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Biosimilar versions of Eylea® (aflibercept) and Xolair® (omalizumab) were listed on the Formulary as Limited Use Benefits with the August 2025 Formulary update and biosimilar version of Actemra® (tocilizumab) was listed as a Limited Use Benefit with the May 2025 Formulary update. In accordance with this New Start Rule, ODB program recipients who are treatment-naïve will only receive coverage for the biosimilar versions of these biologics, provided that they meet the applicable Limited Use criteria for the products. (ontario.ca, Updated November 21, 2025 ↗) ODB program recipients who are using Eylea®, Actemra®, or Xolair® during the transition period and require continued coverage of their product after the end of the transition period, must have their prescriber apply to the EAP for a medically necessary exemption. Requests for medically necessary exemptions are assessed on a case-by-case basis, and prescribers are encouraged to apply during the transition period to avoid an unintended gap in coverage. Requests for medically necessary exemptions must include documentation that the recipient has tried up to two biosimilar versions (where applicable) and experienced an adverse effect documented on the Health Canada side effect reporting form. A copy of each completed Health Canada reporting form must be included in the EAP request. Medically necessary exemptions will not be considered for ODB recipients subject to the New Start Rule. (ontario.ca, Updated November 21, 2025 ↗)

Reason for Use code 697 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 100 kg or more, a dosage of 162mg sc every week is recommended. Coverage limit: LU Authorization Period: 1 year Reason for Use code 698 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. 15mg/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 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. Coverage limit: LU Authorization Period: 1 year Reason for Use code 720 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 Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 162 mg/0.9 mL inj (PFS), 162mg/0.9mL Auto Inj. — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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 253 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 253, record 153, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 80 mg/4 mL Vial, 200 mg/10 mL Vial, 400 mg/20 mL — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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). Optimal use of DMARDs (hydroxychloroquine, methotrexate, sulfasalazine, leflunomide, cyclosporine, azathioprine, penicillamine, chloroquine and gold compounds) defined as: a) Methotrexate (20 mg/week) for at least 3 months AND b) 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 c) Methotrexate (20 mg/week) for at least 3 months AND leflunomide in combination with methotrexate for at least 3 months; OR 1 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. d) Methotrexate (20 mg/week), sulfasalazine (2 G/day) and hydroxychloroquine (400 mg/day)2 for at least 3 months. 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. 2 Hydroxychloroquine is based by weight up to 400 mg per day The requesting physician is required to provide the planned dosing regimen on the request. 449 Tocilizumab Brand(s): Actemra DOSAGE FORM/ STRENGTH: 80 mg / 4 mL Vial, 200 mg /10 mL Vial, 400 mg/ 20 mL Vial, 162 mg/0.9 mL solution for injection, 162 mg/0.9 mL Autoinjector The following are the recommended doses for tocilizumab (Actemra) IV and SC for rheumatoid arthritis: IV recommended dose: Approval for 4mg/kg/dose once every 4 weeks followed by an increase to 8mg/kg/dose based on clinical response; even for individuals whose body weight is more than 100kg, doses exceeding 800mg 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 at or above 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 450 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 449, record 285, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 80 mg / 4 mL, 200 mg / 10 mL, 400 mg / 20 mL, — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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: o rash of systemic JIA o serositis (e.g. pericarditis , pleuritis, or peritonitis) o lymphadenopathy (e.g. cervical, axillary, inguinal) o hepatomegaly o 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): o The patient is unresponsive and/or refractory to systemic corticosteroids; OR o 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 o The patient has experienced an adverse drug reaction to a systemic corticosteroid; OR o 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) Tocilizumab 454 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 Autoinjector Dosing: 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: a) 162 mg once every 2 weeks if the Patient weighs less than 30kg b) 162 mg once every week if the Patient weighs 30 kg or more 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 455 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 454, record 288, corpus 2025-01-01; name match only, not an eligibility decision

Tyenne · DIN 02552450 Manufacturer: Fresenius Kabi Canada Ltd.; listing date 2025-05-30 Health Canada: Marketed since 2025-04-14 · brand TYENNE · ATC L04AC07 TOCILIZUMAB · form Solution · route Intravenous · ingredients TOCILIZUMAB 80 MG/4ML · company Fresenius kabi canada ltd · schedule Schedule d, Prescription

DIN 02552450: Tyenne Raw flags: sec12=Y, sec3=Y Item: 923600064; group id 1032; item number 2383; lccId 00408; manufacturer id FKC Source form: Inj Sol-4mL Vial Pk; strength: 80mg/4mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $124.7610; ministry $124.7610 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02552450 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=104142

Shortage status: anticipated shortage (last updated 2026-08-21); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02552450

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Biosimilar versions of Eylea® (aflibercept) and Xolair® (omalizumab) were listed on the Formulary as Limited Use Benefits with the August 2025 Formulary update and biosimilar version of Actemra® (tocilizumab) was listed as a Limited Use Benefit with the May 2025 Formulary update. In accordance with this New Start Rule, ODB program recipients who are treatment-naïve will only receive coverage for the biosimilar versions of these biologics, provided that they meet the applicable Limited Use criteria for the products. (ontario.ca, Updated November 21, 2025 ↗) ODB program recipients who are using Eylea®, Actemra®, or Xolair® during the transition period and require continued coverage of their product after the end of the transition period, must have their prescriber apply to the EAP for a medically necessary exemption. Requests for medically necessary exemptions are assessed on a case-by-case basis, and prescribers are encouraged to apply during the transition period to avoid an unintended gap in coverage. Requests for medically necessary exemptions must include documentation that the recipient has tried up to two biosimilar versions (where applicable) and experienced an adverse effect documented on the Health Canada side effect reporting form. A copy of each completed Health Canada reporting form must be included in the EAP request. Medically necessary exemptions will not be considered for ODB recipients subject to the New Start Rule. (ontario.ca, Updated November 21, 2025 ↗)

