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Reason for Use code 512 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.) 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 over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week or 25mg twice weekly. Coverage limit: LU Authorization Period: 1 year Reason for Use code 513 For the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. NOTE: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week or 25mg twice weekly. Coverage limit: LU Authorization Period: 1 year Reason for Use code 514 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 should be documented. 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 over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen for pediatric patients ages 4 to 17 years with active pJIA is 0.8mg/kg per week (up to a maximum of 50mg per week). Prescribers should be informed and stay current with a drug's official Health Canada product monograph including available dosage formats. Coverage limit: LU Authorization Period: 1 year Reason for Use code 563 For the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite treatment with methotrexate (20mg/week) for at least 3 months and one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20% reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week or 25mg twice weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Coverage limit: LU Authorization Period: 1 year Reason for Use code 591 For the treatment of severe* plaque psoriasis in patients who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. * Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. ** Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND 12 week trial of phototherapy (unless not accessible), AND 6 month trial of at least 2 systemic, oral agents used alone or in combination -Methotrexate 15-30mg per week -Acitretin (could have been used with phototherapy) -Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: -At least a 50% reduction in PASI, AND -at least a 50% reduction in BSA involvement, AND -at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for etanercept: The recommended dose is 50mg subcutaneous twice weekly for 12 weeks followed by maintenance therapy at 25-50mg subcutaneous once weekly as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended and the physician should consider switching to an alternative biologic agent. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Enbrel and formulary listed biosimilars; DOSAGE FORM/ STRENGTH: 25mg/vial and 50mg prefilled syringe for — 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 Adalimumab – See Formulary for funded biosimilars Brand(s): Humira and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 40mg/0.8mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection Certolizumab Brand(s): Cimzia DOSAGE FORM/ STRENGTH: 200 mg/mL prefilled syringe and autoinjector Etanercept – See Formulary for funded biosimilars Brand(s): Enbrel and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 25mg/vial and 50mg prefilled syringe for subcutaneous injection Golimumab Brand(s): Simponi DOSAGE FORM/ STRENGTH: 50 mg/0.5 ml prefilled syringe and autoinjector Infliximab- See Formulary for funded biosimilars Brand(s): Remicade and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 100mg/10mL intravenous infusion Secukinumab Brand(s): Cosentyx DOSAGE FORM/ STRENGTH: 150 mg/mL prefilled syringe and 150 mg/mL prefilled pen Refer to the Executive Officer Communications on the Ministry website for the Ministry’s Biosimilar Policy including frequently asked questions and updates for the biosimilar policy updates. http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions. In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 to 8 of this document). 54 It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on an originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, will be expected to be provided ongoing access of the originator biologic through the patient’s original payer mechanism (e.g. manufacturer’s patient support program) or to switch to an ODB funded biosimilar version upon meeting specified criteria. The Ministry will no longer consider funding of originator biologics that are part of the biosimilar policy with limited exemptions on or after December 29, 2023. For the treatment of ankylosing spondylitis (AS) OR psoriatic spondylitis (PS) in patients who have severe active disease with: • Age of disease onset 50 years of age or younger; AND • Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND • Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND • BASDAI score of ≥ 4 for at least 4 weeks while on standard therapy; AND • A list of current concomitant medications related to the AS/PS, including pain medications (if relevant) with dosing regimens provided. *NSAIDs include coxibs; use of DMARDS instead of NSAIDs not acceptable The information submitted with the request must include the following: • A list of current concomitant medications related to the AS/PS, including pain medications (if relevant). Please include dosing regimens. • Details of review of radiographic reports for severe active disease. o X-ray or CT scan report stating the presence of “SI joint fusion” or “SI joint erosion” OR o MRI report stating the presence of “inflammation” or “edema” of the SI joint o Actual radiographic reports must be submitted with the request. If the radiographic reports do not specify the above, the request will be reviewed by external medical experts. Additional information that should be provided if applicable: • Schober measurement and chest expansion measurement • Evidence of restricted spinal mobility 55 • If the patient has AS/PS with predominantly peripheral joint involvement, additional information pertaining to trials of DMARDs must be provided, and these requests will be reviewed by external medical experts. Duration of Approval: 1 year Renewal will be considered for patients with objective evidence of at least a 50% reduction in BASDAI score or ≥ 2 absolute point reduction in BASDAI score. Please provide an update on concomitant medications for AS/PS and whether there has been a reduction in pain medication for AS/PS since initiating the biologic (if applicable). For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. The planned dosing regimen for the requested biologic should be provided. The recommended doses for the treatment of AS/PS are: • Adalimumab 40 mg every two weeks • Certolizumab 400mg at 0, 2, and 4 weeks followed by maintenance therapy of 200 mg every 2 weeks or 400 mg every 4 weeks. • Etanercept 25 mg twice weekly or 50 mg once weekly • Golimumab 50mg once a month • Infliximab 3-5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of up to 5mg/kg/dose every 6 to 8 weeks • Secukinumab 150 mg sc at weeks 0, 1, 2, and 3 followed by monthly maintenance dosing starting at week 4. Duration of Approval: First renewal: 1 year, Second and subsequent renewals: 5 years 56 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 54, record 34, corpus 2025-01-01; name match only, not an eligibility decision

