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Reason for Use code 574 For the treatment of severe plaque psoriasis (see Note 1 below) in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies (see Note 2 below). Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. Approvals will only allow for standard dosing for Skyrizi 150mg subcutaneously at weeks 0 and 4, and then every 12 weeks. 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. Note 1: Definition of severe plaque psoriasis: - Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND - Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND - Dermatology Life Quality Index (DLQI) score of at least 10. Note 2: Definition of failure, intolerance or contraindication to adequate trials of standard therapies: - 6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND - 12 week trial of phototherapy (unless not accessible), AND - 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg 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 50% reduction in PASI, AND - at least 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score. Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Skyrizi; DOSAGE FORM/ STRENGTH: 600 mg/10 mL, 360 mg/2.4 mL Injection — 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 Risankizumab Brand(s): Skyrizi DOSAGE FORM/ STRENGTH: 600 mg/10 mL, 360 mg/2.4 mL Injection Effective date: April 12, 2024 Moderate to severe luminal Crohn's disease Initiation Criteria: For the treatment of moderate to severe luminal Crohn's disease in adult patients who meet ALL of the following criteria: 1. Has a Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe luminal Crohn’s disease); AND 2. Has failed conventional treatment with a corticosteroid (prednisone 40–60 mg/day [or equivalent]) for a minimum of 14 days (or an intravenous corticosteroid for 1 week); OR Has responded to or has stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate) and is requiring maintenance using a corticosteroid-free treatment; OR Has a contraindication to corticosteroids which prevents the use of initial conventional treatment with corticosteroids; AND 3. Risankizumab is being used to induce remission or as a steroid-sparing maintenance therapy. Note: 1. Patients with mild Crohn’s disease (e.g., HBI less than 7) may be considered on a case-by-case basis but the application must include the rationale for coverage and other relevant details. Renewal Criteria: 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. 144 Risankizumab Brand(s): Skyrizi DOSAGE FORM/ STRENGTH: 600 mg/10 mL 360 mg/2.4 mL injection Exclusion criteria (for Initials and Renewals): 1. Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Approved Initial and Maintenance dose: The recommended dose is 600 mg administered by intravenous infusion at Week 0, Week 4, and Week 8, followed by 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter as maintenance. Approval Durations: Initial approval: 6 months First EAP renewal: 1 year Second and subsequent EAP renewals: 2 years Fistulising Crohn’s Disease with Concomitant Luminal Disease Initiation Criteria: For the treatment of fistulising Crohn’s disease with concomitant luminal disease in patients who meet ALL the following criteria: 1. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred or persist despite a course of o appropriate antibiotic therapy (e.g. ciprofloxacin and/or metronidazole) and immunosuppressive therapy (e.g. azathioprine or 6-mercaptopurine) (Note 1) OR o appropriate antibiotic therapy (e.g. ciprofloxacin and/or metronidazole) and adalimumab or infliximab with or without an immunosuppressive therapy AND 2. Harvey Bradshaw Index (HBI) score greater than or the same as 7 (or other validated disease activity score confirming moderate to severe disease) Note: 1. Patients should have received a trial of an anti-tumour necrosis factor (anti-TNF) therapy (e.g. infliximab or adalimumab) for their fistulizing Crohn’s disease. 145 Risankizumab Brand(s): Skyrizi DOSAGE FORM/ STRENGTH: 600 mg/10 mL 360 mg/2.4 mL injection Renewal Criteria Maintenance therapy is funded for patients who met the initiation criteria and who achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Please include information describing the patient’s fistula(e) resolution (e.g., partial or complete resolution) and HBI score. Exclusion criteria (for Initials and Renewals): 1. Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Approved Initial and Maintenance dose: The recommended dose is 600 mg administered by intravenous infusion at Week 0, Week 4, and Week 8, followed by 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter as maintenance. Approval durations: Initial approval: 6 months First renewal: 6 months to 1 year pending fistula(e) resolution Second and subsequent renewals: 2 years with complete resolution The duration of approval for patients with partial resolution will be provided on a case- by-case basis. 146 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 144, record 89, corpus 2025-01-01; name match only, not an eligibility decision

Skyrizi · DIN 02519291 Manufacturer: AbbVie Corporation; listing date 2022-10-31 Health Canada: Marketed since 2022-06-01 · brand SKYRIZI · ATC L04AC18 RIZANKIZUMAB · form Solution · route Subcutaneous · ingredients RISANKIZUMAB 150 MG/1ML · company Abbvie corporation · schedule Schedule d, Prescription

DIN 02519291: Skyrizi Raw flags: sec12=Y, sec3=Y Item: 843600108; group id 867; item number 2096; lccId 00325; manufacturer id ABV Source form: Inj Sol-Pref Pen (Preservative-Free); strength: 150mg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $4935.0000; ministry $4935.0000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02519291 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100857