Reason for Use code 697 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 100 kg or more, a dosage of 162mg sc every week is recommended. Coverage limit: LU Authorization Period: 1 year Reason for Use code 698 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. 15mg/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 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. Coverage limit: LU Authorization Period: 1 year Reason for Use code 720 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 Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 162 mg/0.9 mL inj (PFS), 162mg/0.9mL Auto Inj. — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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 253 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 253, record 153, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 80 mg/4 mL Vial, 200 mg/10 mL Vial, 400 mg/20 mL — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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). Optimal use of DMARDs (hydroxychloroquine, methotrexate, sulfasalazine, leflunomide, cyclosporine, azathioprine, penicillamine, chloroquine and gold compounds) defined as: a) Methotrexate (20 mg/week) for at least 3 months AND b) 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 c) Methotrexate (20 mg/week) for at least 3 months AND leflunomide in combination with methotrexate for at least 3 months; OR 1 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. d) Methotrexate (20 mg/week), sulfasalazine (2 G/day) and hydroxychloroquine (400 mg/day)2 for at least 3 months. 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. 2 Hydroxychloroquine is based by weight up to 400 mg per day The requesting physician is required to provide the planned dosing regimen on the request. 449 Tocilizumab Brand(s): Actemra DOSAGE FORM/ STRENGTH: 80 mg / 4 mL Vial, 200 mg /10 mL Vial, 400 mg/ 20 mL Vial, 162 mg/0.9 mL solution for injection, 162 mg/0.9 mL Autoinjector The following are the recommended doses for tocilizumab (Actemra) IV and SC for rheumatoid arthritis: IV recommended dose: Approval for 4mg/kg/dose once every 4 weeks followed by an increase to 8mg/kg/dose based on clinical response; even for individuals whose body weight is more than 100kg, doses exceeding 800mg 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 at or above 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 450 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 449, record 285, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 80 mg / 4 mL, 200 mg / 10 mL, 400 mg / 20 mL, — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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: o rash of systemic JIA o serositis (e.g. pericarditis , pleuritis, or peritonitis) o lymphadenopathy (e.g. cervical, axillary, inguinal) o hepatomegaly o 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): o The patient is unresponsive and/or refractory to systemic corticosteroids; OR o 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 o The patient has experienced an adverse drug reaction to a systemic corticosteroid; OR o 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) Tocilizumab 454 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 Autoinjector Dosing: 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: a) 162 mg once every 2 weeks if the Patient weighs less than 30kg b) 162 mg once every week if the Patient weighs 30 kg or more 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 455 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 454, record 288, corpus 2025-01-01; name match only, not an eligibility decision

Avtozma · DIN 02562022 Manufacturer: Celltrion Inc.; listing date 2025-12-30 Health Canada: Marketed since 2026-01-14 · brand AVTOZMA · ATC L04AC07 TOCILIZUMAB · form Solution · route Intravenous · ingredients TOCILIZUMAB 80 MG/4ML · company Celltrion inc. · schedule Prescription, Schedule d

DIN 02562022: Avtozma Raw flags: sec12=Y, sec3=Y Item: 923600068; group id 1033; item number 2384; lccId 00423; manufacturer id CEI Source form: Inj Sol-4mL Vial Pk (Preservative-Free); strength: 80mg/4mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $124.7610; ministry $124.7610 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02562022 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106494

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02562022

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Biosimilar versions of Eylea® (aflibercept) and Xolair® (omalizumab) were listed on the Formulary as Limited Use Benefits with the August 2025 Formulary update and biosimilar version of Actemra® (tocilizumab) was listed as a Limited Use Benefit with the May 2025 Formulary update. In accordance with this New Start Rule, ODB program recipients who are treatment-naïve will only receive coverage for the biosimilar versions of these biologics, provided that they meet the applicable Limited Use criteria for the products. (ontario.ca, Updated November 21, 2025 ↗) ODB program recipients who are using Eylea®, Actemra®, or Xolair® during the transition period and require continued coverage of their product after the end of the transition period, must have their prescriber apply to the EAP for a medically necessary exemption. Requests for medically necessary exemptions are assessed on a case-by-case basis, and prescribers are encouraged to apply during the transition period to avoid an unintended gap in coverage. Requests for medically necessary exemptions must include documentation that the recipient has tried up to two biosimilar versions (where applicable) and experienced an adverse effect documented on the Health Canada side effect reporting form. A copy of each completed Health Canada reporting form must be included in the EAP request. Medically necessary exemptions will not be considered for ODB recipients subject to the New Start Rule. (ontario.ca, Updated November 21, 2025 ↗)

Reason for Use code 697 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 100 kg or more, a dosage of 162mg sc every week is recommended. Coverage limit: LU Authorization Period: 1 year Reason for Use code 698 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. 15mg/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 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. Coverage limit: LU Authorization Period: 1 year Reason for Use code 720 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 Coverage limit: LU Authorization Period: 1 year Reason for Use code 721 For the treatment of giant cell arteritis (GCA) in symptomatic adult patients who meet the following: 1. A confirmed diagnosis of GCA by temporal artery biopsy and/or imaging tests (i.e., ultrasonography, magnetic resonance angiography, computed tomography angiography or positron emission scanning); AND 2. Tocilizumab is initiated as combination therapy with 20mg to 60mg of prednisone (or an equivalent glucocorticoid) with subsequent glucocorticoid tapering as symptoms stabilize; AND 3. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in the diagnosis and management of GCA; AND 4. The patient is using tocilizumab for up to 52 weeks. Note: Patients with other sight-threatening ocular diseases must have their prescribers apply for case-by-case funding consideration through the ministry's Compassionate Review Policy. Limited Renewal: Renewal after an initial treatment period of 52 weeks can occur in limited circumstances when directed by a prescriber based on the patient's clinical remission status, disease activity and relevant bloodwork, imaging results, severity of disease manifestations, and risk of relapse. Recommended Dose: The recommended dose of tocilizumab for adult patients is 162mg subcutaneously once every week in combination with a tapering dose of glucocorticoids. A dose of 162mg subcutaneously once every other week, in combination with a tapering dose of glucocorticoids, may be considered based on clinical considerations. Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 162 mg/0.9 mL inj (PFS), 162mg/0.9mL Auto Inj. — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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 253 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 253, record 153, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 80 mg/4 mL Vial, 200 mg/10 mL Vial, 400 mg/20 mL — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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). Optimal use of DMARDs (hydroxychloroquine, methotrexate, sulfasalazine, leflunomide, cyclosporine, azathioprine, penicillamine, chloroquine and gold compounds) defined as: a) Methotrexate (20 mg/week) for at least 3 months AND b) 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 c) Methotrexate (20 mg/week) for at least 3 months AND leflunomide in combination with methotrexate for at least 3 months; OR 1 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. d) Methotrexate (20 mg/week), sulfasalazine (2 G/day) and hydroxychloroquine (400 mg/day)2 for at least 3 months. 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. 2 Hydroxychloroquine is based by weight up to 400 mg per day The requesting physician is required to provide the planned dosing regimen on the request. 449 Tocilizumab Brand(s): Actemra DOSAGE FORM/ STRENGTH: 80 mg / 4 mL Vial, 200 mg /10 mL Vial, 400 mg/ 20 mL Vial, 162 mg/0.9 mL solution for injection, 162 mg/0.9 mL Autoinjector The following are the recommended doses for tocilizumab (Actemra) IV and SC for rheumatoid arthritis: IV recommended dose: Approval for 4mg/kg/dose once every 4 weeks followed by an increase to 8mg/kg/dose based on clinical response; even for individuals whose body weight is more than 100kg, doses exceeding 800mg 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 at or above 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 450 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 449, record 285, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 80 mg / 4 mL, 200 mg / 10 mL, 400 mg / 20 mL, — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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: o rash of systemic JIA o serositis (e.g. pericarditis , pleuritis, or peritonitis) o lymphadenopathy (e.g. cervical, axillary, inguinal) o hepatomegaly o 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): o The patient is unresponsive and/or refractory to systemic corticosteroids; OR o 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 o The patient has experienced an adverse drug reaction to a systemic corticosteroid; OR o 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) Tocilizumab 454 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 Autoinjector Dosing: 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: a) 162 mg once every 2 weeks if the Patient weighs less than 30kg b) 162 mg once every week if the Patient weighs 30 kg or more 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 455 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 454, record 288, corpus 2025-01-01; name match only, not an eligibility decision