Erelzi · DIN 02462877 Manufacturer: Sandoz Canada Inc.; listing date 2017-12-21 Health Canada: Marketed since 2017-12-08 · brand ERELZI · ATC L04AB01 ETANERCEPT · form Solution · route Subcutaneous · ingredients ETANERCEPT 25 MG/0.5ML · company Sandoz canada incorporated · schedule Schedule d, Prescription

DIN 02462877: Erelzi Raw flags: sec12=Y, sec3=Y Item: 923600008; group id 1021; item number 2366; lccId 00291; manufacturer id SDZ Source form: Inj Sol-0.5mL Pref Syr Pk; strength: 25mg/0.5mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $120.5000; ministry $120.5000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02462877 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=95074

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=02462877

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

Reason for Use code 512 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.) 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 over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week or 25mg twice weekly. Coverage limit: LU Authorization Period: 1 year Reason for Use code 513 For the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. NOTE: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week or 25mg twice weekly. Coverage limit: LU Authorization Period: 1 year Reason for Use code 514 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 should be documented. 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 over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen for pediatric patients ages 4 to 17 years with active pJIA is 0.8mg/kg per week (up to a maximum of 50mg per week). Prescribers should be informed and stay current with a drug's official Health Canada product monograph including available dosage formats. Coverage limit: LU Authorization Period: 1 year Reason for Use code 563 For the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite treatment with methotrexate (20mg/week) for at least 3 months and one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20% reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week or 25mg twice weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Coverage limit: LU Authorization Period: 1 year Reason for Use code 591 For the treatment of severe* plaque psoriasis in patients who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. * Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. ** Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND 12 week trial of phototherapy (unless not accessible), AND 6 month trial of at least 2 systemic, oral agents used alone or in combination -Methotrexate 15-30mg per week -Acitretin (could have been used with phototherapy) -Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: -At least a 50% reduction in PASI, AND -at least a 50% reduction in BSA involvement, AND -at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for etanercept: The recommended dose is 50mg subcutaneous twice weekly for 12 weeks followed by maintenance therapy at 25-50mg subcutaneous once weekly as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended and the physician should consider switching to an alternative biologic agent. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Enbrel and formulary listed biosimilars; DOSAGE FORM/ STRENGTH: 25mg/vial and 50mg prefilled syringe for — 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 Adalimumab – See Formulary for funded biosimilars Brand(s): Humira and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 40mg/0.8mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection Certolizumab Brand(s): Cimzia DOSAGE FORM/ STRENGTH: 200 mg/mL prefilled syringe and autoinjector Etanercept – See Formulary for funded biosimilars Brand(s): Enbrel and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 25mg/vial and 50mg prefilled syringe for subcutaneous injection Golimumab Brand(s): Simponi DOSAGE FORM/ STRENGTH: 50 mg/0.5 ml prefilled syringe and autoinjector Infliximab- See Formulary for funded biosimilars Brand(s): Remicade and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 100mg/10mL intravenous infusion Secukinumab Brand(s): Cosentyx DOSAGE FORM/ STRENGTH: 150 mg/mL prefilled syringe and 150 mg/mL prefilled pen Refer to the Executive Officer Communications on the Ministry website for the Ministry’s Biosimilar Policy including frequently asked questions and updates for the biosimilar policy updates. http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions. In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 to 8 of this document). 54 It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on an originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, will be expected to be provided ongoing access of the originator biologic through the patient’s original payer mechanism (e.g. manufacturer’s patient support program) or to switch to an ODB funded biosimilar version upon meeting specified criteria. The Ministry will no longer consider funding of originator biologics that are part of the biosimilar policy with limited exemptions on or after December 29, 2023. For the treatment of ankylosing spondylitis (AS) OR psoriatic spondylitis (PS) in patients who have severe active disease with: • Age of disease onset 50 years of age or younger; AND • Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND • Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND • BASDAI score of ≥ 4 for at least 4 weeks while on standard therapy; AND • A list of current concomitant medications related to the AS/PS, including pain medications (if relevant) with dosing regimens provided. *NSAIDs include coxibs; use of DMARDS instead of NSAIDs not acceptable The information submitted with the request must include the following: • A list of current concomitant medications related to the AS/PS, including pain medications (if relevant). Please include dosing regimens. • Details of review of radiographic reports for severe active disease. o X-ray or CT scan report stating the presence of “SI joint fusion” or “SI joint erosion” OR o MRI report stating the presence of “inflammation” or “edema” of the SI joint o Actual radiographic reports must be submitted with the request. If the radiographic reports do not specify the above, the request will be reviewed by external medical experts. Additional information that should be provided if applicable: • Schober measurement and chest expansion measurement • Evidence of restricted spinal mobility 55 • If the patient has AS/PS with predominantly peripheral joint involvement, additional information pertaining to trials of DMARDs must be provided, and these requests will be reviewed by external medical experts. Duration of Approval: 1 year Renewal will be considered for patients with objective evidence of at least a 50% reduction in BASDAI score or ≥ 2 absolute point reduction in BASDAI score. Please provide an update on concomitant medications for AS/PS and whether there has been a reduction in pain medication for AS/PS since initiating the biologic (if applicable). For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. The planned dosing regimen for the requested biologic should be provided. The recommended doses for the treatment of AS/PS are: • Adalimumab 40 mg every two weeks • Certolizumab 400mg at 0, 2, and 4 weeks followed by maintenance therapy of 200 mg every 2 weeks or 400 mg every 4 weeks. • Etanercept 25 mg twice weekly or 50 mg once weekly • Golimumab 50mg once a month • Infliximab 3-5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of up to 5mg/kg/dose every 6 to 8 weeks • Secukinumab 150 mg sc at weeks 0, 1, 2, and 3 followed by monthly maintenance dosing starting at week 4. Duration of Approval: First renewal: 1 year, Second and subsequent renewals: 5 years 56 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 54, record 34, corpus 2025-01-01; name match only, not an eligibility decision

