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INFLIXIMAB

All injection strengths: Limited Use (codes 468, 469, 470, 471, 477, 478, 479)

Other products in the same Health Canada class (L04A, L04AB) — coverage varies; not interchangeable

  • Adalimumab (Hyrimoz): limited Use 600, 601, 602, 603, 604, 605, 606, 607, 609, 611, Limited Use 600, 602, 603, 604, 605, 606, 607, 609, 633, 634
  • Etanercept (Erelzi): limited Use 498, 499, 514, 563, 591, Limited Use 512, 513, 514, 563, 591
  • Tocilizumab (Tyenne): limited Use 697, 698, 720, Limited Use 697, 698, 720, 721
  • Tofacitinib (Xeljanz): limited Use 480, 589, 743, Limited Use 589
  • Tofacitinib (Xeljanz XR): limited Use 565
  • Upadacitinib (Rinvoq): limited Use 637, 684, Limited Use 684

1 more in the class list below

Remdantry · DIN 02419475 · 100mg/Vial · powder for injection, vial

Limited Use — Reason for Use code 468, 469, 470, 471, 477, 478, 479 requiredMarketed · checked 2026-09-19
StatusLimited Use — Reason for Use code 468, 469, 470, 471, 477, 478, 479 required
Write on scriptLU code 468, 469, 470, 471, 477, 478, 479 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Ontario Limited Use criteria — code 468, 469, 470, 471, 477, 478, 479
Reason for Use code 468 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 3mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 3mg/kg/dose every 8 weeks up to a maximum of six maintenance doses per year. Coverage limit: LU Authorization Period: 1 year Reason for Use code 469 For the treatment of ankylosing spondylitis (AS) in patients who have severe active disease (confirmed by radiographic evidence (see notes 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 3 to 5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of up to 5mg/kg/dose every 6 to 8 weeks. Coverage limit: LU Authorization Period: 1 year Reason for Use code 470 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: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. 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 have 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 5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 5mg/kg/dose every 8 weeks. Coverage limit: LU Authorization Period: 1 year Reason for Use code 471 For the treatment of severe (see Note 1 below) plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies (see Note 2 below). 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. Note 1: Definition of severe plaque psoriasis: -Body Surface Area (BSA) involvement of at least 10 percent, 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. Note 2: 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 to 30mg/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 percent reduction in PASI, AND -at least a 50 percent reduction in BSA involvement, AND -at least a 5 point reduction in DLQI score The recommended dosing regimen is 5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 5mg/kg/dose every 8 weeks. Coverage limit: LU Authorization Period: 1 year Reason for Use code 477 Ulcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Infliximab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is 5mg/kg/dose at 0, 2, and 6 weeks. The recommended maintenance dosing regimen is 5mg/kg/dose every 8 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program. Coverage limit: LU Authorization Period: 1 year Reason for Use code 478 Luminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Infliximab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 5mg/kg/dose at 0, 2, and 6 weeks. The recommended maintenance dosing regimen is 5mg/kg/dose every 8 weeks. (Note: higher doses up to 10mg/kg/dose may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program. Coverage limit: LU Authorization Period: 1 year Reason for Use code 479 Fistulising Crohn's disease For the treatment of fistulising Crohn's disease in patients who meet the following criteria: - Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole) The recommended induction dosing regimen is 5mg/kg/dose at 0, 2, and 6 weeks. The recommended maintenance dosing regimen is 5mg/kg/dose every 8 weeks. (Note: higher doses up to 10mg/kg/dose may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Remicade and formulary listed biosimilars; DOSAGE FORM/ STRENGTH: 100mg/10mL intravenous infusion — 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 36, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Avsola, Inflectra, Renflexis (Biosimilars); Remicade (Originator); DOSAGE FORM/ STRENGTH: 100mg/vial Injection for Infusion — 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 Infliximab-See formulary for funded biosimilars Brand(s): Avsola, Inflectra, Renflexis (Biosimilars); Remicade (Originator) DOSAGE FORM/ STRENGTH: 100mg/vial Injection for Infusion Refer to the Executive Officer Communications on the Ministry website for the Ministry’s Biosimilar Policy including frequently asked questions and updates for the biosimilar policy updates. http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions. In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 to 8 of this document). It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on an originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, will be expected to be provided ongoing access of the originator biologic through the patient’s original payer mechanism (e.g. manufacturer’s patient support program) or to switch to an ODB funded biosimilar version upon meeting specified criteria. The Ministry will no longer consider funding of originator biologics that are part of the biosimilar policy with limited exemptions on or after December 29, 2023. 133 Infliximab-See formulary for funded biosimilars Brand(s): Avsola, Inflectra, Renflexis (Biosimilars); Remicade (Only for those approved for biosimilar exemption) DOSAGE FORM/ STRENGTH: 100mg/vial Injection for Infusion The below criteria are for Infliximab as Remicade. Refer to the ODB formulary for the Limited Use Criteria for Infliximab biosimilars which was updated with the January 2023 ODB Formulary Update. Treatment of moderate to severe (luminal) Crohn’s Disease in patients who have: • HBI (Harvey Bradshaw Index) score ≥7*; and • Failed to respond to conventional treatment with glucocorticoids (prednisone 40mg/day or equivalent for at least 2 weeks or dose cannot be tapered to below prednisone 20 mg/day or equivalent); and • Failed to respond to an immunosuppressive agent (azathioprine, 6- mercaptopurine, methotrexate, or cyclosporine) tried for at least 3 months. Note: Any intolerance(s) or contraindication(s) to treatment with required alternative(s) must be described in detail. *If the patient has HBI <7, the request will be reviewed by external medical experts when the following information is provided: bloodwork (with hematocrit, hemoglobin, C reactive protein, ESR, platelets, and ferritin levels); supporting endoscopy; details of weight loss; and a list of narcotic analgesics being used. Pediatric patients will be considered case-by-case. Duration of Approval: 6 months Renewal will be considered for patients with 50% reduction in HBI from pre-treatment as well as improvement of symptoms (e.g., absence of bloody diarrhea and weight stabilization or increase) and no longer using steroids. Biochemical improvements may also be required. The planned dosing regimen for the requested biologic should be provided. 