Tyenne · DIN 02552485 Manufacturer: Fresenius Kabi Canada Ltd.; listing date 2025-05-30 Health Canada: Marketed since 2025-04-14 · brand TYENNE · ATC L04AC07 TOCILIZUMAB · form Solution · route Subcutaneous · ingredients TOCILIZUMAB 162 MG/0.9ML · company Fresenius kabi canada ltd · schedule Prescription, Schedule d

DIN 02552485: Tyenne Raw flags: sec12=Y, sec3=Y Item: 923600062; group id 1034; item number 2385; lccId 00410; manufacturer id FKC Source form: Inj Sol-Pref Autoinj; strength: 162mg/0.9mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $242.2875; ministry $242.2875 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02552485 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=104145

Shortage status: anticipated shortage (last updated 2026-08-21); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02552485

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Biosimilar versions of Eylea® (aflibercept) and Xolair® (omalizumab) were listed on the Formulary as Limited Use Benefits with the August 2025 Formulary update and biosimilar version of Actemra® (tocilizumab) was listed as a Limited Use Benefit with the May 2025 Formulary update. In accordance with this New Start Rule, ODB program recipients who are treatment-naïve will only receive coverage for the biosimilar versions of these biologics, provided that they meet the applicable Limited Use criteria for the products. (ontario.ca, Updated November 21, 2025 ↗) ODB program recipients who are using Eylea®, Actemra®, or Xolair® during the transition period and require continued coverage of their product after the end of the transition period, must have their prescriber apply to the EAP for a medically necessary exemption. Requests for medically necessary exemptions are assessed on a case-by-case basis, and prescribers are encouraged to apply during the transition period to avoid an unintended gap in coverage. Requests for medically necessary exemptions must include documentation that the recipient has tried up to two biosimilar versions (where applicable) and experienced an adverse effect documented on the Health Canada side effect reporting form. A copy of each completed Health Canada reporting form must be included in the EAP request. Medically necessary exemptions will not be considered for ODB recipients subject to the New Start Rule. (ontario.ca, Updated November 21, 2025 ↗)

Reason for Use code 697 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 100 kg or more, a dosage of 162mg sc every week is recommended. Coverage limit: LU Authorization Period: 1 year Reason for Use code 698 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. 15mg/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 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. Coverage limit: LU Authorization Period: 1 year Reason for Use code 720 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 Coverage limit: LU Authorization Period: 1 year Reason for Use code 721 For the treatment of giant cell arteritis (GCA) in symptomatic adult patients who meet the following: 1. A confirmed diagnosis of GCA by temporal artery biopsy and/or imaging tests (i.e., ultrasonography, magnetic resonance angiography, computed tomography angiography or positron emission scanning); AND 2. Tocilizumab is initiated as combination therapy with 20mg to 60mg of prednisone (or an equivalent glucocorticoid) with subsequent glucocorticoid tapering as symptoms stabilize; AND 3. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in the diagnosis and management of GCA; AND 4. The patient is using tocilizumab for up to 52 weeks. Note: Patients with other sight-threatening ocular diseases must have their prescribers apply for case-by-case funding consideration through the ministry's Compassionate Review Policy. Limited Renewal: Renewal after an initial treatment period of 52 weeks can occur in limited circumstances when directed by a prescriber based on the patient's clinical remission status, disease activity and relevant bloodwork, imaging results, severity of disease manifestations, and risk of relapse. Recommended Dose: The recommended dose of tocilizumab for adult patients is 162mg subcutaneously once every week in combination with a tapering dose of glucocorticoids. A dose of 162mg subcutaneously once every other week, in combination with a tapering dose of glucocorticoids, may be considered based on clinical considerations. Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 162 mg/0.9 mL inj (PFS), 162mg/0.9mL Auto Inj. — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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 253 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 253, record 153, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 80 mg/4 mL Vial, 200 mg/10 mL Vial, 400 mg/20 mL — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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). Optimal use of DMARDs (hydroxychloroquine, methotrexate, sulfasalazine, leflunomide, cyclosporine, azathioprine, penicillamine, chloroquine and gold compounds) defined as: a) Methotrexate (20 mg/week) for at least 3 months AND b) 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 c) Methotrexate (20 mg/week) for at least 3 months AND leflunomide in combination with methotrexate for at least 3 months; OR 1 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. d) Methotrexate (20 mg/week), sulfasalazine (2 G/day) and hydroxychloroquine (400 mg/day)2 for at least 3 months. 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. 2 Hydroxychloroquine is based by weight up to 400 mg per day The requesting physician is required to provide the planned dosing regimen on the request. 449 Tocilizumab Brand(s): Actemra DOSAGE FORM/ STRENGTH: 80 mg / 4 mL Vial, 200 mg /10 mL Vial, 400 mg/ 20 mL Vial, 162 mg/0.9 mL solution for injection, 162 mg/0.9 mL Autoinjector The following are the recommended doses for tocilizumab (Actemra) IV and SC for rheumatoid arthritis: IV recommended dose: Approval for 4mg/kg/dose once every 4 weeks followed by an increase to 8mg/kg/dose based on clinical response; even for individuals whose body weight is more than 100kg, doses exceeding 800mg 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 at or above 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 450 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 449, record 285, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 80 mg / 4 mL, 200 mg / 10 mL, 400 mg / 20 mL, — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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: o rash of systemic JIA o serositis (e.g. pericarditis , pleuritis, or peritonitis) o lymphadenopathy (e.g. cervical, axillary, inguinal) o hepatomegaly o 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): o The patient is unresponsive and/or refractory to systemic corticosteroids; OR o 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 o The patient has experienced an adverse drug reaction to a systemic corticosteroid; OR o 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) Tocilizumab 454 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 Autoinjector Dosing: 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: a) 162 mg once every 2 weeks if the Patient weighs less than 30kg b) 162 mg once every week if the Patient weighs 30 kg or more 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 455 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 454, record 288, corpus 2025-01-01; name match only, not an eligibility decision

