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Reason for Use code 637 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 treatment with other disease modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: i) Methotrexate (i.e. 20mg/week for at least 3 months) ii) Methotrexate (20mg/week) for at least 3 months AND leflunomide (20mg/day) for at least 3 months iii) Methotrexate 20mg/week, sulfasalazine (2g/day) AND hydroxychloroquine (dose based on weight up to 400mg per day) for at least 3 months. In patients who demonstrated initial response to treatment (defined as an achievement of an American College of Rheumatology [ACR] improvement criteria of at least 20% [ACR20] at week 12), ongoing maintenance therapy is funded. Maintenance/Renewal: After 12 weeks of treatment, maintenance therapy is funded for patients who achieved an American College of Rheumatology (ACR) improvement criteria of at least 20% (ACR20) and a minimum of improvement in 2 swollen joints by week 12. For renewals beyond 12 months, 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 15mg administered once daily. Upadacitinib shoud not be used in combination with other Janus kinase (JAK) inhibitors or other biologic DMARDs to treat the patient's RA. Coverage limit: LU Authorization Period: 1 year Reason for Use code 684 For the treatment of ulcerative colitis disease in patients who meet the following criteria: 1. 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 greater than or equal to 40mg (or a 1 week course of IV equivalent) OR d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated). 2. Severe disease a. Mayo score greater than 10 AND b. Endoscopy* subscore of greater than or equal to 2 AND c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) OR d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated). *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. Maintenance/Renewal: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and whose disease is maintained at Mayo score less than 6 AND who demonstrate at least 50% reduction in the dose of prednisone compared with the starting dose following the first 6 months of treatment with upadacitinib or be off corticosteroids after the first year of treatment. Approved Dose: Induction: Up to 45mg once daily for 8 weeks Maintenance: 15mg or 30mg once daily. For patients greater or equal to 65 years of age, the maintenance dose is 15mg once daily. Depending on therapeutic response, 30mg once daily may also be used for maintenance in some patients younger than 65 years of age. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects. Coverage limit: LU Authorization Period: 1 year 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 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg Extended Release tablet Effective date: August 8, 2024 (AS) Upadacitinib for Ankylosing Spondylitis Initiation Criteria: For the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic report with: • 18 years of age and older; and • Age of disease onset ≤ 50 year; and • Low back pain and stiffness for > 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, including pain medications (if relevant). Please include dosing regimens. • Details of review of radiographic reports for severe active disease. • X-ray or CT scan report stating the presence of “SI joint fusion” or “SI joint erosion” OR • MRI report stating the presence of “inflammation” or “edema” of the SI joint • 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 • 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. 57 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg ER Tablet First Renewal: 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.) Second and subsequent renewals: For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. Exclusion criteria (for Initials and Renewals): 1. Combination therapy with another biologic or JAK inhibitor treatment used to treat ankylosing spondylitis or other rheumatological condition will not be funded. Approved dose: 15 mg once daily Approval duration: Initial: 1 year First renewal: 1 year Second and subsequent renewal: 2 years 58 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 57, record 38, corpus 2025-01-01; name match only, not an eligibility decision 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 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg, 30 mg Extended Release tablet Effective date: October 31, 2023 (AD) Upadacitinib for Atopic Dermatitis Initiation Criteria: For the treatment of moderate to severe atopic dermatitis in patients meeting all the following criteria; 1. 12 years of age or older; AND 2. Diagnosed with moderate-to-severe atopic dermatitis (AD) by the Eczema Area and Severity Index (EASI) score equal to or greater than 16 points and the Investigators (Physician) Global Assessment score of 3 to 4; AND 3. Failure to maintain adequate control of their dermatitis with maximally tolerated medical topical therapies for AD combined with phototherapy (where available);1,2 AND 4. Failure to maintain adequate control of their dermatitis with maximally tolerated medical topical therapies for AD combined with at least 1 of the 4 systemic immunomodulators (methotrexate, cyclosporine, mycophenolate mofetil, or azathioprine).1,2 5. Upadacitinib is prescribed by a dermatologist, allergist, pediatrician or clinical immunologist, or in consultation with one of these specialists. (Please include the consult note with the EAP application.) Exclusion Criteria: Upadacitinib will not be funded if it is used in combination with phototherapy or any immunomodulatory drugs (including biologics3 or a Janus kinase [JAK] inhibitor treatment) for treatment of AD. Notes: 1For each treatment used, provide documentation of refractory disease and/or intolerance (including a description of the adverse effect and severity of reaction). If a patient is deemed to be ineligible or contraindicated to receive the treatment, provide the reason(s) for their ineligibility. 2An adequate trial for patients with AD who undergo therapy with phototherapy, methotrexate, cyclosporine, mycophenolate mofetil, and azathioprine is defined as follows: • For phototherapy: the typical duration would be considered 12 weeks (3 times per week). • For methotrexate: an adequate trial would be 10 mg to 20 mg per week for 12 weeks. • For cyclosporine: an adequate trial would be 2.5 mg/kg to 5 mg/kg per day for 12 weeks. 