Erelzi · DIN 02462869 Manufacturer: Sandoz Canada Inc.; listing date 2017-12-21 Health Canada: Marketed since 2017-08-04 · brand ERELZI · ATC L04AB01 ETANERCEPT · form Solution · route Subcutaneous · ingredients ETANERCEPT 50 MG/ML · company Sandoz canada incorporated · schedule Schedule d, Prescription

DIN 02462869: Erelzi Raw flags: sec12=Y, sec3=Y Item: 923600007; group id 1021; item number 2367; lccId 00291; manufacturer id SDZ Source form: Inj Sol-1mL Pref Syr Pk; strength: 50mg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $241.0000; ministry $241.0000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02462869 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=95073

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=02462869

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

Reason for Use code 512 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.) 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 over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week or 25mg twice weekly. Coverage limit: LU Authorization Period: 1 year Reason for Use code 513 For the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. NOTE: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week or 25mg twice weekly. Coverage limit: LU Authorization Period: 1 year Reason for Use code 514 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 should be documented. 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 over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen for pediatric patients ages 4 to 17 years with active pJIA is 0.8mg/kg per week (up to a maximum of 50mg per week). Prescribers should be informed and stay current with a drug's official Health Canada product monograph including available dosage formats. Coverage limit: LU Authorization Period: 1 year Reason for Use code 563 For the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite treatment with methotrexate (20mg/week) for at least 3 months and one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20% reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week or 25mg twice weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Coverage limit: LU Authorization Period: 1 year Reason for Use code 591 For the treatment of severe* plaque psoriasis in patients who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. * Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. ** Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND 12 week trial of phototherapy (unless not accessible), AND 6 month trial of at least 2 systemic, oral agents used alone or in combination -Methotrexate 15-30mg per week -Acitretin (could have been used with phototherapy) -Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: -At least a 50% reduction in PASI, AND -at least a 50% reduction in BSA involvement, AND -at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for etanercept: The recommended dose is 50mg subcutaneous twice weekly for 12 weeks followed by maintenance therapy at 25-50mg subcutaneous once weekly as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended and the physician should consider switching to an alternative biologic agent. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Enbrel and formulary listed biosimilars; DOSAGE FORM/ STRENGTH: 25mg/vial and 50mg prefilled syringe for — 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 Adalimumab – See Formulary for funded biosimilars Brand(s): Humira and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 40mg/0.8mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection Certolizumab Brand(s): Cimzia DOSAGE FORM/ STRENGTH: 200 mg/mL prefilled syringe and autoinjector Etanercept – See Formulary for funded biosimilars Brand(s): Enbrel and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 25mg/vial and 50mg prefilled syringe for subcutaneous injection Golimumab Brand(s): Simponi DOSAGE FORM/ STRENGTH: 50 mg/0.5 ml prefilled syringe and autoinjector Infliximab- See Formulary for funded biosimilars Brand(s): Remicade and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 100mg/10mL intravenous infusion Secukinumab Brand(s): Cosentyx DOSAGE FORM/ STRENGTH: 150 mg/mL prefilled syringe and 150 mg/mL prefilled pen Refer to the Executive Officer Communications on the Ministry website for the Ministry’s Biosimilar Policy including frequently asked questions and updates for the biosimilar policy updates. http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions. In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 to 8 of this document). 54 It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on an originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, will be expected to be provided ongoing access of the originator biologic through the patient’s original payer mechanism (e.g. manufacturer’s patient support program) or to switch to an ODB funded biosimilar version upon meeting specified criteria. The Ministry will no longer consider funding of originator biologics that are part of the biosimilar policy with limited exemptions on or after December 29, 2023. For the treatment of ankylosing spondylitis (AS) OR psoriatic spondylitis (PS) in patients who have severe active disease with: • Age of disease onset 50 years of age or younger; AND • Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND • Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND • BASDAI score of ≥ 4 for at least 4 weeks while on standard therapy; AND • A list of current concomitant medications related to the AS/PS, including pain medications (if relevant) with dosing regimens provided. *NSAIDs include coxibs; use of DMARDS instead of NSAIDs not acceptable The information submitted with the request must include the following: • A list of current concomitant medications related to the AS/PS, including pain medications (if relevant). Please include dosing regimens. • Details of review of radiographic reports for severe active disease. o X-ray or CT scan report stating the presence of “SI joint fusion” or “SI joint erosion” OR o MRI report stating the presence of “inflammation” or “edema” of the SI joint o Actual radiographic reports must be submitted with the request. If the radiographic reports do not specify the above, the request will be reviewed by external medical experts. Additional information that should be provided if applicable: • Schober measurement and chest expansion measurement • Evidence of restricted spinal mobility 55 • If the patient has AS/PS with predominantly peripheral joint involvement, additional information pertaining to trials of DMARDs must be provided, and these requests will be reviewed by external medical experts. Duration of Approval: 1 year Renewal will be considered for patients with objective evidence of at least a 50% reduction in BASDAI score or ≥ 2 absolute point reduction in BASDAI score. Please provide an update on concomitant medications for AS/PS and whether there has been a reduction in pain medication for AS/PS since initiating the biologic (if applicable). For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. The planned dosing regimen for the requested biologic should be provided. The recommended doses for the treatment of AS/PS are: • Adalimumab 40 mg every two weeks • Certolizumab 400mg at 0, 2, and 4 weeks followed by maintenance therapy of 200 mg every 2 weeks or 400 mg every 4 weeks. • Etanercept 25 mg twice weekly or 50 mg once weekly • Golimumab 50mg once a month • Infliximab 3-5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of up to 5mg/kg/dose every 6 to 8 weeks • Secukinumab 150 mg sc at weeks 0, 1, 2, and 3 followed by monthly maintenance dosing starting at week 4. Duration of Approval: First renewal: 1 year, Second and subsequent renewals: 5 years 56 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 54, record 34, corpus 2025-01-01; name match only, not an eligibility decision