134 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 133, record 84, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Avsola, Inflectra, Renflexis (Biosimilars); Remicade (Originator); DOSAGE FORM/ STRENGTH: 100mg/vial Injection for infusion — 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 Infliximab – See Formulary funded biosimilars Brand(s): Avsola, Inflectra, Renflexis (Biosimilars); Remicade (Originator) DOSAGE FORM/ STRENGTH: 100mg/vial Injection for infusion Recommended dose: Infliximab 5 mg/kg/dose at 0, 2 and 6 weeks followed by 5mg/kg/dose every 8 weeks Requests for higher doses of infliximab must provide a description of symptoms and HBI score on standard dosing and may include laboratory support of infliximab levels for consideration of case-by-case consideration. Duration of Approval: First renewal: 1 year Second and subsequent renewals: 2 years The below criteria are for Infliximab as Remicade. Refer to the ODB formulary for the Limited Use Criteria for Infliximab biosimilars which was updated with the January 2023 ODB Formulary Update. Remicade for fistulizing Crohn's disease: Actively draining perianal or enterocutaneous fistula(e) that have recurred or persist despite a course of: • appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole); AND • immunosuppressive therapy (azathioprine or 6-mercaptopurine therapy). Duration of approval: Infliximab 3 doses of 5mg/kg/dose, administered at 0, 2 and 6 weeks. Duration of Approval: 6 months If the patient has been using a higher dosing regimen over the past year, the requesting MD must provide the rationale for this dose by comparing the patient’s symptoms on standard dosing and the current dosing. Then the request should be sent for external review. Renewal of funding of patients using Remicade for the treatment of fistulizing Crohn’s Disease will be considered for patients with resolution of fistulae. The planned dosing regimen for the requested biologic should be provided. The recommended dose for the treatment of Crohn’s Disease is 5 mg/kg/dose at 0, 2 and 6 weeks followed by 5mg/kg/dose every 8 weeks with up to 10 mg/kg/dose every 8 weeks being considered on a case-by-case basis. Approval duration of first renewal: 6 months to 1 year pending fistula(e) resolution Approval duration of second and subsequent renewals: 2 years with complete resolution; case-by-case duration with partial resolution 135 Infliximab – See Formulary funded biosimilars Brand(s): Avsola, Inflectra, Renflexis (Biosimilars); Remicade (Originator) DOSAGE FORM/ STRENGTH: 100mg/vial Injection for infusion Initial induction requests for infliximab for patients with mild Ulcerative Colitis (Mayo score < 6) may be considered for Infliximab as Inflectra on a case-by-case basis through EAP but the submission must include the rationale for coverage. Patients treatment experienced to Remicade and transitioning to public funding must meet the initiation (induction) criteria before consideration of funding of maintenance under renewal criteria will be applied. Induction (Initiation) Criteria For the treatment of ulcerative colitis disease in patients who meet the following criteria: 1. Moderate disease • Mayo score between 6 and 10 (inclusive); AND • *Endoscopic subscore of 2; AND • Failed 2 weeks of oral prednisone ≥ 40mg (or IV equivalent for at least 1 week) AND 3 months of azathioprine(AZA)/ 6-mercaptopurine (6-MP) (or where the use of immunosuppressants is contraindicated**) OR Stabilized with 2 weeks of oral prednisone ≥40mg (or a 1 week course of IV equivalent) but the prednisone dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated**) *The endoscopy procedure must be done within the last year but does not have to be full endoscopy. **Contraindication to Aza/6MP includes pancreatitis, allergic reaction [fever and/or rash and arthritis], malaise, diarrhea and hepatitis Approved Dose: Infliximab 5mg/kg/dose at 0, 2 and 6 weeks followed by 5mg/kg/dose every 8 weeks. Approval duration: 6 months 2. Severe disease • Mayo score >10; AND • *Endoscopy subscore of 2 or more; AND • Failed 2 weeks of oral prednisone ≥40mg (or 1 week IV equivalent) OR Stabilized with 2 weeks of oral prednisone ≥40mg (or 1 week of IV equivalent) but the prednisone dose cannot be tapered despite 3 months of Aza/6MP (or where the use of immunosuppressants is contraindicated**) 136 Infliximab – See Formulary funded biosimilars Brand(s): Avsola, Inflectra, Renflexis (Biosimilars); Remicade (Originator) DOSAGE FORM/ STRENGTH: 100mg/vial Injection for infusion *The endoscopy procedure must be done within the last year but does not have to be full endoscopy. **Contraindication to Aza/6MP includes pancreatitis, allergic reaction [fever and/or rash and arthritis], malaise, diarrhea and hepatitis Approval duration: 6 months Dose: Remicade 5mg/kg/dose at 0, 2 and 6 weeks followed by 5mg/kg/dose every 8 weeks. Maintenance (Renewal) Criteria for first renewal After 3 loading doses of Remicade if Mayo score <6 AND 50% reduction in prednisone from the starting dose Approval duration: 6 months If After 3 loading doses of Remicade if Mayo score <6 AND patient is no longer on prednisone Approval duration: 12 months Approved Dose: Infliximab 5mg/kg/dose up to every 6 weeks Maintenance (Renewal) Criteria for second and subsequent renewals a. Mayo score <6* AND b. Must be off steroids Patients who remain on steroids will be considered on a case-by-case basis. Approval duration: 12 months to up to 2 years for those off steroids Approved Dose: 5 mg/kg/dose up to every 6 weeks 1Note that the endoscopy procedure must be done within the last year but does not have to be full endoscopy. Pediatric patients will be considered case-by-case. 137 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 135, record 85, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Remicade (Only for those approved for biosimilar exemption); DOSAGE FORM/ STRENGTH: 100 mg/Vial Injection for infusion — 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 (Only for those approved for biosimilar exemption) DOSAGE FORM/ STRENGTH: 40 mg/0.8 mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection Infliximab - See formulary for funded biosimilars Brand(s): Remicade (Only for those approved for biosimilar exemption) DOSAGE FORM/ STRENGTH: 100 mg/Vial Injection for infusion Refer to the Executive Officer Communications on the Ministry website for the Ministry’s Biosimilar Policy including frequently asked questions and updates for the biosimilar policy updates. http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions. In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 to 8 of this document). It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on an originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, will be expected to be provided ongoing access of the originator biologic through the patient’s original payer mechanism (e.g. manufacturer’s patient support program) or to switch to an ODB funded biosimilar version upon meeting specified criteria. The Ministry will no longer consider funding of originator biologics that are part of the biosimilar policy with limited exemptions on or after December 29, 2023. For the treatment of severe non-infectious ocular inflammatory disease (OID) in patients meeting one of the following criteria; • Experienced failure, intolerance, or contraindication to oral corticosteroid (or topical corticosteroid for anterior uveitis) and failure or intolerance to at least one immunosuppressive therapy; OR • For the treatment of chronic Juvenile Idiopathic Arthritis (JIA)-associated uveitis after failure or intolerance to a first-line immunosuppressive agent; OR 254 • For patients who have immediately vision-threatening OID and do not meet the above criteria, where consultation notes/ letter from an ophthalmologist expert specializing in OIDs (who may be the requesting physician) confirm the severity of the patient’s condition and indicate detailed rationale for an immediate biologic therapy (e.g. ocular inflammation associated with Behcet’s disease; severe non- necrotizing scleritis; necrotizing scleritis; etc.); AND • Patient must be followed by a uveitis specialist, a retina specialist familiar with ocular inflammatory diseases, or a pediatric ophthalmologist. Approved Dose: Adalimumab 40 mg subcutaneous every 1 to 2 weeks. Infliximab 5-10 mg/kg IV at weeks 0, 2, 6 and maintenance every 4-8 weeks Duration of Approval: 1 year Renewals will be considered for requests where consultation notes or a letter is provided by the requesting physician to confirm that treatment has resulted in improvement/stability of vision and other treatment goals (e.g., remission from/control of ocular inflammation) have been met. Duration of Approval: 2 years 255 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 254, record 155, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Avsola, Inflectra, Renflexis Biosimilars); Remicade (Only for those; DOSAGE FORM/ STRENGTH: 100 mg/vial — 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 Abatacept Brand(s): Orencia DOSAGE FORM/ STRENGTH: 250 mg/15 mL vial (Note that the sc injection is not approved for this indication) Infliximab - See formulary for funded biosimilars Brand(s): Avsola, Inflectra, Renflexis Biosimilars); Remicade (Only for those approved for biosimilar exemption) DOSAGE FORM/ STRENGTH: 100 mg/vial Rituximab -See formulary for funded biosimilars Brand(s): Riximyo, Ruxience, and Truxima (biosimilar); Rituxan (Only for those approved for biosimilar exemption) DOSAGE FORM/ STRENGTH: 10 mg/mL intravenous injection Refer to the Executive Officer Communications on the Ministry website for the Ministry’s Biosimilar Policy including frequently asked questions and updates for the biosimilar policy updates. http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions. In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 to 8 of this document). It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on an originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, will be expected to be provided ongoing access of the originator biologic through the patient’s original payer mechanism (e.g. manufacturer’s patient support program) or to switch to an ODB funded biosimilar version upon meeting specified criteria. The Ministry will no longer consider funding of originator biologics that are part of the biosimilar policy with limited exemptions on or after December 29, 2023. For the treatment of polyarticular-course juvenile idiopathic arthritis in patients meeting the following criteria; • Patient has active disease (a minimum of 3 (three) swollen joints and a total of 5 active joints); AND 440 • Patient has had an inadequate response to a three month course of methotrexate administered subcutaneously at a dosage of at least 15 mg/m2 per week for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate the nature of the intolerance or contraindication must be described in detail.; AND • Patient has had an inadequate response to a three month course of etanercept OR adalimumab OR tociluzumab. If the patient is unable to tolerate or has a contraindication to etanercept OR adalimumab OR tociluzumab, the nature of the intolerance or contraindication must be described in detail. Duration of Approval: 1 Year Renewals will be considered for patients with objective evidence of at least a 20% reduction in swollen joint count. For renewals beyond the second year, objective evidence of preservation of treatment effect should be provided. (i.e. the current joint count should be compared to the count prior to initiating treatment with the biologic agent) Duration of Approval: 5 Year Approved Dose: Abatacept refer to the Orencia product monograph for dosing information Infliximab dose up to 6mg/kg/dose at 0, 2 and 6 weeks followed by maintenance of up to 6mg/kg/dose every 8 weeks 441 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 440, record 273, corpus 2025-01-01; name match only, not an eligibility decision
No interchangeable product listed in the Ontario extract
Remdantry · DIN 02419475 Manufacturer: Celltrion Inc.; listing date 2016-02-25 Health Canada: Marketed since 2025-03-12 · brand REMDANTRY · ATC L04AB02 INFLIXIMAB · form Powder for solution · route Intravenous · ingredients INFLIXIMAB 100 MG/VIAL · company Celltrion inc. · schedule Schedule d, Prescription
Check this DIN again · Health Canada product record