Avtozma · DIN 02562065 Manufacturer: Celltrion Inc.; listing date 2025-12-30 Health Canada: Marketed since 2026-01-14 · brand AVTOZMA · ATC L04AC07 TOCILIZUMAB · form Solution · route Subcutaneous · ingredients TOCILIZUMAB 162 MG/0.9ML · company Celltrion inc. · schedule Schedule d, Prescription

DIN 02562065: Avtozma Raw flags: sec12=Y, sec3=Y Item: 923600072; group id 1035; item number 2386; lccId 00424; manufacturer id CEI Source form: Inj Sol-Pref Autoinj (Preservative-Free); strength: 162mg/0.9mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $242.2875; ministry $242.2875 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02562065 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106498

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02562065

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Biosimilar versions of Eylea® (aflibercept) and Xolair® (omalizumab) were listed on the Formulary as Limited Use Benefits with the August 2025 Formulary update and biosimilar version of Actemra® (tocilizumab) was listed as a Limited Use Benefit with the May 2025 Formulary update. In accordance with this New Start Rule, ODB program recipients who are treatment-naïve will only receive coverage for the biosimilar versions of these biologics, provided that they meet the applicable Limited Use criteria for the products. (ontario.ca, Updated November 21, 2025 ↗) ODB program recipients who are using Eylea®, Actemra®, or Xolair® during the transition period and require continued coverage of their product after the end of the transition period, must have their prescriber apply to the EAP for a medically necessary exemption. Requests for medically necessary exemptions are assessed on a case-by-case basis, and prescribers are encouraged to apply during the transition period to avoid an unintended gap in coverage. Requests for medically necessary exemptions must include documentation that the recipient has tried up to two biosimilar versions (where applicable) and experienced an adverse effect documented on the Health Canada side effect reporting form. A copy of each completed Health Canada reporting form must be included in the EAP request. Medically necessary exemptions will not be considered for ODB recipients subject to the New Start Rule. (ontario.ca, Updated November 21, 2025 ↗)

Reason for Use code 697 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 100 kg or more, a dosage of 162mg sc every week is recommended. Coverage limit: LU Authorization Period: 1 year Reason for Use code 698 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. 15mg/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 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. Coverage limit: LU Authorization Period: 1 year Reason for Use code 720 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 Coverage limit: LU Authorization Period: 1 year Reason for Use code 721 For the treatment of giant cell arteritis (GCA) in symptomatic adult patients who meet the following: 1. A confirmed diagnosis of GCA by temporal artery biopsy and/or imaging tests (i.e., ultrasonography, magnetic resonance angiography, computed tomography angiography or positron emission scanning); AND 2. Tocilizumab is initiated as combination therapy with 20mg to 60mg of prednisone (or an equivalent glucocorticoid) with subsequent glucocorticoid tapering as symptoms stabilize; AND 3. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in the diagnosis and management of GCA; AND 4. The patient is using tocilizumab for up to 52 weeks. Note: Patients with other sight-threatening ocular diseases must have their prescribers apply for case-by-case funding consideration through the ministry's Compassionate Review Policy. Limited Renewal: Renewal after an initial treatment period of 52 weeks can occur in limited circumstances when directed by a prescriber based on the patient's clinical remission status, disease activity and relevant bloodwork, imaging results, severity of disease manifestations, and risk of relapse. Recommended Dose: The recommended dose of tocilizumab for adult patients is 162mg subcutaneously once every week in combination with a tapering dose of glucocorticoids. A dose of 162mg subcutaneously once every other week, in combination with a tapering dose of glucocorticoids, may be considered based on clinical considerations. Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 162 mg/0.9 mL inj (PFS), 162mg/0.9mL Auto Inj. — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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 253 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 253, record 153, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 80 mg/4 mL Vial, 200 mg/10 mL Vial, 400 mg/20 mL — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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). Optimal use of DMARDs (hydroxychloroquine, methotrexate, sulfasalazine, leflunomide, cyclosporine, azathioprine, penicillamine, chloroquine and gold compounds) defined as: a) Methotrexate (20 mg/week) for at least 3 months AND b) 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 c) Methotrexate (20 mg/week) for at least 3 months AND leflunomide in combination with methotrexate for at least 3 months; OR 1 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. d) Methotrexate (20 mg/week), sulfasalazine (2 G/day) and hydroxychloroquine (400 mg/day)2 for at least 3 months. 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. 2 Hydroxychloroquine is based by weight up to 400 mg per day The requesting physician is required to provide the planned dosing regimen on the request. 449 Tocilizumab Brand(s): Actemra DOSAGE FORM/ STRENGTH: 80 mg / 4 mL Vial, 200 mg /10 mL Vial, 400 mg/ 20 mL Vial, 162 mg/0.9 mL solution for injection, 162 mg/0.9 mL Autoinjector The following are the recommended doses for tocilizumab (Actemra) IV and SC for rheumatoid arthritis: IV recommended dose: Approval for 4mg/kg/dose once every 4 weeks followed by an increase to 8mg/kg/dose based on clinical response; even for individuals whose body weight is more than 100kg, doses exceeding 800mg 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 at or above 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 450 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 449, record 285, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 80 mg / 4 mL, 200 mg / 10 mL, 400 mg / 20 mL, — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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: o rash of systemic JIA o serositis (e.g. pericarditis , pleuritis, or peritonitis) o lymphadenopathy (e.g. cervical, axillary, inguinal) o hepatomegaly o 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): o The patient is unresponsive and/or refractory to systemic corticosteroids; OR o 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 o The patient has experienced an adverse drug reaction to a systemic corticosteroid; OR o 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) Tocilizumab 454 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 Autoinjector Dosing: 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: a) 162 mg once every 2 weeks if the Patient weighs less than 30kg b) 162 mg once every week if the Patient weighs 30 kg or more 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 455 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 454, record 288, corpus 2025-01-01; name match only, not an eligibility decision