117 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg, 30mg ER Tablet • For mycophenolate mofetil: an adequate trial would be 1 g twice daily for 12 weeks. • For azathioprine: an adequate trial would be 1.5 to 2.5 mg/kg/day for 12 weeks 3 The concurrent use of upadacitinib used in combination with other biologics used for other conditions will be considered on a case-by-case basis. 4Funding of patients who meet the above criteria and who are experiencing inadequate response using another systemic treatment (e.g. biologics, steroids) for AD will be considered on a case-by-case basis. Renewal Criteria: First renewal: Renewal of funding will be considered in patients with documentation of benefit from treatment. Benefit from treatment is defined as a 75% or greater improvement from baseline in the Eczema Area and Severity Index (EASI) score (EASI-75) in the first 20 weeks of treatment initiation with upadacitinib. Subsequent renewals: Subsequent renewal of funding will be considered in patient who maintain the 75% or greater improvement in EASI score response from baseline. Duration of Approval for initial requests: 6 months Duration of Approval for first and second renewal: 6 months Duration of Approval for 3rd and subsequent renewals: 1 year Approved dose: Up to 30 mg orally once daily. Please refer to the product monograph for dose recommendations. 118 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 117, record 74, corpus 2025-01-01; name match only, not an eligibility decision 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 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 40 mg Extended Release tablet Effective date: August 8, 2024 (CD) Upadacitinib for Luminal Crohn’s disease Initiation Criteria: For the treatment of moderate to severe luminal Crohn's disease in 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 3. Upadacitinib is being used to induce remission or as a steroid-sparing maintenance therapy. Notes: 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. 2. Patients who have not demonstrated prior treatment failure, (i.e., an inadequate response to, loss of response to, or intolerance to at least one of conventional and/or biologic therapy) will be considered on a case-by-case basis. 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. 151 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg, 30mg, 40 mg ER Tablet Approved doses: Induction dose: Up to 45 mg once daily for 12 weeks Maintenance dose:15 mg or 30 mg* once daily. For patient 65 years of age or older: 15 mg once daily *Depending on therapeutic response, 30 mg once daily may also be used for maintenance in some patients younger than 65 years of age. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects. Exclusion criteria (for Initials and Renewals): 1. Combination therapy with another biologic or JAK inhibitor treatment used to treat inflammatory bowel disease will not be funded. Approved doses: Induction dose: 45 mg once daily for 12 weeks Maintenance dose:15 mg or 30 mg once daily For patient 65 years of age or older: 15 mg once daily Approval Durations: Initial approval: 6 months First EAP renewal: 1 year Second and subsequent EAP renewals: 2 years 152 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg, 30mg, 40 mg ER Tablet Upadacitinib for Fistulising Crohn’s disease with concomitant luminal disease Initiation Criteria: For the treatment of fistulising Crohn’s disease with concomitant luminal disease inpatients 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 a. appropriate antibiotic therapy (e.g. ciprofloxacin and/or metronidazole) and immunosuppressive therapy (e.g. azathioprine or 6-mercaptopurine) OR b. appropriate antibiotic therapy (e.g. ciprofloxacin and/or metronidazole) and a biologic (e.g. adalimumab, infliximab, ustekinumab) 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) Initial approved dose: Doses exceeding the standard recommended doses will be considered on a case-by- case basis. Please provide clinical rationale to support the request for higher doses. 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 or other JAK inhibitor treatments used to treat inflammatory bowel disease will not be funded. 153 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg, 30mg, 40 mg ER Tablet Approved doses: Induction dose: Up to 45 mg once daily for 12 weeks Maintenance dose:15 mg or 30 mg* once daily. For patient 65 years of age or older: 15 mg once daily *Depending on therapeutic response, 30 mg once daily may also be used for maintenance in some patients younger than 65 years of age. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects 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. 154 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 151, record 91, corpus 2025-01-01; name match only, not an eligibility decision 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 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg Extended Release tablet Effective date: November 16, 2022 (PsA) Upadacitinib for Psoriatic Arthritis Initiation criteria For the treatment of psoriatic arthritis (PsA) in patients who have: • Severe active disease (Greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite treatment with methotrexate (20 mg/week) for at least 3 months and one of leflunomide (20 mg/day) or sulfasalazine (1 g 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. Renewal Criteria: Renewals 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. Exclusion Criteria: Upadacitinib will not be reimbursed when used in combination with other Janus Kinase (JAK) inhibitor treatments for psoriatic arthritis or other biologic disease-modifying antirheumatic drugs (DMARDs) for psoriatic arthritis. Recommended Dose: 15 mg once daily. Approval durations: Initials: 1 year First renewal: 1 year Second and subsequent renewals: 5 years 413 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 413, record 244, corpus 2025-01-01; name match only, not an eligibility decision

