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Reason for Use code 600 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. Approvals will only allow for standard dosing for adalimumab. The recommended dosing regimen is 40mg every two weeks. Coverage limit: LU Authorization Period: 1 year Reason for Use code 601 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 is for pediatric patients 2 years of age and older: - 10kg to less than 30kg: 20mg every other week* - 30kg and greater: 40mg every other week *a dose of 10mg every other week can be considered for patients weighing 10kg to less than 15kg It should be noted that some adalimumab products may not be available as 20mg injectables. 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 602 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 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program. Coverage limit: LU Authorization Period: 1 year Reason for Use code 603 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 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program. Coverage limit: LU Authorization Period: 1 year Reason for Use code 604 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. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 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., 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 605 Fistulising Crohn's disease For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria: A. 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); AND B. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease) The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 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 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 Reason for Use code 606 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. Adalimumab 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 up to 160mg at week 0, followed by up to 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 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 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 607 For the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A. A total abscess and nodule count of 3 or greater; AND B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND C. Experienced an inadequate response to a 90-day trial of oral antibiotics. Therapy must be prescribed by a practitioner with expertise in the management of patients with HS. The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter. The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response. If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewal: Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline. Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab). The recommended maintenance dose is 40mg 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 609 For the treatment of severe* 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**. 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 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. **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 12 week trial of phototherapy (unless not accessible) 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 adalimumab. The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, 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. Coverage limit: LU Authorization Period: 1 year Reason for Use code 611 For the treatment of severe uveitis in patients meeting the following criteria: A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND B. Treatment must be prescribed by an opthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases. Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program. The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subsubcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses. The recommended dose for pediatric patients (2 years of age and older) with anterior uveitis is: Less than 30kg: 20mg every other week in combination with methotrexate 30kg or greater: 40mg every other week in combination with methotrexate For patients 6 years of age or older and less than 30kg, an optional loading dose of 40mg at week 0 may be administered before starting maintenance therapy. For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy. It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewals: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g. reduction or control of ocular inflammation). Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Humira and formulary listed biosimilars; DOSAGE FORM/ STRENGTH: 40mg/0.8mL prefilled syringe, 40mg/0.8mL and 20 — 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 32, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Humira and formulary listed biosimilars; DOSAGE FORM/ STRENGTH: 40 mg/0.8 mL prefilled syringe, 40mg/0.8mL and 20 — 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: 40 mg/0.8 mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection For the treatment of adult patients with active moderate to severe hidradenitis suppurativa who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: 1. A total abscess and nodule count of 3 or greater 2. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III 3. An inadequate response to a 90-day trial of oral antibiotics 4. Prescribed by a practitioner with expertise in the management of patients with HS 5. Note: Treatment with adalimumab should be discontinued if there is no improvement after 12 weeks of treatment First renewal: • Requests for renewal should provide objective evidence of a treatment response, defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline at week 12. Subsequent renewal: • For renewals beyond the second year, objective evidence of the preservation of treatment effect should be provided (i.e. the current AN (abscess and inflammatory nodule) count and draining fistula count should be compared to the count prior to initiating treatment with adalimumab). Approval duration: • Initial approval: 3 months • First renewals: 1 year • Subsequent renewals: 2 years Recommended dose: • The recommended dose is 160 mg initially (week 0), followed by 80 mg at week 2, then 40 mg at week 4, and 40 mg weekly thereafter 110 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 110, record 68, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Humira and formulary listed biosimilars; DOSAGE FORM/ STRENGTH: 40 mg/0.8 mL prefilled syringe, 40mg/0.8mL and 20 — 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: 40 mg/0.8 mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous 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. The below criteria are for Adalimumab as Humira. Refer to the ODB formulary for the Limited Use Criteria for Adalimumab biosimilars which was updated with the January 2023 ODB Formulary Update. For the treatment of fistulising Crohn’s disease with concomitant luminal disease in patients who meet the following criteria; • Patient with 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 (e.g. azathioprine or 6-mercaptopurine) AND • Harvey Bradshaw Index (HBI) score ≥ 7 The dose that will be considered is Adalimumab 160 mg at week zero, 80 mg at week two, followed by 40 mg every two weeks. 