Tyenne · DIN 02552493 Manufacturer: Fresenius Kabi Canada Ltd.; listing date 2025-05-30 Health Canada: Marketed since 2025-04-14 · brand TYENNE · ATC L04AC07 TOCILIZUMAB · form Solution · route Subcutaneous · ingredients TOCILIZUMAB 162 MG/0.9ML · company Fresenius kabi canada ltd · schedule Schedule d, Prescription

DIN 02552493: Tyenne Raw flags: sec12=Y, sec3=Y Item: 923600063; group id 1036; item number 2387; lccId 00410; manufacturer id FKC Source form: Inj Sol-Pref Syr; strength: 162mg/0.9mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $244.9525; ministry $244.9525 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02552493 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=104146

Shortage status: anticipated shortage (last updated 2026-08-21); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02552493

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Biosimilar versions of Eylea® (aflibercept) and Xolair® (omalizumab) were listed on the Formulary as Limited Use Benefits with the August 2025 Formulary update and biosimilar version of Actemra® (tocilizumab) was listed as a Limited Use Benefit with the May 2025 Formulary update. In accordance with this New Start Rule, ODB program recipients who are treatment-naïve will only receive coverage for the biosimilar versions of these biologics, provided that they meet the applicable Limited Use criteria for the products. (ontario.ca, Updated November 21, 2025 ↗) ODB program recipients who are using Eylea®, Actemra®, or Xolair® during the transition period and require continued coverage of their product after the end of the transition period, must have their prescriber apply to the EAP for a medically necessary exemption. Requests for medically necessary exemptions are assessed on a case-by-case basis, and prescribers are encouraged to apply during the transition period to avoid an unintended gap in coverage. Requests for medically necessary exemptions must include documentation that the recipient has tried up to two biosimilar versions (where applicable) and experienced an adverse effect documented on the Health Canada side effect reporting form. A copy of each completed Health Canada reporting form must be included in the EAP request. Medically necessary exemptions will not be considered for ODB recipients subject to the New Start Rule. (ontario.ca, Updated November 21, 2025 ↗)

Reason for Use code 697 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 100 kg or more, a dosage of 162mg sc every week is recommended. Coverage limit: LU Authorization Period: 1 year Reason for Use code 698 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. 15mg/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 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. Coverage limit: LU Authorization Period: 1 year Reason for Use code 720 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 Coverage limit: LU Authorization Period: 1 year Reason for Use code 721 For the treatment of giant cell arteritis (GCA) in symptomatic adult patients who meet the following: 1. A confirmed diagnosis of GCA by temporal artery biopsy and/or imaging tests (i.e., ultrasonography, magnetic resonance angiography, computed tomography angiography or positron emission scanning); AND 2. Tocilizumab is initiated as combination therapy with 20mg to 60mg of prednisone (or an equivalent glucocorticoid) with subsequent glucocorticoid tapering as symptoms stabilize; AND 3. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in the diagnosis and management of GCA; AND 4. The patient is using tocilizumab for up to 52 weeks. Note: Patients with other sight-threatening ocular diseases must have their prescribers apply for case-by-case funding consideration through the ministry's Compassionate Review Policy. Limited Renewal: Renewal after an initial treatment period of 52 weeks can occur in limited circumstances when directed by a prescriber based on the patient's clinical remission status, disease activity and relevant bloodwork, imaging results, severity of disease manifestations, and risk of relapse. Recommended Dose: The recommended dose of tocilizumab for adult patients is 162mg subcutaneously once every week in combination with a tapering dose of glucocorticoids. A dose of 162mg subcutaneously once every other week, in combination with a tapering dose of glucocorticoids, may be considered based on clinical considerations. Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 162 mg/0.9 mL inj (PFS), 162mg/0.9mL Auto Inj. — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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 253 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 253, record 153, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 80 mg/4 mL Vial, 200 mg/10 mL Vial, 400 mg/20 mL — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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). Optimal use of DMARDs (hydroxychloroquine, methotrexate, sulfasalazine, leflunomide, cyclosporine, azathioprine, penicillamine, chloroquine and gold compounds) defined as: a) Methotrexate (20 mg/week) for at least 3 months AND b) 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 c) Methotrexate (20 mg/week) for at least 3 months AND leflunomide in combination with methotrexate for at least 3 months; OR 1 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. d) Methotrexate (20 mg/week), sulfasalazine (2 G/day) and hydroxychloroquine (400 mg/day)2 for at least 3 months. 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. 2 Hydroxychloroquine is based by weight up to 400 mg per day The requesting physician is required to provide the planned dosing regimen on the request. 449 Tocilizumab Brand(s): Actemra DOSAGE FORM/ STRENGTH: 80 mg / 4 mL Vial, 200 mg /10 mL Vial, 400 mg/ 20 mL Vial, 162 mg/0.9 mL solution for injection, 162 mg/0.9 mL Autoinjector The following are the recommended doses for tocilizumab (Actemra) IV and SC for rheumatoid arthritis: IV recommended dose: Approval for 4mg/kg/dose once every 4 weeks followed by an increase to 8mg/kg/dose based on clinical response; even for individuals whose body weight is more than 100kg, doses exceeding 800mg 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 at or above 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 450 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 449, record 285, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 80 mg / 4 mL, 200 mg / 10 mL, 400 mg / 20 mL, — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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: o rash of systemic JIA o serositis (e.g. pericarditis , pleuritis, or peritonitis) o lymphadenopathy (e.g. cervical, axillary, inguinal) o hepatomegaly o 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): o The patient is unresponsive and/or refractory to systemic corticosteroids; OR o 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 o The patient has experienced an adverse drug reaction to a systemic corticosteroid; OR o 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) Tocilizumab 454 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 Autoinjector Dosing: 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: a) 162 mg once every 2 weeks if the Patient weighs less than 30kg b) 162 mg once every week if the Patient weighs 30 kg or more 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 455 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 454, record 288, corpus 2025-01-01; name match only, not an eligibility decision