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

Rinvoq · DIN 02495155 Manufacturer: AbbVie Corporation; listing date 2022-10-31 Health Canada: Marketed since 2020-01-16 · brand RINVOQ · ATC L04AF03 UPADACITINIB · form Tablet (extended-release) · route Oral · ingredients UPADACITINIB 15 MG · company Abbvie corporation · schedule Prescription

DIN 02495155: Rinvoq Raw flags: sec12=Y, sec3=Y Item: 923600039; group id 1041; item number 2392; lccId 00364; manufacturer id ABV Source form: ER Tab; strength: 15mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $51.6810; ministry $51.6810 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02495155 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98509

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=02495155

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

Reason for Use code 684 For the treatment of ulcerative colitis disease in patients who meet the following criteria: 1. 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 greater than or equal to 40mg (or a 1 week course of IV equivalent) OR d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated). 2. Severe disease a. Mayo score greater than 10 AND b. Endoscopy* subscore of greater than or equal to 2 AND c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) OR d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated). *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. Maintenance/Renewal: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and whose disease is maintained at Mayo score less than 6 AND who demonstrate at least 50% reduction in the dose of prednisone compared with the starting dose following the first 6 months of treatment with upadacitinib or be off corticosteroids after the first year of treatment. Approved Dose: Induction: Up to 45mg once daily for 8 weeks Maintenance: 15mg or 30mg once daily. For patients greater or equal to 65 years of age, the maintenance dose is 15mg once daily. Depending on therapeutic response, 30mg once daily may also be used for maintenance in some patients younger than 65 years of age. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects. Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Rinvoq; DOSAGE FORM/ STRENGTH: 15 mg Extended Release tablet — 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 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg Extended Release tablet Effective date: August 8, 2024 (AS) Upadacitinib for Ankylosing Spondylitis Initiation Criteria: For the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic report with: • 18 years of age and older; and • Age of disease onset ≤ 50 year; and • Low back pain and stiffness for > 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, including pain medications (if relevant). Please include dosing regimens. • Details of review of radiographic reports for severe active disease. • X-ray or CT scan report stating the presence of “SI joint fusion” or “SI joint erosion” OR • MRI report stating the presence of “inflammation” or “edema” of the SI joint • 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 • 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. 57 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg ER Tablet First Renewal: 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.) Second and subsequent renewals: For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. Exclusion criteria (for Initials and Renewals): 1. Combination therapy with another biologic or JAK inhibitor treatment used to treat ankylosing spondylitis or other rheumatological condition will not be funded. Approved dose: 15 mg once daily Approval duration: Initial: 1 year First renewal: 1 year Second and subsequent renewal: 2 years 58 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 57, record 38, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Rinvoq; DOSAGE FORM/ STRENGTH: 15 mg Extended Release tablet — 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 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg Extended Release tablet Effective date: November 16, 2022 (PsA) Upadacitinib for Psoriatic Arthritis Initiation criteria For the treatment of psoriatic arthritis (PsA) in patients who have: • Severe active disease (Greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite treatment with methotrexate (20 mg/week) for at least 3 months and one of leflunomide (20 mg/day) or sulfasalazine (1 g 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. Renewal Criteria: Renewals 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. Exclusion Criteria: Upadacitinib will not be reimbursed when used in combination with other Janus Kinase (JAK) inhibitor treatments for psoriatic arthritis or other biologic disease-modifying antirheumatic drugs (DMARDs) for psoriatic arthritis. Recommended Dose: 15 mg once daily. Approval durations: Initials: 1 year First renewal: 1 year Second and subsequent renewals: 5 years 413 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 413, record 244, corpus 2025-01-01; name match only, not an eligibility decision 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 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg, 30 mg Extended Release tablet Effective date: October 31, 2023 (AD) Upadacitinib for Atopic Dermatitis Initiation Criteria: For the treatment of moderate to severe atopic dermatitis in patients meeting all the following criteria; 1. 