Ocular Inflammatory Disease
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