Avtozma · DIN 02562057 Manufacturer: Celltrion Inc.; listing date 2025-12-30 Health Canada: Marketed since 2026-01-14 · brand AVTOZMA · ATC L04AC07 TOCILIZUMAB · form Solution · route Subcutaneous · ingredients TOCILIZUMAB 162 MG/0.9ML · company Celltrion inc. · schedule Schedule d, Prescription

DIN 02562057: Avtozma Raw flags: sec12=Y, sec3=Y Item: 923600071; group id 1037; item number 2388; lccId 00424; manufacturer id CEI Source form: Inj Sol-Pref Syr (Preservative-Free); strength: 162mg/0.9mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $244.9525; ministry $244.9525 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02562057 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106497

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02562057

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Biosimilar versions of Eylea® (aflibercept) and Xolair® (omalizumab) were listed on the Formulary as Limited Use Benefits with the August 2025 Formulary update and biosimilar version of Actemra® (tocilizumab) was listed as a Limited Use Benefit with the May 2025 Formulary update. In accordance with this New Start Rule, ODB program recipients who are treatment-naïve will only receive coverage for the biosimilar versions of these biologics, provided that they meet the applicable Limited Use criteria for the products. (ontario.ca, Updated November 21, 2025 ↗) ODB program recipients who are using Eylea®, Actemra®, or Xolair® during the transition period and require continued coverage of their product after the end of the transition period, must have their prescriber apply to the EAP for a medically necessary exemption. Requests for medically necessary exemptions are assessed on a case-by-case basis, and prescribers are encouraged to apply during the transition period to avoid an unintended gap in coverage. Requests for medically necessary exemptions must include documentation that the recipient has tried up to two biosimilar versions (where applicable) and experienced an adverse effect documented on the Health Canada side effect reporting form. A copy of each completed Health Canada reporting form must be included in the EAP request. Medically necessary exemptions will not be considered for ODB recipients subject to the New Start Rule. (ontario.ca, Updated November 21, 2025 ↗)

Reason for Use code 697 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 100 kg or more, a dosage of 162mg sc every week is recommended. Coverage limit: LU Authorization Period: 1 year Reason for Use code 698 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. 15mg/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 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. Coverage limit: LU Authorization Period: 1 year Reason for Use code 720 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 Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 162 mg/0.9 mL inj (PFS), 162mg/0.9mL Auto Inj. — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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 253 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 253, record 153, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 80 mg/4 mL Vial, 200 mg/10 mL Vial, 400 mg/20 mL — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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). Optimal use of DMARDs (hydroxychloroquine, methotrexate, sulfasalazine, leflunomide, cyclosporine, azathioprine, penicillamine, chloroquine and gold compounds) defined as: a) Methotrexate (20 mg/week) for at least 3 months AND b) 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 c) Methotrexate (20 mg/week) for at least 3 months AND leflunomide in combination with methotrexate for at least 3 months; OR 1 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. d) Methotrexate (20 mg/week), sulfasalazine (2 G/day) and hydroxychloroquine (400 mg/day)2 for at least 3 months. 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. 2 Hydroxychloroquine is based by weight up to 400 mg per day The requesting physician is required to provide the planned dosing regimen on the request. 449 Tocilizumab Brand(s): Actemra DOSAGE FORM/ STRENGTH: 80 mg / 4 mL Vial, 200 mg /10 mL Vial, 400 mg/ 20 mL Vial, 162 mg/0.9 mL solution for injection, 162 mg/0.9 mL Autoinjector The following are the recommended doses for tocilizumab (Actemra) IV and SC for rheumatoid arthritis: IV recommended dose: Approval for 4mg/kg/dose once every 4 weeks followed by an increase to 8mg/kg/dose based on clinical response; even for individuals whose body weight is more than 100kg, doses exceeding 800mg 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 at or above 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 450 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 449, record 285, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 80 mg / 4 mL, 200 mg / 10 mL, 400 mg / 20 mL, — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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: o rash of systemic JIA o serositis (e.g. pericarditis , pleuritis, or peritonitis) o lymphadenopathy (e.g. cervical, axillary, inguinal) o hepatomegaly o 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): o The patient is unresponsive and/or refractory to systemic corticosteroids; OR o 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 o The patient has experienced an adverse drug reaction to a systemic corticosteroid; OR o 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) Tocilizumab 454 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 Autoinjector Dosing: 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: a) 162 mg once every 2 weeks if the Patient weighs less than 30kg b) 162 mg once every week if the Patient weighs 30 kg or more 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 455 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 454, record 288, corpus 2025-01-01; name match only, not an eligibility decision

Tyenne · DIN 02552469 Manufacturer: Fresenius Kabi Canada Ltd.; listing date 2025-05-30 Health Canada: Marketed since 2025-04-14 · brand TYENNE · ATC L04AC07 TOCILIZUMAB · form Solution · route Intravenous · ingredients TOCILIZUMAB 200 MG/10ML · company Fresenius kabi canada ltd · schedule Prescription, Schedule d

DIN 02552469: Tyenne Raw flags: sec12=Y, sec3=Y Item: 923600065; group id 1028; item number 2379; lccId 00408; manufacturer id FKC Source form: Inj Sol-10mL Vial Pk; strength: 200mg/10mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $311.9025; ministry $311.9025 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02552469 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=104143

Shortage status: anticipated shortage (last updated 2026-08-21); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02552469

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Biosimilar versions of Eylea® (aflibercept) and Xolair® (omalizumab) were listed on the Formulary as Limited Use Benefits with the August 2025 Formulary update and biosimilar version of Actemra® (tocilizumab) was listed as a Limited Use Benefit with the May 2025 Formulary update. In accordance with this New Start Rule, ODB program recipients who are treatment-naïve will only receive coverage for the biosimilar versions of these biologics, provided that they meet the applicable Limited Use criteria for the products. (ontario.ca, Updated November 21, 2025 ↗) ODB program recipients who are using Eylea®, Actemra®, or Xolair® during the transition period and require continued coverage of their product after the end of the transition period, must have their prescriber apply to the EAP for a medically necessary exemption. Requests for medically necessary exemptions are assessed on a case-by-case basis, and prescribers are encouraged to apply during the transition period to avoid an unintended gap in coverage. Requests for medically necessary exemptions must include documentation that the recipient has tried up to two biosimilar versions (where applicable) and experienced an adverse effect documented on the Health Canada side effect reporting form. A copy of each completed Health Canada reporting form must be included in the EAP request. Medically necessary exemptions will not be considered for ODB recipients subject to the New Start Rule. (ontario.ca, Updated November 21, 2025 ↗)

