Tyenne

For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments:

A. i) Methotrexate (20mg/week) for at least 3 months, AND
ii) leflunomide (20mg/day) for at least 3 months, in addition to
iii) an adequate trial of at least one combination of DMARDs for 3 months; OR

B. i) Methotrexate (20mg/week) for at least 3 months, AND
ii) leflunomide in combination with methotrexate for at least 3 months; OR

C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.); AND

Tocilizumab is not being used in combination with another biologic drug used for the treatment of RA; AND

Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology.

Maintenance/Renewal:
After 12 months of treatment, ongoing maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints compared to baseline prior to the use of tocilizumab.

For second and subsequent renewals (i.e., beyond 2 years of ongoing use of tocilizumab) the patient must demonstrate objective evidence of preservation of treatment effect.

For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of RA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology.

Recommended Dose:
The recommended intravenous dose of tocilizumab for adult patients is 4mg/kg followed by an increase to 8mg/kg (up to 800mg per dose as per product monograph) based on clinical response, given once every 4 weeks.
The recommended subcutaneous dose of tocilizumab for adult patients weighing less than 100kg is a starting dose of 162mg sc every other week, followed by an increase to every week based on clinical response; AND
For patients weighing 100kg or more, a dosage of 162mg sc every week is recommended.

For the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15 mg/m?2; 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 documented.

Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology.
Tocilizumab is not being used in combination with another biologic drug used for the treatment of pJIA.

Maintenance/Renewal:
After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints compared to baseline prior to the start of tocilizumab therapy.

For second and subsequent renewals (i.e., beyond 2 years of ongoing use of tocilizumab) the patient must demonstrate objective evidence of preservation of treatment effect.

For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of pJIA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology.

Recommended Dose:
The recommended intravenous (IV) dose of tocilizumab for patients 2 years of age and older:

• 10mg/kg IV every 4 weeks for patients weighing less than 30kg
• 8mg/kg IV every 4 weeks for patients weighing 30kg or greater (up to 800mg per dose as per product monograph)

The recommended subcutaneous (sc) dose of tocilizumab for patients 2 years of age and older:

• 162mg sc once every 3 weeks for patients weighing less than 30kg.
• 162mg sc once every 2 weeks for patients weighing 30kg or greater.

For the treatment of systemic juvenile idiopathic arthritis (sJIA) in patients who meet all the following:

1. Patient is at least 2 years of age; AND

2. Diagnosed with sJIA with fever (temperature greater than 38 degrees Celsius) for at least two weeks; AND

3. Patient has at least one of the following:
   •rash of systemic JIA; OR
   •serositis (e.g. pericarditis, pleuritis, or peritonitis); OR
   •lymphadenopathy (e.g. cervical, axillary, inguinal); OR
   •hepatomegaly; OR
   •splenomegaly

4. Other potential etiologies such as malignancies, serious clinical infections, other inflammatory or connective tissue diseases, have been ruled out by the prescriber; AND

5. Patient was less than 16 years of age at the onset of sJIA; AND

6. Systemic glucocorticoids cannot be used for one or more of the following reasons:
   •The patient is unresponsive and/or refractory to systemic glucocorticoids; OR
   •The patient is glucocorticoid dependent (i.e., the patient has experienced a systemic reaction such as fever, rash of sJIA, serositis, lymphadenopathy, hepatomegaly or splenomegaly while on tapering doses of systemic glucocorticoids); OR
   •The patient has experienced an adverse drug reaction to a systemic glucocorticoid; OR
   •The use of systemic glucocorticoids is contraindicated; AND

7. Tocilizumab is not being used in combination with another biologic drug used for the treatment of sJIA; AND

8. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology

Maintenance/Renewals:
Renewal will be considered for patients who have at least a 50% reduction in glucocorticoid dose (unless contraindicated, not tolerated, unresponsive or refractory at the time of initial request) and no evidence of active systemic disease (e.g., fever, rash of sJIA, serositis, lymphadenopathy, hepatomegaly or splenomegaly).

For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect.

For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of sJIA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology.

Recommended Dose:
The recommended intravenous (IV) dose of tocilizumab for patients 2 years of age and older:
•12mg/kg IV every 2 weeks for patients less than 30kg
•8mg/kg IV every 2 weeks for patients weighing 30kg or more (up to 800mg per dose as per product monograph).

The recommended subcutaneous (sc) dose of tocilizumab for patients 2 years of age and older:
•162mg sc once every 2 weeks for patients less than 30kg.
•162mg sc once every week for patients weighing 30kg or more