129 Duration of Approval: 3 months Renewal will be considered based on the response to therapy. The dose that will be considered on renewals is Adalimumab 40 mg every two weeks. All requests for higher doses will not be approved. Duration of Approval: 3 months to 1 year pending fistula(e) resolution Second Renewal: 2 years for 2nd renewal of requests with complete resolution Case-by-case duration for renewal of requests with partial resolution Pediatric patients will be considered case-by-case. Adalimumab – See Formulary for funded biosimilars Brand(s): Humira and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 40 mg/0.8 mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection The below criteria are for Adalimumab as Humira. Refer to the ODB formulary for the Limited Use Criteria for Adalimumab 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. 130 Adalimumab – See Formulary for funded biosimilars Brand(s): Humira and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 40 mg/0.8 mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection 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. The recommended: Adalimumab: 160mg at week 0; 80mg at week 2; followed by 40mg every two weeks Duration of Approval: First renewal: 1 year Second and subsequent renewals: 2 years The below criteria are for Adalimumab as Humira. Refer to the ODB formulary for the Limited Use Criteria for Adalimumab biosimilars since January 2023. For the treatment of ulcerative colitis disease in adult patients1 who meet the following criteria: Induction Criteria Mild disease a. Mayo score <6 AND b. Patients with mild disease will be considered on a case-by-case basis BUT submission must include the rationale for coverage Moderate disease a. Mayo score between 6 and 10 (inclusive); AND b. Endoscopic* subscore of 2; AND c. Failed 2 weeks of oral prednisone at daily doses ≥40mg (or a 1 week course of IV equivalent) AND 3 months of azathioprine (AZA)/ 6-mercaptopurine (6MP) (or where the use of immunosuppressants is contraindicated); OR Stabilized with 2 weeks of oral prednisone at daily dose ≥ 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) Severe disease a. Mayo score >10 AND b. Endoscopic* subscore of ≥2 AND c. Failed 2 weeks of oral prednisone at daily dose ≥ 40mg (or 1 week IV equivalent); OR 131 Adalimumab – See Formulary for funded biosimilars Brand(s): Humira and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 40 mg/0.8 mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection Stabilized with 2 weeks oral prednisone ≥ 40 mg (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) Initial Approval: 6 months at 160 mg initially administered at week 0, followed by 80mg at week 2, then 40 mg every other week thereafter. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. Maintenance Criteria After 8 weeks of adalimumab therapy: a. Mayo score <6 AND b. 50% reduction in prednisone from the starting dose Approval: 6 months at 40mg every other week. If patient is completely off steroids, Approval: 12 months at 40 mg every other week. Subsequent renewals: a. Mayo score <6; AND b. Must be completely off steroids Approval: 2 years at 40mg every other week. (Patients who remain on steroids will be considered on a case-by-case basis) Pediatric patients will be considered case-by-case. 132 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 129, record 83, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for 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 — 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 154, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Humira (Only for those approved for biosimilar exemption); DOSAGE FORM/ STRENGTH: 40 mg/0.8 mL prefilled syringe, 40 mg/0.8mL and 20 — 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, 40 mg/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 (Only for those approved for biosimilar exemption) DOSAGE FORM/ STRENGTH: 25 mg/vial and 50 mg prefilled syringe or pens for subcutaneous injection per formulary listed options Golimumab Brand(s): Simponi DOSAGE FORM/ STRENGTH: 50 mg/0.5 ml prefilled syringe and autoinjector Guselkumab Brand(s): Tremfya DOSAGE FORM/ STRENGTH: 100 mg/mL prefilled syringe and Patient controlled injector (AI) Effective date: November 27, 2023 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 409 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. Psoriatic Arthritis Initiation Criteria: For the treatment of psoriatic arthritis in patients who have: Severe active disease (≥ 5 swollen joints and radiographic evidence of psoriatic arthritis) despite treatment with methotrexate (20 mg/week) for at least 3 months and 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 (20 mg/day) or sulfasalazine (1 g twice daily) for at least 3 months is required. Details of contraindications and intolerances must also be provided. Duration of Approval of initials: 1 Year Renewal will be considered for patients with objective evidence of at least a 20% reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. Duration of Approval of first renewal: 1 Year The planned dosing regimen for the requested biologic should be provided. The recommended doses for the treatment of psoriatic arthritis are as follows: • Adalimumab 40mg every two weeks • Certolizumab 400 mg at week 0, 2, 4 then maintenance doses of 200 mg every 2 weeks or 400 mg every 4weeks • Etanercept 25 mg twice weekly or 50 mg once weekly • Golimumab 50 mg once a month • Guselkumab 100 mg subcutaneously at week 0 and 4, then maintenance dose of 100 mg every 8 weeks thereafter. Guselkumab may be used alone or in combination with a conventional DMARD (e.g., methotrexate). Duration of Approval of second and subsequent renewals: 5 years 410 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 409, record 237, corpus 2025-01-01; name match only, not an eligibility decision