Remdantry: Formulary list price $493.0000/unit (unit not stated in source; not the patient's cost)

Ministry pays: $493.0000 per source unit.

Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90410 · Verify on the e-Formulary ↗ (DIN 02419475)

Source record
DIN 02419475: Remdantry Raw flags: sec12=Y, sec3=Y Item: 923600001; group id 1023; item number 2373; lccId 00417; manufacturer id CEI Source form: Inj Pd-Vial Pk; strength: 100mg/Vial Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $493.0000; ministry $493.0000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02419475 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90410
Shortage status: not checked (no credentials)
Other drugs in the same formulary class (92:36 Disease-Modifying Antirheumatic Agents) and how they are covered

Matched class: 92:36 Disease-Modifying Antirheumatic Agents

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. No displayed product is listed as a general benefit in this extract. Check its listing requirements below. 92:36 Disease-Modifying Antirheumatic Agents

ADALIMUMAB

· 30 products · Limited Use, codes 600, 601, 602, 603, 604, 605, 606, 607, 609, 611 (23), Limited Use, codes 600, 602, 603, 604, 605, 606, 607, 609, 633, 634 (7) · strengths: 20mg/0.2mL, 40mg/0.4mL, 20mg/0.4mL, 40mg/0.8mL, 80mg/0.8mL · Inj Sol-0.2mL Pref Syr (Preservative-Free), Inj Sol-0.4mL Autoinj (Preservative-Free), Inj Sol-0.4mL Pref Autoinj Pen (Preservative-Free), Inj Sol-0.4mL Pref Autoinj Syr (Preservative-Free), Inj Sol-0.4mL Pref Pen (Preservative-Free), Inj Sol-0.4mL Pref Syr (Preservative-Free), Inj Sol-0.8mL Pref Autoinj (Preservative-Free), Inj Sol-0.8mL Pref Pen (Preservative-Free), Inj Sol-0.8mL Pref Syr (Preservative-Free)

ETANERCEPT

· 7 products · Limited Use, codes 512, 513, 514, 563, 591 (3), Limited Use, codes 498, 499, 514, 563, 591 (4) · strengths: 25mg/0.5mL, 50mg/mL · Inj Sol-0.5mL Pref Syr Pk, Inj Sol-1mL Pref Syr Pk, Inj Sol-1mL Prefilled SensoReady Pen Pk, Inj Sol-Pref Autoinj Pen, Inj Sol-Pref Syr, Sol- Pref AutoInj

TOCILIZUMAB

· 10 products · Limited Use, codes 697, 698, 720 (6), Limited Use, codes 697, 698, 720, 721 (4) · strengths: 200mg/10mL, 400mg/20mL, 80mg/4mL, 162mg/0.9mL · Inj Sol-10mL Vial Pk, Inj Sol-10mL Vial Pk (Preservative-Free), Inj Sol-20mL Vial Pk, Inj Sol-20mL Vial Pk (Preservative-Free), Inj Sol-4mL Vial Pk, Inj Sol-4mL Vial Pk (Preservative-Free), Inj Sol-Pref Autoinj, Inj Sol-Pref Autoinj (Preservative-Free), Inj Sol-Pref Syr, Inj Sol-Pref Syr (Preservative-Free)

TOFACITINIB

· 10 products · Limited Use, codes 480, 589, 743 (6), Limited Use, codes 589 (4) · strengths: 5mg, 10mg · Tab

TOFACITINIB CITRATE

· 2 products · Limited Use, codes 565 · strengths: 11mg · ER Tab

UPADACITINIB

· 3 products · Limited Use, codes 637, 684 (1), Limited Use, codes 684 (2) · strengths: 15mg, 30mg, 45mg · ER Tab