12 years of age or older; AND 2. Diagnosed with moderate-to-severe atopic dermatitis (AD) by the Eczema Area and Severity Index (EASI) score equal to or greater than 16 points and the Investigators (Physician) Global Assessment score of 3 to 4; AND 3. Failure to maintain adequate control of their dermatitis with maximally tolerated medical topical therapies for AD combined with phototherapy (where available);1,2 AND 4. Failure to maintain adequate control of their dermatitis with maximally tolerated medical topical therapies for AD combined with at least 1 of the 4 systemic immunomodulators (methotrexate, cyclosporine, mycophenolate mofetil, or azathioprine).1,2 5. Upadacitinib is prescribed by a dermatologist, allergist, pediatrician or clinical immunologist, or in consultation with one of these specialists. (Please include the consult note with the EAP application.) Exclusion Criteria: Upadacitinib will not be funded if it is used in combination with phototherapy or any immunomodulatory drugs (including biologics3 or a Janus kinase [JAK] inhibitor treatment) for treatment of AD. Notes: 1For each treatment used, provide documentation of refractory disease and/or intolerance (including a description of the adverse effect and severity of reaction). If a patient is deemed to be ineligible or contraindicated to receive the treatment, provide the reason(s) for their ineligibility. 2An adequate trial for patients with AD who undergo therapy with phototherapy, methotrexate, cyclosporine, mycophenolate mofetil, and azathioprine is defined as follows: • For phototherapy: the typical duration would be considered 12 weeks (3 times per week). • For methotrexate: an adequate trial would be 10 mg to 20 mg per week for 12 weeks. • For cyclosporine: an adequate trial would be 2.5 mg/kg to 5 mg/kg per day for 12 weeks. 117 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg, 30mg ER Tablet • For mycophenolate mofetil: an adequate trial would be 1 g twice daily for 12 weeks. • For azathioprine: an adequate trial would be 1.5 to 2.5 mg/kg/day for 12 weeks 3 The concurrent use of upadacitinib used in combination with other biologics used for other conditions will be considered on a case-by-case basis. 4Funding of patients who meet the above criteria and who are experiencing inadequate response using another systemic treatment (e.g. biologics, steroids) for AD will be considered on a case-by-case basis. Renewal Criteria: First renewal: Renewal of funding will be considered in patients with documentation of benefit from treatment. Benefit from treatment is defined as a 75% or greater improvement from baseline in the Eczema Area and Severity Index (EASI) score (EASI-75) in the first 20 weeks of treatment initiation with upadacitinib. Subsequent renewals: Subsequent renewal of funding will be considered in patient who maintain the 75% or greater improvement in EASI score response from baseline. Duration of Approval for initial requests: 6 months Duration of Approval for first and second renewal: 6 months Duration of Approval for 3rd and subsequent renewals: 1 year Approved dose: Up to 30 mg orally once daily. Please refer to the product monograph for dose recommendations. 118 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 117, record 74, corpus 2025-01-01; name match only, not an eligibility decision 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 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 40 mg Extended Release tablet Effective date: August 8, 2024 (CD) Upadacitinib for Luminal Crohn’s disease Initiation Criteria: For the treatment of moderate to severe luminal Crohn's disease in 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 3. Upadacitinib is being used to induce remission or as a steroid-sparing maintenance therapy. Notes: 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. 2. Patients who have not demonstrated prior treatment failure, (i.e., an inadequate response to, loss of response to, or intolerance to at least one of conventional and/or biologic therapy) will be considered on a case-by-case basis. 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. 151 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg, 30mg, 40 mg ER Tablet Approved doses: Induction dose: Up to 45 mg once daily for 12 weeks Maintenance dose:15 mg or 30 mg* once daily. For patient 65 years of age or older: 15 mg once daily *Depending on therapeutic response, 30 mg once daily may also be used for maintenance in some patients younger than 65 years of age. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects. Exclusion criteria (for Initials and Renewals): 1. Combination therapy with another biologic or JAK inhibitor treatment used to treat inflammatory bowel disease will not be funded. Approved doses: Induction dose: 45 mg once daily for 12 weeks Maintenance dose:15 mg or 30 mg once daily For patient 65 years of age or older: 15 mg once daily Approval Durations: Initial approval: 6 months First EAP renewal: 1 year Second and subsequent EAP renewals: 2 years 152 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg, 30mg, 40 mg ER Tablet Upadacitinib for Fistulising Crohn’s disease with concomitant luminal disease Initiation Criteria: For the treatment of fistulising Crohn’s disease with concomitant luminal disease inpatients 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 a. appropriate antibiotic therapy (e.g. ciprofloxacin and/or metronidazole) and immunosuppressive therapy (e.g. azathioprine or 6-mercaptopurine) OR b. appropriate antibiotic therapy (e.g. ciprofloxacin and/or metronidazole) and a biologic (e.g. adalimumab, infliximab, ustekinumab) 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) Initial approved dose: Doses exceeding the standard recommended doses will be considered on a case-by- case basis. Please provide clinical rationale to support the request for higher doses. 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 or other JAK inhibitor treatments used to treat inflammatory bowel disease will not be funded. 153 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg, 30mg, 40 mg ER Tablet Approved doses: Induction dose: Up to 45 mg once daily for 12 weeks Maintenance dose:15 mg or 30 mg* once daily. For patient 65 years of age or older: 15 mg once daily *Depending on therapeutic response, 30 mg once daily may also be used for maintenance in some patients younger than 65 years of age. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects 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. 154 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 151, record 91, corpus 2025-01-01; name match only, not an eligibility decision