Hyrimoz · DIN 02542315 Manufacturer: Sandoz Canada Inc.; listing date 2024-04-30 Health Canada: Marketed since 2024-04-05 · brand HYRIMOZ · ATC L04AB04 ADALIMUMAB · form Solution · route Subcutaneous · ingredients ADALIMUMAB 20 MG/0.2ML · company Sandoz canada incorporated · schedule Schedule d, Prescription

DIN 02542315: Hyrimoz Raw flags: sec12=Y, sec3=Y Item: 923600052; group id 998; item number 2334; lccId 00390; manufacturer id SDZ Source form: Inj Sol-0.2mL Pref Syr (Preservative-Free); strength: 20mg/0.2mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $235.6350; ministry $235.6350 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02542315 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103089

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=02542315

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

Reason for Use code 600 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. Approvals will only allow for standard dosing for adalimumab. The recommended dosing regimen is 40mg every two weeks. Coverage limit: LU Authorization Period: 1 year Reason for Use code 601 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 is for pediatric patients 2 years of age and older: - 10kg to less than 30kg: 20mg every other week* - 30kg and greater: 40mg every other week *a dose of 10mg every other week can be considered for patients weighing 10kg to less than 15kg It should be noted that some adalimumab products may not be available as 20mg injectables. 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 602 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 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program. Coverage limit: LU Authorization Period: 1 year Reason for Use code 603 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 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program. Coverage limit: LU Authorization Period: 1 year Reason for Use code 604 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. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 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., 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 605 Fistulising Crohn's disease For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria: A. 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); AND B. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease) The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 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 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 Reason for Use code 606 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. Adalimumab 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 up to 160mg at week 0, followed by up to 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 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 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 607 For the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A. A total abscess and nodule count of 3 or greater; AND B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND C. Experienced an inadequate response to a 90-day trial of oral antibiotics. Therapy must be prescribed by a practitioner with expertise in the management of patients with HS. The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter. The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response. If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewal: Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline. Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab). The recommended maintenance dose is 40mg 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 609 For the treatment of severe* 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**. 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 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. **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 12 week trial of phototherapy (unless not accessible) 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 adalimumab. The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, 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. Coverage limit: LU Authorization Period: 1 year Reason for Use code 611 For the treatment of severe uveitis in patients meeting the following criteria: A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND B. Treatment must be prescribed by an opthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases. Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program. The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subsubcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses. The recommended dose for pediatric patients (2 years of age and older) with anterior uveitis is: Less than 30kg: 20mg every other week in combination with methotrexate 30kg or greater: 40mg every other week in combination with methotrexate For patients 6 years of age or older and less than 30kg, an optional loading dose of 40mg at week 0 may be administered before starting maintenance therapy. For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy. It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewals: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g. reduction or control of ocular inflammation). Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Humira and formulary listed biosimilars; DOSAGE FORM/ STRENGTH: 40mg/0.8mL prefilled syringe, 40mg/0.8mL and 20 — 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 32, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Humira and formulary listed biosimilars; DOSAGE FORM/ STRENGTH: 40 mg/0.8 mL prefilled syringe, 40mg/0.8mL and 20 — 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: 40 mg/0.8 mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection For the treatment of adult patients with active moderate to severe hidradenitis suppurativa who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: 1. A total abscess and nodule count of 3 or greater 2. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III 3. An inadequate response to a 90-day trial of oral antibiotics 4. Prescribed by a practitioner with expertise in the management of patients with HS 5. Note: Treatment with adalimumab should be discontinued if there is no improvement after 12 weeks of treatment First renewal: • Requests for renewal should provide objective evidence of a treatment response, defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline at week 12. Subsequent renewal: • For renewals beyond the second year, objective evidence of the preservation of treatment effect should be provided (i.e. the current AN (abscess and inflammatory nodule) count and draining fistula count should be compared to the count prior to initiating treatment with adalimumab). Approval duration: • Initial approval: 3 months • First renewals: 1 year • Subsequent renewals: 2 years Recommended dose: • The recommended dose is 160 mg initially (week 0), followed by 80 mg at week 2, then 40 mg at week 4, and 40 mg weekly thereafter 110 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 110, record 68, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Humira and formulary listed biosimilars; DOSAGE FORM/ STRENGTH: 40 mg/0.8 mL prefilled syringe, 40mg/0.8mL and 20 — 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: 40 mg/0.8 mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous 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. The below criteria are for Adalimumab as Humira. Refer to the ODB formulary for the Limited Use Criteria for Adalimumab biosimilars which was updated with the January 2023 ODB Formulary Update. For the treatment of fistulising Crohn’s disease with concomitant luminal disease in patients who meet the following criteria; • Patient with 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 (e.g. azathioprine or 6-mercaptopurine) AND • Harvey Bradshaw Index (HBI) score ≥ 7 The dose that will be considered is Adalimumab 160 mg at week zero, 80 mg at week two, followed by 40 mg every two weeks. 129 Duration of Approval: 3 months Renewal will be considered based on the response to therapy. The dose that will be considered on renewals is Adalimumab 40 mg every two weeks. All requests for higher doses will not be approved. Duration of Approval: 3 months to 1 year pending fistula(e) resolution Second Renewal: 2 years for 2nd renewal of requests with complete resolution Case-by-case duration for renewal of requests with partial resolution Pediatric patients will be considered case-by-case. Adalimumab – See Formulary for funded biosimilars Brand(s): Humira and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 40 mg/0.8 mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection The below criteria are for Adalimumab as Humira. Refer to the ODB formulary for the Limited Use Criteria for Adalimumab 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. 130 Adalimumab – See Formulary for funded biosimilars Brand(s): Humira and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 40 mg/0.8 mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection 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. The recommended: Adalimumab: 160mg at week 0; 80mg at week 2; followed by 40mg every two weeks Duration of Approval: First renewal: 1 year Second and subsequent renewals: 2 years The below criteria are for Adalimumab as Humira. Refer to the ODB formulary for the Limited Use Criteria for Adalimumab biosimilars since January 2023. For the treatment of ulcerative colitis disease in adult patients1 who meet the following criteria: Induction Criteria Mild disease a. Mayo score <6 AND b. Patients with mild disease will be considered on a case-by-case basis BUT submission must include the rationale for coverage Moderate disease a. Mayo score between 6 and 10 (inclusive); AND b. Endoscopic* subscore of 2; AND c. Failed 2 weeks of oral prednisone at daily doses ≥40mg (or a 1 week course of IV equivalent) AND 3 months of azathioprine (AZA)/ 6-mercaptopurine (6MP) (or where the use of immunosuppressants is contraindicated); OR Stabilized with 2 weeks of oral prednisone at daily dose ≥ 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) Severe disease a. Mayo score >10 AND b. Endoscopic* subscore of ≥2 AND c. Failed 2 weeks of oral prednisone at daily dose ≥ 40mg (or 1 week IV equivalent); OR 131 Adalimumab – See Formulary for funded biosimilars Brand(s): Humira and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 40 mg/0.8 mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection Stabilized with 2 weeks oral prednisone ≥ 40 mg (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) Initial Approval: 6 months at 160 mg initially administered at week 0, followed by 80mg at week 2, then 40 mg every other week thereafter. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. Maintenance Criteria After 8 weeks of adalimumab therapy: a. Mayo score <6 AND b. 50% reduction in prednisone from the starting dose Approval: 6 months at 40mg every other week. If patient is completely off steroids, Approval: 12 months at 40 mg every other week. Subsequent renewals: a. Mayo score <6; AND b. Must be completely off steroids Approval: 2 years at 40mg every other week. (Patients who remain on steroids will be considered on a case-by-case basis) Pediatric patients will be considered case-by-case. 132 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 129, record 83, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for 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 — 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 154, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Humira (Only for those approved for biosimilar exemption); DOSAGE FORM/ STRENGTH: 40 mg/0.8 mL prefilled syringe, 40 mg/0.8mL and 20 — 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, 40 mg/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 (Only for those approved for biosimilar exemption) DOSAGE FORM/ STRENGTH: 25 mg/vial and 50 mg prefilled syringe or pens for subcutaneous injection per formulary listed options Golimumab Brand(s): Simponi DOSAGE FORM/ STRENGTH: 50 mg/0.5 ml prefilled syringe and autoinjector Guselkumab Brand(s): Tremfya DOSAGE FORM/ STRENGTH: 100 mg/mL prefilled syringe and Patient controlled injector (AI) Effective date: November 27, 2023 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 409 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. Psoriatic Arthritis Initiation Criteria: For the treatment of psoriatic arthritis in patients who have: Severe active disease (≥ 5 swollen joints and radiographic evidence of psoriatic arthritis) despite treatment with methotrexate (20 mg/week) for at least 3 months and 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 (20 mg/day) or sulfasalazine (1 g twice daily) for at least 3 months is required. Details of contraindications and intolerances must also be provided. Duration of Approval of initials: 1 Year Renewal will be considered for patients with objective evidence of at least a 20% reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. Duration of Approval of first renewal: 1 Year The planned dosing regimen for the requested biologic should be provided. The recommended doses for the treatment of psoriatic arthritis are as follows: • Adalimumab 40mg every two weeks • Certolizumab 400 mg at week 0, 2, 4 then maintenance doses of 200 mg every 2 weeks or 400 mg every 4weeks • Etanercept 25 mg twice weekly or 50 mg once weekly • Golimumab 50 mg once a month • Guselkumab 100 mg subcutaneously at week 0 and 4, then maintenance dose of 100 mg every 8 weeks thereafter. Guselkumab may be used alone or in combination with a conventional DMARD (e.g., methotrexate). Duration of Approval of second and subsequent renewals: 5 years 410 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 409, record 237, corpus 2025-01-01; name match only, not an eligibility decision