APREMILAST

· 12 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 30mg, 10mg & 20mg & 30mg · Tab, Tab-27 Blister Starter Pk Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 92:36
Full class listing Related classes: 92:20 Biologic Response Modifiers, 92:44 Immunosuppressive Agents, 92:92 Other Miscellaneous Therapeutic Agents Same formulary class, not same indication: class membership alone does not establish equivalent uses.
Other drugs whose Health Canada label lists a similar indication: psoriasis
From Health Canada product monographs; label wording only, not a treatment recommendation. Matching is lexical and uses one held product label per generic; formulations and qualifying criteria may differ. Covered without a code on the Ontario formulary: ACITRETIN ACITRETIN · General benefit 1 INDICATIONS SORIATANE (acitretin) is indicated for: • Severe psoriasis (includes erythrodermic and pustular types) • Other disorders of keratinization Severe psoriasis is a condition that involves more than 10% of body surface area or is physically, occupationally or psychologically disabling. PM: https://pdf.hres.ca/dpd_pm/00080165.PDF; date APR 04, 2025; DIN 02070847; fetched 2026-09-10 Product monograph APREMILAST · Off-Formulary Interchangeable, not an ODB benefit Indications • Plaque Psoriasis OTEZLA (apremilast) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. PM: https://pdf.hres.ca/dpd_pm/00084256.PDF; date 2026-04-10; DIN 02434318; fetched 2026-09-10 Product monograph BIMEKIZUMAB · Limited Use, codes 641 Indications Bimzelx (bimekizumab injection) is indicated for: • Psoriasis (PsO) The treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. PM: https://pdf.hres.ca/dpd_pm/00082779.PDF; date 2025-12-12; DIN 02525267; fetched 2026-09-10 Product monograph • Psoriasis (PsO) The treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. PM: https://pdf.hres.ca/dpd_pm/00082779.PDF; date 2025-12-12; DIN 02525267; fetched 2026-09-10 Product monograph CYCLOSPORINE · Off-Formulary Interchangeable, not an ODB benefit (2), General benefit (8) Psoriasis NEORAL capsules and oral solution (cyclosporine) are indicated for the treatment of severe psoriasis in patients for whom conventional therapy is ineffective or inappropriate. PM: https://pdf.hres.ca/dpd_pm/00085584.PDF; date 2026-07-30; DIN 02150662; fetched 2026-09-10 Product monograph ETANERCEPT · Limited Use, codes 512, 513, 514, 563, 591 (3), Limited Use, codes 498, 499, 514, 563, 591 (4) • treatment of adult patients with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. PM: https://pdf.hres.ca/dpd_pm/00083562.PDF; date August 31, 2016; DIN 02455323; fetched 2026-09-10 Product monograph METHOTREXATE · General benefit (29), Listed, not a benefit (1), Off-Formulary Interchangeable, not an ODB benefit (4) • Severe disabling psoriasis/psoriatic arthritis PM: https://pdf.hres.ca/dpd_pm/00078227.PDF; date JAN 08, 2025; DIN 02170698; fetched 2026-09-10 Product monograph RISANKIZUMAB · Limited Use, codes 574 Indications SKYRIZI (risankizumab injection) is indicated for: • the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. PM: https://pdf.hres.ca/dpd_pm/00085642.PDF; date 2026-07-08; DIN 02519283; fetched 2026-09-10 Product monograph SECUKINUMAB · Limited Use, codes 476 Indications COSENTYX® (secukinumab injection/secukinumab for injection) is indicated for: Adult patients Plaque psoriasis COSENTYX is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. PM: https://pdf.hres.ca/dpd_pm/00080972.PDF; date not captured; DIN 02529653; fetched 2026-09-10 Product monograph Hidradenitis Suppurativa COSENTYX is indicated for the treatment of adult patients with moderate to severe hidradenitis suppurativa (acne inversa) who have responded inadequately to conventional systemic hidradenitis suppurativa therapy (see 14.1.5 Hidradenitis suppurativa). 1.1 Pediatrics Plaque psoriasis COSENTYX (secukinumab injection/secukinumab for injection) is indicated for the treatment of moderate to severe plaque psoriasis in patients 6 year and older who are candidates for systemic therapy or phototherapy. PM: https://pdf.hres.ca/dpd_pm/00080972.PDF; date not captured; DIN 02529653; fetched 2026-09-10 Product monograph USTEKINUMAB · Limited Use, codes 669, 670, 671, 672 (5), Limited Use, codes 668, 669, 671, 672 (6), Limited Use, codes 669, 671, 672, 733 (3), Limited Use, codes 669, 671, 672, 742 (2), Limited Use, codes 671, 672 (4) Plaque Psoriasis JAMTEKI (ustekinumab) is indicated for: • the treatment of chronic moderate to severe plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy. PM: https://pdf.hres.ca/dpd_pm/00077781.PDF; date November 9, 2023; DIN 02543036; fetched 2026-09-10 Product monograph Coverage source: ON formulary extract 2026-08-26
What the Health Canada label says it is for
1 INDICATIONS REMDANTRYTM (infliximab for injection) is indicated for: • use in combination with methotrexate for the reduction in signs and symptoms, inhibition of the progression of structural damage and improvement in physical function in adult patients with moderately to severely active rheumatoid arthritis. • the reduction of signs and symptoms and improvement in physical function in patients with active ankylosing spondylitis who have responded inadequately, or are intolerant to, conventional therapies. • the reduction of signs and symptoms, induction and maintenance of clinical remission and mucosal healing and reduction of corticosteroid use in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to a corticosteroid and/or aminosalicylate. RemdantryTM can be used alone or in combination with conventional therapy. • reduction of signs and symptoms and induction and maintenance of clinical remission in pediatric patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional ther… https://pdf.hres.ca/dpd_pm/00081840.PDF PM date: September 2, 2025 Source product: REMDANTRY; DIN 02419475; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Prepare an Exceptional Access request

SADIE has its own form for many drugs; this checklist prepares the answers; the ministry decides. Open SADIE

Use this text in SADIE’s free-text fields or read from it on a Telephone Request Service call. Review marks do not indicate eligibility. Evidence stays in this page until you copy it; nothing entered here is sent or saved. Do not enter patient identifiers.