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

Rinvoq · DIN 02520893 Manufacturer: AbbVie Corporation; listing date 2024-08-30 Health Canada: Marketed since 2021-10-28 · brand RINVOQ · ATC L04AF03 UPADACITINIB · form Tablet (extended-release) · route Oral · ingredients UPADACITINIB 30 MG · company Abbvie corporation · schedule Prescription

DIN 02520893: Rinvoq Raw flags: sec12=Y, sec3=Y Item: 923600045; group id 1042; item number 2393; lccId 00396; manufacturer id ABV Source form: ER Tab; strength: 30mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $80.0384; ministry $80.0384 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02520893 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=101013

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=02520893

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

Reason for Use code 684 For the treatment of ulcerative colitis disease in patients who meet the following criteria: 1. 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 greater than or equal to 40mg (or a 1 week course of IV equivalent) OR d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated). 2. Severe disease a. Mayo score greater than 10 AND b. Endoscopy* subscore of greater than or equal to 2 AND c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) OR d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated). *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. Maintenance/Renewal: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and whose disease is maintained at Mayo score less than 6 AND who demonstrate at least 50% reduction in the dose of prednisone compared with the starting dose following the first 6 months of treatment with upadacitinib or be off corticosteroids after the first year of treatment. Approved Dose: Induction: Up to 45mg once daily for 8 weeks Maintenance: 15mg or 30mg once daily. For patients greater or equal to 65 years of age, the maintenance dose is 15mg once daily. Depending on therapeutic response, 30mg once daily may also be used for maintenance in some patients younger than 65 years of age. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects. Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Rinvoq; DOSAGE FORM/ STRENGTH: 15 mg Extended Release tablet — 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 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg Extended Release tablet Effective date: August 8, 2024 (AS) Upadacitinib for Ankylosing Spondylitis Initiation Criteria: For the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic report with: • 18 years of age and older; and • Age of disease onset ≤ 50 year; and • Low back pain and stiffness for > 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, including pain medications (if relevant). Please include dosing regimens. • Details of review of radiographic reports for severe active disease. • X-ray or CT scan report stating the presence of “SI joint fusion” or “SI joint erosion” OR • MRI report stating the presence of “inflammation” or “edema” of the SI joint • 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 • 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. 57 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg ER Tablet First Renewal: 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.) Second and subsequent renewals: For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. Exclusion criteria (for Initials and Renewals): 1. Combination therapy with another biologic or JAK inhibitor treatment used to treat ankylosing spondylitis or other rheumatological condition will not be funded. Approved dose: 15 mg once daily Approval duration: Initial: 1 year First renewal: 1 year Second and subsequent renewal: 2 years 58 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 57, record 38, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Rinvoq; DOSAGE FORM/ STRENGTH: 15 mg, 30 mg Extended Release tablet — 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 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg, 30 mg Extended Release tablet Effective date: October 31, 2023 (AD) Upadacitinib for Atopic Dermatitis Initiation Criteria: For the treatment of moderate to severe atopic dermatitis in patients meeting all the following criteria; 1. 