ocular Inflammatory Disease

Documents Criteria

Tocilizumab

  • Brand(s): Actemra
  • Dosage Form/Strength:
    • 162 mg/0.9 mL inj (PFS)
    • 162 mg/0.9 mL Auto Inj.
  • Effective Date: August 11, 2015

For the treatment of new onset or relapsed Giant Cell Arteritis (GCA) in adult patients meeting all the following criteria:

  • Symptomatic for GCA; AND
  • Diagnosis of GCA confirmed by temporal artery biopsy and/or imaging tests (magnetic resonance angiography, computed tomography angiography, or positron emission scanning); AND
  • Tocilizumab subcutaneous is used as combination therapy with 20 mg to 60 mg of prednisone (or an equivalent corticosteroid) with subsequent corticosteroid tapering as symptoms stabilize; AND
  • Prescribed by a rheumatologist or a prescriber with expertise in the diagnosis and management of GCA.

Note: Where these tests are not available or results may be deemed unreliable, C-reactive protein and/or Erythrocyte Sedimentation Rate results may be submitted.

Recommended Dose:

  • 162 mg subcutaneously once a week (or once every other week, based on clinical considerations) in combination with a tapering course of corticosteroid.

Approval Duration: 1 year

Renewals:

  • Renewals will be considered on a case-by-case basis.
  • Duration of Renewals: 1 year

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

For the treatment of severe non-infectious ocular inflammatory disease (OID) in patients meeting one of the following criteria:

  • Experienced failure, intolerance, or contraindication to oral corticosteroid (or topical corticosteroid for anterior uveitis) and failure or intolerance to at least one immunosuppressive therapy; OR
  • Treatment of chronic Juvenile Idiopathic Arthritis (JIA)-associated uveitis after failure or intolerance to a first-line immunosuppressive agent; OR
  • Patients with immediately vision-threatening OID not meeting the above criteria, confirmed by consultation notes/letter from an ophthalmologist expert specializing in OIDs, detailing rationale for immediate biologic therapy (e.g., ocular inflammation associated with Behçet’s disease; severe non-necrotizing scleritis; necrotizing scleritis); AND
  • Patient must be followed by a uveitis specialist, retina specialist familiar with ocular inflammatory diseases, or a pediatric ophthalmologist.

Approved Dose:

  • 40 mg subcutaneous every 1 to 2 weeks.

Approval Duration: 1 year

Renewals:

  • Renewals will be considered where consultation notes or a letter confirms treatment has resulted in improvement/stability of vision and other treatment goals have been met.
  • Duration of Renewals: 2 years

Infliximab

  • See Formulary for funded biosimilars
  • Brand(s): Remicade (Only for those approved for biosimilar exemption)
  • Dosage Form/Strength:
    • 100 mg/Vial Injection for infusion

For the treatment of severe non-infectious ocular inflammatory disease (OID) in patients meeting one of the following criteria:

  • Experienced failure, intolerance, or contraindication to oral corticosteroid (or topical corticosteroid for anterior uveitis) and failure or intolerance to at least one immunosuppressive therapy; OR
  • Treatment of chronic Juvenile Idiopathic Arthritis (JIA)-associated uveitis after failure or intolerance to a first-line immunosuppressive agent; OR
  • Patients with immediately vision-threatening OID not meeting the above criteria, confirmed by consultation notes/letter from an ophthalmologist expert specializing in OIDs, detailing rationale for immediate biologic therapy (e.g., ocular inflammation associated with Behçet’s disease; severe non-necrotizing scleritis; necrotizing scleritis); AND
  • Patient must be followed by a uveitis specialist, retina specialist familiar with ocular inflammatory diseases, or a pediatric ophthalmologist.

Approved Dose:

  • 5-10 mg/kg IV at weeks 0, 2, and 6, with maintenance every 4-8 weeks.

Approval Duration: 1 year

Renewals:

  • Renewals will be considered where consultation notes or a letter confirms treatment has resulted in improvement/stability of vision and other treatment goals have been met.
  • Duration of Renewals: 2 years

Rituximab

  • Brand(s): Riximyo, Ruxience, and Truxima (biosimilar); Rituxan (Only for those approved for biosimilar exemption)
  • Dosage Form/Strength:
    • 10 mg/mL intravenous injection
  • Effective Date: August 11, 2015

For the treatment of severe non-infectious ocular inflammatory disease (OID) in patients who failed or did not tolerate treatment with infliximab or adalimumab, or have a contraindication to anti-TNF therapy, and who meet one of the following criteria:

  • Experienced failure, intolerance, or contraindication to oral corticosteroid (or topical corticosteroid for anterior uveitis) and failure or intolerance to at least one immunosuppressive therapy; OR
  • Treatment of chronic Juvenile Idiopathic Arthritis (JIA)-associated uveitis after failure or intolerance to a first-line immunosuppressive agent; OR
  • Patients with immediately vision-threatening OID not meeting the above criteria, confirmed by consultation notes/letter from an ophthalmologist expert specializing in OIDs, detailing rationale for immediate biologic therapy; AND
  • Patient must be followed by a uveitis specialist, retina specialist familiar with ocular inflammatory diseases, or a pediatric ophthalmologist.

Approved Dose:

  • Up to 1000 mg IV per infusion on days 1 and 15, with a third infusion at 6-12 months.
  • Note: Maintenance infusions are not funded.

Approval Duration: 1 year

Renewals:

  • Renewals will be considered where consultation notes or a letter confirms treatment has resulted in improvement/stability of vision and other treatment goals have been met.
  • Patients must also demonstrate subsequent deterioration of symptoms, at least 6 months from the last dose of rituximab.
  • Duration of Renewals: 2 years
Read More
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 Code

Truxima

Manufacturer: Teva

View LU Codes

Riximyo

Manufacturer: Sandoz

View LU Codes

Ruxience

Manufacturer: Pfizer

View LU Codes
Originators
  • Tocilizumab