Reason for Use code 697 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 100 kg or more, a dosage of 162mg sc every week is recommended. Coverage limit: LU Authorization Period: 1 year Reason for Use code 698 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. 15mg/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 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. Coverage limit: LU Authorization Period: 1 year Reason for Use code 720 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 Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 162 mg/0.9 mL inj (PFS), 162mg/0.9mL Auto Inj. — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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 253 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 253, record 153, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 80 mg/4 mL Vial, 200 mg/10 mL Vial, 400 mg/20 mL — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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). Optimal use of DMARDs (hydroxychloroquine, methotrexate, sulfasalazine, leflunomide, cyclosporine, azathioprine, penicillamine, chloroquine and gold compounds) defined as: a) Methotrexate (20 mg/week) for at least 3 months AND b) 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 c) Methotrexate (20 mg/week) for at least 3 months AND leflunomide in combination with methotrexate for at least 3 months; OR 1 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. d) Methotrexate (20 mg/week), sulfasalazine (2 G/day) and hydroxychloroquine (400 mg/day)2 for at least 3 months. 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. 2 Hydroxychloroquine is based by weight up to 400 mg per day The requesting physician is required to provide the planned dosing regimen on the request. 449 Tocilizumab Brand(s): Actemra DOSAGE FORM/ STRENGTH: 80 mg / 4 mL Vial, 200 mg /10 mL Vial, 400 mg/ 20 mL Vial, 162 mg/0.9 mL solution for injection, 162 mg/0.9 mL Autoinjector The following are the recommended doses for tocilizumab (Actemra) IV and SC for rheumatoid arthritis: IV recommended dose: Approval for 4mg/kg/dose once every 4 weeks followed by an increase to 8mg/kg/dose based on clinical response; even for individuals whose body weight is more than 100kg, doses exceeding 800mg 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 at or above 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 450 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 449, record 285, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 80 mg / 4 mL, 200 mg / 10 mL, 400 mg / 20 mL, — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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: o rash of systemic JIA o serositis (e.g. pericarditis , pleuritis, or peritonitis) o lymphadenopathy (e.g. cervical, axillary, inguinal) o hepatomegaly o 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): o The patient is unresponsive and/or refractory to systemic corticosteroids; OR o 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 o The patient has experienced an adverse drug reaction to a systemic corticosteroid; OR o 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) Tocilizumab 454 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 Autoinjector Dosing: 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: a) 162 mg once every 2 weeks if the Patient weighs less than 30kg b) 162 mg once every week if the Patient weighs 30 kg or more 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 455 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 454, record 288, corpus 2025-01-01; name match only, not an eligibility decision

Avtozma · DIN 02562030 Manufacturer: Celltrion Inc.; listing date 2025-12-30 Health Canada: Marketed since 2026-01-14 · brand AVTOZMA · ATC L04AC07 TOCILIZUMAB · form Solution · route Intravenous · ingredients TOCILIZUMAB 200 MG/10ML · company Celltrion inc. · schedule Prescription, Schedule d

DIN 02562030: Avtozma Raw flags: sec12=Y, sec3=Y Item: 923600069; group id 1029; item number 2380; lccId 00423; manufacturer id CEI Source form: Inj Sol-10mL Vial Pk (Preservative-Free); strength: 200mg/10mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $311.9025; ministry $311.9025 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02562030 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106495

Shortage status: resolved shortage (ended 2026-08-18); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02562030

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Biosimilar versions of Eylea® (aflibercept) and Xolair® (omalizumab) were listed on the Formulary as Limited Use Benefits with the August 2025 Formulary update and biosimilar version of Actemra® (tocilizumab) was listed as a Limited Use Benefit with the May 2025 Formulary update. In accordance with this New Start Rule, ODB program recipients who are treatment-naïve will only receive coverage for the biosimilar versions of these biologics, provided that they meet the applicable Limited Use criteria for the products. (ontario.ca, Updated November 21, 2025 ↗) ODB program recipients who are using Eylea®, Actemra®, or Xolair® during the transition period and require continued coverage of their product after the end of the transition period, must have their prescriber apply to the EAP for a medically necessary exemption. Requests for medically necessary exemptions are assessed on a case-by-case basis, and prescribers are encouraged to apply during the transition period to avoid an unintended gap in coverage. Requests for medically necessary exemptions must include documentation that the recipient has tried up to two biosimilar versions (where applicable) and experienced an adverse effect documented on the Health Canada side effect reporting form. A copy of each completed Health Canada reporting form must be included in the EAP request. Medically necessary exemptions will not be considered for ODB recipients subject to the New Start Rule. (ontario.ca, Updated November 21, 2025 ↗)

Reason for Use code 697 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 100 kg or more, a dosage of 162mg sc every week is recommended. Coverage limit: LU Authorization Period: 1 year Reason for Use code 698 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. 15mg/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 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. Coverage limit: LU Authorization Period: 1 year Reason for Use code 720 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 Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 162 mg/0.9 mL inj (PFS), 162mg/0.9mL Auto Inj. — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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 253 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 253, record 153, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 80 mg/4 mL Vial, 200 mg/10 mL Vial, 400 mg/20 mL — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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). Optimal use of DMARDs (hydroxychloroquine, methotrexate, sulfasalazine, leflunomide, cyclosporine, azathioprine, penicillamine, chloroquine and gold compounds) defined as: a) Methotrexate (20 mg/week) for at least 3 months AND b) 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 c) Methotrexate (20 mg/week) for at least 3 months AND leflunomide in combination with methotrexate for at least 3 months; OR 1 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. d) Methotrexate (20 mg/week), sulfasalazine (2 G/day) and hydroxychloroquine (400 mg/day)2 for at least 3 months. 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. 2 Hydroxychloroquine is based by weight up to 400 mg per day The requesting physician is required to provide the planned dosing regimen on the request. 449 Tocilizumab Brand(s): Actemra DOSAGE FORM/ STRENGTH: 80 mg / 4 mL Vial, 200 mg /10 mL Vial, 400 mg/ 20 mL Vial, 162 mg/0.9 mL solution for injection, 162 mg/0.9 mL Autoinjector The following are the recommended doses for tocilizumab (Actemra) IV and SC for rheumatoid arthritis: IV recommended dose: Approval for 4mg/kg/dose once every 4 weeks followed by an increase to 8mg/kg/dose based on clinical response; even for individuals whose body weight is more than 100kg, doses exceeding 800mg 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 at or above 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 450 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 449, record 285, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 80 mg / 4 mL, 200 mg / 10 mL, 400 mg / 20 mL, — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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: o rash of systemic JIA o serositis (e.g. pericarditis , pleuritis, or peritonitis) o lymphadenopathy (e.g. cervical, axillary, inguinal) o hepatomegaly o 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): o The patient is unresponsive and/or refractory to systemic corticosteroids; OR o 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 o The patient has experienced an adverse drug reaction to a systemic corticosteroid; OR o 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) Tocilizumab 454 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 Autoinjector Dosing: 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: a) 162 mg once every 2 weeks if the Patient weighs less than 30kg b) 162 mg once every week if the Patient weighs 30 kg or more 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 455 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 454, record 288, corpus 2025-01-01; name match only, not an eligibility decision

