Product Details

Actemra

Tocilizumab
162 mg/0.9 mL
Solution for Subcutaneous Injection
Single-Use 0.9-mL Pre-Filled Syringe (Preservative-Free)

DIN/PIN/NPN

02424770

Manufacturer

Hoffmann-La Roche Limited

Formulary Listing Date

2017-04-27

Unit Price

376.8500

Amount MOH Pays

376.8500

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

92:36:00 Disease-Modifying Antirheumatic Agents

Therapeutic Note

NO

ATC Code

L04AC07

Interchangeable Products

NO

LU Clinical Criteria

NO

Requirements

EAP Criteria

Therapeutic Class	Reimbursement Criteria
Polyarticular Juvenile Idiopathic Arthritis	Etanercept – see Formulary for funded biosimilars Brand(s): Enbrel Dosage Form/Strength: 25 mg/vial, 25 mg and 50 mg prefilled syringe or pens for subcutaneous injection per formulary listed options Adalimumab – see Formulary for funded biosimilars Brand(s): Humira and formulary listed biosimilars Dosage Form/Strength: 40 mg/0.8mL prefilled syringe, 40 mg/0.8mL and and 20 mg/0.2 mL prefilled pens for subcutaneous injection Tociluzumab Brand(s): Actemra Dosage Form/Strength: 80 mg/4 mL Vial, 200 mg/10 mL Vial, 400 mg/20 mL Vial, 162mg/0.9mL Inj (Prefilled syringe), 162mg/0.9mL Auto Injector Rituximab Brand(s): Riximyo, Ruxience, and Truxima (biosimilar); Rituxan (biologic originator for those meeting biosimilar exemption) Dosage Form/Strength: 10 mg/mL intravenous injection Refer to the Executive Officer Communications on the Ministry website for the Ministry’s Biosimilar Policy including frequently asked questions and updates for the biosimilar policy updates. http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions. In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 to 8 of this document). It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on an originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, will be expected to be provided ongoing access of the originator biologic through the patient’s original payer mechanism (e.g. manufacturer’s patient support program) or to switch to an ODB funded biosimilar version upon meeting specified criteria. The Ministry will no longer consider funding of originator biologics that are part of the biosimilar policy with limited exemptions on or after December 29, 2023. For the first-line treatment of polyarticular-course juvenile idiopathic arthritis in patients meeting the following criteria: Patient has active disease (≥ 3 swollen joints and ≥ 5 active joints) despite a trial of optimal dose of subcutaneously administered methotrexate (i.e., 15 mg/m² 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 described in detail. Duration of Approval: 1 Year Renewal will be considered for 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. Duration of Approval: 5 Year Dosing for Etanercept: The planned dosing regimen should be provided. The maximum recommended dose is 50mg once weekly. Recommended dosing for Adalimumab: - 24 mg/m² (maximum 40 mg) every two weeks; OR - 20 mg every 2 weeks, if the Patient weighs less than 30 kg; OR - 40 mg every 2 weeks, if the Patient weighs more than 30 kg. Recommended dosing for Tocilizumab in combination with Methotrexate: IV dosing regimen: - 10 mg/kg every 4 weeks, if the Patient weighs less than 30 kg; OR - 8 mg/kg every 4 weeks, if the Patient weighs more than or equal to 30 kg. SC dosing regimen: - 162 mg once every 3 weeks if the Patient weighs less than 30 kg - 162 mg once every 2 weeks if the Patient weighs 30 kg or more EAP Drug Request Form: Standard Form for EAP Drug Requests
Rheumatoid Arthritis	Tocilizumab Brand(s): Actemra Dosage Form/Strength: 80 mg/4 mL Vial, 200 mg/10 mL Vial, 400 mg/20 mL Vial, 162mg/0.9mL Inj (Prefilled syringe), 162mg/0.9mL Auto Injector For the treatment of rheumatoid arthritis in adult patients with: Severe active disease (≥ 5 swollen joints and rheumatoid factor positive and/or anti-CCP positive and/or has radiographic evidence of rheumatoid arthritis); AND Failure to respond to optimal use¹ of DMARDs or with documented intolerance to DMARDs (per current EAP reimbursement criteria for anti-TNF agents). ¹Optimal use of DMARDs (hydroxychloroquine, methotrexate, sulfasalazine, leflunomide, cyclosporine, azathioprine, penicillamine, chloroquine and gold compounds) defined as: Methotrexate (20 mg/week) for at least 3 months AND Leflunomide (20 mg/day) for at least 3 months, in addition to an adequate trial (3 months) of at least one combination of DMARDs; OR Methotrexate (20 mg/week) for at least 3 months AND leflunomide in combination with methotrexate for at least 3 months; Note: If the patient could not receive adequate trial(s) of methotrexate and/or leflunomide due to contraindication(s) or intolerance(s), the nature of the contraindication(s) or intolerance(s) must be provided along with details of trials of other DMARDs or clear rationale as to why other DMARDs cannot be considered. OR Methotrexate (20 mg/week), sulfasalazine (2 G/day) and hydroxychloroquine (400 mg/day)² for at least 3 months. Note: If the