EAP Telephone Request Service: The TRS can be accessed by calling toll-free at 1-866-811-9893 or 416-327-8109 (Toronto area) between 8:30 a.m. and 5:00 p.m. Monday through Friday (except holidays) and selecting the TRS option. Source; updated September 15, 2026

EAP fax: In Ontario: 1-866-811-9908 or 416-327-7526 (Toronto area). Outside Ontario: 1-833-905-4260. Source; updated September 15, 2026

Posted turnaround and Telephone Request Service scope
Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days |
For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day.
Source; updated September 15, 2026

Infliximab- See Formulary for funded biosimilars (Remicade and formulary listed biosimilars)

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Prepare answers: For the treatment of ankylosing spondylitis (AS) OR psoriatic spondylitis (PS) in patients who have severe active disease with:

Ministry criteria corpus 2025-01-01; page 54

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

Prepared from the ministry's published criteria; eligibility is decided by the Exceptional Access Program.

Infliximab-See formulary for funded biosimilars (Avsola, Inflectra, Renflexis (Biosimilars); Remicade (Originator))

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Prepare answers: See the ministry wording below; no separate indication heading is held.

Ministry criteria corpus 2025-01-01; page 133

Infliximab-See formulary for funded biosimilars Brand(s): Avsola, Inflectra, Renflexis (Biosimilars); Remicade (Originator) DOSAGE FORM/ STRENGTH: 100mg/vial Injection for Infusion
Refer to the Executive Officer Communications on the Ministry website for the Ministry’s Biosimilar Policy including frequently asked questions and updates for the biosimilar policy updates. http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx
Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions.
Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions. In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 to 8 of this document).
It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on an originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, will be expected to be provided ongoing access of the originator biologic through the patient’s original payer mechanism (e.g. manufacturer’s patient support program) or to switch to an ODB funded biosimilar version upon meeting specified criteria. The Ministry will no longer consider funding of originator biologics that are part of the biosimilar policy with limited exemptions on or after December 29, 2023.
133 Infliximab-See formulary for funded biosimilars Brand(s): Avsola, Inflectra, Renflexis (Biosimilars); Remicade (Only for those approved for biosimilar exemption) DOSAGE FORM/ STRENGTH: 100mg/vial Injection for Infusion
The below criteria are for Infliximab as Remicade. Refer to the ODB formulary for the Limited Use Criteria for Infliximab biosimilars which was updated with the January 2023 ODB Formulary Update.
Treatment of moderate to severe (luminal) Crohn’s Disease in patients who have:
• HBI (Harvey Bradshaw Index) score ≥7*; and
• Failed to respond to conventional treatment with glucocorticoids (prednisone 40mg/day or equivalent for at least 2 weeks or dose cannot be tapered to below prednisone 20 mg/day or equivalent); and
• Failed to respond to an immunosuppressive agent (azathioprine, 6- mercaptopurine, methotrexate, or cyclosporine) tried for at least 3 months.
Note: Any intolerance(s) or contraindication(s) to treatment with required alternative(s) must be described in detail.
*If the patient has HBI <7, the request will be reviewed by external medical experts when the following information is provided: bloodwork (with hematocrit, hemoglobin, C reactive protein, ESR, platelets, and ferritin levels); supporting endoscopy; details of weight loss; and a list of narcotic analgesics being used.
Pediatric patients will be considered case-by-case.
Duration of Approval: 6 months
Renewal will be considered for patients with 50% reduction in HBI from pre-treatment as well as improvement of symptoms (e.g., absence of bloody diarrhea and weight stabilization or increase) and no longer using steroids. Biochemical improvements may also be required.
The planned dosing regimen for the requested biologic should be provided.
134

Prepared from the ministry's published criteria; eligibility is decided by the Exceptional Access Program.

Infliximab – See Formulary funded biosimilars (Avsola, Inflectra, Renflexis (Biosimilars); Remicade (Originator))

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Prepare answers: For the treatment of ulcerative colitis disease in patients who meet the following criteria:

Ministry criteria corpus 2025-01-01; page 135

Infliximab – See Formulary funded biosimilars Brand(s): Avsola, Inflectra, Renflexis (Biosimilars); Remicade (Originator) DOSAGE FORM/ STRENGTH: 100mg/vial Injection for infusion
Recommended dose: Infliximab 5 mg/kg/dose at 0, 2 and 6 weeks followed by 5mg/kg/dose every 8 weeks
Requests for higher doses of infliximab must provide a description of symptoms and HBI score on standard dosing and may include laboratory support of infliximab levels for consideration of case-by-case consideration. Duration of Approval: First renewal: 1 year Second and subsequent renewals: 2 years
The below criteria are for Infliximab as Remicade. Refer to the ODB formulary for the Limited Use Criteria for Infliximab biosimilars which was updated with the January 2023 ODB Formulary Update.
Remicade for fistulizing Crohn's disease:
Actively draining perianal or enterocutaneous fistula(e) that have recurred or persist despite a course of:
• appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole); AND
• immunosuppressive therapy (azathioprine or 6-mercaptopurine therapy).
Duration of approval: Infliximab 3 doses of 5mg/kg/dose, administered at 0, 2 and 6 weeks.
Duration of Approval: 6 months
If the patient has been using a higher dosing regimen over the past year, the requesting MD must provide the rationale for this dose by comparing the patient’s symptoms on standard dosing and the current dosing. Then the request should be sent for external review.
Renewal of funding of patients using Remicade for the treatment of fistulizing Crohn’s Disease will be considered for patients with resolution of fistulae.
The planned dosing regimen for the requested biologic should be provided. The recommended dose for the treatment of Crohn’s Disease is 5 mg/kg/dose at 0, 2 and 6 weeks followed by 5mg/kg/dose every 8 weeks with up to 10 mg/kg/dose every 8 weeks being considered on a case-by-case basis.
Approval duration of first renewal: 6 months to 1 year pending fistula(e) resolution
Approval duration of second and subsequent renewals: 2 years with complete resolution; case-by-case duration with partial resolution
135 Infliximab – See Formulary funded biosimilars Brand(s): Avsola, Inflectra, Renflexis (Biosimilars); Remicade (Originator) DOSAGE FORM/ STRENGTH: 100mg/vial Injection for infusion
Initial induction requests for infliximab for patients with mild Ulcerative Colitis (Mayo score < 6) may be considered for Infliximab as Inflectra on a case-by-case basis through EAP but the submission must include the rationale for coverage.
Patients treatment experienced to Remicade and transitioning to public funding must meet the initiation (induction) criteria before consideration of funding of maintenance under renewal criteria will be applied.
Induction (Initiation) Criteria
For the treatment of ulcerative colitis disease in patients who meet the following criteria:
1. Moderate disease
• Mayo score between 6 and 10 (inclusive); AND
• *Endoscopic subscore of 2; AND
• Failed 2 weeks of oral prednisone ≥ 40mg (or IV equivalent for at least 1 week) AND 3 months of azathioprine(AZA)/ 6-mercaptopurine (6-MP) (or where the use of immunosuppressants is contraindicated**) OR Stabilized with 2 weeks of oral prednisone ≥40mg (or a 1 week course of IV equivalent) but the prednisone dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated**)
*The endoscopy procedure must be done within the last year but does not have to be full endoscopy.
**Contraindication to Aza/6MP includes pancreatitis, allergic reaction [fever and/or rash and arthritis], malaise, diarrhea and hepatitis
Approved Dose: Infliximab 5mg/kg/dose at 0, 2 and 6 weeks followed by 5mg/kg/dose every 8 weeks. Approval duration: 6 months
2. Severe disease
• Mayo score >10; AND
• *Endoscopy subscore of 2 or more; AND
• Failed 2 weeks of oral prednisone ≥40mg (or 1 week IV equivalent) OR Stabilized with 2 weeks of oral prednisone ≥40mg (or 1 week of IV equivalent) but the prednisone dose cannot be tapered despite 3 months of Aza/6MP (or where the use of immunosuppressants is contraindicated**)
136 Infliximab – See Formulary funded biosimilars Brand(s): Avsola, Inflectra, Renflexis (Biosimilars); Remicade (Originator) DOSAGE FORM/ STRENGTH: 100mg/vial Injection for infusion
*The endoscopy procedure must be done within the last year but does not have to be full endoscopy.
**Contraindication to Aza/6MP includes pancreatitis, allergic reaction [fever and/or rash and arthritis], malaise, diarrhea and hepatitis
Approval duration: 6 months Dose: Remicade 5mg/kg/dose at 0, 2 and 6 weeks followed by 5mg/kg/dose every 8 weeks.
Maintenance (Renewal) Criteria for first renewal
After 3 loading doses of Remicade if Mayo score <6 AND 50% reduction in prednisone from the starting dose
Approval duration: 6 months
If After 3 loading doses of Remicade if Mayo score <6 AND patient is no longer on prednisone
Approval duration: 12 months
Approved Dose: Infliximab 5mg/kg/dose up to every 6 weeks
Maintenance (Renewal) Criteria for second and subsequent renewals
a. Mayo score <6* AND b. Must be off steroids
Patients who remain on steroids will be considered on a case-by-case basis.
Approval duration: 12 months to up to 2 years for those off steroids
Approved Dose: 5 mg/kg/dose up to every 6 weeks
1Note that the endoscopy procedure must be done within the last year but does not
have to be full endoscopy.
Pediatric patients will be considered case-by-case.
137

Prepared from the ministry's published criteria; eligibility is decided by the Exceptional Access Program.