Erelzi · DIN 02462850 Manufacturer: Sandoz Canada Inc.; listing date 2017-12-21 Health Canada: Marketed since 2017-08-04 · brand ERELZI · ATC L04AB01 ETANERCEPT · form Solution · route Subcutaneous · ingredients ETANERCEPT 50 MG/ML · company Sandoz canada incorporated · schedule Schedule d, Prescription

DIN 02462850: Erelzi Raw flags: sec12=Y, sec3=Y Item: 923600006; group id 1021; item number 2368; lccId 00291; manufacturer id SDZ Source form: Inj Sol-1mL Prefilled SensoReady Pen Pk; strength: 50mg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $241.0000; ministry $241.0000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02462850 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=95072

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=02462850

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

Reason for Use code 498 For the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset less than or equal to 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. NOTE: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week. Coverage limit: LU Authorization Period: 1 year Reason for Use code 499 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.) 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 over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week. Coverage limit: LU Authorization Period: 1 year Reason for Use code 514 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 should be documented. 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 over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen for pediatric patients ages 4 to 17 years with active pJIA is 0.8mg/kg per week (up to a maximum of 50mg per week). Prescribers should be informed and stay current with a drug's official Health Canada product monograph including available dosage formats. Coverage limit: LU Authorization Period: 1 year Reason for Use code 563 For the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite treatment with methotrexate (20mg/week) for at least 3 months and one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20% reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week or 25mg twice weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Coverage limit: LU Authorization Period: 1 year Reason for Use code 591 For the treatment of severe* plaque psoriasis in patients who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. * Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. ** Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND 12 week trial of phototherapy (unless not accessible), AND 6 month trial of at least 2 systemic, oral agents used alone or in combination -Methotrexate 15-30mg per week -Acitretin (could have been used with phototherapy) -Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: -At least a 50% reduction in PASI, AND -at least a 50% reduction in BSA involvement, AND -at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for etanercept: The recommended dose is 50mg subcutaneous twice weekly for 12 weeks followed by maintenance therapy at 25-50mg subcutaneous once weekly as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended and the physician should consider switching to an alternative biologic agent. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Enbrel and formulary listed biosimilars; DOSAGE FORM/ STRENGTH: 25mg/vial and 50mg prefilled syringe for — 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 Adalimumab – See Formulary for funded biosimilars Brand(s): Humira and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 40mg/0.8mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection Certolizumab Brand(s): Cimzia DOSAGE FORM/ STRENGTH: 200 mg/mL prefilled syringe and autoinjector Etanercept – See Formulary for funded biosimilars Brand(s): Enbrel and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 25mg/vial and 50mg prefilled syringe for subcutaneous injection Golimumab Brand(s): Simponi DOSAGE FORM/ STRENGTH: 50 mg/0.5 ml prefilled syringe and autoinjector Infliximab- See Formulary for funded biosimilars Brand(s): Remicade and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 100mg/10mL intravenous infusion Secukinumab Brand(s): Cosentyx DOSAGE FORM/ STRENGTH: 150 mg/mL prefilled syringe and 150 mg/mL prefilled pen Refer to the Executive Officer Communications on the Ministry website for the Ministry’s Biosimilar Policy including frequently asked questions and updates for the biosimilar policy updates. http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions. In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 to 8 of this document). 54 It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on an originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, will be expected to be provided ongoing access of the originator biologic through the patient’s original payer mechanism (e.g. manufacturer’s patient support program) or to switch to an ODB funded biosimilar version upon meeting specified criteria. The Ministry will no longer consider funding of originator biologics that are part of the biosimilar policy with limited exemptions on or after December 29, 2023. For the treatment of ankylosing spondylitis (AS) OR psoriatic spondylitis (PS) in patients who have severe active disease with: • Age of disease onset 50 years of age or younger; AND • Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND • Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND • BASDAI score of ≥ 4 for at least 4 weeks while on standard therapy; AND • A list of current concomitant medications related to the AS/PS, including pain medications (if relevant) with dosing regimens provided. *NSAIDs include coxibs; use of DMARDS instead of NSAIDs not acceptable The information submitted with the request must include the following: • A list of current concomitant medications related to the AS/PS, including pain medications (if relevant). Please include dosing regimens. • Details of review of radiographic reports for severe active disease. o X-ray or CT scan report stating the presence of “SI joint fusion” or “SI joint erosion” OR o MRI report stating the presence of “inflammation” or “edema” of the SI joint o Actual radiographic reports must be submitted with the request. If the radiographic reports do not specify the above, the request will be reviewed by external medical experts. Additional information that should be provided if applicable: • Schober measurement and chest expansion measurement • Evidence of restricted spinal mobility 55 • If the patient has AS/PS with predominantly peripheral joint involvement, additional information pertaining to trials of DMARDs must be provided, and these requests will be reviewed by external medical experts. Duration of Approval: 1 year Renewal will be considered for patients with objective evidence of at least a 50% reduction in BASDAI score or ≥ 2 absolute point reduction in BASDAI score. Please provide an update on concomitant medications for AS/PS and whether there has been a reduction in pain medication for AS/PS since initiating the biologic (if applicable). For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. The planned dosing regimen for the requested biologic should be provided. The recommended doses for the treatment of AS/PS are: • Adalimumab 40 mg every two weeks • Certolizumab 400mg at 0, 2, and 4 weeks followed by maintenance therapy of 200 mg every 2 weeks or 400 mg every 4 weeks. • Etanercept 25 mg twice weekly or 50 mg once weekly • Golimumab 50mg once a month • Infliximab 3-5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of up to 5mg/kg/dose every 6 to 8 weeks • Secukinumab 150 mg sc at weeks 0, 1, 2, and 3 followed by monthly maintenance dosing starting at week 4. Duration of Approval: First renewal: 1 year, Second and subsequent renewals: 5 years 56 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 54, record 34, corpus 2025-01-01; name match only, not an eligibility decision