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=02519291

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

Reason for Use code 574 For the treatment of severe plaque psoriasis (see Note 1 below) in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies (see Note 2 below). Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. Approvals will only allow for standard dosing for Skyrizi 150mg subcutaneously at weeks 0 and 4, and then every 12 weeks. 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. Note 1: Definition of severe plaque psoriasis: - Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND - Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND - Dermatology Life Quality Index (DLQI) score of at least 10. Note 2: Definition of failure, intolerance or contraindication to adequate trials of standard therapies: - 6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND - 12 week trial of phototherapy (unless not accessible), AND - 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg 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 50% reduction in PASI, AND - at least 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score. Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Skyrizi; DOSAGE FORM/ STRENGTH: 600 mg/10 mL, 360 mg/2.4 mL Injection — 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 Risankizumab Brand(s): Skyrizi DOSAGE FORM/ STRENGTH: 600 mg/10 mL, 360 mg/2.4 mL Injection Effective date: April 12, 2024 Moderate to severe luminal Crohn's disease Initiation Criteria: For the treatment of moderate to severe luminal Crohn's disease in adult patients who meet ALL of the following criteria: 1. Has a Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe luminal Crohn’s disease); AND 2. Has failed conventional treatment with a corticosteroid (prednisone 40–60 mg/day [or equivalent]) for a minimum of 14 days (or an intravenous corticosteroid for 1 week); OR Has responded to or has stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate) and is requiring maintenance using a corticosteroid-free treatment; OR Has a contraindication to corticosteroids which prevents the use of initial conventional treatment with corticosteroids; AND 3. Risankizumab is being used to induce remission or as a steroid-sparing maintenance therapy. Note: 1. Patients with mild Crohn’s disease (e.g., HBI less than 7) may be considered on a case-by-case basis but the application must include the rationale for coverage and other relevant details. Renewal Criteria: 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. 144 Risankizumab Brand(s): Skyrizi DOSAGE FORM/ STRENGTH: 600 mg/10 mL 360 mg/2.4 mL injection Exclusion criteria (for Initials and Renewals): 1. Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Approved Initial and Maintenance dose: The recommended dose is 600 mg administered by intravenous infusion at Week 0, Week 4, and Week 8, followed by 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter as maintenance. Approval Durations: Initial approval: 6 months First EAP renewal: 1 year Second and subsequent EAP renewals: 2 years Fistulising Crohn’s Disease with Concomitant Luminal Disease Initiation Criteria: For the treatment of fistulising Crohn’s disease with concomitant luminal disease in patients who meet ALL the following criteria: 1. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred or persist despite a course of o appropriate antibiotic therapy (e.g. ciprofloxacin and/or metronidazole) and immunosuppressive therapy (e.g. azathioprine or 6-mercaptopurine) (Note 1) OR o appropriate antibiotic therapy (e.g. ciprofloxacin and/or metronidazole) and adalimumab or infliximab with or without an immunosuppressive therapy AND 2. Harvey Bradshaw Index (HBI) score greater than or the same as 7 (or other validated disease activity score confirming moderate to severe disease) Note: 1. Patients should have received a trial of an anti-tumour necrosis factor (anti-TNF) therapy (e.g. infliximab or adalimumab) for their fistulizing Crohn’s disease. 145 Risankizumab Brand(s): Skyrizi DOSAGE FORM/ STRENGTH: 600 mg/10 mL 360 mg/2.4 mL injection Renewal Criteria Maintenance therapy is funded for patients who met the initiation criteria and who achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Please include information describing the patient’s fistula(e) resolution (e.g., partial or complete resolution) and HBI score. Exclusion criteria (for Initials and Renewals): 1. Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Approved Initial and Maintenance dose: The recommended dose is 600 mg administered by intravenous infusion at Week 0, Week 4, and Week 8, followed by 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter as maintenance. Approval durations: Initial approval: 6 months First renewal: 6 months to 1 year pending fistula(e) resolution Second and subsequent renewals: 2 years with complete resolution The duration of approval for patients with partial resolution will be provided on a case- by-case basis. 146 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 144, record 89, corpus 2025-01-01; name match only, not an eligibility decision

Skyrizi · DIN 02519283 Manufacturer: AbbVie Corporation; listing date 2022-10-31 Health Canada: Marketed since 2022-06-01 · brand SKYRIZI · ATC L04AC18 RIZANKIZUMAB · form Solution · route Subcutaneous · ingredients RISANKIZUMAB 150 MG/1ML · company Abbvie corporation · schedule Prescription, Schedule d

DIN 02519283: Skyrizi Raw flags: sec12=Y, sec3=Y Item: 843600107; group id 867; item number 2097; lccId 00325; manufacturer id ABV Source form: Inj Sol-Pref Syr (Preservative-Free); strength: 150mg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $4935.0000; ministry $4935.0000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02519283 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100855

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=02519283

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