patient could not receive an adequate trial of methotrexate, sulfasalazine and hydroxychloroquine due to intolerance, then the above DMARD trial criteria must be met. ²Hydroxychloroquine is based by weight up to 400 mg per day The requesting physician is required to provide the planned dosing regimen on the request. The following are the recommended doses for tocilizumab (Actemra) IV and SC for rheumatoid arthritis: IV recommended dose: Approval for 4 mg/kg/dose once every 4 weeks followed by an increase to 8 mg/kg/dose based on clinical response; even for individuals whose body weight is more than 100 kg, doses exceeding 800 mg per infusion are not recommended SC recommended dose: - For patients <100 kg weight, starting dose of 162 mg every other week, followed by an increase to every week based on clinical response. - For patients ≥100 kg weight, 162 mg every week. Duration of Approval: 1 Year Renewal will be considered for patients with objective evidence of at least a 20% reduction in swollen joint count and a minimum of improvement in 2 joints over the previous year. For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. Duration of Approval of first Renewal – 1 Year Duration of Second and Subsequent Renewals – 5 Years EAP Drug Request Form: Standard Form for EAP Drug Requests
Ocular Treatments	Tocilizumab Brand(s): Actemra Dosage Form/Strength: 162 mg/0.9 mL inj (PFS), 162mg/0.9mL Auto Inj. 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 (i.e., magnetic resonance angiography, computed tomography angiography or positron emission scanning)¹; 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. ¹Where these tests are not available or where a result may be deemed unreliable (e.g., a negative biopsy in a patient on corticosteroids), the prescriber may C-reactive protein and/or Erythrocyte Sedimentation Rate results with the request. Recommended dose: 162 mg SC 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 will be considered on a case-by-case basis. Approval Duration of renewals: 1 year EAP Drug Request Form: Standard Form for EAP Drug Requests
Systemic Juvenile Idiopathic Arthritis	Tocilizumab Brand(s): Actemra Dosage Form/Strength: 80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL, 162 mg SC Inj (Prefilled Syringe), 162 mg Auto Injector For the treatment of systemic juvenile idiopathic arthritis in patients who meet the following criteria: Patient must have a diagnosis of sJIA with fever (>38 degrees Celsius) for at least 2 weeks AND at least ONE of the following: • rash of systemic JIA • serositis (e.g., pericarditis, pleuritis, or peritonitis) • lymphadenopathy (e.g., cervical, axillary, inguinal) • hepatomegaly • splenomegaly The physician has ruled out other potential etiologies (e.g., malignancies, serious clinical infections, and other inflammatory or connective tissue diseases); AND Age of disease onset is younger than 16 years of age. (Note: the physician must specify age of disease onset in the request); AND Systemic corticosteroids cannot be used for at least ONE of the following reasons (please specify name and current dose of corticosteroid, if applicable): • The patient is unresponsive and/or refractory to systemic corticosteroids; OR • The patient has experienced a systemic reaction (e.g., fever, rash of sJIA, serositis, lymphadenopathy, hepatomegaly or splenomegaly) while on tapering doses of systemic cortico-steroids (i.e., the patient is corticosteroid dependent); OR • The patient has experienced an adverse drug reaction to a systemic corticosteroid; OR • The use of systemic corticosteroids is contraindicated in this patient. Note: The following requests will undergo external review on a case-by-case basis: Patients with Macrophage Activation Syndrome Patients who meet initial sJIA criteria and are currently 16 years of age or older Patients who meet initial sJIA criteria and are requesting higher dosing regimens (Please provide rationale for the higher dosing regimen with your request) Dosing: IV dosing regimen: - For those less than 30 kg,12 mg/kg IV every 2 weeks - For those greater than or the same as 30 kg, 8 mg/kg IV every 2 weeks Note: Recommended maximum adult dose is 800 mg. SC dosing regimen: - Patient weighs less than 30 kg, 162 mg once every 2 weeks - Patient weighs 30 kg or more, 162 mg once every week Duration of Approval: 1 Year Renewal will be considered for patients demonstrating at least a 50% reduction in corticosteroid dose (unless contraindicated, not tolerated, unresponsive or refractory at the time of initial request) and no evidence of active systemic disease. For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. The following renewal requests will undergo external review: Evidence of active systemic disease Requests for higher dosing regimens (Please provide rationale for the higher dosing regimen with your request) Patient is currently 16 years of age or older Duration of Approval: 1 Year EAP Drug Request Form: Standard Form for EAP Drug Requests

Product Monograph