Rymti · DIN 02530309 Manufacturer: Lupin Pharma Canada Limited; listing date 2024-03-28 Health Canada: Marketed since 2024-04-05 · brand RYMTI · ATC L04AB01 ETANERCEPT · form Solution · route Subcutaneous · ingredients ETANERCEPT 50 MG/1ML · company Lupin pharma canada limited · schedule Prescription, Schedule d

DIN 02530309: Rymti Raw flags: sec12=Y, sec3=Y Item: 923600051; group id 1022; item number 2369; lccId 00289; manufacturer id LUP Source form: Inj Sol-Pref Autoinj Pen; strength: 50mg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $236.1800; ministry $236.1800 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02530309 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=101949

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=02530309

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

Reason for Use code 498 For the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset less than or equal to 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. NOTE: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week. Coverage limit: LU Authorization Period: 1 year Reason for Use code 499 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.) 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 over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week. Coverage limit: LU Authorization Period: 1 year Reason for Use code 514 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 should be documented. 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 over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen for pediatric patients ages 4 to 17 years with active pJIA is 0.8mg/kg per week (up to a maximum of 50mg per week). Prescribers should be informed and stay current with a drug's official Health Canada product monograph including available dosage formats. Coverage limit: LU Authorization Period: 1 year Reason for Use code 563 For the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite treatment with methotrexate (20mg/week) for at least 3 months and one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20% reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week or 25mg twice weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Coverage limit: LU Authorization Period: 1 year Reason for Use code 591 For the treatment of severe* plaque psoriasis in patients who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. * Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. ** Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND 12 week trial of phototherapy (unless not accessible), AND 6 month trial of at least 2 systemic, oral agents used alone or in combination -Methotrexate 15-30mg per week -Acitretin (could have been used with phototherapy) -Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: -At least a 50% reduction in PASI, AND -at least a 50% reduction in BSA involvement, AND -at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for etanercept: The recommended dose is 50mg subcutaneous twice weekly for 12 weeks followed by maintenance therapy at 25-50mg subcutaneous once weekly as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended and the physician should consider switching to an alternative biologic agent. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Enbrel and formulary listed biosimilars; DOSAGE FORM/ STRENGTH: 25mg/vial and 50mg prefilled syringe for — 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 Adalimumab – See Formulary for funded biosimilars Brand(s): Humira and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 40mg/0.8mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection Certolizumab Brand(s): Cimzia DOSAGE FORM/ STRENGTH: 200 mg/mL prefilled syringe and autoinjector Etanercept – See Formulary for funded biosimilars Brand(s): Enbrel and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 25mg/vial and 50mg prefilled syringe for subcutaneous injection Golimumab Brand(s): Simponi DOSAGE FORM/ STRENGTH: 50 mg/0.5 ml prefilled syringe and autoinjector Infliximab- See Formulary for funded biosimilars Brand(s): Remicade and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 100mg/10mL intravenous infusion Secukinumab Brand(s): Cosentyx DOSAGE FORM/ STRENGTH: 150 mg/mL prefilled syringe and 150 mg/mL prefilled pen Refer to the Executive Officer Communications on the Ministry website for the Ministry’s Biosimilar Policy including frequently asked questions and updates for the biosimilar policy updates. http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions. In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 to 8 of this document). 