Abrilada · DIN 02511061 Manufacturer: Pfizer Canada Inc.; listing date 2025-06-30 Health Canada: Marketed since 2023-03-13 · brand ABRILADA · ATC L04AB04 ADALIMUMAB · form Solution · route Subcutaneous · ingredients ADALIMUMAB 20 MG/0.4ML · company Pfizer canada ulc · schedule Prescription, Schedule d

DIN 02511061: Abrilada Raw flags: sec12=Y, sec3=Y Item: 923600067; group id 1004; item number 2342; lccId 00360; manufacturer id PFI Source form: Inj Sol-0.4mL Pref Syr (Preservative-Free); strength: 20mg/0.4mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $235.6300; ministry $235.6300 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02511061 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100031

Shortage status: shortage reported ended 2026-06-05 (report last updated 2026-06-05); confirm supply with the pharmacy; reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02511061

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

Reason for Use code 600 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. Approvals will only allow for standard dosing for adalimumab. The recommended dosing regimen is 40mg every two weeks. Coverage limit: LU Authorization Period: 1 year Reason for Use code 601 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 is for pediatric patients 2 years of age and older: - 10kg to less than 30kg: 20mg every other week* - 30kg and greater: 40mg every other week *a dose of 10mg every other week can be considered for patients weighing 10kg to less than 15kg It should be noted that some adalimumab products may not be available as 20mg injectables. 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 602 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 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program. Coverage limit: LU Authorization Period: 1 year Reason for Use code 603 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 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program. Coverage limit: LU Authorization Period: 1 year Reason for Use code 604 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. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 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., 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 605 Fistulising Crohn's disease For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria: A. 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); AND B. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease) The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 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 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 Reason for Use code 606 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. Adalimumab 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 up to 160mg at week 0, followed by up to 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 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 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 607 For the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A. A total abscess and nodule count of 3 or greater; AND B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND C. Experienced an inadequate response to a 90-day trial of oral antibiotics. Therapy must be prescribed by a practitioner with expertise in the management of patients with HS. The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter. The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response. If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewal: Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline. Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab). The recommended maintenance dose is 40mg 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 609 For the treatment of severe* 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**. 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 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. **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 12 week trial of phototherapy (unless not accessible) 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 adalimumab. The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, 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. Coverage limit: LU Authorization Period: 1 year Reason for Use code 611 For the treatment of severe uveitis in patients meeting the following criteria: A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND B. Treatment must be prescribed by an opthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases. Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program. The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subsubcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses. The recommended dose for pediatric patients (2 years of age and older) with anterior uveitis is: Less than 30kg: 20mg every other week in combination with methotrexate 30kg or greater: 40mg every other week in combination with methotrexate For patients 6 years of age or older and less than 30kg, an optional loading dose of 40mg at week 0 may be administered before starting maintenance therapy. For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy. It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewals: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g. reduction or control of ocular inflammation). Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Humira and formulary listed biosimilars; DOSAGE FORM/ STRENGTH: 40mg/0.8mL prefilled syringe, 40mg/0.8mL and 20 — 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 32, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Humira and formulary listed biosimilars; DOSAGE FORM/ STRENGTH: 40 mg/0.8 mL prefilled syringe, 40mg/0.8mL and 20 — 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: 40 mg/0.8 mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection For the treatment of adult patients with active moderate to severe hidradenitis suppurativa who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: 1. A total abscess and nodule count of 3 or greater 2. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III 3. An inadequate response to a 90-day trial of oral antibiotics 4. Prescribed by a practitioner with expertise in the management of patients with HS 5. Note: Treatment with adalimumab should be discontinued if there is no improvement after 12 weeks of treatment First renewal: • Requests for renewal should provide objective evidence of a treatment response, defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline at week 12. Subsequent renewal: • For renewals beyond the second year, objective evidence of the preservation of treatment effect should be provided (i.e. the current AN (abscess and inflammatory nodule) count and draining fistula count should be compared to the count prior to initiating treatment with adalimumab). Approval duration: • Initial approval: 3 months • First renewals: 1 year • Subsequent renewals: 2 years Recommended dose: • The recommended dose is 160 mg initially (week 0), followed by 80 mg at week 2, then 40 mg at week 4, and 40 mg weekly thereafter 110 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 110, record 68, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Humira and formulary listed biosimilars; DOSAGE FORM/ STRENGTH: 40 mg/0.8 mL prefilled syringe, 40mg/0.8mL and 20 — 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: 40 mg/0.8 mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous 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. The below criteria are for Adalimumab as Humira. Refer to the ODB formulary for the Limited Use Criteria for Adalimumab biosimilars which was updated with the January 2023 ODB Formulary Update. For the treatment of fistulising Crohn’s disease with concomitant luminal disease in patients who meet the following criteria; • Patient with 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 (e.g. azathioprine or 6-mercaptopurine) AND • Harvey Bradshaw Index (HBI) score ≥ 7 The dose that will be considered is Adalimumab 160 mg at week zero, 80 mg at week two, followed by 40 mg every two weeks. 129 Duration of Approval: 3 months Renewal will be considered based on the response to therapy. The dose that will be considered on renewals is Adalimumab 40 mg every two weeks. All requests for higher doses will not be approved. Duration of Approval: 3 months to 1 year pending fistula(e) resolution Second Renewal: 2 years for 2nd renewal of requests with complete resolution Case-by-case duration for renewal of requests with partial resolution Pediatric patients will be considered case-by-case. Adalimumab – See Formulary for funded biosimilars Brand(s): Humira and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 40 mg/0.8 mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection The below criteria are for Adalimumab as Humira. Refer to the ODB formulary for the Limited Use Criteria for Adalimumab 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. 130 Adalimumab – See Formulary for funded biosimilars Brand(s): Humira and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 40 mg/0.8 mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection 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. The recommended: Adalimumab: 160mg at week 0; 80mg at week 2; followed by 40mg every two weeks Duration of Approval: First renewal: 1 year Second and subsequent renewals: 2 years The below criteria are for Adalimumab as Humira. Refer to the ODB formulary for the Limited Use Criteria for Adalimumab biosimilars since January 2023. For the treatment of ulcerative colitis disease in adult patients1 who meet the following criteria: Induction Criteria Mild disease a. Mayo score <6 AND b. Patients with mild disease will be considered on a case-by-case basis BUT submission must include the rationale for coverage Moderate disease a. Mayo score between 6 and 10 (inclusive); AND b. Endoscopic* subscore of 2; AND c. Failed 2 weeks of oral prednisone at daily doses ≥40mg (or a 1 week course of IV equivalent) AND 3 months of azathioprine (AZA)/ 6-mercaptopurine (6MP) (or where the use of immunosuppressants is contraindicated); OR Stabilized with 2 weeks of oral prednisone at daily dose ≥ 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) Severe disease a. Mayo score >10 AND b. Endoscopic* subscore of ≥2 AND c. Failed 2 weeks of oral prednisone at daily dose ≥ 40mg (or 1 week IV equivalent); OR 131 Adalimumab – See Formulary for funded biosimilars Brand(s): Humira and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 40 mg/0.8 mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection Stabilized with 2 weeks oral prednisone ≥ 40 mg (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) Initial Approval: 6 months at 160 mg initially administered at week 0, followed by 80mg at week 2, then 40 mg every other week thereafter. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. Maintenance Criteria After 8 weeks of adalimumab therapy: a. Mayo score <6 AND b. 50% reduction in prednisone from the starting dose Approval: 6 months at 40mg every other week. If patient is completely off steroids, Approval: 12 months at 40 mg every other week. Subsequent renewals: a. Mayo score <6; AND b. Must be completely off steroids Approval: 2 years at 40mg every other week. (Patients who remain on steroids will be considered on a case-by-case basis) Pediatric patients will be considered case-by-case. 132 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 129, record 83, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for 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 — 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 154, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Humira (Only for those approved for biosimilar exemption); DOSAGE FORM/ STRENGTH: 40 mg/0.8 mL prefilled syringe, 40 mg/0.8mL and 20 — 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, 40 mg/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 (Only for those approved for biosimilar exemption) DOSAGE FORM/ STRENGTH: 25 mg/vial and 50 mg prefilled syringe or pens for subcutaneous injection per formulary listed options Golimumab Brand(s): Simponi DOSAGE FORM/ STRENGTH: 50 mg/0.5 ml prefilled syringe and autoinjector Guselkumab Brand(s): Tremfya DOSAGE FORM/ STRENGTH: 100 mg/mL prefilled syringe and Patient controlled injector (AI) Effective date: November 27, 2023 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 409 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. Psoriatic Arthritis Initiation Criteria: For the treatment of psoriatic arthritis in patients who have: Severe active disease (≥ 5 swollen joints and radiographic evidence of psoriatic arthritis) despite treatment with methotrexate (20 mg/week) for at least 3 months and 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 (20 mg/day) or sulfasalazine (1 g twice daily) for at least 3 months is required. Details of contraindications and intolerances must also be provided. Duration of Approval of initials: 1 Year Renewal will be considered for patients with objective evidence of at least a 20% reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. Duration of Approval of first renewal: 1 Year The planned dosing regimen for the requested biologic should be provided. The recommended doses for the treatment of psoriatic arthritis are as follows: • Adalimumab 40mg every two weeks • Certolizumab 400 mg at week 0, 2, 4 then maintenance doses of 200 mg every 2 weeks or 400 mg every 4weeks • Etanercept 25 mg twice weekly or 50 mg once weekly • Golimumab 50 mg once a month • Guselkumab 100 mg subcutaneously at week 0 and 4, then maintenance dose of 100 mg every 8 weeks thereafter. Guselkumab may be used alone or in combination with a conventional DMARD (e.g., methotrexate). Duration of Approval of second and subsequent renewals: 5 years 410 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 409, record 237, corpus 2025-01-01; name match only, not an eligibility decision

Amgevita · DIN 02459310 Manufacturer: Amgen Canada Inc.; listing date 2021-03-29 Health Canada: Marketed since 2021-02-19 · brand AMGEVITA · ATC L04AB04 ADALIMUMAB · form Solution · route Subcutaneous · ingredients ADALIMUMAB 50 MG/ML · company Amgen canada inc · schedule Prescription, Schedule d

DIN 02459310: Amgevita Raw flags: sec12=Y, sec3=Y Item: 923600019; group id 1002; item number 2339; lccId 00345; manufacturer id AMG Source form: Inj Sol-0.4mL Pref Syr (Preservative-Free); strength: 20mg/0.4mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $235.6400; ministry $235.6400 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02459310 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94651

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=02459310

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