12 years of age or older; AND 2. Diagnosed with moderate-to-severe atopic dermatitis (AD) by the Eczema Area and Severity Index (EASI) score equal to or greater than 16 points and the Investigators (Physician) Global Assessment score of 3 to 4; AND 3. Failure to maintain adequate control of their dermatitis with maximally tolerated medical topical therapies for AD combined with phototherapy (where available);1,2 AND 4. Failure to maintain adequate control of their dermatitis with maximally tolerated medical topical therapies for AD combined with at least 1 of the 4 systemic immunomodulators (methotrexate, cyclosporine, mycophenolate mofetil, or azathioprine).1,2 5. Upadacitinib is prescribed by a dermatologist, allergist, pediatrician or clinical immunologist, or in consultation with one of these specialists. (Please include the consult note with the EAP application.) Exclusion Criteria: Upadacitinib will not be funded if it is used in combination with phototherapy or any immunomodulatory drugs (including biologics3 or a Janus kinase [JAK] inhibitor treatment) for treatment of AD. Notes: 1For each treatment used, provide documentation of refractory disease and/or intolerance (including a description of the adverse effect and severity of reaction). If a patient is deemed to be ineligible or contraindicated to receive the treatment, provide the reason(s) for their ineligibility. 2An adequate trial for patients with AD who undergo therapy with phototherapy, methotrexate, cyclosporine, mycophenolate mofetil, and azathioprine is defined as follows: • For phototherapy: the typical duration would be considered 12 weeks (3 times per week). • For methotrexate: an adequate trial would be 10 mg to 20 mg per week for 12 weeks. • For cyclosporine: an adequate trial would be 2.5 mg/kg to 5 mg/kg per day for 12 weeks. 117 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg, 30mg ER Tablet • For mycophenolate mofetil: an adequate trial would be 1 g twice daily for 12 weeks. • For azathioprine: an adequate trial would be 1.5 to 2.5 mg/kg/day for 12 weeks 3 The concurrent use of upadacitinib used in combination with other biologics used for other conditions will be considered on a case-by-case basis. 4Funding of patients who meet the above criteria and who are experiencing inadequate response using another systemic treatment (e.g. biologics, steroids) for AD will be considered on a case-by-case basis. Renewal Criteria: First renewal: Renewal of funding will be considered in patients with documentation of benefit from treatment. Benefit from treatment is defined as a 75% or greater improvement from baseline in the Eczema Area and Severity Index (EASI) score (EASI-75) in the first 20 weeks of treatment initiation with upadacitinib. Subsequent renewals: Subsequent renewal of funding will be considered in patient who maintain the 75% or greater improvement in EASI score response from baseline. Duration of Approval for initial requests: 6 months Duration of Approval for first and second renewal: 6 months Duration of Approval for 3rd and subsequent renewals: 1 year Approved dose: Up to 30 mg orally once daily. Please refer to the product monograph for dose recommendations. 118 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 117, record 74, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Rinvoq; DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 40 mg Extended Release tablet — 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 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 40 mg Extended Release tablet Effective date: August 8, 2024 (CD) Upadacitinib for Luminal Crohn’s disease Initiation Criteria: For the treatment of moderate to severe luminal Crohn's disease in 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 3. Upadacitinib is being used to induce remission or as a steroid-sparing maintenance therapy. Notes: 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. 2. Patients who have not demonstrated prior treatment failure, (i.e., an inadequate response to, loss of response to, or intolerance to at least one of conventional and/or biologic therapy) will be considered on a case-by-case basis. 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. 