54 It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on an originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, will be expected to be provided ongoing access of the originator biologic through the patient’s original payer mechanism (e.g. manufacturer’s patient support program) or to switch to an ODB funded biosimilar version upon meeting specified criteria. The Ministry will no longer consider funding of originator biologics that are part of the biosimilar policy with limited exemptions on or after December 29, 2023. For the treatment of ankylosing spondylitis (AS) OR psoriatic spondylitis (PS) in patients who have severe active disease with: • Age of disease onset 50 years of age or younger; AND • Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND • Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND • BASDAI score of ≥ 4 for at least 4 weeks while on standard therapy; AND • A list of current concomitant medications related to the AS/PS, including pain medications (if relevant) with dosing regimens provided. *NSAIDs include coxibs; use of DMARDS instead of NSAIDs not acceptable The information submitted with the request must include the following: • A list of current concomitant medications related to the AS/PS, including pain medications (if relevant). Please include dosing regimens. • Details of review of radiographic reports for severe active disease. o X-ray or CT scan report stating the presence of “SI joint fusion” or “SI joint erosion” OR o MRI report stating the presence of “inflammation” or “edema” of the SI joint o Actual radiographic reports must be submitted with the request. If the radiographic reports do not specify the above, the request will be reviewed by external medical experts. Additional information that should be provided if applicable: • Schober measurement and chest expansion measurement • Evidence of restricted spinal mobility 55 • If the patient has AS/PS with predominantly peripheral joint involvement, additional information pertaining to trials of DMARDs must be provided, and these requests will be reviewed by external medical experts. Duration of Approval: 1 year Renewal will be considered for patients with objective evidence of at least a 50% reduction in BASDAI score or ≥ 2 absolute point reduction in BASDAI score. Please provide an update on concomitant medications for AS/PS and whether there has been a reduction in pain medication for AS/PS since initiating the biologic (if applicable). For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. The planned dosing regimen for the requested biologic should be provided. The recommended doses for the treatment of AS/PS are: • Adalimumab 40 mg every two weeks • Certolizumab 400mg at 0, 2, and 4 weeks followed by maintenance therapy of 200 mg every 2 weeks or 400 mg every 4 weeks. • Etanercept 25 mg twice weekly or 50 mg once weekly • Golimumab 50mg once a month • Infliximab 3-5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of up to 5mg/kg/dose every 6 to 8 weeks • Secukinumab 150 mg sc at weeks 0, 1, 2, and 3 followed by monthly maintenance dosing starting at week 4. Duration of Approval: First renewal: 1 year, Second and subsequent renewals: 5 years 56 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 54, record 34, corpus 2025-01-01; name match only, not an eligibility decision

Brenzys · DIN 02455323 Manufacturer: Samsung Bioepis Co. Ltd; listing date 2017-07-31 Health Canada: Marketed since 2016-09-23 · brand BRENZYS · ATC L04AB01 ETANERCEPT · form Solution · route Subcutaneous · ingredients ETANERCEPT 50 MG/ML · company Samsung bioepis co., ltd · schedule Schedule d, Prescription

DIN 02455323: Brenzys Raw flags: sec12=Y, sec3=Y Item: 923600004; group id 1022; item number 2370; lccId 00289; manufacturer id SAM Source form: Inj Sol-Pref Syr; strength: 50mg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $236.1800; ministry $236.1800 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02455323 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94214