Infliximab - See formulary for funded biosimilars (Remicade (Only for those approved for biosimilar exemption))

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Prepare answers: For the treatment of severe non-infectious ocular inflammatory disease (OID) in patients meeting one of the following criteria;

Ministry criteria corpus 2025-01-01; page 254

Adalimumab – See Formulary for funded biosimilars Brand(s): Humira (Only for those approved for biosimilar exemption) DOSAGE FORM/ STRENGTH: 40 mg/0.8 mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection
Infliximab - See formulary for funded biosimilars Brand(s): Remicade (Only for those approved for biosimilar exemption) DOSAGE FORM/ STRENGTH: 100 mg/Vial Injection for infusion
Refer to the Executive Officer Communications on the Ministry website for the Ministry’s Biosimilar Policy including frequently asked questions and updates for the biosimilar policy updates. http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx
Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions.
Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions. In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 to 8 of this document).
It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on an originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, will be expected to be provided ongoing access of the originator biologic through the patient’s original payer mechanism (e.g. manufacturer’s patient support program) or to switch to an ODB funded biosimilar version upon meeting specified criteria. The Ministry will no longer consider funding of originator biologics that are part of the biosimilar policy with limited exemptions on or after December 29, 2023.
For the treatment of severe non-infectious ocular inflammatory disease (OID) in patients meeting one of the following criteria;
• Experienced failure, intolerance, or contraindication to oral corticosteroid (or topical corticosteroid for anterior uveitis) and failure or intolerance to at least one immunosuppressive therapy; OR
• For the treatment of chronic Juvenile Idiopathic Arthritis (JIA)-associated uveitis after failure or intolerance to a first-line immunosuppressive agent; OR
254 • For patients who have immediately vision-threatening OID and do not meet the above criteria, where consultation notes/ letter from an ophthalmologist expert specializing in OIDs (who may be the requesting physician) confirm the severity of the patient’s condition and indicate detailed rationale for an immediate biologic therapy (e.g. ocular inflammation associated with Behcet’s disease; severe non- necrotizing scleritis; necrotizing scleritis; etc.); AND
• Patient must be followed by a uveitis specialist, a retina specialist familiar with ocular inflammatory diseases, or a pediatric ophthalmologist.
Approved Dose:
Adalimumab 40 mg subcutaneous every 1 to 2 weeks.
Infliximab 5-10 mg/kg IV at weeks 0, 2, 6 and maintenance every 4-8 weeks
Duration of Approval: 1 year
Renewals will be considered for requests where consultation notes or a letter is provided by the requesting physician to confirm that treatment has resulted in improvement/stability of vision and other treatment goals (e.g., remission from/control of ocular inflammation) have been met.
Duration of Approval: 2 years
255

Prepared from the ministry's published criteria; eligibility is decided by the Exceptional Access Program.

Infliximab - See formulary for funded biosimilars (Avsola, Inflectra, Renflexis Biosimilars); Remicade (Only for those)

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Prepare answers: For the treatment of polyarticular-course juvenile idiopathic arthritis in patients meeting the following criteria;

Ministry criteria corpus 2025-01-01; page 440

Abatacept Brand(s): Orencia DOSAGE FORM/ STRENGTH: 250 mg/15 mL vial (Note that the sc injection is not approved for this indication)
Infliximab - See formulary for funded biosimilars Brand(s): Avsola, Inflectra, Renflexis Biosimilars); Remicade (Only for those approved for biosimilar exemption) DOSAGE FORM/ STRENGTH: 100 mg/vial
Rituximab -See formulary for funded biosimilars Brand(s): Riximyo, Ruxience, and Truxima (biosimilar); Rituxan (Only for those approved for biosimilar exemption) DOSAGE FORM/ STRENGTH: 10 mg/mL intravenous injection
Refer to the Executive Officer Communications on the Ministry website for the Ministry’s Biosimilar Policy including frequently asked questions and updates for the biosimilar policy updates. http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx
Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions.
Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions. In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 to 8 of this document).
It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on an originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, will be expected to be provided ongoing access of the originator biologic through the patient’s original payer mechanism (e.g. manufacturer’s patient support program) or to switch to an ODB funded biosimilar version upon meeting specified criteria. The Ministry will no longer consider funding of originator biologics that are part of the biosimilar policy with limited exemptions on or after December 29, 2023.
For the treatment of polyarticular-course juvenile idiopathic arthritis in patients meeting the following criteria;
• Patient has active disease (a minimum of 3 (three) swollen joints and a total of 5 active joints); AND
440 • Patient has had an inadequate response to a three month course of methotrexate administered subcutaneously at a dosage of at least 15 mg/m2 per week for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate the nature of the intolerance or contraindication must be described in detail.; AND
• Patient has had an inadequate response to a three month course of etanercept OR adalimumab OR tociluzumab. If the patient is unable to tolerate or has a contraindication to etanercept OR adalimumab OR tociluzumab, the nature of the intolerance or contraindication must be described in detail.
Duration of Approval: 1 Year
Renewals will be considered for patients with objective evidence of at least a 20% reduction in swollen joint count. For renewals beyond the second year, objective evidence of preservation of treatment effect should be provided. (i.e. the current joint count should be compared to the count prior to initiating treatment with the biologic agent)
Duration of Approval: 5 Year
Approved Dose:
Abatacept refer to the Orencia product monograph for dosing information
Infliximab dose up to 6mg/kg/dose at 0, 2 and 6 weeks followed by maintenance of up to 6mg/kg/dose every 8 weeks
441

Prepared from the ministry's published criteria; eligibility is decided by the Exceptional Access Program.