151 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg, 30mg, 40 mg ER Tablet Approved doses: Induction dose: Up to 45 mg once daily for 12 weeks Maintenance dose:15 mg or 30 mg* once daily. For patient 65 years of age or older: 15 mg once daily *Depending on therapeutic response, 30 mg once daily may also be used for maintenance in some patients younger than 65 years of age. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects. Exclusion criteria (for Initials and Renewals): 1. Combination therapy with another biologic or JAK inhibitor treatment used to treat inflammatory bowel disease will not be funded. Approved doses: Induction dose: 45 mg once daily for 12 weeks Maintenance dose:15 mg or 30 mg once daily For patient 65 years of age or older: 15 mg once daily Approval Durations: Initial approval: 6 months First EAP renewal: 1 year Second and subsequent EAP renewals: 2 years 152 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg, 30mg, 40 mg ER Tablet Upadacitinib for Fistulising Crohn’s disease with concomitant luminal disease Initiation Criteria: For the treatment of fistulising Crohn’s disease with concomitant luminal disease inpatients 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 a. appropriate antibiotic therapy (e.g. ciprofloxacin and/or metronidazole) and immunosuppressive therapy (e.g. azathioprine or 6-mercaptopurine) OR b. appropriate antibiotic therapy (e.g. ciprofloxacin and/or metronidazole) and a biologic (e.g. adalimumab, infliximab, ustekinumab) 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) Initial approved dose: Doses exceeding the standard recommended doses will be considered on a case-by- case basis. Please provide clinical rationale to support the request for higher doses. 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 or other JAK inhibitor treatments used to treat inflammatory bowel disease will not be funded. 153 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg, 30mg, 40 mg ER Tablet Approved doses: Induction dose: Up to 45 mg once daily for 12 weeks Maintenance dose:15 mg or 30 mg* once daily. For patient 65 years of age or older: 15 mg once daily *Depending on therapeutic response, 30 mg once daily may also be used for maintenance in some patients younger than 65 years of age. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects 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. 154 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 151, record 91, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Rinvoq; DOSAGE FORM/ STRENGTH: 15 mg Extended Release tablet — 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 Upadacitinib Brand(s): Rinvoq DOSAGE FORM/ STRENGTH: 15 mg Extended Release tablet Effective date: November 16, 2022 (PsA) Upadacitinib for Psoriatic Arthritis Initiation criteria For the treatment of psoriatic arthritis (PsA) in patients who have: • Severe active disease (Greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite treatment with methotrexate (20 mg/week) for at least 3 months and one of leflunomide (20 mg/day) or sulfasalazine (1 g 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. Renewal Criteria: Renewals 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. Exclusion Criteria: Upadacitinib will not be reimbursed when used in combination with other Janus Kinase (JAK) inhibitor treatments for psoriatic arthritis or other biologic disease-modifying antirheumatic drugs (DMARDs) for psoriatic arthritis. Recommended Dose: 15 mg once daily. Approval durations: Initials: 1 year First renewal: 1 year Second and subsequent renewals: 5 years 413 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 413, record 244, corpus 2025-01-01; name match only, not an eligibility decision

Rinvoq · DIN 02539721 Manufacturer: AbbVie Corporation; listing date 2024-08-30 Health Canada: Marketed since 2023-09-07 · brand RINVOQ · ATC L04AF03 UPADACITINIB · form Tablet (extended-release) · route Oral · ingredients UPADACITINIB 45 MG · company Abbvie corporation · schedule Prescription

DIN 02539721: Rinvoq Raw flags: sec12=Y, sec3=Y Item: 923600057; group id 1042; item number 2394; lccId 00396; manufacturer id ABV Source form: ER Tab; strength: 45mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $105.8824; ministry $105.8824 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02539721 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102847

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=02539721

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