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=02455323

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

Reason for Use code 498 For the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset less than or equal to 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. NOTE: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week. Coverage limit: LU Authorization Period: 1 year Reason for Use code 499 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.) 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 over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week. Coverage limit: LU Authorization Period: 1 year Reason for Use code 514 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 should be documented. 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 over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen for pediatric patients ages 4 to 17 years with active pJIA is 0.8mg/kg per week (up to a maximum of 50mg per week). Prescribers should be informed and stay current with a drug's official Health Canada product monograph including available dosage formats. Coverage limit: LU Authorization Period: 1 year Reason for Use code 563 For the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite treatment with methotrexate (20mg/week) for at least 3 months and one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20% reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week or 25mg twice weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Coverage limit: LU Authorization Period: 1 year Reason for Use code 591 For the treatment of severe* plaque psoriasis in patients who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. * Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. ** Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND 12 week trial of phototherapy (unless not accessible), AND 6 month trial of at least 2 systemic, oral agents used alone or in combination -Methotrexate 15-30mg per week -Acitretin (could have been used with phototherapy) -Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: -At least a 50% reduction in PASI, AND -at least a 50% reduction in BSA involvement, AND -at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for etanercept: The recommended dose is 50mg subcutaneous twice weekly for 12 weeks followed by maintenance therapy at 25-50mg subcutaneous once weekly as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended and the physician should consider switching to an alternative biologic agent. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Enbrel and formulary listed biosimilars; DOSAGE FORM/ STRENGTH: 25mg/vial and 50mg prefilled syringe for — 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 Adalimumab – See Formulary for funded biosimilars Brand(s): Humira and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 40mg/0.8mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection Certolizumab Brand(s): Cimzia DOSAGE FORM/ STRENGTH: 200 mg/mL prefilled syringe and autoinjector Etanercept – See Formulary for funded biosimilars Brand(s): Enbrel and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 25mg/vial and 50mg prefilled syringe for subcutaneous injection Golimumab Brand(s): Simponi DOSAGE FORM/ STRENGTH: 50 mg/0.5 ml prefilled syringe and autoinjector Infliximab- See Formulary for funded biosimilars Brand(s): Remicade and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 100mg/10mL intravenous infusion Secukinumab Brand(s): Cosentyx DOSAGE FORM/ STRENGTH: 150 mg/mL prefilled syringe and 150 mg/mL prefilled pen Refer to the Executive Officer Communications on the Ministry website for the Ministry’s Biosimilar Policy including frequently asked questions and updates for the biosimilar policy updates. http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions. In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 to 8 of this document). 54 It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on an originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, will be expected to be provided ongoing access of the originator biologic through the patient’s original payer mechanism (e.g. manufacturer’s patient support program) or to switch to an ODB funded biosimilar version upon meeting specified criteria. The Ministry will no longer consider funding of originator biologics that are part of the biosimilar policy with limited exemptions on or after December 29, 2023. For the treatment of ankylosing spondylitis (AS) OR psoriatic spondylitis (PS) in patients who have severe active disease with: • Age of disease onset 50 years of age or younger; AND • Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND • Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND • BASDAI score of ≥ 4 for at least 4 weeks while on standard therapy; AND • A list of current concomitant medications related to the AS/PS, including pain medications (if relevant) with dosing regimens provided. *NSAIDs include coxibs; use of DMARDS instead of NSAIDs not acceptable The information submitted with the request must include the following: • A list of current concomitant medications related to the AS/PS, including pain medications (if relevant). Please include dosing regimens. • Details of review of radiographic reports for severe active disease. o X-ray or CT scan report stating the presence of “SI joint fusion” or “SI joint erosion” OR o MRI report stating the presence of “inflammation” or “edema” of the SI joint o Actual radiographic reports must be submitted with the request. If the radiographic reports do not specify the above, the request will be reviewed by external medical experts. Additional information that should be provided if applicable: • Schober measurement and chest expansion measurement • Evidence of restricted spinal mobility 55 • If the patient has AS/PS with predominantly peripheral joint involvement, additional information pertaining to trials of DMARDs must be provided, and these requests will be reviewed by external medical experts. Duration of Approval: 1 year Renewal will be considered for patients with objective evidence of at least a 50% reduction in BASDAI score or ≥ 2 absolute point reduction in BASDAI score. Please provide an update on concomitant medications for AS/PS and whether there has been a reduction in pain medication for AS/PS since initiating the biologic (if applicable). For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. The planned dosing regimen for the requested biologic should be provided. The recommended doses for the treatment of AS/PS are: • Adalimumab 40 mg every two weeks • Certolizumab 400mg at 0, 2, and 4 weeks followed by maintenance therapy of 200 mg every 2 weeks or 400 mg every 4 weeks. • Etanercept 25 mg twice weekly or 50 mg once weekly • Golimumab 50mg once a month • Infliximab 3-5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of up to 5mg/kg/dose every 6 to 8 weeks • Secukinumab 150 mg sc at weeks 0, 1, 2, and 3 followed by monthly maintenance dosing starting at week 4. Duration of Approval: First renewal: 1 year, Second and subsequent renewals: 5 years 56 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 54, record 34, corpus 2025-01-01; name match only, not an eligibility decision

Rymti · DIN 02530295 Manufacturer: Lupin Pharma Canada Limited; listing date 2024-03-28 Health Canada: Marketed since 2024-04-05 · brand RYMTI · ATC L04AB01 ETANERCEPT · form Solution · route Subcutaneous · ingredients ETANERCEPT 50 MG/1ML · company Lupin pharma canada limited · schedule Prescription, Schedule d

DIN 02530295: Rymti Raw flags: sec12=Y, sec3=Y Item: 923600050; group id 1022; item number 2371; lccId 00289; manufacturer id LUP Source form: Inj Sol-Pref Syr; strength: 50mg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $236.1800; ministry $236.1800 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02530295 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=101948

Shortage status: resolved shortage (ended 2026-05-28); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02530295