Tyenne · DIN 02552477 Manufacturer: Fresenius Kabi Canada Ltd.; listing date 2025-05-30 Health Canada: Marketed since 2025-04-14 · brand TYENNE · ATC L04AC07 TOCILIZUMAB · form Solution · route Intravenous · ingredients TOCILIZUMAB 400 MG/20ML · company Fresenius kabi canada ltd · schedule Prescription, Schedule d

DIN 02552477: Tyenne Raw flags: sec12=Y, sec3=Y Item: 923600066; group id 1030; item number 2381; lccId 00408; manufacturer id FKC Source form: Inj Sol-20mL Vial Pk; strength: 400mg/20mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $623.8050; ministry $623.8050 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02552477 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=104144

Shortage status: anticipated shortage (last updated 2026-08-21); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02552477

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Biosimilar versions of Eylea® (aflibercept) and Xolair® (omalizumab) were listed on the Formulary as Limited Use Benefits with the August 2025 Formulary update and biosimilar version of Actemra® (tocilizumab) was listed as a Limited Use Benefit with the May 2025 Formulary update. In accordance with this New Start Rule, ODB program recipients who are treatment-naïve will only receive coverage for the biosimilar versions of these biologics, provided that they meet the applicable Limited Use criteria for the products. (ontario.ca, Updated November 21, 2025 ↗) ODB program recipients who are using Eylea®, Actemra®, or Xolair® during the transition period and require continued coverage of their product after the end of the transition period, must have their prescriber apply to the EAP for a medically necessary exemption. Requests for medically necessary exemptions are assessed on a case-by-case basis, and prescribers are encouraged to apply during the transition period to avoid an unintended gap in coverage. Requests for medically necessary exemptions must include documentation that the recipient has tried up to two biosimilar versions (where applicable) and experienced an adverse effect documented on the Health Canada side effect reporting form. A copy of each completed Health Canada reporting form must be included in the EAP request. Medically necessary exemptions will not be considered for ODB recipients subject to the New Start Rule. (ontario.ca, Updated November 21, 2025 ↗)

Reason for Use code 697 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 100 kg or more, a dosage of 162mg sc every week is recommended. Coverage limit: LU Authorization Period: 1 year Reason for Use code 698 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. 15mg/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 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. Coverage limit: LU Authorization Period: 1 year Reason for Use code 720 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 Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 162 mg/0.9 mL inj (PFS), 162mg/0.9mL Auto Inj. — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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 253 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 253, record 153, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 80 mg/4 mL Vial, 200 mg/10 mL Vial, 400 mg/20 mL — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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). Optimal use of DMARDs (hydroxychloroquine, methotrexate, sulfasalazine, leflunomide, cyclosporine, azathioprine, penicillamine, chloroquine and gold compounds) defined as: a) Methotrexate (20 mg/week) for at least 3 months AND b) 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 c) Methotrexate (20 mg/week) for at least 3 months AND leflunomide in combination with methotrexate for at least 3 months; OR 1 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. d) Methotrexate (20 mg/week), sulfasalazine (2 G/day) and hydroxychloroquine (400 mg/day)2 for at least 3 months. 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. 2 Hydroxychloroquine is based by weight up to 400 mg per day The requesting physician is required to provide the planned dosing regimen on the request. 449 Tocilizumab Brand(s): Actemra DOSAGE FORM/ STRENGTH: 80 mg / 4 mL Vial, 200 mg /10 mL Vial, 400 mg/ 20 mL Vial, 162 mg/0.9 mL solution for injection, 162 mg/0.9 mL Autoinjector The following are the recommended doses for tocilizumab (Actemra) IV and SC for rheumatoid arthritis: IV recommended dose: Approval for 4mg/kg/dose once every 4 weeks followed by an increase to 8mg/kg/dose based on clinical response; even for individuals whose body weight is more than 100kg, doses exceeding 800mg 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 at or above 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 450 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 449, record 285, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Actemra; DOSAGE FORM/ STRENGTH: 80 mg / 4 mL, 200 mg / 10 mL, 400 mg / 20 mL, — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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: o rash of systemic JIA o serositis (e.g. pericarditis , pleuritis, or peritonitis) o lymphadenopathy (e.g. cervical, axillary, inguinal) o hepatomegaly o 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): o The patient is unresponsive and/or refractory to systemic corticosteroids; OR o 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 o The patient has experienced an adverse drug reaction to a systemic corticosteroid; OR o 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) Tocilizumab 454 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 Autoinjector Dosing: 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: a) 162 mg once every 2 weeks if the Patient weighs less than 30kg b) 162 mg once every week if the Patient weighs 30 kg or more 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 455 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 454, record 288, corpus 2025-01-01; name match only, not an eligibility decision

Avtozma · DIN 02562049 Manufacturer: Celltrion Inc.; listing date 2025-12-30 Health Canada: Marketed since 2026-01-14 · brand AVTOZMA · ATC L04AC07 TOCILIZUMAB · form Solution · route Intravenous · ingredients TOCILIZUMAB 400 MG/20ML · company Celltrion inc. · schedule Prescription, Schedule d

DIN 02562049: Avtozma Raw flags: sec12=Y, sec3=Y Item: 923600070; group id 1031; item number 2382; lccId 00423; manufacturer id CEI Source form: Inj Sol-20mL Vial Pk (Preservative-Free); strength: 400mg/20mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $623.8050; ministry $623.8050 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02562049 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106496

Shortage status: resolved shortage (ended 2026-08-18); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02562049

Shortage record checked 2026-09-13T08:10:21.292534+00:00