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

Reason for Use code 498 For the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset less than or equal to 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. NOTE: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week. Coverage limit: LU Authorization Period: 1 year Reason for Use code 499 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.) 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 over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week. Coverage limit: LU Authorization Period: 1 year Reason for Use code 514 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 should be documented. 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 over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen for pediatric patients ages 4 to 17 years with active pJIA is 0.8mg/kg per week (up to a maximum of 50mg per week). Prescribers should be informed and stay current with a drug's official Health Canada product monograph including available dosage formats. Coverage limit: LU Authorization Period: 1 year Reason for Use code 563 For the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite treatment with methotrexate (20mg/week) for at least 3 months and one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20% reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week or 25mg twice weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Coverage limit: LU Authorization Period: 1 year Reason for Use code 591 For the treatment of severe* plaque psoriasis in patients who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. * Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. ** Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND 12 week trial of phototherapy (unless not accessible), AND 6 month trial of at least 2 systemic, oral agents used alone or in combination -Methotrexate 15-30mg per week -Acitretin (could have been used with phototherapy) -Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: -At least a 50% reduction in PASI, AND -at least a 50% reduction in BSA involvement, AND -at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for etanercept: The recommended dose is 50mg subcutaneous twice weekly for 12 weeks followed by maintenance therapy at 25-50mg subcutaneous once weekly as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended and the physician should consider switching to an alternative biologic agent. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Enbrel and formulary listed biosimilars; DOSAGE FORM/ STRENGTH: 25mg/vial and 50mg prefilled syringe for — 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 Adalimumab – See Formulary for funded biosimilars Brand(s): Humira and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 40mg/0.8mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection Certolizumab Brand(s): Cimzia DOSAGE FORM/ STRENGTH: 200 mg/mL prefilled syringe and autoinjector Etanercept – See Formulary for funded biosimilars Brand(s): Enbrel and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 25mg/vial and 50mg prefilled syringe for subcutaneous injection Golimumab Brand(s): Simponi DOSAGE FORM/ STRENGTH: 50 mg/0.5 ml prefilled syringe and autoinjector Infliximab- See Formulary for funded biosimilars Brand(s): Remicade and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 100mg/10mL intravenous infusion Secukinumab Brand(s): Cosentyx DOSAGE FORM/ STRENGTH: 150 mg/mL prefilled syringe and 150 mg/mL prefilled pen Refer to the Executive Officer Communications on the Ministry website for the Ministry’s Biosimilar Policy including frequently asked questions and updates for the biosimilar policy updates. http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions. In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 to 8 of this document). 54 It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on an originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, will be expected to be provided ongoing access of the originator biologic through the patient’s original payer mechanism (e.g. manufacturer’s patient support program) or to switch to an ODB funded biosimilar version upon meeting specified criteria. The Ministry will no longer consider funding of originator biologics that are part of the biosimilar policy with limited exemptions on or after December 29, 2023. For the treatment of ankylosing spondylitis (AS) OR psoriatic spondylitis (PS) in patients who have severe active disease with: • Age of disease onset 50 years of age or younger; AND • Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND • Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND • BASDAI score of ≥ 4 for at least 4 weeks while on standard therapy; AND • A list of current concomitant medications related to the AS/PS, including pain medications (if relevant) with dosing regimens provided. *NSAIDs include coxibs; use of DMARDS instead of NSAIDs not acceptable The information submitted with the request must include the following: • A list of current concomitant medications related to the AS/PS, including pain medications (if relevant). Please include dosing regimens. • Details of review of radiographic reports for severe active disease. o X-ray or CT scan report stating the presence of “SI joint fusion” or “SI joint erosion” OR o MRI report stating the presence of “inflammation” or “edema” of the SI joint o Actual radiographic reports must be submitted with the request. If the radiographic reports do not specify the above, the request will be reviewed by external medical experts. Additional information that should be provided if applicable: • Schober measurement and chest expansion measurement • Evidence of restricted spinal mobility 55 • If the patient has AS/PS with predominantly peripheral joint involvement, additional information pertaining to trials of DMARDs must be provided, and these requests will be reviewed by external medical experts. Duration of Approval: 1 year Renewal will be considered for patients with objective evidence of at least a 50% reduction in BASDAI score or ≥ 2 absolute point reduction in BASDAI score. Please provide an update on concomitant medications for AS/PS and whether there has been a reduction in pain medication for AS/PS since initiating the biologic (if applicable). For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. The planned dosing regimen for the requested biologic should be provided. The recommended doses for the treatment of AS/PS are: • Adalimumab 40 mg every two weeks • Certolizumab 400mg at 0, 2, and 4 weeks followed by maintenance therapy of 200 mg every 2 weeks or 400 mg every 4 weeks. • Etanercept 25 mg twice weekly or 50 mg once weekly • Golimumab 50mg once a month • Infliximab 3-5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of up to 5mg/kg/dose every 6 to 8 weeks • Secukinumab 150 mg sc at weeks 0, 1, 2, and 3 followed by monthly maintenance dosing starting at week 4. Duration of Approval: First renewal: 1 year, Second and subsequent renewals: 5 years 56 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 54, record 34, corpus 2025-01-01; name match only, not an eligibility decision

Brenzys · DIN 02455331 Manufacturer: Samsung Bioepis Co. Ltd; listing date 2017-07-31 Health Canada: Marketed since 2016-09-13 · brand BRENZYS · ATC L04AB01 ETANERCEPT · form Solution · route Subcutaneous · ingredients ETANERCEPT 50 MG/ML · company Samsung bioepis co., ltd · schedule Schedule d, Prescription

DIN 02455331: Brenzys Raw flags: sec12=Y, sec3=Y Item: 923600005; group id 1022; item number 2372; lccId 00289; manufacturer id SAM Source form: Sol- Pref AutoInj; strength: 50mg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $236.1800; ministry $236.1800 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02455331 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94215

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=02455331

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